Safety and Efficacy of Exposed Endoscopic Full-thickness Resection for Colorectal Submucosal Tumors Originating from Muscularis Propria

Safety and Efficacy of Exposed Endoscopic Full-thickness Resection for Colorectal Submucosal Tumors Originating from Muscularis Propria | 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 Safety and Efficacy of Exposed Endoscopic Full-thickness Resection for Colorectal Submucosal Tumors Originating from Muscularis Propria Ayimukedisi Yalikong, Zhi-peng Qi, Kadinur Ablat, Dongli He, Zhen-tao Lv, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4484601/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objectives Endoscopic resection of the submucosal tumors (SMTs) is a promising minimally invasive alternative surgery for the treatment of SMTs. The aim of this study was to evaluate the safety and efficacy of exposed EFTR in the treatment of colorectal SMTs through retrospective data analysis. Methods The patients who underwent exposed endoscopic full-thickness resection (EFTR) for colorectal SMTs in Zhongshan Hospital of Fudan University and Zhongshan-Xuhui Hospital between March 2012 and December 2022 were enrolled. The information of patients, such as basic information, medical history, preoperative and postoperative conditions, surgical conditions, postoperative complications, etc. were collected for analysis. Results The study enrolled 26 patients. Most of the patients were asymptomatic (76.92%) and found the colorectal SMT through physical examination. The size of the tumor was13.5(8.5,20.0) mm. And, the tumor located mostly in the rectum. During the resection, the technical success rate was 100%. The median procedural time was 46.5(29.25,63.25) min. Of the 26 cases of colorectal SMTs, 13 (50%) were determined to be GIST. As for the adverse events, 3 of the 26 patients were suffered from post-polypectomy syndrome (11.54%), one patient was suffered from postoperative bleeding (3.85%), of whom performed emergency endoscopic hemostasis; One patient (3.85) suffered from postoperative perforation and transferred to perform exploratory laparotomy to repair the defect. All patients improved after treatment, and no patient died because of the adverse events. During the follow-up time 43.5(22.5,48) months, no metastasis or recurrence was observed. Conclusions Exposed EFTR for colorectal SMTs originating from muscularis propria is effective with an acceptable incidence rate of adverse events and good postoperative recovery. endoscopic full-thickness resection submucosal tumors colorectum Figures Figure 1 Originality statement This paper adds to the literature by demonstrating the safety and efficacy of exposed endoscopic full-thickness resection (EFTR) for colorectal submucosal tumors, providing evidence of successful tumor removal, low complication rates, and good postoperative outcomes, expanding the indications for endoscopic treatment of SMTs. Introduction Colorectal submucosal tumors (SMTs) refer to the prominent change of the colon and rectum, whose epithelium of the mucosa is intact. And, it includes the pathological changes from the structure of each layer of the intestinal wall and the masses formed by the compression of the intestinal wall by extraluminal physiological or pathological tissues[ 1 ]. SMT is usually asymptomatic and is mostly detected in physical examination. However, with the increase of the lesion volume, bleeding, obstruction and other symptoms may also occur[ 2 , 3 ]. Endoscopic resection of the SMTs is a promising minimally invasive alternative surgery for the treatment of gastrointestinal SMTs, due to the rapidly development of endoscopic resection technics. Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are two acceptable endoscopic resection techniques, which are applicable to lesions involving the mucosa and submucosa 4 . However, ESD and EMR have some limitation for the lesion with bigger size or from the deeper muscularis propria (MP)[ 5 – 7 ] Therefore, with the continuous development of suture technology and endoscopic instruments, endoscopic full-thickness resection (EFTR) has attracted extensive attention of endoscopists. EFTR can be divided into exposed EFTR and non-exposed EFTR according to the sequence of lesion resection and serosal closure during operation[ 4 ]. In western countries, with advanced instruments, always adopt non-exposed EFTR, that is, with the aid of FTRD devices, suture first and then resect[ 4 ]. Due to the special intraluminal environment, exposed EFTR in colon and rectum will increase the risk of abdominal infection[ 8 ]. Also, exposed EFTR has high requirements for surgical and suturing techniques. Therefore, at present, exposed EFTR is mostly used in the resection of upper gastrointestinal diseases, while the evidence of colorectal SMT removed by exposed EFTR is less 9 . Considering that closed EFTR devices such as FTRD are not available in most of the endoscopy centers in China. And, in recent years, endoscopic suturing devices and technologies such as OTSC system, purse suture with clip and nylon rope have been proved to be effective in suturing of gastrointestinal wall defects[ 10 , 11 ]. In our study, we aimed to research the safety and efficacy of exposed EFTR in the treatment of colorectal SMTs through retrospective data analysis. Patient and method Patients’ data We retrospectively analyzed the patients who underwent exposed EFTR for colorectal SMT in Zhongshan Hospital of Fudan University (n = 19) and Zhongshan-Xuhui Hospital (n = 7) between March 2012 and December 2022. All patients underwent computed tomography (CT) or endoscopic ultrasonography (EUS) before the resection to determine the origin of the tumor and its relationship with adjacent vessels. And, we registered the information of patients in detail, such as basic information, medical history, preoperative and postoperative conditions, surgical conditions, postoperative complications, etc. for analysis. This study was approved by the Ethics Committee of Zhongshan Hospital affiliated to Fudan University. All patients voluntarily chose the treatment course and provided written informed consent. In this study, EFTR procedure were performed by experts who were familiar with ESD and EFTR technology. Procedure The peri-tumor colorectal tissues were incised with a knife, and then, the tumor and peri-tumor colorectal tissues were gradually resected in full thickness using an insulated-tip knife. An iatrogenic colorectal perforation was created. During the