Diagnostic Yield of Colon Capsule Endoscopy for Crohn’s Disease Lesions in the Whole Gastrointestinal Tract

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BACKGROUNDCrohn’s disease (CD) can involve the upper gastrointestinal (GI) tract as well as the small and large bowel. PillCam colon capsule endoscopy (PCCE-2) enables to observe the whole GI tract, but its diagnostic yield for CD lesions in the whole GI tract remains unknown. AIMTo elucidate the diagnostic yield of PCCE-2 in patients with CD.METHODSPatients with CD who underwent PCCE-2 and double-balloon endoscopy (DBE) using oral and anal approaches were evaluated for CD lesions in the whole GI tract. We divided the small bowel into three segments (jejunum, ileum, and terminal ileum), and the large bowel into four segments (right colon, transverse colon, left colon, rectum). Detection of ulcer scars, erosion, ulcers, bamboo joint-like appearance, and notch-like appearance was assessed in each segment. The diagnostic yield of PCCE-2 was analyzed based on the DBE results as the gold standard.RESULTSOf the total 124 segments, the sensitivities of PCCE-2 for ulcer scars, erosion, and ulcers were 83.3%, 93.8%, and 88.5%, respectively, and the specificities were 76.0%, 78.3%, and 81.6%, respectively. For the 60 small bowel segments, the sensitivities were 84.2%, 95.5%, and 90.0%, respectively, and the specificities were 63.4%, 86.8%, and 87.5%, respectively. For the 64 large bowel segments, the sensitivities were 80.0%, 90.0%, and 83.3%, respectively, and the specificities were 84.7%, 72.2%, and 77.6%, respectively.CONCLUSIONPCCE-2 provides a high diagnostic yield for lesions in the whole GI tract of patients with CD. Thus, we recommend its use as a pan-enteric tool in clinical settings.
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Diagnostic Yield of Colon Capsule Endoscopy for Crohn’s Disease Lesions in the Whole Gastrointestinal Tract | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Diagnostic Yield of Colon Capsule Endoscopy for Crohn’s Disease Lesions in the Whole Gastrointestinal Tract Keisaku Yamada, Masanao Nakamura, Takeshi Yamamura, Keiko Maeda, and 11 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-119671/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 16 Feb, 2021 Read the published version in BMC Gastroenterology → Version 1 posted 8 You are reading this latest preprint version Abstract BACKGROUND Crohn’s disease (CD) can involve the upper gastrointestinal (GI) tract as well as the small and large bowel. PillCam colon capsule endoscopy (PCCE-2) enables to observe the whole GI tract, but its diagnostic yield for CD lesions in the whole GI tract remains unknown. AIM To elucidate the diagnostic yield of PCCE-2 in patients with CD. METHODS Patients with CD who underwent PCCE-2 and double-balloon endoscopy (DBE) using oral and anal approaches were evaluated for CD lesions in the whole GI tract. We divided the small bowel into three segments (jejunum, ileum, and terminal ileum), and the large bowel into four segments (right colon, transverse colon, left colon, rectum). Detection of ulcer scars, erosion, ulcers, bamboo joint-like appearance, and notch-like appearance was assessed in each segment. The diagnostic yield of PCCE-2 was analyzed based on the DBE results as the gold standard. RESULTS Of the total 124 segments, the sensitivities of PCCE-2 for ulcer scars, erosion, and ulcers were 83.3%, 93.8%, and 88.5%, respectively, and the specificities were 76.0%, 78.3%, and 81.6%, respectively. For the 60 small bowel segments, the sensitivities were 84.2%, 95.5%, and 90.0%, respectively, and the specificities were 63.4%, 86.8%, and 87.5%, respectively. For the 64 large bowel segments, the sensitivities were 80.0%, 90.0%, and 83.3%, respectively, and the specificities were 84.7%, 72.2%, and 77.6%, respectively. CONCLUSION PCCE-2 provides a high diagnostic yield for lesions in the whole GI tract of patients with CD. Thus, we recommend its use as a pan-enteric tool in clinical settings. Gastroenterology & Hepatology Colon capsule endoscopy Crohn’s disease Diagnostic yield Retention Whole gastrointestinal tract Prospective study Figures Figure 1 Figure 1 Figure 2 Figure 2 Figure 3 Figure 3 Introduction Crohn’s disease (CD) is a chronic inflammatory bowel disease (IBD) that mainly involves the small and large bowel. The goals of treatment in CD have evolved in recent years from symptom control to healing of mucosal lesions visualized on endoscopy [1]. Mucosal healing has been associated with improved clinical outcomes, including sustained steroid-free clinical remission, decreased rates of surgery and hospitalization, reduced occurrence of new perianal complications, as well as improvement in quality of life and increased work productivity [2, 3]. With the development of small bowel capsule endoscopy (SBCE), direct endoscopic examination of the whole small bowel mucosa is available with high diagnostic yield [4-6]. However, in addition to SBCE, colonoscopy (CS) is required to evaluate the large-bowel mucosa, particularly in the case of ileocolonic CD. The introduction of a minimally invasive and highly performing tool for evaluating the whole gastrointestinal (GI) tract is highly anticipated because even with balloon-assisted enteroscopy, it can be challenging to examine the whole GI tract. The second-generation PillCam colon capsule endoscope (PCCE-2; Medtronic Co. Ltd., Dublin, Ireland) has been developed and can be used to examine the whole GI tract, including the small and large bowel, although it was originally designed as a tool to diagnose colorectal lesions [6]. PCCE-2 is a non-invasive procedure that can visualize the GI tract without sedation or gas insufflation [7]. The feasibility and safety of its use in colonic assessment have been investigated for polyps and cancer [8-11]. Furthermore, PCCE-2 has been clinically applied as a tool to replace CS for observing the large bowel in patients with ulcerative colitis (UC) [10], and an original preparation regimen has been developed [11, 12]. Although some studies confirmed the safety and feasibility of PCCE-2 as a pan-enteric tool for patients with CD, [6, 13] the diagnostic yield of PCCE-2 for the whole GI CD lesions remains unknown. On the other hand, balloon-assisted enteroscopy, such as double-balloon endoscopy (DBE) and single balloon endoscopy (SBE), has been shown to have a high diagnostic yield of the small bowel and diagnosis of small bowel diseases [14]. SBE results have been reported as the gold standard for small bowel lesions of CD [15]. Therefore, the aim of this study was to prospectively elucidate the diagnostic yield of PCCE-2 for the whole GI CD lesions in reference to DBE results. Materials And Methods Patients From June 2018 to August 2019, patients who were scheduled for DBE for assessment of CD activity at the Nagoya University Hospital were enrolled in this prospective study. The study protocol was approved by the local ethics committee (Nagoya University IRB 2015-372) and registered at UMIN-CTR (UMIN000019632). Patients provided informed consent. The work performed in this study was in accordance with the principles of the Declaration of Helsinki. Study protocol The details of the study protocol are shown in Table 1. On the first day, transoral DBE was performed, and patients who showed no stricture on DBE proceeded to PCCE-2 preparation. In addition to PCCE-2 preparation, patency of the GI tract was assessed using the PillCam patency capsule (PC) (Medtronic Co. Ltd., Dublin, Ireland). PCCE-2 was not performed for patients in whom patency was not confirmed. After the excretion of PCCE-2, trans-anal DBE was performed. Definitions of DBE and PCCE-2 recordings The whole GI tract was observed on both DBE and PCCE-2 recordings. Whole GI tract observation with DBE was defined when the landmark CD lesion was observed using both oral and anal approaches, or several endoscopists judged that DBE observed the whole GI tract using fluoroscopy (Figure 1). In cases where the CCE was not excreted, CD lesions were analyzed as far as the CCE reached. Two readers who were blinded to the clinical background and DBE findings of the patient analyzed each PCCE-2 video. We divided the small bowel into three segments, namely, the jejunum, ileum, and terminal ileum, and the large bowel into four segments, namely, the right side of the colon (cecum, ascending colon), transverse colon, and left side of the colon (descending colon, sigmoid colon), and rectum (Figure 2). The terminal ileum was defined as the section 10 cm from the ileocecal valve on DBE, and the video segment 5 min before the cecum was reached on PCCE-2. In the small bowel postoperative cases, the remaining bowel was divided into three segments as previously defined. The diagnostic yield of PCCE-2 for ulcer scars, erosion, and ulcers was evaluated in each of the seven segments with the DBE results defined as the reference gold standard. PCCE-2 findings were also evaluated for esophageal and gastric lesions using the same strategy. Colon cleansing level Colon cleanliness was determined in accordance with a four-point grading scale consisting of excellent, good (categorized as adequate), fair, and poor (categorized as inadequate), as reported in a previous study [16]. Statistical analysis All data were analyzed using SPSS version 24.0 statistical software (IBM, Tokyo, Japan). Differences in each segment of the small and large bowel were analyzed using Fisher’s exact test. The factors that influenced the incomplete PCCE-2 were analyzed using a logistic regression model. Differences with a p -value <0.05 were considered statistically significant. Results Patients A total of 22 patients were enrolled and underwent DBE using an oral approach. Small bowel obstruction was suspected in one patient, and patency was not confirmed by PC in another patient. Finally, 20 patients underwent PCCE-2 and subsequent DBE using an anal approach. Table 2 shows the characteristics of the 20 patients. Results of the PCCE-2 procedure and number of segments evaluated by both modalities The PCCE-2 excretion rate within the battery life was 75% (15/20). Of the five patients who did not excrete the PCCE-2, two were observed up to the left colon, one was observed up to the transverse colon, and two were observed up to the right colon. Of the 15 patients who excreted the PCCE-2, the median duration of the entire examination was 484 min, the gastric transit time was 80 min, the small intestinal transit time was 69 min, and the colorectal transit time was 265 min. The colon cleansing level was evaluated as