Comparison of purse-string suture versus over-the-scope clip for gastric endoscopic full-thickness closure: traction and leak pressure testing in ex vivo porcine model

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The main closure methods are the purse-string suture (PSS) technique and over-the-scope clip (OTSC) technique; however, basic data on the suture strength of each technique are lacking. This study was performed to compare the suture strengths of these two methods in an ex vivo porcine model. Methods In the traction test, a virtual 5-cm full-thickness suture line was closed by the following six methods three times each: conventional hemoclips, mucosal PSS, seromuscular PSS, mucosal OTSC, seromuscular OTSC, and surgical suture. The primary endpoint was the tension at the starting point of dehiscence, measured in Newtons (N) by an automatic traction machine. In the leak test, a 15-mm gastric full-thickness defect was closed by PSS or OTSC six times each, and the sutured stomach was then pressurized in a water container. The primary endpoint was the leak pressure when air bubbles appeared. The secondary endpoints were the procedure time and presence of complete inverted closure. Results The mean tension was 2.16, 3.68, 5.15, 18.30, 19.30, and 62.40 N for conventional hemoclips, mucosal PSS, seromuscular PSS, mucosal OTSC, seromuscular OTSC, and surgical suture, respectively. Complete inverted closure was observed for seromuscular PSS, seromuscular OTSC, and surgical suture. The mean leak pressure was 13.7 and 24.8 mmHg in the PSS and OTSC group, respectively (P < 0.01). The mean procedure time was 541 and 169 seconds in the PSS and OTSC group, respectively (P < 0.01). Complete inverted closure was observed in OTSC alone. Conclusion The OTSC, which allows complete inverted closure, showed greater suture strength than PSS. Endoscopic closure Endoscopic full-thickness resection Purse-string suture Over-the-scope clip Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Introduction Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors of the gastrointestinal tract[1], with a reported incidence of 10 to 15 per million people per year[2]. The stomach is the most common site of GISTs, accounting for 55.6% of cases[2]. The 5-year survival rate in patients with GISTs is 83%, and this rate increases to 93% when GISTs are organ-confined[3]. Therefore, it is important to treat GISTs when they are organ-confined. Surgical intervention is the first therapeutic option for resectable GISTs, and partial gastrectomy or gastric wedge resection is the standard of care[4]. Laparoscopic and endoscopic cooperative surgery emerged in 2008[5] as a minimally invasive treatment for GISTs. Because of its high reported efficacy and safety[6], this procedure has been widely performed in Japan and around the world. In 2001, endoscopic full-thickness resection (EFTR) was developed to achieve complete resection of gastrointestinal neuroendocrine tumors and defect closure using only a flexible endoscope[7]. EFTR without laparoscopic assistance has several advantages over conventional approaches. No scar occurs on the skin surface, leading to a reduction in patient complaints. Additionally, the nerves around the stomach are preserved, preventing postoperative gastric motility disorder[8]. Thus, EFTR is considered a more minimally invasive procedure. Although EFTR has already been clinically introduced in some countries[9] [10], several issues remain unresolved[11]. The most important of these issues is reliable endoscopic closure of the full-thickness defect after EFTR. Major endoscopic closure methods include the use of hemoclips[12], the purse-string suture method (PSS)[13], and the over-the-scope clip (OTSC)[14][15] , but sufficient evidence regarding these closure methods during EFTR is lacking. Accordingly, the suture strength of each method must be compared to establish the most appropriate closure technique. However, few reports have examined and compared the suture strength of these closure methods. This study was performed to examine the suture strengths of PSS and OTSC in an ex vivo porcine model and explore a closure method suitable for EFTR. Methods This ex vivo study involved 18 porcine stomachs isolated from pigs used for food. Fresh ex vivo stomachs were harvested from mixed-breed pigs