resection, hemostasis was obtained with electric cautery. Then, closed the wound with a metal clip, or combine nylon lanyard for purse suture. Postoperative treatment included 24 hours fasting (both food and water), and routine use of antibiotics. All patients were closely observed. For the patients who suffered obvious adverse events. If conservative treatment fails, surgical treatment shall be performed. Adverse event Delayed perforation: Patients may have sudden severe abdominal pain and bloating after surgery, and abdominal upright films or abdominal CT reveal new free gas under the diaphragm or retroperitoneal gas, or upper gastrointestinal tract imaging shows signs of contrast agent leakage[ 12 ]. Bleeding: Patients may have bleeding symptoms such as hematemesis or melena caused by endoscopic treatment of lesions 0–28 days after surgery, and the bleeding site is identified by endoscopy[ 12 ]. Post-polypectomy syndrome: Fever accompanied by moderate or severe localized abdominal pain occurs after EFTR surgery. Meanwhile, imaging examination excludes obvious perforation[ 5 ]. Pathological examination After the endoscopic resection, all tumor specimens were fixed in 10.0% formalin solution, and nailed on the plate to send for pathological evaluation. The routine pathological assessment was stained by hematoxylin and eosin. For the differentiation, immunohistochemical staining was necessary. Statistical analysis All data were analyzed by IBM SPSS statistics 20 statistical software. Continuous values were presented as the mean ± standard deviation (SD) or median (IQR). Categorical values were presented as frequencies and proportions. Results Patient and lesion data The clinicopathological characteristics of 26 patients were presented in Table 1 . The study enrolled 26 patients aged 56(45.25,65) year, including 12 males and 14 females. Most of the patients were asymptomatic (76.92%) and found the colorectal SMT incidentally through physical examination. While among the patients who actively consult a doctor due to symptoms, 2 presented with the change of defecation habits (7.69%), 2 with abdominal pain (7.69%), 1 with hematochezia (3.85%), and 1 with the increased CEA level (3.85%). The median tumor diameter was 13.5(8.5, 20.0) mm. The tumor was located mostly in the rectum. And, 8 lesions located in the anatomically difficult part: 2 in the Ileocecum, 2 in the sigmoid colon. 4 in the lower rectum. According to the histopathology, of the 26 cases of colorectal SMTs, 13 (50%) were determined to be GIST, 7(26.92%) were schwannoma, 3(11.54%) were endometriosis, 2(7.69%) were Leiomyoma. During the follow-up time 43.5(22.5,48) months, no metastasis or recurrence was observed. Table 1 Patient and lesion data Patient characteristic Sex, n (%) Male 12(46.15%) Female 14(53.85%) Age, median (IQR) 56(45.25,65) Comorbidity, n (%) Hypertension 2(7.69%) Cardiovascular disease 1(3.85%) Others 0 History of abdominal surgery 5(19.23%) Symptom Asymptomatic 20(76.92%) Change of defecation habits 2(7.69%) Hematochezia 1(3.85%) Abdominal pain 2(7.69%) Increased CEA 1(3.85%) Location of lesion, n (%) Ileocecum 2(7.69%) Cecum 6(23.08%) Ascending colon 2(7.69%) Transverse colon 2(7.69%) Descending colon 2(7.69%) Sigmoid 2(7.69%) Rectum 10(38.46%) Lower rectum (0-5cm from anus) 4(15.38%) Upper rectum (>5-12cm from anus) 6(23.07%) Maximum diameter of lesion, median (IQR)mm 13.5(8.5, 20.0) Histopathology of the lesion Endometriosis 3(11.54%) GIST 13(50%) Schwannoma 7(26.92%) Leiomyoma 2(7.69%) Collagenous fibroma 1(3.85%) Follow up time 43.5(22.5,48) Procedural data During the resection, the technical success rate was 100%. All lesions were resected completely. The median procedural time was 46.5(29.25, 63.25) min. During the surgery, endoscopist find that most of the SMTs were originated from the muscularis propria (65.38%). And, 7(26.92%) lesions were originated from deeper muscularis propria and closed adhesion with serosa. After the removal of the tumor, 13(50%) surgical wound were sutured by metal clip and 13(50%) were sutured with metal clips combined with nylon cord (Table 2 ). Table 2 Procedural data Median procedure time, median (IQR), min 46.5(29.25, 63.25) Origin of the lesion Muscularis propria 17(65.38%) Serosa 7(26.92%) Technical success 26(100%) Complete resection 26(100%) Dental floss ligation 4(15.38%) Method of suture Metal clips 13(50%) Metal clips combined with nylon cord 13(50%) Adverse events. Three of the 26 patients were suffered from post-polypectomy syndrome (11.54%). All were improved after conservative treatment such as fasting, strengthening anti-inflammatory treatment, rehydration and gastrointestinal decompression. 1 patient were suffered from postoperative bleeding (3.85%), of whom performed emergency endoscopic hemostasis. One patient (3.85%) suffered postoperative perforation and transferred to perform exploratory laparotomy to repair the defect. All patients improved after treatment, and no patient died because of the adverse events. Table 3 Adverse event Adverse event n (%) Post-polypectomy syndrome 3(11.54%) Bleeding 1(3.85%) Delayed Perforation 1(3.85%) Discussion The pathological types of SMTs are complex, but most of them are benign, while only a few are malignant. Gastrointestinal stromal tumor (GIST) is a tumor with certain malignant potential, but its malignant potential depends on its size, location, and type [ 13 ]. GIST with a diameter of less than 2 cm has a low risk of malignancy, and the treatment recommended in the guidelines is controversial[ 2 , 13 ]. For GIST larger than 2cm, surgical treatment is recommended due to its high risk of malignancy[ 2 , 13 , 14 ]. In our study, 13 of 26 lesions were determined to be GIST, and only 5 of them were larger than 2 cm. Considering that both endoscopy and EUS are invasive examinations, and long-term follow-up will pose a significant economic burden, most patients who came to our center hope to undergo endoscopic resection even if small SMTs were found during the examination process. Clinically, lesions of the gastrointestinal tract which originate from the MP layer, closely adhere to the serous layer or grow outside the cavity are the surgical indications of EFTR. Studies have shown that exposed EFTR can treat the lesion originated from MP of the stomach with good safety and efficacy[ 15 – 17 ]. But for the colorectal lesions, the studies were mainly focused on the non-exposed EFTR. The full-thickness resection device (FTRD) of the colorectal non-exposed EFTR