adequate in 80% of the patients. Of the 20 patients, 20 gastric, 60 small bowel, and 64 large bowel segments were evaluated. As for large bowel segments, 16 segments were excluded because PCCE-2 could not be observed or evaluated in postoperative cases. Positive findings of PCCE-2 in the whole GI tract Various lesions, including ulcer scars, erosion, ulcers, bamboo joint-like appearance, and notch-like appearance, were detected in the whole GI tract of patients with CD by PCCE-2. Among them, ulcer scars, erosion, and ulcers were frequently observed in the small and large bowel, and erosion and bamboo joint-like appearance were most commonly observed in the stomach. The detection rates of PCCE-2 for ulcer scars, erosion, and ulcers per segment were 52%, 43.3%, and 10% in the small bowel, and 20%, 38%, and 28%, respectively, in the large bowel. The detection rates for erosion and bamboo joint-like appearance in the stomach were 35% and 10%, respectively. Diagnostic yield of PCCE-2 The diagnostic yield of PCCE-2 for the small and large bowel is shown in Table 3. The PCCE-2 sensitivities for ulcer scars, erosion, and ulcers were 83.3%, 93.8%, and 88.5%, respectively, and the specificities were 76.0%, 78.3%, and 81.6%, respectively. The diagnostic yield of PCCE-2 for the small bowel is shown in Table 4. Sensitivities and specificities for active CD lesions, such as erosion and ulcers, were more than 85%. No significant difference was found in the sensitivities and specificities between the three segments of the small bowel (Table 5). Table 6 shows the diagnostic yield of PCCE-2 for the large bowel. The sensitivities were satisfactory, but the specificities for erosion and ulcers were relatively low compared with those of the small bowel. No significant difference was observed between the four segments of the large bowel, as was found for the small bowel (Table 7). For gastric lesions, erosion and bamboo joint-like appearance were detected. Supplementary Table 1 shows the diagnostic yield of these gastric lesions. No esophageal lesions were noted in any of the patients. Incidence and severity of PCCE-2 procedure-related adverse events PCCE-2 retention was not observed in patients with CD in whom patency was confirmed by PC. Of the 20 patients, one patient had moderate and three had mild abdominal bloating, two had mild abdominal pain, and two had mild nausea during PCCE-2 examination. Eighteen of the 20 patients indicated that they would undergo PCCE-2 again, and they preferred PCCE-2 to CS and DBE. Discussion PCCE-2 can observe CD lesions that involve the whole GI tract in a single examination. Although some studies have reported the safety and feasibility of PCCE-2 for patients with CD [13, 15], the diagnostic yield of PCCE-2 for CD lesions of the whole GI is still unknown. This study is the first to elucidate the diagnostic yield of PCCE-2 for the whole GI tract. We demonstrated that PCCE-2 has high diagnostic yield for CD lesions of the whole GI. With regard to the small bowel, a number of studies have already reported on the diagnostic yield of SBCE for small bowel CD lesions. The results of these studies vary with sensitivities of approximately 80% and specificities of approximately 50%–75% [17, 18]. Solem et al. [17] reported that the specificity for small bowel CD lesions is significantly lower with SBCE than with other small bowel imaging modalities, such as CT enterography, ileocolonoscopy, and small bowel follow-through. We showed that the sensitivity and specificity of PCCE-2 for small bowel ulcer lesions were 90.0% and 87.5%, respectively. We can conclude that the specificity of PCCE-2 is high, suggesting that PCCE-2 may reduce false positives. The higher diagnostic accuracy of PCCE-2 has several potential explanations. First, the PCCE-2 has two head cameras, each with a 172° angle of view, allowing for almost 360° visual coverage of the colon. Second, PCCE-2 has improved image acquisition and adaptive frame rates of 4 to 35 images per second [19 ,20], which are much higher than the 2 to 6 image frame rates of SBCE. Therefore, the performance of PCCE-2 could improve the diagnostic yield for small bowel lesions. Furthermore, the use of laxatives has been reported to be beneficial in patients likely to have subtle findings on SBCE because laxatives improve small bowel visualization quality [21]. In this study, the regular bowel preparation before PCCE-2 ingestion may also have contributed to the improved diagnostic yield. The specificities of PCCE-2 for erosion and ulcers of the large bowel were 72.2% and 77.6%, respectively, which were lower than those of the small bowel. D'Haens et al. [1] stated that the low specificity may be related to bowel preparation, with adherent stools being erroneously identified as ulcerations (Figure 3). With regard to the diagnostic yield of the large bowel, there is still room for improvement. In addition to the observation of the small and large bowel, PCCE-2 can also observe upper GI lesions simultaneously. In patients with CD, gastric lesions, such as erosion, ulcers, and bamboo joint-like appearance, are detected at a relatively high frequency (24%–73%) [22], and bamboo joint-like appearance is a characteristic finding in the upper GI. Fujiya et al. [23] reported that the detection rates of this finding are 38.3% in patients with CD, 2.5% in gender- and age-matched patients without IBD, and 1.5% in patients with UC. Therefore, PCCE-2 may be helpful in diagnosing patients with CD by distinguishing them from patients without IBD and patients with UC. Furthermore, we demonstrated that the PCCE-2 procedure is safe for patients with CD. CD is a chronic inflammatory disease, and patients with CD need to undergo repeated GI examinations. Therefore, examination tools that are highly acceptable with fewer complications are desired. PCCE-2 retention was not observed in patients with CD in whom patency was confirmed by PC, and a high percentage of patients (18/20) indicated that they would undergo PCCE-2 again and preferred PCCE-2 to CS and DBE. The use of castor oil (Himashi Oil; Yoshida Pharmaceutical, Tokyo, Japan) as part of the PCCE-2 regimen has been widely established as the standard regimen for bowel preparation because it improves capsule excretion rate and shortens capsule transit time [24, 25]. Although castor oil was also used in this study, the excretion rate of PCCE-2 was not sufficient. This was attributed to the limited PCCE-2 examination time because DBE using an anal approach had to be performed later. Another reason was inflammation of the GI tract due to CD. In patients with UC, the presence of colonic mucosal inflammation has been reported to correlate with longer PCCE-2 transit times because inflammation decreases the motility of the PCCE-2 [12]. Supplementary Table 2 shows the modified SES-CD score for small and large bowel inflammation (details are described in Supplementary Table 2), which was identified as a factor resulting in incomplete PCCE-2. Therefore, PCCE-2 seemed to be less likely to be excreted in patients with CD with an active lesion compared with patients with UC. Furthermore, postoperative cases tended to be classified more often to the non-excretion group, despite the short bowel. A possible reason was that the PCCE-2 moved around in a few cases for several hours at the anastomosis and did not flow to the anal side because of local intestinal peristalsis. However, in contrast to UC that affects the colon in a retrograde and continuous manner starting from the rectum and extending proximally [26], CD involves discontinuous lesions, and the most common site is the terminal ileum [27]. Although five patients with CD did not excrete the PCCE-2 in this study, the terminal ileum could be observed in all cases, and no CD lesions were observed on DBE at the segment that could not be observed by PCCE-2. Therefore, even if the PCCE-2 is not excreted, the mucosal evaluation of CD is considered sufficient. Limitations The main limitation of this study was the small number of patients enrolled and the low number of patients with large bowel CD lesions. However, no studies have compared PCCE-2 results with DBE findings for the whole GI tract in patients with CD. Therefore, this study contributes significantly to the evidence supporting the clinical usefulness of the PCCE-2 as a pan-enteric tool for evaluating CD. In conclusion, PCCE-2 is a safe and feasible tool to examine the whole GI tract in patients with CD with a high diagnostic yield for CD lesions in the entire GI. Further large-scale studies are required for an in-depth understanding of the usefulness of PCCE-2 for CD. Declarations Conflict of Interest: The authors declare that they have no conflict of interest. Author contributions: conception and design: Yamada K, Nakamura M; analysis and interpretation of the data: Yamada K, Nakamura M, Yamamura T, Maeda K, Sawada T, Mizutani Y, Ishikawa E, Furukawa K; drafting of the article: Nakamura M, Yamada K; statistical analysis: Nakamura M; critical revision of the article for important intellectual content: Ishikawa T, Ohno E, Honda T, Kawashima H, Ishigami M, Kakushima N; final approval of the article: Fujishiro M. Acknowledgements None. Availability of data and materials The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Ethics approval and consent to participate The study protocol was approved by the local ethics committee (Nagoya University Hospital ethic committee ID 2015-372), registered at UMIN-CTR (UMIN000019632) and written informed consent was obtained from all patients who met the inclusion criteria and agreed to participate in the study. The work performed in this study was in accordance with the principles of the Declaration of Helsinki. Consent for publication Not applicable. References D’Haens G, Löwenberg M, Samaan MA, Franchimont D, Ponsioen C, van den Brink GR, et al. Safety and feasibility of using the second-generation Pillcam colon capsule to assess active colonic Crohn’s disease. Clin Gastroenterol Hepatol 2015;13:1480-6.e3. Frøslie KF, Jahnsen J, Moum BA, Vatn M, IBSEN Group. Mucosal healing in inflammatory bowel disease: Results from a Norwegian population-based cohort. Gastroenterology 2007;133:412-22. Casellas F, Barreiro De Acosta M, Iglesias M, Robles V, Nos P, et al. 