weighing 100 to 120 kg at 6 months of age (Tokyo Shibaura Zouki, Tokyo, Japan). These pigs were raised on farms in Japan and euthanized for food while unconscious from CO2. The porcine stomachs were frozen and thawed immediately before use. We then washed the insides of the stomachs with tap water. A flexible endoscope and endoscopic instruments were prepared for performance of each endoscopic closure method. The ex vivo study consisted of traction and air leak pressure tests to evaluate the suture strength of each closure method for EFTR. Finally, all obtained data were compared among the suture methods. Traction test Study protocol Six porcine stomachs were prepared, and for each porcine stomach, three specimens of 8-cm length and 5-cm width were excised from the greater curvature of the body of the stomach, resulting in a total of 18 specimens. The full-thickness layers were disconnected at the center of the 8-cm-long side of the specimen, and the dehiscence line was sutured by each closure method. Each stomach was sutured using the same method for each of the three specimens (Figure 1). All closure methods using endoscopic instruments were performed using a flexible endoscope. The closure methods were categorized into the six methods described below and shown in Figure 2. Endoscopic procedures Group A: Hemoclip closure (n = 3) Hemoclips (HX-610-090; Olympus, Tokyo, Japan) were used to suture the dehiscence line at 7-mm intervals. Group B: PSS (mucosal closure) (n = 3) A detachable endoloop (MAJ-254; Olympus) was placed to cover both sides of the dehiscence line. After fixing it to the mucosal surface with eight hemoclips at 7-mm intervals, the dehiscence line was sutured while tightening the endoloop. Group C: PSS (seromuscular closure) (n = 3) After anchoring the endoloop on both the serosa and muscle using hemoclips, the above-described PSS method was applied. Group D: OTSC closure (mucosal closure) (n = 3) A 12-mm OTSC (12-gc type; Ovesco Endoscopy AG, Tübingen, Germany)[15] was mounted on the tip of the endoscope (GIF-260QJ; Olympus). After only the mucosa of both edges on the dehiscence line was grasped with Twin Grasper forceps (TG forceps) (Ovesco Endoscopy AG), an OTSC was fired while pulling the TG forceps into the cap. Two OTSCs were used to suture the 5-cm dehiscence line. Group E: OTSC closure (seromuscular closure) (n = 3) After the serosa as well as the muscle layers of both edges on the dehiscence line were grasped with the TG forceps, the above-described OTSC closure technique was used. Group F: Surgical hand suture (n = 3) Using a 3-0 surgical nylon thread, the surgeon sutured the 5-cm dehiscence line from the serosal side with Albert-Lembert sutures at 7-mm intervals. Mechanical measurement A traction machine (Autograph; Shimadzu Corporation, Kyoto, Japan) was used to measure the traction strength. Both sides of each sutured specimen were fixed on the lower and upper arms. The upper arm automatically pulled the specimen toward the upper direction at the speed of 1 mm/s (Figure 3). The traction strength was measured in Newtons (N) based on the computer-generated waveform. Outcome measures The primary endpoint was comparison of the tension when the dehiscence began, which correlated with the top of the first waveform. The secondary endpoint was the presence or absence of complete inverted closure on the serosal surface. Complete inverted closure was defined as inversion of the whole suture line. The presence of complete inverted closure was evaluated by three specialized endoscopists. Air leak test Study protocol A 15- × 15-mm full-thickness defect was created with a surgical scalpel from the serosal side in the anterior wall of the gastric upper body. A 15- × 15-mm circular paper was used to unify the size of all defects. The hole on the duodenal side was closed with surgical nylon to prevent other air leaks. An endoscope was inserted into the stomach via the hole on the esophageal side, and closure was then performed. Twelve porcine stomachs were randomly assigned to two groups for defect closure: the PSS group (n = 6) or OTSC group (n = 6). The defect was closed by PSS or OTSC without hand assistance. Endoscopic procedures In the PSS group (n = 6), an endoloop was placed on the defect. After fixing it onto the full-thickness layer with six hemoclips at 5-mm