can remove the lesions after the OTSC closes the wound, but it is limited by the size of the lesion, and is mainly applicable to complex adenoma, early adenocarcinoma and SMT with a diameter of < 2.0 cm[ 18 ]. Schmidt et al[ 18 ] reviewed 25 cases of colorectal EFTR treated with FTRD, of which 2 cases were colon SMT, with a complete resection rate of 75.0% (18/24). And, 1 patient was unable to use the FTRD device due to sigmoid stenosis. There were no significant adverse events happened. Subsequently, many studies have suggested that non-exposed EFTR is safe and effective in the treatment of colorectal lesions, but the lesions involved in the study are mostly mucosal lesions, and there are only a few reports of submucosal tumors[ 11 , 19 ]. In our study, we demonstrated a total technical success rate of 100% for exposed EFTR on treatment of colorectal SMTs. The median tumor diameter was 13.5(8.5, 20.0) mm. And, 9 of 26 lesions were larger than 2 cm, which may suggest that exposed EFTR may not be limited by the size of the lesion as non-exposed EFTR. Additionally, lesions located in the ileocecum, sigmoid, and lower rectum were considered as technical difficult location for EMR or ESD, which is associated with high risk of adverse event or long procedure time[ 20 ]. In our study, 8 lesions located in the anatomically difficult part. All these lesions were removed completely without adverse event. Therefore, we supposed that compared with non-exposed EFTR, ESD and EMR, exposed EFTR were further extended the indication of endoscopic treatment for SMTs. It is worth noted that exposed EFTR require a high level of endoscopic treatment techniques, and the surgeons performing the procedures in our study were all expert with extensive experience in endoscopic treatment. During the exposed EFTR procedure, physicians should pay more attention to the prevention of air and fluid leakage as well as the completeness of wound closure. Metal clip suturing is the most basic suturing technique for EFTR intraoperative wound closure. As the span of metal clamps is limited, the perforation cannot be closed at one time for larger wound. So, the Chinese guideline recommends "suction-clamping suture", which means to suction the gas in the lumen of the digestive tract to sufficiently reduce the perforation, and then use multiple metal clamps to close the perforation[ 21 ]. Alternatively, a double-clamp endoscope can be used to reinforced the suturing with nylon string using a "string suture" method[ 21 ]. In recent years, the development of novel techniques such as over-the-scope clip and OverStitch suture for repairing GI injuries and managing bleeding will further promote the use of EFTR techniques[ 22 ]. Among our study, 13(50%) surgical wounds were sutured by metal clip and 13(50%) were sutured with Metal clips combined with nylon cord. Literatures reported that postoperative bleeding rate of EFTR with FTRD were 2.2%-4.5%[ 10 , 18 , 23 ]. The common complications were post-polypectomy syndrome with abdominal pain, fever and signs of inflammation on blood chemistry tests of which the accident rate was 1.7%-8.9%[ 7 , 10 , 18 ]. In our study. only one patient (3.85%) whose lesion sized 10mm and located in cecum suffered from postoperative perforation and transferred to perform exploratory laparotomy to repair the defect. And, 3 of the 26 patients were suffered from post-polypectomy syndrome (11.54%). 1 patient were suffered from postoperative bleeding and performed emergency endoscopic hemostasis. All patients improved after treatment, and no patient died because of the adverse events. Compared with the previous study, we supposed that adverse events in our study were acceptable. Our study still has some limitations. The sample size of our study is still insufficient for factor regression analysis. Moreover, our study was included two centers’ data for analysis. It’s necessary to carry out a multi-center study with large sample for further analysis of the safety and efficacy of exposed EFTR. In summary, exposed EFTR of colorectal SMTs have a reliable efficacy and the complication rates are acceptable. Therefore, exposed EFTR as a treatment of colorectal SMT considered to be safe and effective, but adequate preoperative evaluation should be done, and the procedure should be conducted by expert with sufficient experiences. Declarations Ethics approval and patient consent statement: This study was approved by the Ethics Committee of Zhongshan Hospital affiliated to Fudan University. All patients voluntarily chose the treatment course and provided written informed consent before treatment. Potential conflict of interest: The authors have no competing interests to declare. Funding statement: This work was supported by grants from Shanghai Municipal Health Commission, Collaborative Innovation Cluster Project (grant no. 2019CXJQ02), the National Natural Science Foundation of China (grant no. 82273025, 82203460), and the Science and Technology Commission Foundation of Shanghai Municipality (grant no. 22XD1402200, 22JC1403003, 23ZR1458900). Author Contributions: Ayimukedisi·Yalikong, Dong-li He. Zhen-tao Lv, Kdinur·Ablat: Data collection and article writing ; Yun-shi Zhong, Zhi-peng Qi, Qiang Shi: Critical revision of the article for important intellectual content; Ayimukedisi·Yalikong, Zhi-peng Qi, Dong-li He, Zhen-tao Lv, Yun-shi Zhong. Final approval of the article. References Zhou PH, Zhong YS, Li QL. Guideline and Consensus Chinese Consensus on Endoscopic Diagnosis and Management of Gastrointestinal Submucosal Tumor (Version 2023). Chinese Journal of Practical Surgery. 2023;43(3):241-251. doi:10.19538/j.cjps.issn1005-2208.2023.03.01 Sharzehi K, Sethi A, Savides T. AGA Clinical Practice Update on Management of Subepithelial Lesions Encountered During Routine Endoscopy: Expert Review. Clin Gastroenterol Hepatol Off Clin Pract J Am Gastroenterol Assoc . 2022;20(11):2435-2443.e4. doi:10.1016/j.cgh.2022.05.054 Aghdassi A, Christoph A, Dombrowski F, et al. 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Endoscopy . 2013;45(5):329-334. doi:10.1055/s-0032-1326214 Modayil RJ, Zhang X, Khodorskiy D, Stavropoulos SN. Advanced resection and closure techniques for endoscopic full-thickness resection in the gastric fundus. VideoGIE Off Video J Am Soc Gastrointest Endosc . 2020;5(2):61-63. doi:10.1016/j.vgie.2019.11.001 Schmidt A, Beyna T, Schumacher B, et al. Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications. Gut . 