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Tables Table 1: Original regimen of PCCE-2 plus DBE examinations Day time procedure First Day Day time DBE oral approach Before bedtime 2 senna tablets and PC Second Day Before bedtime Magnesium citrate 50 g (180 ml): hypertonic method 2 senna tablets Third Day 8:30 1.0 L PEG and patency confirmation 10:00 capsule ingestion with mosapride citrate 20 mg 1st boost (when the PCCE-2 reaches the small intestine) a mixture of PEG 1000 ml and water 1000 ml castor oil 30 ml 2nd boost sodium picosulfate 48 mg castor oil 30 ml 3rd boost magnesium citrate 50 g (900 ml): isotonic method (after the excretion of PCCE-2) DBE anal approach PCCE-2, the second-generation PillCam colon capsule endoscopy; DBE, double-balloon endoscopy; PC, patency capsule; PEG, polyethylene glycol Table 2: Patient characteristics (N=20) Age (years) Median, range 35 (19-67) Sex Male/Female 15/5 Disease duration (years) Median, range 10 (1-22) Disease location L1/L2/L3* 5/15/0 CDAI Median, range 142 (60-324)** History of surgery (%) 70.0% (14/20) Medication (%) Mesalazine 80.0% (16/20) Elemental diet 70.0% (14/20) Anti-TNF agents 55.0% (11/20) Thiopurines 25.0% (5/20) Ustekinumab 10.0% (2/20) *L1/L2/L3: small intestines/small intestine and colorectum/colorectum **CDAI could not be evaluated in one patient because of the stoma CDAI, Crohn’s disease activity index; TNF, tumor necrosis factor Table 3: Diagnostic yield of PCCE-2 for small and large bowel ulcer scar erosion ulcer sensitivity 83.3% (20/24) 93.8% (30/32) 88.5% (23/26) specificity 76.0% (76/100) 78.3% (72/92) 81.6% (80/98) PPV 45.5% (20/44) 60.0% (30/50) 56.1% (23/41) NPV 95.0% (76/80) 97.3% (72/74) 96.4% (80/83) accuracy 77.4% (96/124) 82.3% (102/124) 83.1% (103/124) PPV, positive predictive value; NPV, negative predictive value; PCCE-2, the second-generation PillCam colon capsule endoscopy Table 4: Diagnostic yield of PCCE-2 for small bowel ulcer scar erosion ulcer sensitivity 84.2% (16/19) 95.5% (21/22) 90.0% (18/20) specificity 63.4% (26/41) 86.8% (33/38) 87.5% (35/40) PPV 51.6% (16/31) 80.8% (21/26) 78.3% (18/23) NPV 89.7% (26/29) 97.1% (33/34) 94.6% (35/37) accuracy 70.0% (42/60) 90.0% (54/60) 88.3% (53/60) PPV, positive predictive value; NPV, negative predictive value; PCCE-2, the second-generation PillCam colon capsule endoscopy Table 5: Diagnostic yield of PCCE-2 for small bowel by segment ulcer scar jejunum ileum terminal ileum p value sensitivity 100% (5/5) 75.0% (6/8) 83.3% (5/6) n.s. * specificity 53.3% (8/15) 66.7% (8/12) 71.4% (10/14) n.s. * erosion jejunum ileum terminal ileum p value sensitivity 100% (4/4) 90.0% (9/10) 100% (8/8) n.s. * specificity 93.8% (15/16) 90.0% (9/10) 75.0% (9/12) n.s. * ulcer jejunum ileum terminal ileum p value sensitivity 100% (4/4) 87.5% (7/8) 87.5% (7/8) n.s. * specificity 87.5% (14/16) 83.3% (10/12) 83.3% (10/12) n.s. * * Fisher’s exact test PCCE-2, the second-generation PillCam colon capsule endoscopy Table 6: Diagnostic yield of PCCE-2 for large bowel ulcer scar erosion ulcer sensitivity 80.0% (4/5) 90.0% (9/10) 83.3% (5/6) specificity 84.7% (50/59) 72.2% (39/54) 77.6% (45/58) PPV 30.8% (4/13) 37.5% (9/24) 27.8% (5/18) NPV 98.0% (50/51) 97.5% (39/40) 97.8% (45/46) accuracy 84.4% (54/64) 75.0% (48/64) 78.1% (50/64) PPV, positive predictive value; NPV, negative predictive value; PCCE-2, the second-generation PillCam colon capsule endoscopy Table 7: Diagnostic yield of PCCE-2 for large bowel by segment ulcer scar right colon transverse colon left colon rectum p value sensitivity 100% (1/1) 50% (1/2) 100% (1/1) 100% (1/1) n.s. * specificity 86.7% (13/15) 86.7% (13/15) 86.7% (13/15) 84.6% (11/13) n.s. * erosion right colon transverse colon left colon rectum p value sensitivity 100% (3/3) 100% (3/3) 66.7% (2/3) 100% (1/1) n.s. * specificity 69.2% (9/13) 64.3% (9/14) 78.6% (11/14) 76.9% (10/13) n.s. * ulcer right colon transverse colon left colon rectum p value sensitivity 100% (1/1) 66.7% (2/3) 100% (1/1) 100% (1/1) n.s. * specificity 80.0% (12/15) 78.6% (11/14) 75.0% (12/16) 76.9% (10/13) n.s. * * Fisher’s exact test PCCE-2, the second-generation PillCam colon capsule endoscopy Supplementary Files CCECDBMCSupplementalmaterial.docx CCECDBMCSupplementalmaterial.docx Cite Share Download PDF Status: Published Journal Publication published 16 Feb, 2021 Read the published version in BMC Gastroenterology → Version 1 posted Editorial decision: Major revision 23 Dec, 2020 Reviews received at journal 12 Dec, 2020 Reviewers agreed at journal 05 Dec, 2020 Reviewers invited by journal 04 Dec, 2020 Editor assigned by journal 04 Dec, 2020 Editor invited by journal 04 Dec, 2020 Submission checks completed at journal 04 Dec, 2020 First submitted to journal 01 Dec, 2020 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Mitsuhiro","middleName":"","lastName":"Fujishiro","suffix":""}],"badges":[],"createdAt":"2020-12-01 16:14:05","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-119671/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-119671/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12876-021-01657-0","type":"published","date":"2021-02-16T15:00:29+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":4130257,"identity":"8b60e20f-ba24-43b0-b02e-74ba1740744a","added_by":"auto","created_at":"2020-12-09 16:49:20","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":64470,"visible":true,"origin":"","legend":"The landmark Crohn’s disease lesion is observed by double-balloon endoscopy with oral and anal approaches (top). The whole gastrointestinal tract observation is achieved using fluoroscopy (bottom).","description":"","filename":"Fig1.JPG","url":"https://assets-eu.researchsquare.com/files/rs-119671/v1/c6dfd0fe9bf2f3469b193d15.JPG"},{"id":4130252,"identity":"0ab8c456-9616-490c-8083-e10db9e42672","added_by":"auto","created_at":"2020-12-09 16:49:14","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":64470,"visible":true,"origin":"","legend":"The landmark Crohn’s disease lesion is observed by double-balloon endoscopy with oral and anal approaches (top). The whole gastrointestinal tract observation is achieved using fluoroscopy (bottom).","description":"","filename":"Fig1.JPG","url":"https://assets-eu.researchsquare.com/files/rs-119671/v1/d57b129dc6b1f488cbf784a3.JPG"},{"id":4130258,"identity":"00f59ec1-bed0-4e66-b38c-f001daca8d09","added_by":"auto","created_at":"2020-12-09 16:49:20","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":98699,"visible":true,"origin":"","legend":"Images of double-balloon endoscopy (top) and the corresponding second-generation PillCam colon capsule endoscopy (PCCE-2) image (bottom) of the ulcer lesion.\n\n","description":"","filename":"Fig2.JPG","url":"https://assets-eu.researchsquare.com/files/rs-119671/v1/adb84ad9291b97d88178d841.JPG"},{"id":4130253,"identity":"a2fb3d9a-7511-4892-b016-95bd40962c69","added_by":"auto","created_at":"2020-12-09 16:49:14","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":98699,"visible":true,"origin":"","legend":"Images of double-balloon endoscopy (top) and the corresponding second-generation PillCam colon capsule endoscopy (PCCE-2) image (bottom) of the ulcer lesion.\n\n","description":"","filename":"Fig2.JPG","url":"https://assets-eu.researchsquare.com/files/rs-119671/v1/a1d69d5e58078fa7dc07a1e2.JPG"},{"id":4130259,"identity":"d5f5bc79-220c-4058-833e-e3b813423297","added_by":"auto","created_at":"2020-12-09 16:49:20","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":42576,"visible":true,"origin":"","legend":"False positive cases: stools may be erroneously identified as erosion and ulcer.","description":"","filename":"Fig3.JPG","url":"https://assets-eu.researchsquare.com/files/rs-119671/v1/1157c088b898d50fe7f147d3.JPG"},{"id":4130254,"identity":"f62928c3-2067-4204-99c6-e052921dbc4b","added_by":"auto","created_at":"2020-12-09 16:49:14","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":42576,"visible":true,"origin":"","legend":"False positive cases: stools may be erroneously identified as erosion and ulcer.","description":"","filename":"Fig3.JPG","url":"https://assets-eu.researchsquare.com/files/rs-119671/v1/457543c3d1d7bb1351a35a01.JPG"},{"id":13631385,"identity":"17df12c2-b739-4dc1-903d-7bf517328b1c","added_by":"auto","created_at":"2021-09-17 08:16:32","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":662194,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-119671/v1/1c5ab9d8-a147-4f43-aae8-eff3d25f11fa.pdf"},{"id":4130256,"identity":"ec501493-d61d-4ce9-9dac-41935078f4e5","added_by":"auto","created_at":"2020-12-09 16:49:20","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":35521,"visible":true,"origin":"","legend":"","description":"","filename":"CCECDBMCSupplementalmaterial.docx","url":"https://assets-eu.researchsquare.com/files/rs-119671/v1/ccc933adc8e3073592c82162.docx"},{"id":4130251,"identity":"1a973ff1-7ebb-4d0a-80f6-2c0608148dfe","added_by":"auto","created_at":"2020-12-09 16:49:14","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":35521,"visible":true,"origin":"","legend":"","description":"","filename":"CCECDBMCSupplementalmaterial.docx","url":"https://assets-eu.researchsquare.com/files/rs-119671/v1/383e0c56e93ba3c339ca007b.docx"}],"financialInterests":"","formattedTitle":"\u003cp\u003eDiagnostic Yield of Colon Capsule Endoscopy for Crohn’s Disease Lesions in the Whole Gastrointestinal Tract\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eCrohn\u0026rsquo;s disease (CD) is a chronic inflammatory bowel disease (IBD) that mainly involves the small and large bowel. The goals of treatment in CD have evolved in recent years from symptom control to healing of mucosal lesions visualized on endoscopy [1]. Mucosal healing has been associated with improved clinical outcomes, including sustained steroid-free clinical remission, decreased rates of surgery and hospitalization, reduced occurrence of new perianal complications, as well as improvement in quality of life and increased work productivity [2, 3]. With the development of small bowel capsule endoscopy (SBCE), direct endoscopic examination of the whole small bowel mucosa is available with high diagnostic yield [4-6]. However, in addition to SBCE, colonoscopy (CS) is required to evaluate the large-bowel mucosa, particularly in the case of ileocolonic CD. The introduction of a minimally invasive and highly performing tool for evaluating the whole gastrointestinal (GI) tract is highly anticipated because even with balloon-assisted enteroscopy, it can be challenging to examine the whole GI tract.\u003c/p\u003e\n\u003cp\u003eThe second-generation PillCam colon capsule endoscope (PCCE-2; Medtronic Co. Ltd., Dublin, Ireland) has been developed and can be used to examine the whole GI tract, including the small and large bowel, although it was originally designed as a tool to diagnose colorectal lesions [6]. PCCE-2 is a non-invasive procedure that can visualize the GI tract without sedation or gas insufflation [7]. The feasibility and safety of its use in colonic assessment have been investigated for polyps and cancer [8-11]. Furthermore, PCCE-2 has been clinically applied as a tool to replace CS for observing the large bowel in patients with ulcerative colitis (UC) [10], and an original preparation regimen has been developed [11, 12].