intervals, the defect was sutured while tightening the endoloop. In the OTSC group (n = 6), the full-thickness layers of both edges of the defect were grasped with the TG forceps, and the above-described OTSC closure technique was then performed using a single OTSC. Mechanical measurement After completion of the defect closure, two tubes of a blood pressure instrument were inserted into the stomach via the hole on the esophageal side of the endoscopic access route One of the tubes was connected to a pump that could be pressurized to inflate the porcine stomach, and the other tube was connected to a vacuum gauge calibrated in millimeters of mercury (mmHg) to measure the pressure in the stomach. The sealed stomach was inserted into a container filled with water using multiple surgical forceps. The stomach was slowly inflated using the air pump. Finally, the pressure gauge reading was recorded as the leak pressure when air bubbles were observed at the suture site (Figure 4). Outcome measures The primary endpoint was comparison of the mean leak pressure (mmHg) between PSS and OTSC. The secondary endpoints were the procedure time and presence of complete inverted closure. The procedure time was the duration between the start and completion of each closure method. The criterion for the start was deployment of the endoloop around the defect in the PSS group or the grasping of one side of the defect with the TG forceps in the OTSC group. In both groups, completion of a closure method was defined as the confirmation of complete closure. Statistical analyses All statistical analyses were performed with GraphPad Prism 7.0 (GraphPad Software, San Diego, CA, USA). Comparisons between each group were performed by one-way analysis of variance and the Mann-Whitney U test. A P -value of <0.05 was considered significant. This study did not require IRB approval. Results Traction test The mean ± standard deviation (SD) traction tension measured for three samples in each group was 2.16 ± 0.11 N, 3.68 ± 0.70 N, 5.15 ± 0.61 N, 18.30 ± 2.16 N, 19.30 ± 0.34 N, and 62.40 ± 7.26 N for Groups A, B, C, D, E, and F, respectively (Fig. 5 ). There were no significant differences among Groups A, B, and C. Compared with these three groups, Groups D, E, and F had significantly stronger traction tension. In addition, there was no significant difference between Groups D and E. However, the traction tension was significantly stronger in Group F than in Groups D and E (Fig. 5 ). Complete inverted closure was observed in Groups C, E, and F (Fig. 6 ). Air leak test The mean ± SD air leak pressure by the suture method was 13.7 ± 3.35 mmHg in the PSS group and 24.8 ± 3.13 mmHg in the OTSC group (Fig. 7 ). In the statistical analysis, the OTSC group showed a significantly higher leak pressure than the PSS group ( P < 0.01). The mean ± SD procedure time was significantly shorter in the OTSC group than in the PSS group (168.5 ± 25.1 vs. 540.8 ± 101 seconds, respectively) (Fig. 8 ). Complete inverted closure was observed only in the OTSC group; the PSS group showed absence of complete inverted closure [50% (3/6)] as well as partial closure [50% (3/6)] (Fig. 9 ). Discussion This is the first study to compare the suture strength of endoscopic closure methods for gastric full-thickness defects using traction force and air leak pressure testing. In this basic study, we found that an OTSC suitable for inverted closure produced a higher suture strength than PSS. EFTR is still challenging, and several issues regarding its establishment have been raised. Among these issues, the most important is the development of a reliable endoscopic closure method for full-thickness defects. Inadequate closure can cause dehiscence of the suture line, leading to serious complications such as peritonitis and sepsis. Therefore, the suture strength of current closure methods should be fundamentally acknowledged. In our comparative study, we selected conventional hemoclip closure, PSS[ 16 ], and OTSC[ 16 ], all of which have been reported as the main endoscopic closure methods after EFTR. We then performed two tests, namely mechanical traction and air leak pressure tests, that have been traditionally evaluated in the surgical field. The traction test showed no significant difference in traction strength between hemoclip closure and PSS; however, the traction