2018;67(7):1280-1289. doi:10.1136/gutjnl-2016-313677 Pal P, Ramchandani M, Inavolu P, Reddy DN, Tandan M. Endoscopic Full Thickness Resection: A Systematic Review. J Dig Endosc . 2022;13(03):152-169. doi:10.1055/s-0042-1755304 Li B, Shi Q, Xu EP, et al. Prediction of technically difficult endoscopic submucosal dissection for large superficial colorectal tumors: a novel clinical score model. Gastrointest Endosc . 2021;94(1):133-144.e3. doi:10.1016/j.gie.2020.11.012 Zhou PH, Zhong YS, Li QL. Guideline and Consensus Chinese Consensus on Endoscopic Diagnosis and Management of Gastrointestinal Submucosal Tumor (Version 2018). Chin J Gastrointest Surg, 2018,21(8): 841-852. DOI: 10.3760/cma.j.issn.1671-0274.2018.08.001 Bhandari P, Longcroft-Wheaton G. Faculty Opinions recommendation of Over-the-scope clip-assisted endoscopic full-thickness resection of epithelial and subepithelial GI lesions. Published online March 6, 2018:793543405. doi:10.3410/f.726694349.793543405 Schmidt A, Damm M, Caca K. Endoscopic full-thickness resection using a novel over-the-scope device. Gastroenterology . 2014;147(4):740-742.e2. doi:10.1053/j.gastro.2014.07.045 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted 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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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4484601","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":307472950,"identity":"5b6d4c92-597a-433f-947f-affcdb5d9606","order_by":0,"name":"Ayimukedisi Yalikong","email":"","orcid":"","institution":"Fudan University","correspondingAuthor":false,"prefix":"","firstName":"Ayimukedisi","middleName":"","lastName":"Yalikong","suffix":""},{"id":307472951,"identity":"0f88e966-d220-4165-b27f-43490c51ac13","order_by":1,"name":"Zhi-peng Qi","email":"","orcid":"","institution":"Fudan University","correspondingAuthor":false,"prefix":"","firstName":"Zhi-peng","middleName":"","lastName":"Qi","suffix":""},{"id":307472952,"identity":"b00ea812-63a3-4003-b34a-67295699269d","order_by":2,"name":"Kadinur Ablat","email":"","orcid":"","institution":"Fudan University","correspondingAuthor":false,"prefix":"","firstName":"Kadinur","middleName":"","lastName":"Ablat","suffix":""},{"id":307472953,"identity":"7be1b12b-8351-492b-9870-7fe5d15f203e","order_by":3,"name":"Dongli He","email":"","orcid":"","institution":"Xuhui Hospital, Zhongshan Hospital of Fudan University","correspondingAuthor":false,"prefix":"","firstName":"Dongli","middleName":"","lastName":"He","suffix":""},{"id":307472954,"identity":"5f6a6067-baf9-4477-b3c9-bfb05f1be194","order_by":4,"name":"Zhen-tao Lv","email":"","orcid":"","institution":"Fudan University","correspondingAuthor":false,"prefix":"","firstName":"Zhen-tao","middleName":"","lastName":"Lv","suffix":""},{"id":307472955,"identity":"8486dc60-dfb5-41b4-af65-ee27bacaed85","order_by":5,"name":"Qiang Shi","email":"","orcid":"","institution":"Fudan University","correspondingAuthor":false,"prefix":"","firstName":"Qiang","middleName":"","lastName":"Shi","suffix":""},{"id":307472956,"identity":"f354d8c8-4e0e-4d22-a60b-af1d28384b3f","order_by":6,"name":"Yun-shi Zhong","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA3UlEQVRIiWNgGAWjYDACCTiDsfEBA8MB0rQ0G5CqhYFNgigt8rObjz382nY4D8hoq+apuSPHz8D88NENPFoY5xxLN5ZtO1xscOdg222eY8+MJRvYjI1z8Ghhlsgxk5ZsO5y4QSIRqIUNyDjAwyaNTwsbTMv8GYltxTz/iNDCA9Qi+RGopeFGYhszbxsRWiQk0tKkGc6lJ264kdgsObfvsLFkMwG/yM9IPib5o8wa6LD0hx/efDssx8/e/PAxPi0gwMzLBmEw8YC5BJSDAOOPPzAGEapHwSgYBaNg5AEA87hPgrtTpyoAAAAASUVORK5CYII=","orcid":"","institution":"Fudan University","correspondingAuthor":true,"prefix":"","firstName":"Yun-shi","middleName":"","lastName":"Zhong","suffix":""}],"badges":[],"createdAt":"2024-05-27 11:17:09","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4484601/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4484601/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":58172498,"identity":"1b900622-eee1-4ec4-b58b-4a4a5a5ca297","added_by":"auto","created_at":"2024-06-12 03:53:55","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":862959,"visible":true,"origin":"","legend":"\u003cp\u003eEFTR procedure: A, An submucosal tumor was located in the rectum. B, Mark the edge of the tumor. C, Resect the tumor. D, The wound surface after tumor resection. E, Closing the defect with clips. F, Specimen of the tumor.\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-4484601/v1/e046b76f19cfed465a3ac0f0.png"},{"id":72116229,"identity":"879b127b-b2a9-4eab-aa3e-a79e09860d84","added_by":"auto","created_at":"2024-12-22 22:46:20","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1950090,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4484601/v1/e32b865b-07f0-4a18-9e25-7777f51714d9.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Safety and Efficacy of Exposed Endoscopic Full-thickness Resection for Colorectal Submucosal Tumors Originating from Muscularis Propria","fulltext":[{"header":"Originality statement","content":"\u003cp\u003eThis paper adds to the literature by demonstrating the safety and efficacy of exposed endoscopic full-thickness resection (EFTR) for colorectal submucosal tumors, providing evidence of successful tumor removal, low complication rates, and good postoperative outcomes, expanding the indications for endoscopic treatment of SMTs.\u003c/p\u003e"},{"header":"Introduction","content":"\u003cp\u003eColorectal submucosal tumors (SMTs) refer to the prominent change of the colon and rectum, whose epithelium of the mucosa is intact. And, it includes the pathological changes from the structure of each layer of the intestinal wall and the masses formed by the compression of the intestinal wall by extraluminal physiological or pathological tissues[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. SMT is usually asymptomatic and is mostly detected in physical examination. However, with the increase of the lesion volume, bleeding, obstruction and other symptoms may also occur[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eEndoscopic resection of the SMTs is a promising minimally invasive alternative surgery for the treatment of gastrointestinal SMTs, due to the rapidly development of endoscopic resection technics. Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are two acceptable endoscopic resection techniques, which are applicable to lesions involving the mucosa and submucosa\u003csup\u003e4\u003c/sup\u003e. However, ESD and EMR have some limitation for the lesion with bigger size or from the deeper muscularis propria (MP)[\u003cspan additionalcitationids=\"CR6\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] Therefore, with the continuous development of suture technology and endoscopic instruments, endoscopic full-thickness resection (EFTR) has attracted extensive attention of endoscopists. EFTR can be divided into exposed EFTR and non-exposed EFTR according to the sequence of lesion resection and serosal closure during operation[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. In western countries, with advanced instruments, always adopt non-exposed EFTR, that is, with the aid of FTRD devices, suture first and then resect[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Due to the special intraluminal environment, exposed EFTR in colon and rectum will increase the risk of abdominal infection[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Also, exposed EFTR has high requirements for surgical and suturing techniques. Therefore, at present, exposed EFTR is mostly used in the resection of upper gastrointestinal diseases, while the evidence of colorectal SMT removed by exposed EFTR is less\u003csup\u003e9\u003c/sup\u003e. Considering that closed EFTR devices such as FTRD are not available in most of the endoscopy centers in China. And, in recent years, endoscopic suturing devices and technologies such as OTSC system, purse suture with clip and nylon rope have been proved to be effective in suturing of gastrointestinal wall defects[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. In our study, we aimed to research the safety and efficacy of exposed EFTR in the treatment of colorectal SMTs through retrospective data analysis.\u003c/p\u003e"},{"header":"Patient and method","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003ePatients\u0026rsquo; data\u003c/h2\u003e \u003cp\u003eWe retrospectively analyzed the patients who underwent exposed EFTR for colorectal SMT in Zhongshan Hospital of Fudan University (n\u0026thinsp;=\u0026thinsp;19) and Zhongshan-Xuhui Hospital (n\u0026thinsp;=\u0026thinsp;7) between March 2012 and December 2022. All patients underwent computed tomography (CT) or endoscopic ultrasonography (EUS) before the resection to determine the origin of the tumor and its relationship with adjacent vessels. And, we registered the information of patients in detail, such as basic information, medical history, preoperative and postoperative conditions, surgical conditions, postoperative complications, etc. for analysis.\u003c/p\u003e \u003cp\u003eThis study was approved by the Ethics Committee of Zhongshan Hospital affiliated to Fudan University. All patients voluntarily chose the treatment course and provided written informed consent. In this study, EFTR procedure were performed by experts who were familiar with ESD and EFTR technology.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eProcedure\u003c/h2\u003e \u003cp\u003eThe peri-tumor colorectal tissues were incised with a knife, and then, the tumor and peri-tumor colorectal tissues were gradually resected in full thickness using an insulated-tip knife. An iatrogenic colorectal perforation was created. During the resection, hemostasis was obtained with electric cautery. Then, closed the wound with a metal clip, or combine nylon lanyard for purse suture.\u003c/p\u003e \u003cp\u003ePostoperative treatment included 24 hours fasting (both food and water), and routine use of antibiotics. All patients were closely observed. For the patients who suffered obvious adverse events. If conservative treatment fails, surgical treatment shall be performed.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eAdverse event\u003c/h2\u003e \u003cp\u003eDelayed perforation: Patients may have sudden severe abdominal pain and bloating after surgery, and abdominal upright films or abdominal CT reveal new free gas under the diaphragm or retroperitoneal gas, or upper gastrointestinal tract imaging shows signs of contrast agent leakage[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eBleeding: Patients may have bleeding symptoms such as hematemesis or melena caused by endoscopic treatment of lesions 0\u0026ndash;28 days after surgery, and the bleeding site is identified by endoscopy[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e \u003cp\u003ePost-polypectomy syndrome: Fever accompanied by moderate or severe localized abdominal pain occurs after EFTR surgery. Meanwhile, imaging examination excludes obvious perforation[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cdiv id=\"Sec6\" class=\"Section3\"\u003e \u003ch2\u003ePathological examination\u003c/h2\u003e \u003cp\u003eAfter the endoscopic resection, all tumor specimens were fixed in 10.0% formalin solution, and nailed on the plate to send for pathological evaluation. The routine pathological assessment was stained by hematoxylin and eosin. For the differentiation, immunohistochemical staining was necessary.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eAll data were analyzed by IBM SPSS statistics 20 statistical software. Continuous values were presented as the mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation (SD) or median (IQR). Categorical values were presented as frequencies and proportions.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003ePatient and lesion data\u003c/h2\u003e \u003cp\u003eThe clinicopathological characteristics of 26 patients were presented in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. The study enrolled 26 patients aged 56(45.25,65) year, including 12 males and 14 females. Most of the patients were asymptomatic (76.92%) and found the colorectal SMT incidentally through physical examination. While among the patients who actively consult a doctor due to symptoms, 2 presented with the change of defecation habits (7.69%), 2 with abdominal pain (7.69%), 1 with hematochezia (3.85%), and 1 with the increased CEA level (3.85%).\u003c/p\u003e \u003cp\u003eThe median tumor diameter was 13.5(8.5, 20.0) mm. The tumor was located mostly in the rectum. And, 8 lesions located in the anatomically difficult part: 2 in the Ileocecum, 2 in the sigmoid colon. 4 in the lower rectum. According to the histopathology, of the 26 cases of colorectal SMTs, 13 (50%) were determined to be GIST, 7(26.92%) were schwannoma, 3(11.54%) were endometriosis, 2(7.69%) were Leiomyoma. During the follow-up time 43.5(22.5,48) months, no metastasis or recurrence was observed.