\u003c/p\u003e\n\u003cp\u003eAlthough some studies confirmed the safety and feasibility of PCCE-2 as a pan-enteric tool for patients with CD, [6, 13] the diagnostic yield of PCCE-2 for the whole GI CD lesions remains unknown. On the other hand, balloon-assisted enteroscopy, such as double-balloon endoscopy (DBE) and single balloon endoscopy (SBE), has been shown to have a high diagnostic yield of the small bowel and diagnosis of small bowel diseases [14]. SBE results have been reported as the gold standard for small bowel lesions of CD [15]. Therefore, the aim of this study was to prospectively elucidate the diagnostic yield of PCCE-2 for the whole GI CD lesions in reference to DBE results.\u003c/p\u003e"},{"header":"Materials And Methods","content":"\u003cp\u003e\u003cem\u003ePatients\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eFrom June 2018 to August 2019, patients who were scheduled for DBE for assessment of CD activity at the Nagoya University Hospital were enrolled in this prospective study. The study protocol was approved by the local ethics committee (Nagoya University IRB 2015-372) and registered at UMIN-CTR (UMIN000019632). Patients provided informed consent. The work performed in this study was in accordance with the principles of the Declaration of Helsinki.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStudy protocol\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe details of the study protocol are shown in Table 1. On the first day, transoral DBE was performed, and patients who showed no stricture on DBE proceeded to PCCE-2 preparation. In addition to PCCE-2 preparation, patency of the GI tract was assessed using the PillCam patency capsule (PC) (Medtronic Co. Ltd., Dublin, Ireland). PCCE-2 was not performed for patients in whom patency was not confirmed. After the excretion of PCCE-2, trans-anal DBE was performed.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eDefinitions of DBE and PCCE-2 recordings\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe whole GI tract was observed on both DBE and PCCE-2 recordings. Whole GI tract observation with DBE was defined when the landmark CD lesion was observed using both oral and anal approaches, or several endoscopists judged that DBE observed the whole GI tract using fluoroscopy (Figure 1). In cases where the CCE was not excreted, CD lesions were analyzed as far as the CCE reached. Two readers who were blinded to the clinical background and DBE findings of the patient analyzed each PCCE-2 video.\u003c/p\u003e\n\u003cp\u003eWe divided the small bowel into three segments, namely, the jejunum, ileum, and terminal ileum, and the large bowel into four segments, namely, the right side of the colon (cecum, ascending colon), transverse colon, and left side of the colon (descending colon, sigmoid colon), and rectum (Figure 2). The terminal ileum was defined as the section 10 cm from the ileocecal valve on DBE, and the video segment 5 min before the cecum was reached on PCCE-2. In the small bowel postoperative cases, the remaining bowel was divided into three segments as previously defined. The diagnostic yield of PCCE-2 for ulcer scars, erosion, and ulcers was evaluated in each of the seven segments with the DBE results defined as the reference gold standard. PCCE-2 findings were also evaluated for esophageal and gastric lesions using the same strategy.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eColon cleansing level\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eColon cleanliness was determined in accordance with a four-point grading scale consisting of excellent, good (categorized as adequate), fair, and poor (categorized as inadequate), as reported in a previous study [16].\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStatistical analysis\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAll data were analyzed using SPSS version 24.0 statistical software (IBM, Tokyo, Japan). Differences in each segment of the small and large bowel were analyzed using Fisher\u0026rsquo;s exact test. The factors that influenced the incomplete PCCE-2 were analyzed using a logistic regression model. Differences with a \u003cem\u003ep\u003c/em\u003e-value \u0026lt;0.05 were considered statistically significant.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cem\u003ePatients \u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eA total of 22 patients were enrolled and underwent DBE using an oral approach. Small bowel obstruction was suspected in one patient, and patency was not confirmed by PC in another patient. Finally, 20 patients underwent PCCE-2 and subsequent DBE using an anal approach. Table 2 shows the characteristics of the 20 patients.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eResults of the PCCE-2 procedure and number of segments evaluated by both modalities\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe PCCE-2 excretion rate within the battery life was 75% (15/20). Of the five patients who did not excrete the PCCE-2, two were observed up to the left colon, one was observed up to the transverse colon, and two were observed up to the right colon. Of the 15 patients who excreted the PCCE-2, the median duration of the entire examination was 484 min, the gastric transit time was 80 min, the small intestinal transit time was 69 min, and the colorectal transit time was 265 min. The colon cleansing level was evaluated as adequate in 80% of the patients.\u003c/p\u003e\n\u003cp\u003eOf the 20 patients, 20 gastric, 60 small bowel, and 64 large bowel segments were evaluated. As for large bowel segments, 16 segments were excluded because PCCE-2 could not be observed or evaluated in postoperative cases.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ePositive findings of PCCE-2 in the whole GI tract\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eVarious lesions, including ulcer scars, erosion, ulcers, bamboo joint-like appearance, and notch-like appearance, were detected in the whole GI tract of patients with CD by PCCE-2. Among them, ulcer scars, erosion, and ulcers were frequently observed in the small and large bowel, and erosion and bamboo joint-like appearance were most commonly observed in the stomach. The detection rates of PCCE-2 for ulcer scars, erosion, and ulcers per segment were 52%, 43.3%, and 10% in the small bowel, and 20%, 38%, and 28%, respectively, in the large bowel. The detection rates for erosion and bamboo joint-like appearance in the stomach were 35% and 10%, respectively.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eDiagnostic yield of PCCE-2 \u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe diagnostic yield of PCCE-2 for the small and large bowel is shown in Table 3. The PCCE-2 sensitivities for ulcer scars, erosion, and ulcers were 83.3%, 93.8%, and 88.5%, respectively, and the specificities were 76.0%, 78.3%, and 81.6%, respectively.\u003c/p\u003e\n\u003cp\u003eThe diagnostic yield of PCCE-2 for the small bowel is shown in Table 4. Sensitivities and specificities for active CD lesions, such as erosion and ulcers, were more than 85%. No significant difference was found in the sensitivities and specificities between the three segments of the small bowel (Table 5).\u003c/p\u003e\n\u003cp\u003eTable 6 shows the diagnostic yield of PCCE-2 for the large bowel. The sensitivities were satisfactory, but the specificities for erosion and ulcers were relatively low compared with those of the small bowel. No significant difference was observed between the four segments of the large bowel, as was found for the small bowel (Table 7).\u003c/p\u003e\n\u003cp\u003eFor gastric lesions, erosion and bamboo joint-like appearance were detected. Supplementary Table 1 shows the diagnostic yield of these gastric lesions. No esophageal lesions were noted in any of the patients.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eIncidence and severity of PCCE-2 procedure-related adverse events\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePCCE-2 retention was not observed in patients with CD in whom patency was confirmed by PC. Of the 20 patients, one patient had moderate and three had mild abdominal bloating, two had mild abdominal pain, and two had mild nausea during PCCE-2 examination. Eighteen of the 20 patients indicated that they would undergo PCCE-2 again, and they preferred PCCE-2 to CS and DBE.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003ePCCE-2 can observe CD lesions that involve the whole GI tract in a single examination. Although some studies have reported the safety and feasibility of PCCE-2 for patients with CD [13, 15], the diagnostic yield of PCCE-2 for CD lesions of the whole GI is still unknown. This study is the first to elucidate the diagnostic yield of PCCE-2 for the whole GI tract. We demonstrated that PCCE-2 has high diagnostic yield for CD lesions of the whole GI.\u003c/p\u003e\n\u003cp\u003eWith regard to the small bowel, a number of studies have already reported on the diagnostic yield of SBCE for small bowel CD lesions. The results of these studies vary with sensitivities of approximately 80% and specificities of approximately 50%\u0026ndash;75% [17, 18]. Solem \u003cem\u003eet al.\u003c/em\u003e [17] reported that the specificity for small bowel CD lesions is significantly lower with SBCE than with other small bowel imaging modalities, such as CT enterography, ileocolonoscopy, and small bowel follow-through. We showed that the sensitivity and specificity of PCCE-2 for small bowel ulcer lesions were 90.0% and 87.5%, respectively. We can conclude that the specificity of PCCE-2 is high, suggesting that PCCE-2 may reduce false positives. The higher diagnostic accuracy of PCCE-2 has several potential explanations. First, the PCCE-2 has two head cameras, each with a 172\u0026deg; angle of view, allowing for almost 360\u0026deg; visual coverage of the colon. Second, PCCE-2 has improved image acquisition and adaptive frame rates of 4 to 35 images per second [19 ,20], which are much higher than the 2 to 6 image frame rates of SBCE. Therefore, the performance of PCCE-2 could improve the diagnostic yield for small bowel lesions. Furthermore, the use of laxatives has been reported to be beneficial in patients likely to have subtle findings on SBCE because laxatives improve small bowel visualization quality\u0026nbsp; [21]. In this study, the regular bowel preparation before PCCE-2 ingestion may also have contributed to the improved diagnostic yield.