strength of OTSC was significantly stronger than that of hemoclip closure and PSS. The air leak test also showed that the intragastric pressure required to cause an air leak was significantly higher in OTSC than in PSS, indicating that OTSC has greater suture strength. The procedure time was shorter in OTSC than in PSS. Whereas anchoring several hemoclips around the endoloop requires a longer time in PSS, TG forceps-assisted OTSC enables closure of a large defect in a single step. These two tests concluded that the suture strength was greater in the OTSC group than in the PSS group. Meanwhile, both the traction strength and air leak pressure were lower in the OTSC group than in the surgical suture group. In clinical practice, the degree of leak pressure needed for durable closure after EFTR should be discussed. The intragastric pressure during physiological fasting is considered to be 6.6 mmHg[ 17 ], and the pressure does not increase even with food intake[ 18 ]. The mean leak pressures in this study, which were 13.7 mmHg in the PSS group and 24.8 mmHg in the OTSC group, were higher than the previously reported pressure of 6.6 mmHg. Therefore, both PSS and OTSC may be acceptable means of closing the suture line after EFTR under usual conditions. However, because the intragastric pressure increases with obesity[ 19 ] and markedly increases during coughing and vomiting[ 20 ], a tighter suture is preferable in these situations. Whether mucosal closure or seromuscular closure is suitable for full-thickness closure remains unclear. The PSS technique[ 21 ] principally anchors the circumferential mucosa around the defect, whereas clip anchoring of the seromuscular layer of both defect edges is expected to be better for inverted closure. In OTSC, the areas grasped by the TG forceps were also divided into mucosa or serosa-muscle. We therefore conducted two patterns of mucosal closure or seromuscular closure. In this comparison in the PSS group, although not significant, the traction strength tended to be slightly stronger in seromuscular closure than in mucosal closure. In the traction test, complete inverted closure of the serosa-muscle layer was observed only in seromuscular closure in both the PSS and OTSC groups. In the air leak test, complete inverted closure was observed only in the OTSC group. The principle of surgical suturing is traditionally based on inverted suturing of the serosa-muscle layer, such as the Albert-Lembert suture technique[ 22 ] , [ 23 ]. However, even if endoscopic closure using hemoclips (as in PSS) appears endoluminally to be complete defect closure, the state of the serosal side is not well known. The present study clarified that mucosal closure does not satisfy the criterion for inverted closure being suitable for surgical suture. Thus, anchoring hemoclips on the serosa-muscle or full-thickness layer seems mandatory in PSS, and grasping these layers with TG forceps is also favorable in OTSC. A previous ex vivo porcine study showed that gastric OTSC closure of 15-mm full-thickness defects sustained a higher mean (± SD) air leak pressure (74.9 ± 17.5 mmHg) than surgical stapling (64.6 mmHg)[ 24 ]. Moreover, gastric OTSC closure of mean 16.29 -mm full-thickness defects sustained a similar air leak pressure (72.5 mmHg) in the porcine stomach in natural orifice transluminal endoscopic surgery (NOTES)[ 25 ]. These leak pressures were higher than that obtained in the present study (24.8 mmHg). The difference may be explained by technical aspects, such as pulling the defect into the OTSC cap using TG forceps, as well as the difference in the gastric wall thickness of the porcine models. In a previous study, the mean leak pressures at the gastric closure sites were 32.5 mmHg for 5-mm defects, 111.9 mmHg for 10-mm defects, 74.9 mmHg for 15-mm defects, 49.3 mmHg for 20-mm defects, and 15.2 mmHg for 25-mm defects[ 24 ]. Thus, the closure pressure decreased as the defect size increased. As addressed below in the description of the third limitation of this study, the leak pressure for a 30-mm defect that meets the defect size suitable for EFTR should be further investigated. A recent meta-analysis revealed that the clinical complication rate of EFTR was 1.6%, including a 0.1% rate of delayed suture dehiscence and a 0.9% rate of intra-abdominal infection[ 9 ]. Three studies