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ePatient and lesion data\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePatient characteristic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12(46.15%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14(53.85%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge, median (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e56(45.25,65)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eComorbidity, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypertension\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2(7.69%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCardiovascular disease\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1(3.85%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOthers\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHistory of abdominal surgery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5(19.23%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSymptom\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAsymptomatic\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20(76.92%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChange of defecation habits\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2(7.69%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHematochezia\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1(3.85%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAbdominal pain\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2(7.69%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIncreased CEA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1(3.85%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLocation of lesion, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIleocecum\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2(7.69%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCecum\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6(23.08%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAscending colon\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2(7.69%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTransverse colon\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2(7.69%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDescending colon\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2(7.69%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSigmoid\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2(7.69%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRectum\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10(38.46%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLower rectum (0-5cm from anus)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4(15.38%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUpper rectum (\u0026gt;5-12cm from anus)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6(23.07%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMaximum diameter of lesion, median (IQR)mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13.5(8.5, 20.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHistopathology of the lesion\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEndometriosis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3(11.54%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGIST\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13(50%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSchwannoma\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7(26.92%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLeiomyoma\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2(7.69%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCollagenous fibroma\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1(3.85%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFollow up time\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e43.5(22.5,48)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eProcedural data\u003c/h2\u003e \u003cp\u003eDuring the resection, the technical success rate was 100%. All lesions were resected completely. The median procedural time was 46.5(29.25, 63.25) min. During the surgery, endoscopist find that most of the SMTs were originated from the muscularis propria (65.38%). And, 7(26.92%) lesions were originated from deeper muscularis propria and closed adhesion with serosa. After the removal of the tumor, 13(50%) surgical wound were sutured by metal clip and 13(50%) were sutured with metal clips combined with nylon cord (Table \u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eProcedural data\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedian procedure time, median (IQR), min\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e46.5(29.25, 63.25)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOrigin of the lesion\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMuscularis propria\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e17(65.38%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSerosa\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7(26.92%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTechnical success\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26(100%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eComplete resection\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26(100%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDental floss ligation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4(15.38%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMethod of suture\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMetal clips\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13(50%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMetal clips combined with nylon cord\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13(50%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eAdverse events.\u003c/p\u003e \u003cp\u003eThree of the 26 patients were suffered from post-polypectomy syndrome (11.54%). All were improved after conservative treatment such as fasting, strengthening anti-inflammatory treatment, rehydration and gastrointestinal decompression. 1 patient were suffered from postoperative bleeding (3.85%), of whom performed emergency endoscopic hemostasis. One patient (3.85%) suffered postoperative perforation and transferred to perform exploratory laparotomy to repair the defect. All patients improved after treatment, and no patient died because of the adverse events.