\u003c/p\u003e\n\u003cp\u003eThe specificities of PCCE-2 for erosion and ulcers of the large bowel were 72.2% and 77.6%, respectively, which were lower than those of the small bowel. D'Haens \u003cem\u003eet al.\u003c/em\u003e [1] stated that the low specificity may be related to bowel preparation, with adherent stools being erroneously identified as ulcerations (Figure 3). With regard to the diagnostic yield of the large bowel, there is still room for improvement.\u003c/p\u003e\n\u003cp\u003eIn addition to the observation of the small and large bowel, PCCE-2 can also observe upper GI lesions simultaneously. In patients with CD, gastric lesions, such as erosion, ulcers, and bamboo joint-like appearance, are detected at a relatively high frequency (24%\u0026ndash;73%) [22], and bamboo joint-like appearance is a characteristic finding in the upper GI. Fujiya \u003cem\u003eet al.\u003c/em\u003e [23] reported that the detection rates of this finding are 38.3% in patients with CD, 2.5% in gender- and age-matched patients without IBD, and 1.5% in patients with UC. Therefore, PCCE-2 may be helpful in diagnosing patients with CD by distinguishing them from patients without IBD and patients with UC.\u003c/p\u003e\n\u003cp\u003eFurthermore, we demonstrated that the PCCE-2 procedure is safe for patients with CD. CD is a chronic inflammatory disease, and patients with CD need to undergo repeated GI examinations. Therefore, examination tools that are highly acceptable with fewer complications are desired. PCCE-2 retention was not observed in patients with CD in whom patency was confirmed by PC, and a high percentage of patients (18/20) indicated that they would undergo PCCE-2 again and preferred PCCE-2 to CS and DBE.\u003c/p\u003e\n\u003cp\u003eThe use of castor oil (Himashi Oil; Yoshida Pharmaceutical, Tokyo, Japan) as part of the PCCE-2 regimen has been widely established as the standard regimen for bowel preparation because it improves capsule excretion rate and shortens capsule transit time [24, 25]. Although castor oil was also used in this study, the excretion rate of PCCE-2 was not sufficient. This was attributed to the limited PCCE-2 examination time because DBE using an anal approach had to be performed later. Another reason was inflammation of the GI tract due to CD. In patients with UC, the presence of colonic mucosal inflammation has been reported to correlate with longer PCCE-2 transit times because inflammation decreases the motility of the PCCE-2 [12]. Supplementary Table 2 shows the modified SES-CD score for small and large bowel inflammation (details are described in Supplementary Table 2), which was identified as a factor resulting in incomplete PCCE-2. Therefore, PCCE-2 seemed to be less likely to be excreted in patients with CD with an active lesion compared with patients with UC. Furthermore, postoperative cases tended to be classified more often to the non-excretion group, despite the short bowel. A possible reason was that the PCCE-2 moved around in a few cases for several hours at the anastomosis and did not flow to the anal side because of local intestinal peristalsis.\u003c/p\u003e\n\u003cp\u003eHowever, in contrast to UC that affects the colon in a retrograde and continuous manner starting from the rectum and extending proximally [26], CD involves discontinuous lesions, and the most common site is the terminal ileum [27]. Although five patients with CD did not excrete the PCCE-2 in this study, the terminal ileum could be observed in all cases, and no CD lesions were observed on DBE at the segment that could not be observed by PCCE-2. Therefore, even if the PCCE-2 is not excreted, the mucosal evaluation of CD is considered sufficient.\u003c/p\u003e"},{"header":"Limitations","content":"\u003cp\u003eThe main limitation of this study was the small number of patients enrolled and the low number of patients with large bowel CD lesions. However, no studies have compared PCCE-2 results with DBE findings for the whole GI tract in patients with CD. Therefore, this study contributes significantly to the evidence supporting the clinical usefulness of the PCCE-2 as a pan-enteric tool for evaluating CD.\u003c/p\u003e\n\u003cp\u003eIn conclusion, PCCE-2 is a safe and feasible tool to examine the whole GI tract in patients with CD with a high diagnostic yield for CD lesions in the entire GI. Further large-scale studies are required for an in-depth understanding of the usefulness of PCCE-2 for CD.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eConflict of Interest: \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no conflict of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions:\u003c/strong\u003e conception and design: Yamada K, Nakamura M; analysis and interpretation of the data: Yamada K, Nakamura M, Yamamura T, Maeda K, Sawada T, Mizutani Y, Ishikawa E, Furukawa K; drafting of the article: Nakamura M, Yamada K; statistical analysis: Nakamura M; critical revision of the article for important intellectual content: Ishikawa T, Ohno E, Honda T, Kawashima H, Ishigami M, Kakushima N; final approval of the article: Fujishiro M.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e \u0026nbsp;None.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study protocol was approved by the local ethics committee (Nagoya University Hospital ethic committee ID 2015-372), registered at UMIN-CTR (UMIN000019632) and written informed consent was obtained from all patients who met the inclusion criteria and agreed to participate in the study. The work performed in this study was in accordance with the principles of the Declaration of Helsinki.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e \u0026nbsp;Not applicable.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eD\u0026rsquo;Haens G, L\u0026ouml;wenberg M, Samaan MA, Franchimont D, Ponsioen C, van den Brink GR, et al. Safety and feasibility of using the second-generation Pillcam colon capsule to assess active colonic Crohn\u0026rsquo;s disease. Clin Gastroenterol Hepatol 2015;13:1480-6.e3.\u003c/li\u003e\n\u003cli\u003eFr\u0026oslash;slie KF, Jahnsen J, Moum BA, Vatn M, IBSEN Group. Mucosal healing in inflammatory bowel disease: Results from a Norwegian population-based cohort. Gastroenterology 2007;133:412-22.\u003c/li\u003e\n\u003cli\u003eCasellas F, Barreiro De Acosta M, Iglesias M, Robles V, Nos P, et al. Mucosal healing restores normal health and quality of life in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol 2012;24:762-9.\u003c/li\u003e\n\u003cli\u003eKopylov U, Seidman EG. Clinical applications of small bowel capsule endoscopy. Clin Exp Gastroenterol 2013;6:129-37.\u003c/li\u003e\n\u003cli\u003ePark SK, Ye BD, Kim KO, Park CH, Lee WS, Jang BI, et al. Guidelines for video capsule endoscopy: Emphasis on Crohn\u0026rsquo;s disease. Clin Endosc 2015;48:128-35.\u003c/li\u003e\n\u003cli\u003eCarvalho PB, Rosa B, De Castro FD, Moreira MJ, Cotter J. PillCam COLON 2\u0026copy; in Crohn\u0026rsquo;s disease: A new concept of pan-enteric mucosal healing assessment. World J Gastroenterol 2015;21:7233-41.\u003c/li\u003e\n\u003cli\u003eSchoofs N, Devi\u0026egrave;re J, Van Gossum A. PillCam colon capsule endoscopy compared with colonoscopy for colorectal tumor diagnosis: A prospective pilot study. Endoscopy 2006;38:971-7.\u003c/li\u003e\n\u003cli\u003eVan Gossum A, Munoz-Navas M, Fernandez-Urien I, Carretero C, Gay G, Delvaux M, et al. Capsule endoscopy for the detection of polyps and cancer. N Engl J Med 2009;361:264-70.\u003c/li\u003e\n\u003cli\u003eYamada K, Nakamura M, Yamamura T, Maeda K, Sawada T, Mizutani Y, et al. Clinical factors associated with missing colorectal polyp on colon capsule endoscopy. Digestion 2020;101:316-22.\u003c/li\u003e\n\u003cli\u003eHosoe N, Nakano M, Takeuchi K, Endo Y, Matsuoka K, Abe T,et al. Establishment of a novel scoring system for colon capsule endoscopy to assess the severity of ulcerative colitis-Capsule scoring of ulcerative colitis. Inflamm Bowel Dis 2018;24:2641-7.\u003c/li\u003e\n\u003cli\u003eShi HY, Chan FKL, Higashimori A, Kyaw M, Ching JYL, Chan HCH,et al. A prospective study on second-generation colon capsule endoscopy to detect mucosal lesions and disease activity in ulcerative colitis (with video). Gastrointest Endosc 2017;86:1139-46.e6\u003c/li\u003e\n\u003cli\u003eOkabayashi S, Kobayashi T, Nakano M, Toyonaga T, Ozaki R, Tablante MC, et al. A simple 1-day colon capsule endoscopy procedure demonstrated to be a highly acceptable monitoring tool for ulcerative colitis. Inflamm Bowel Dis 2018;24:2404-12.\u003c/li\u003e\n\u003cli\u003eHall B, Holleran G, McNamara D. PillCam COLON 2 \u0026copy; as a pan-enteroscopic test in Crohn\u0026rsquo;s disease. World J Gastrointest Endosc 2015;7:1230-2.\u003c/li\u003e\n\u003cli\u003ePasha SF, Leighton JA, Das A, Harrison ME, Decker GA, Fleischer DE, et al. Double-balloon enteroscopy and capsule endoscopy have comparable diagnostic yield in small-bowel disease: A meta-analysis. Clin Gastroenterol Hepatol 2008;6:671-6.\u003c/li\u003e\n\u003cli\u003eTakenaka K, Ohtsuka K, Kitazume Y, Nagahori M, Fujii T, Saito E, et al. Comparison of magnetic resonance and balloon enteroscopic examination of the small intestine in patients with Crohn\u0026rsquo;s disease. Gastroenterology 2014;147:334-42.e3.\u003c/li\u003e\n\u003cli\u003eZhou J, Tang X, Wang J, Chen Z, Wang X, Jiang B. Feasibility of a novel low‐volume and sodium phosphate‐free bowel preparation regimen for colon capsule endoscopy. Exp Ther Med 2017;14:1739-43.\u003c/li\u003e\n\u003cli\u003eSolem CA, Loftus E V., Fletcher JG, Baron TH, Gostout CJ, Petersen BT, et al. Small bowel imaging in Crohn\u0026rsquo;s disease: A prospective, blinded, 4-way comparison trial. Gastrointest Endosc 2008;68:255-66.\u003c/li\u003e\n\u003cli\u003eAloi M, Nardo G Di, Romano G, Casciani E, Civitelli F, Oliva S, et al. Magnetic resonance enterography, small-intestine contrast US, and capsule endoscopy to evaluate the small bowel in pediatric Crohn\u0026rsquo;s disease: A prospective, blinded, comparison study. Gastrointest Endosc 2015;81:420-7.\u003c/li\u003e\n\u003cli\u003eTal AO, Vermehren J, Albert JG. Colon capsule endoscopy: current status and future directions. World J Gastroenterol 2014;20:16596-602.\u003c/li\u003e\n\u003cli\u003eEliakim R, Yassin K, Niv Y, Metzger Y, Lachter J, Gal E, Sapoznikov B, et al. Prospective multicenter performance evaluation of the second-generation colon capsule compared with colonoscopy. Endoscopy 2009;41:1026-31.