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eAdverse event\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAdverse event\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003en (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePost-polypectomy syndrome\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3(11.54%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBleeding\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1(3.85%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDelayed Perforation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1(3.85%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe pathological types of SMTs are complex, but most of them are benign, while only a few are malignant. Gastrointestinal stromal tumor (GIST) is a tumor with certain malignant potential, but its malignant potential depends on its size, location, and type [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. GIST with a diameter of less than 2 cm has a low risk of malignancy, and the treatment recommended in the guidelines is controversial[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. For GIST larger than 2cm, surgical treatment is recommended due to its high risk of malignancy[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. In our study, 13 of 26 lesions were determined to be GIST, and only 5 of them were larger than 2 cm. Considering that both endoscopy and EUS are invasive examinations, and long-term follow-up will pose a significant economic burden, most patients who came to our center hope to undergo endoscopic resection even if small SMTs were found during the examination process.\u003c/p\u003e \u003cp\u003eClinically, lesions of the gastrointestinal tract which originate from the MP layer, closely adhere to the serous layer or grow outside the cavity are the surgical indications of EFTR. Studies have shown that exposed EFTR can treat the lesion originated from MP of the stomach with good safety and efficacy[\u003cspan additionalcitationids=\"CR16\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. But for the colorectal lesions, the studies were mainly focused on the non-exposed EFTR. The full-thickness resection device (FTRD) of the colorectal non-exposed EFTR can remove the lesions after the OTSC closes the wound, but it is limited by the size of the lesion, and is mainly applicable to complex adenoma, early adenocarcinoma and SMT with a diameter of \u0026lt;\u0026thinsp;2.0 cm[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Schmidt et al[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] reviewed 25 cases of colorectal EFTR treated with FTRD, of which 2 cases were colon SMT, with a complete resection rate of 75.0% (18/24). And, 1 patient was unable to use the FTRD device due to sigmoid stenosis. There were no significant adverse events happened. Subsequently, many studies have suggested that non-exposed EFTR is safe and effective in the treatment of colorectal lesions, but the lesions involved in the study are mostly mucosal lesions, and there are only a few reports of submucosal tumors[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. In our study, we demonstrated a total technical success rate of 100% for exposed EFTR on treatment of colorectal SMTs. The median tumor diameter was 13.5(8.5, 20.0) mm. And, 9 of 26 lesions were larger than 2 cm, which may suggest that exposed EFTR may not be limited by the size of the lesion as non-exposed EFTR. Additionally, lesions located in the ileocecum, sigmoid, and lower rectum were considered as technical difficult location for EMR or ESD, which is associated with high risk of adverse event or long procedure time[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. In our study, 8 lesions located in the anatomically difficult part. All these lesions were removed completely without adverse event. Therefore, we supposed that compared with non-exposed EFTR, ESD and EMR, exposed EFTR were further extended the indication of endoscopic treatment for SMTs. It is worth noted that exposed EFTR require a high level of endoscopic treatment techniques, and the surgeons performing the procedures in our study were all expert with extensive experience in endoscopic treatment.\u003c/p\u003e \u003cp\u003eDuring the exposed EFTR procedure, physicians should pay more attention to the prevention of air and fluid leakage as well as the completeness of wound closure. Metal clip suturing is the most basic suturing technique for EFTR intraoperative wound closure. As the span of metal clamps is limited, the perforation cannot be closed at one time for larger wound. So, the Chinese guideline recommends \"suction-clamping suture\", which means to suction the gas in the lumen of the digestive tract to sufficiently reduce the perforation, and then use multiple metal clamps to close the perforation[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Alternatively, a double-clamp endoscope can be used to reinforced the suturing with nylon string using a \"string suture\" method[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. In recent years, the development of novel techniques such as over-the-scope clip and OverStitch suture for repairing GI injuries and managing bleeding will further promote the use of EFTR techniques[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. Among our study, 13(50%) surgical wounds were sutured by metal clip and 13(50%) were sutured with Metal clips combined with nylon cord.\u003c/p\u003e \u003cp\u003eLiteratures reported that postoperative bleeding rate of EFTR with FTRD were 2.2%-4.5%[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. The common complications were post-polypectomy syndrome with abdominal pain, fever and signs of inflammation on blood chemistry tests of which the accident rate was 1.7%-8.9%[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. In our study. only one patient (3.85%) whose lesion sized 10mm and located in cecum suffered from postoperative perforation and transferred to perform exploratory laparotomy to repair the defect. And, 3 of the 26 patients were suffered from post-polypectomy syndrome (11.54%). 1 patient were suffered from postoperative bleeding and performed emergency endoscopic hemostasis. All patients improved after treatment, and no patient died because of the adverse events. Compared with the previous study, we supposed that adverse events in our study were acceptable.\u003c/p\u003e \u003cp\u003eOur study still has some limitations. The sample size of our study is still insufficient for factor regression analysis. Moreover, our study was included two centers\u0026rsquo; data for analysis. It\u0026rsquo;s necessary to carry out a multi-center study with large sample for further analysis of the safety and efficacy of exposed EFTR.\u003c/p\u003e \u003cp\u003eIn summary, exposed EFTR of colorectal SMTs have a reliable efficacy and the complication rates are acceptable. Therefore, exposed EFTR as a treatment of colorectal SMT considered to be safe and effective, but adequate preoperative evaluation should be done, and the procedure should be conducted by expert with sufficient experiences.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and patient consent statement:\u0026nbsp;\u003c/strong\u003eThis study was approved by the Ethics Committee of Zhongshan Hospital affiliated to Fudan University. All patients voluntarily chose the treatment course and provided written informed consent before treatment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePotential conflict of interest:\u003c/strong\u003e The authors have no competing interests to declare.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding statement:\u003c/strong\u003e This work was supported by grants from Shanghai Municipal Health Commission, Collaborative Innovation Cluster Project (grant no. 2019CXJQ02), the National Natural Science Foundation of China (grant no. 82273025, 82203460), and the Science and Technology Commission Foundation of Shanghai Municipality (grant no. 22XD1402200, 22JC1403003, 23ZR1458900).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions:\u0026nbsp;\u003c/strong\u003eAyimukedisi\u0026middot;Yalikong, Dong-li He. Zhen-tao Lv, Kdinur\u0026middot;Ablat: Data collection and article writing\u003cstrong\u003e;\u0026nbsp;\u003c/strong\u003eYun-shi Zhong, Zhi-peng Qi, Qiang Shi: Critical revision of the article for important intellectual content; Ayimukedisi\u0026middot;Yalikong, Zhi-peng Qi, Dong-li He, Zhen-tao Lv, Yun-shi Zhong. Final approval of the article.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eZhou PH, Zhong YS, Li QL. Guideline and Consensus Chinese Consensus on Endoscopic Diagnosis and Management of Gastrointestinal Submucosal Tumor (Version 2023). Chinese Journal of Practical Surgery. 2023;43(3):241-251. doi:10.19538/j.cjps.issn1005-2208.2023.03.01\u003c/li\u003e\n\u003cli\u003eSharzehi K, Sethi A, Savides T. 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Endoscopic Full Thickness Resection: A Systematic Review. \u003cem\u003eJ Dig Endosc\u003c/em\u003e. 2022;13(03):152-169. doi:10.1055/s-0042-1755304\u003c/li\u003e\n\u003cli\u003eLi B, Shi Q, Xu EP, et al. Prediction of technically difficult endoscopic submucosal dissection for large superficial colorectal tumors: a novel clinical score model. \u003cem\u003eGastrointest Endosc\u003c/em\u003e. 2021;94(1):133-144.e3. doi:10.1016/j.gie.2020.11.012\u003c/li\u003e\n\u003cli\u003eZhou PH, Zhong YS, Li QL. Guideline and Consensus Chinese Consensus on Endoscopic Diagnosis and Management of Gastrointestinal Submucosal Tumor (Version 2018). Chin J Gastrointest Surg, 2018,21(8): 841-852. DOI: 10.3760/cma.j.issn.1671-0274.2018.08.001\u003c/li\u003e\n\u003cli\u003eBhandari P, Longcroft-Wheaton G. Faculty Opinions recommendation of Over-the-scope clip-assisted endoscopic full-thickness resection of epithelial and subepithelial GI lesions. Published online March 6, 2018:793543405. doi:10.3410/f.726694349.793543405\u003c/li\u003e\n\u003cli\u003eSchmidt A, Damm M, Caca K. Endoscopic full-thickness resection using a novel over-the-scope device. \u003cem\u003eGastroenterology\u003c/em\u003e. 2014;147(4):740-742.e2. doi:10.1053/j.gastro.2014.07.045\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"endoscopic full-thickness resection, submucosal tumors, colorectum","lastPublishedDoi":"10.21203/rs.3.rs-4484601/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4484601/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjectives\u003c/h2\u003e \u003cp\u003eEndoscopic resection of the submucosal tumors (SMTs) is a promising minimally invasive alternative surgery for the treatment of SMTs. The aim of this study was to evaluate the safety and efficacy of exposed EFTR in the treatment of colorectal SMTs through retrospective data analysis.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThe patients who underwent exposed endoscopic full-thickness resection (EFTR) for colorectal SMTs in Zhongshan Hospital of Fudan University and Zhongshan-Xuhui Hospital between March 2012 and December 2022 were enrolled. The information of patients, such as basic information, medical history, preoperative and postoperative conditions, surgical conditions, postoperative complications, etc. were collected for analysis.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe study enrolled 26 patients. Most of the patients were asymptomatic (76.92%) and found the colorectal SMT through physical examination. The size of the tumor was13.5(8.5,20.0) mm. And, the tumor located mostly in the rectum. During the resection, the technical success rate was 100%. The median procedural time was 46.5(29.25,63.25) min. Of the 26 cases of colorectal SMTs, 13 (50%) were determined to be GIST. As for the adverse events, 3 of the 26 patients were suffered from post-polypectomy syndrome (11.54%), one patient was suffered from postoperative bleeding (3.85%), of whom performed emergency endoscopic hemostasis; One patient (3.85) suffered from postoperative perforation and transferred to perform exploratory laparotomy to repair the defect. All patients improved after treatment, and no patient died because of the adverse events. During the follow-up time 43.5(22.5,48) months, no metastasis or recurrence was observed.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eExposed EFTR for colorectal SMTs originating from muscularis propria is effective with an acceptable incidence rate of adverse events and good postoperative recovery.\u003c/p\u003e","manuscriptTitle":"Safety and Efficacy of Exposed Endoscopic Full-thickness Resection for Colorectal Submucosal Tumors Originating from Muscularis Propria","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-06-12 03:53:50","doi":"10.21203/rs.3.rs-4484601/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"1c0cfba7-bff5-40e6-a8ce-1629bc7c3738","owner":[],"postedDate":"June 12th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-12-22T22:38:12+00:00","versionOfRecord":[],"versionCreatedAt":"2024-06-12 03:53:50","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4484601","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4484601","identity":"rs-4484601","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}