\u003c/li\u003e\n\u003cli\u003eYung DE, Rondonotti E, Sykes C, Pennazio M, Plevris JN, Koulaouzidis A. Systematic review and meta-analysis: Is bowel preparation still necessary in small bowel capsule endoscopy? Expert Rev Gastroenterol Hepatol 2017;11:979-93.\u003c/li\u003e\n\u003cli\u003eNomura Y, Moriichi K, Fujiya M, Okumura T. The endoscopic findings of the upper gastrointestinal tract in patients with Crohn\u0026rsquo;s disease. Clin J Gastroenterol 2017;10:289-96.\u003c/li\u003e\n\u003cli\u003eFujiya M, Sakatani A, Dokoshi T, Tanaka K, Ando K, Ueno N,et al. A bamboo joint-like appearance is a characteristic finding in the upper gastrointestinal tract of Crohn\u0026rsquo;s disease patients: A case-control study. Medicine 2015;94:e1500.\u003c/li\u003e\n\u003cli\u003eHotta N. The use of castor oil for bowel preparation for colon capsule endoscopy. Open J Med Imaging 2016;6:103-7.\u003c/li\u003e\n\u003cli\u003eOhmiya N, Hotta N, Mitsufuji S, Nakamura M, Omori T, Maeda K,et al. Multicenter feasibility study of bowel preparation with castor oil for colon capsule endoscopy. Dig Endosc 2019;31:164-72.\u003c/li\u003e\n\u003cli\u003eConrad K, Roggenbuck D, Laass MW. Diagnosis and classification of ulcerative colitis. Autoimmun Rev 2014;13:463-6.\u003c/li\u003e\n\u003cli\u003eSamuel S, Bruining DH, Loftus EV Jr, Becker B, Fletcher JG, Mandrekar JN, et al. Endoscopic skipping of the distal terminal ileum in Crohn\u0026rsquo;s disease can lead to negative results from ileocolonoscopy. Clin Gastroenterol Hepatol 2012;10:1253-9.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1: Original regimen of PCCE-2 plus DBE examinations\u003c/p\u003e\n\u003ctable border=\"1\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd width=\"98\"\u003e\n\u003cp\u003e\u003cstrong\u003eDay\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e\u003cstrong\u003etime\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"412\"\u003e\n\u003cp\u003e\u003cstrong\u003eprocedure\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"98\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eFirst Day\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"412\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"98\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003eDay time\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"412\"\u003e\n\u003cp\u003eDBE oral approach\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"98\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003eBefore bedtime\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"412\"\u003e\n\u003cp\u003e2 senna tablets and PC\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"98\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eSecond Day\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003e\u0026nbsp;\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"412\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"98\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003eBefore bedtime\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"412\"\u003e\n\u003cp\u003eMagnesium citrate 50 g (180 ml): hypertonic method\u003c/p\u003e\n\u003cp\u003e2 senna tablets\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"98\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eThird Day\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003e\u0026nbsp;\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"412\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"98\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e8:30\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"412\"\u003e\n\u003cp\u003e1.0 L PEG and patency confirmation\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"98\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e10:00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"412\"\u003e\n\u003cp\u003ecapsule ingestion with mosapride citrate 20 mg\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"98\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e1st boost (when the PCCE-2 reaches the small intestine)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"412\"\u003e\n\u003cp\u003ea mixture of PEG 1000 ml and water 1000 ml\u003c/p\u003e\n\u003cp\u003ecastor oil 30 ml\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"98\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e2nd boost\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"412\"\u003e\n\u003cp\u003esodium picosulfate 48 mg\u003c/p\u003e\n\u003cp\u003ecastor oil 30 ml\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"98\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e3rd boost\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"412\"\u003e\n\u003cp\u003emagnesium citrate 50 g (900 ml): isotonic method\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"98\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e(after the excretion of PCCE-2)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"412\"\u003e\n\u003cp\u003eDBE anal approach\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003ePCCE-2, the second-generation PillCam colon capsule endoscopy; DBE, double-balloon endoscopy; PC, patency capsule; PEG, polyethylene glycol\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 2: Patient characteristics (N=20)\u003c/p\u003e\n\u003ctable border=\"1\" width=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd width=\"189\"\u003e\n\u003cp\u003eAge (years)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"206\"\u003e\n\u003cp\u003eMedian, range\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"163\"\u003e\n\u003cp\u003e35 (19-67)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"189\"\u003e\n\u003cp\u003eSex\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"206\"\u003e\n\u003cp\u003eMale/Female\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"163\"\u003e\n\u003cp\u003e15/5\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"189\"\u003e\n\u003cp\u003eDisease duration (years)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"206\"\u003e\n\u003cp\u003eMedian, range\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"163\"\u003e\n\u003cp\u003e10 (1-22)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"189\"\u003e\n\u003cp\u003eDisease location\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"206\"\u003e\n\u003cp\u003eL1/L2/L3*\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"163\"\u003e\n\u003cp\u003e5/15/0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"189\"\u003e\n\u003cp\u003eCDAI\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"206\"\u003e\n\u003cp\u003eMedian, range\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"163\"\u003e\n\u003cp\u003e142 (60-324)**\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"189\"\u003e\n\u003cp\u003eHistory of surgery (%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"206\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"163\"\u003e\n\u003cp\u003e70.0% (14/20)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"5\" width=\"189\"\u003e\n\u003cp\u003eMedication (%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"206\"\u003e\n\u003cp\u003eMesalazine\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"163\"\u003e\n\u003cp\u003e80.0% (16/20)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"206\"\u003e\n\u003cp\u003eElemental diet\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"163\"\u003e\n\u003cp\u003e70.0% (14/20)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"206\"\u003e\n\u003cp\u003eAnti-TNF agents\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"163\"\u003e\n\u003cp\u003e55.0% (11/20)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"206\"\u003e\n\u003cp\u003eThiopurines\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"163\"\u003e\n\u003cp\u003e25.0% (5/20)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"206\"\u003e\n\u003cp\u003eUstekinumab\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"163\"\u003e\n\u003cp\u003e10.0% (2/20)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e*L1/L2/L3: small intestines/small intestine and colorectum/colorectum\u003c/p\u003e\n\u003cp\u003e**CDAI could not be evaluated in one patient because of the stoma\u003c/p\u003e\n\u003cp\u003eCDAI, Crohn\u0026rsquo;s disease activity index; TNF, tumor necrosis factor\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 3: Diagnostic yield of PCCE-2 for small and large bowel\u003c/p\u003e\n\u003ctable border=\"1\" width=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd width=\"169\"\u003e\n\u003cp\u003e \u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"220\"\u003e\n\u003cp\u003eulcer scar\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003eerosion\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e\u0026nbsp;ulcer\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"169\"\u003e\n\u003cp\u003esensitivity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"220\"\u003e\n\u003cp\u003e83.3% (20/24)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e93.8% (30/32)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e88.5% (23/26)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"169\"\u003e\n\u003cp\u003especificity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"220\"\u003e\n\u003cp\u003e76.0% (76/100)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e78.3% (72/92)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e81.6% (80/98)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"169\"\u003e\n\u003cp\u003ePPV\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"220\"\u003e\n\u003cp\u003e45.5% (20/44)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e60.0% (30/50)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e56.1% (23/41)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"169\"\u003e\n\u003cp\u003eNPV\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"220\"\u003e\n\u003cp\u003e95.0% (76/80)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e97.3% (72/74)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e96.4% (80/83)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"169\"\u003e\n\u003cp\u003eaccuracy\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"220\"\u003e\n\u003cp\u003e77.4% (96/124)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e82.3% (102/124)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"198\"\u003e\n\u003cp\u003e83.1% (103/124)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003ePPV, positive predictive value; NPV, negative predictive value; PCCE-2, the second-generation PillCam colon capsule endoscopy\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTable 4: Diagnostic yield of PCCE-2 for small bowel\u003c/p\u003e\n\u003ctable border=\"1\" width=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd width=\"211\"\u003e\n\u003cp\u003e \u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"235\"\u003e\n\u003cp\u003eulcer scar\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"233\"\u003e\n\u003cp\u003eerosion\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"205\"\u003e\n\u003cp\u003e\u0026nbsp;ulcer\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"211\"\u003e\n\u003cp\u003esensitivity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"235\"\u003e\n\u003cp\u003e84.2% (16/19)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"233\"\u003e\n\u003cp\u003e95.5% (21/22)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"205\"\u003e\n\u003cp\u003e90.0% (18/20)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"211\"\u003e\n\u003cp\u003especificity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"235\"\u003e\n\u003cp\u003e63.4% (26/41)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"233\"\u003e\n\u003cp\u003e86.8% (33/38)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"205\"\u003e\n\u003cp\u003e87.5% (35/40)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"211\"\u003e\n\u003cp\u003ePPV\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"235\"\u003e\n\u003cp\u003e51.6% (16/31)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"233\"\u003e\n\u003cp\u003e80.8% (21/26)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"205\"\u003e\n\u003cp\u003e78.3% (18/23)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"211\"\u003e\n\u003cp\u003eNPV\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"235\"\u003e\n\u003cp\u003e89.7% (26/29)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"233\"\u003e\n\u003cp\u003e97.1% (33/34)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"205\"\u003e\n\u003cp\u003e94.6% (35/37)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"211\"\u003e\n\u003cp\u003eaccuracy\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"235\"\u003e\n\u003cp\u003e70.0% (42/60)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"233\"\u003e\n\u003cp\u003e90.0% (54/60)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"205\"\u003e\n\u003cp\u003e88.3% (53/60)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003ePPV, positive predictive value; NPV, negative predictive value; PCCE-2, the second-generation PillCam colon capsule endoscopy\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 5: Diagnostic yield of PCCE-2 for small bowel by segment\u003c/p\u003e\n\u003ctable border=\"1\" width=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd width=\"177\"\u003e\n\u003cp\u003eulcer scar \u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003ejejunum\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003eileum\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003eterminal ileum\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"177\"\u003e\n\u003cp\u003esensitivity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e100% (5/5)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e\u0026nbsp;75.0% (6/8)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e83.3% (5/6)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003en.s. *\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"177\"\u003e\n\u003cp\u003especificity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e53.3% (8/15)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e66.7% (8/12)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e71.4% (10/14)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003en.s. *\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"2\" width=\"208\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"232\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"230\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"110\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"105\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"177\"\u003e\n\u003cp\u003eerosion \u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003ejejunum\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003eileum\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003eterminal ileum\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"177\"\u003e\n\u003cp\u003esensitivity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e100% (4/4)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e\u0026nbsp;90.0% (9/10)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e100% (8/8)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003en.s. *\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"177\"\u003e\n\u003cp\u003especificity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e93.8% (15/16)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e90.0% (9/10)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e75.0% (9/12)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003en.s. *\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"177\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"177\"\u003e\n\u003cp\u003eulcer \u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003ejejunum\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003eileum\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003eterminal ileum\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"177\"\u003e\n\u003cp\u003esensitivity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e100% (4/4)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e87.5% (7/8)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e87.5% (7/8)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003en.s. *\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"177\"\u003e\n\u003cp\u003especificity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e87.5% (14/16)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e83.3% (10/12)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003e83.3% (10/12)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"177\"\u003e\n\u003cp\u003en.s. *\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"177\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"31\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"146\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"86\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"91\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"38\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"72\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"105\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e*\u003cem\u003eFisher\u0026rsquo;s exact test\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePCCE-2, the second-generation PillCam colon capsule endoscopy\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 6: Diagnostic yield of PCCE-2 for large bowel\u003c/p\u003e\n\u003ctable border=\"1\" width=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd width=\"211\"\u003e\n\u003cp\u003e \u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"235\"\u003e\n\u003cp\u003eulcer scar\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"233\"\u003e\n\u003cp\u003eerosion\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"205\"\u003e\n\u003cp\u003eulcer\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"211\"\u003e\n\u003cp\u003esensitivity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"235\"\u003e\n\u003cp\u003e80.0% (4/5)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"233\"\u003e\n\u003cp\u003e90.0% (9/10)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"205\"\u003e\n\u003cp\u003e83.3% (5/6)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"211\"\u003e\n\u003cp\u003especificity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"235\"\u003e\n\u003cp\u003e84.7% (50/59)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"233\"\u003e\n\u003cp\u003e72.2% (39/54)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"205\"\u003e\n\u003cp\u003e77.6% (45/58)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"211\"\u003e\n\u003cp\u003ePPV\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"235\"\u003e\n\u003cp\u003e30.8% (4/13)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"233\"\u003e\n\u003cp\u003e37.5% (9/24)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"205\"\u003e\n\u003cp\u003e27.8% (5/18)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"211\"\u003e\n\u003cp\u003eNPV\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"235\"\u003e\n\u003cp\u003e98.0% (50/51)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"233\"\u003e\n\u003cp\u003e97.5% (39/40)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"205\"\u003e\n\u003cp\u003e97.8% (45/46)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"211\"\u003e\n\u003cp\u003eaccuracy\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"235\"\u003e\n\u003cp\u003e84.4% (54/64)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"233\"\u003e\n\u003cp\u003e75.0% (48/64)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"205\"\u003e\n\u003cp\u003e78.1% (50/64)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003ePPV, positive predictive value; NPV, negative predictive value; PCCE-2, the second-generation PillCam colon capsule endoscopy\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 7: Diagnostic yield of PCCE-2 for large bowel by segment\u003c/p\u003e\n\u003ctable style=\"width: 1025px;\" border=\"1\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 261px;\"\u003e\n\u003cp\u003eulcer scar \u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 167px;\"\u003e\n\u003cp\u003eright colon\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 142px;\"\u003e\n\u003cp\u003etransverse colon\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 149px;\"\u003e\n\u003cp\u003eleft colon\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 148px;\" colspan=\"6\"\u003e\n\u003cp\u003erectum\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 88px;\"\u003e\n\u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 261px;\"\u003e\n\u003cp\u003esensitivity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 167px;\"\u003e\n\u003cp\u003e100% (1/1)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 142px;\"\u003e\n\u003cp\u003e50% (1/2)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 149px;\"\u003e\n\u003cp\u003e100% (1/1)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 148px;\" colspan=\"6\"\u003e\n\u003cp\u003e100% (1/1)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 88px;\"\u003e\n\u003cp\u003en.s. *\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 261px;\"\u003e\n\u003cp\u003especificity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 167px;\"\u003e\n\u003cp\u003e86.7% (13/15)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 142px;\"\u003e\n\u003cp\u003e86.7% (13/15)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 149px;\"\u003e\n\u003cp\u003e86.7% (13/15)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 144px;\" colspan=\"5\"\u003e\n\u003cp\u003e84.6% (11/13)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 92px;\" colspan=\"2\"\u003e\n\u003cp\u003en.s. *\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 261px;\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd style=\"width: 167px;\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd style=\"width: 142px;\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd style=\"width: 158px;\" colspan=\"2\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd style=\"width: 131px;\" colspan=\"3\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 96px;\" colspan=\"3\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 261px;\"\u003e\n\u003cp\u003eerosion \u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 167px;\"\u003e\n\u003cp\u003eright colon\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 142px;\"\u003e\n\u003cp\u003etransverse colon\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 158px;\" colspan=\"2\"\u003e\n\u003cp\u003eleft colon\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127px;\" colspan=\"2\"\u003e\n\u003cp\u003erectum\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 100px;\" colspan=\"4\"\u003e\n\u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 261px;\"\u003e\n\u003cp\u003esensitivity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 167px;\"\u003e\n\u003cp\u003e100% (3/3)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 142px;\"\u003e\n\u003cp\u003e100% (3/3)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 158px;\" colspan=\"2\"\u003e\n\u003cp\u003e66.7% (2/3)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127px;\" colspan=\"2\"\u003e\n\u003cp\u003e100% (1/1)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 100px;\" colspan=\"4\"\u003e\n\u003cp\u003en.s. *\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 261px;\"\u003e\n\u003cp\u003especificity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 167px;\"\u003e\n\u003cp\u003e69.2% (9/13)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 142px;\"\u003e\n\u003cp\u003e64.3% (9/14)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 158px;\" colspan=\"2\"\u003e\n\u003cp\u003e78.6% (11/14)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127px;\" colspan=\"2\"\u003e\n\u003cp\u003e76.9% (10/13)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 100px;\" colspan=\"4\"\u003e\n\u003cp\u003en.s. *\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 261px;\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd style=\"width: 167px;\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 142px;\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 158px;\" colspan=\"2\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127px;\" colspan=\"2\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 100px;\" colspan=\"4\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 261px;\"\u003e\n\u003cp\u003eulcer \u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 167px;\"\u003e\n\u003cp\u003eright colon\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 142px;\"\u003e\n\u003cp\u003etransverse colon\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 158px;\" colspan=\"2\"\u003e\n\u003cp\u003eleft colon\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127px;\" colspan=\"2\"\u003e\n\u003cp\u003erectum\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 100px;\" colspan=\"4\"\u003e\n\u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 261px;\"\u003e\n\u003cp\u003esensitivity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 167px;\"\u003e\n\u003cp\u003e100% (1/1)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 142px;\"\u003e\n\u003cp\u003e66.7% (2/3)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 158px;\" colspan=\"2\"\u003e\n\u003cp\u003e100% (1/1)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127px;\" colspan=\"2\"\u003e\n\u003cp\u003e100% (1/1)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 100px;\" colspan=\"4\"\u003e\n\u003cp\u003en.s. *\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 261px;\"\u003e\n\u003cp\u003especificity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 167px;\"\u003e\n\u003cp\u003e80.0% (12/15)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 142px;\"\u003e\n\u003cp\u003e78.6% (11/14)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 158px;\" colspan=\"2\"\u003e\n\u003cp\u003e75.0% (12/16)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 123px;\"\u003e\n\u003cp\u003e76.9% (10/13)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 104px;\" colspan=\"5\"\u003e\n\u003cp\u003en.s. *\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 261px;\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd style=\"width: 167px;\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd style=\"width: 142px;\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd style=\"width: 149px;\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd style=\"width: 9px;\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd style=\"width: 123px;\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd style=\"width: 4px;\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd style=\"width: 4px;\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd style=\"width: 4px;\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd style=\"width: 4px;\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd style=\"width: 88px;\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e*\u003cem\u003eFisher\u0026rsquo;s exact test\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePCCE-2, the second-generation PillCam colon capsule endoscopy\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-gastroenterology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmge","sideBox":"Learn more about [BMC Gastroenterology](http://bmcgastroenterol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bmge/default.aspx","title":"BMC Gastroenterology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Colon capsule endoscopy, Crohn’s disease, Diagnostic yield, Retention, Whole gastrointestinal tract, Prospective study","lastPublishedDoi":"10.21203/rs.3.rs-119671/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-119671/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBACKGROUND\u003c/p\u003e\u003cp\u003eCrohn’s disease (CD) can involve the upper gastrointestinal (GI) tract as well as the small and large bowel. PillCam colon capsule endoscopy (PCCE-2) enables to observe the whole GI tract, but its diagnostic yield for CD lesions in the whole GI tract remains unknown. \u003c/p\u003e\u003cp\u003eAIM\u003c/p\u003e\u003cp\u003eTo elucidate the diagnostic yield of PCCE-2 in patients with CD.\u003c/p\u003e\u003cp\u003eMETHODS\u003c/p\u003e\u003cp\u003ePatients with CD who underwent PCCE-2 and double-balloon endoscopy (DBE) using oral and anal approaches were evaluated for CD lesions in the whole GI tract. We divided the small bowel into three segments (jejunum, ileum, and terminal ileum), and the large bowel into four segments (right colon, transverse colon, left colon, rectum). Detection of ulcer scars, erosion, ulcers, bamboo joint-like appearance, and notch-like appearance was assessed in each segment. The diagnostic yield of PCCE-2 was analyzed based on the DBE results as the gold standard.\u003c/p\u003e\u003cp\u003eRESULTS\u003c/p\u003e\u003cp\u003eOf the total 124 segments, the sensitivities of PCCE-2 for ulcer scars, erosion, and ulcers were 83.3%, 93.8%, and 88.5%, respectively, and the specificities were 76.0%, 78.3%, and 81.6%, respectively. For the 60 small bowel segments, the sensitivities were 84.2%, 95.5%, and 90.0%, respectively, and the specificities were 63.4%, 86.8%, and 87.5%, respectively. For the 64 large bowel segments, the sensitivities were 80.0%, 90.0%, and 83.3%, respectively, and the specificities were 84.7%, 72.2%, and 77.6%, respectively.\u003c/p\u003e\u003cp\u003eCONCLUSION\u003c/p\u003e\u003cp\u003ePCCE-2 provides a high diagnostic yield for lesions in the whole GI tract of patients with CD. Thus, we recommend its use as a pan-enteric tool in clinical settings.\u003c/p\u003e","manuscriptTitle":"Diagnostic Yield of Colon Capsule Endoscopy for Crohn’s Disease Lesions in the Whole Gastrointestinal Tract","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2020-12-09 16:49:12","doi":"10.21203/rs.3.rs-119671/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2020-12-23T18:37:57+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2020-12-12T13:03:48+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"b1eda433-be3c-4c7a-ab06-a8efaa45b4d3","date":"2020-12-05T10:17:36+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2020-12-05T02:02:49+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2020-12-04T15:21:39+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2020-12-04T15:10:18+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2020-12-04T09:22:54+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Gastroenterology","date":"2020-12-01T16:00:52+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-gastroenterology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmge","sideBox":"Learn more about [BMC Gastroenterology](http://bmcgastroenterol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bmge/default.aspx","title":"BMC Gastroenterology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"116c1dfb-9476-42ac-baa7-9bc9d1e9827c","owner":[],"postedDate":"December 9th, 2020","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":1402217,"name":"Gastroenterology \u0026 Hepatology"}],"tags":[],"updatedAt":"2021-02-21T15:00:41+00:00","versionOfRecord":{"articleIdentity":"rs-119671","link":"https://doi.org/10.1186/s12876-021-01657-0","journal":{"identity":"bmc-gastroenterology","isVorOnly":false,"title":"BMC Gastroenterology"},"publishedOn":"2021-02-16 15:00:29","publishedOnDateReadable":"February 16th, 2021"},"versionCreatedAt":"2020-12-09 16:49:12","video":"","vorDoi":"10.1186/s12876-021-01657-0","vorDoiUrl":"https://doi.org/10.1186/s12876-021-01657-0","workflowStages":[]},"version":"v1","identity":"rs-119671","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-119671","identity":"rs-119671","version":["v1"]},"buildId":"rHA-KDH7Qsr4HCuvH75dn","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}

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