demonstrated that intra-abdominal infection occurred in either hemoclip closures or PSS, whereas none occurred in OTSC use[ 9 ]. This study has three limitations. First, the experiment was conducted using a porcine stomach. The thickness of the mucosa and muscular layer and the expansion and contraction of the gastric wall differ from those of a human stomach. Nevertheless, different endoscopic closure methods were compared under the same conditions to examine the suture strength. Second, the durability and wound healing after suturing were not considered because of the nature of the ex vivo experiments. The healing process may differ depending on the closure method used. In vivo studies are ongoing to investigate this issue. Third, the defect size in the leak test was not substantially large (15 mm). EFTR is indicated for gastric GISTs of ≤ 3 cm; thus, we plan to perform measurement of leak pressure in 3-cm defects. Conclusion This ex vivo experimental study demonstrated that OTSC closure, which facilitates complete inverted closure, has greater strength than PSS in full-thickness layer suturing. A clinical study is required to determine whether the basic data obtained in this study are associated with post-EFTR leakage. Abbreviations GISTs: Gastrointestinal stromal tumors EFTR: endoscopic full-thickness resection PSS: purse-string suture OTSC: over-the-scope clip TG forceps: Twin Grasper forceps SD: standard deviation NOTES: natural orifice transluminal endoscopic surgery Declarations Ethics approval and consent to participate: The need for ethics approval was waived by the Animal Care and Use Committee for Kagawa University. Consent for publication: Not applicable Availability of data and materials: All data generated or analysed during this study are included in this published article Competing interests: The authors declare that they have no competing interests Funding: No funding was received. Authors' contributions : T. M.1 and H.K. were responsible for the study concept and design. N.N., K.N., T.S., N.T., K.K., N.K., T.C., T.Y., A.K., and T.K. were responsible for acquisition of the data. H.K., N.N., K.U., and K.H. were responsible for analysis and interpretation of the data. K.O. and S.F. supplied the materials. T. M.1 and S.F. were responsible for the statistical analysis. H.K. was responsible for revision of the manuscript. T. M.2 was responsible for study supervision Acknowledgements: The authors are grateful to Okura Industrial Co. Ltd., Kagawa, Japan for supporting the traction test using the Autograph device. The authors also thank Angela Morben, DVM, ELS, from Edanz (https://jp.edanz.com/ac) for editing a draft of this manuscript. References Rubin BP, Heinrich MC, Corless CL. Gastrointestinal stromal tumour. Lancet. 2007;369:1731–41. https://doi.org/10.1016/S0140-6736(07)60780-6 . Søreide K, Sandvik OM, Søreide JA, Giljaca V, Jureckova A, Bulusu VR. Global epidemiology of gastrointestinal stromal tumours (GIST): A systematic review of population-based cohort studies. Cancer Epidemiol. 2016;40:39–46. https://doi.org/10.1016/j.canep.2015.10.031 . Wilms C, Be T, Early F, Stages WT. (2018) Wilms Tumor Early Detection, Diagnosis, and Staging Can Wilms Tumors Be Found Early ? Am Cancer Soc 1–15. Grignani G, Boccone P, Varetto T, Cirillo S. (2012) Gastrointestinal stromal tumors. Imaging Tumor Response to Ther 41–60. https://doi.org/10.1007/978-88-470-2613-1_3 . Hiki N, Yamamoto Y, Fukunaga T, Yamaguchi T, Nunobe S, Tokunaga M, Miki A, Ohyama S, Seto Y. Laparoscopic and endoscopic cooperative surgery for gastrointestinal stromal tumor dissection. Surg Endosc Other Interv Tech. 2008;22:1729–35. https://doi.org/10.1007/s00464-007-9696-8 . Matsuda T, Nunobe S, Kosuga T, Kawahira H, Inaki N, Kitashiro S, Abe N, Miyashiro I, Nagao S, Nishizaki M, Hiki N. Laparoscopic and luminal endoscopic cooperative surgery can be a standard treatment for submucosal tumors of the stomach: a retrospective multicenter study. Endoscopy. 2017;49:476–83. https://doi.org/10.1055/s-0043-104526 . Suzuki H, Ikeda K. Endoscopic mucosal resection and full thickness resection with complete defect closure for early gastrointestinal malignancies. Endoscopy. 2001;33:437–9. https://doi.org/10.1055/s-2001-14269 . Waseda Y, Doyama H, Inaki N, Nakanishi H, Yoshida N, Tsuji S, Takemura K, Yamada S, Okada T. Does laparoscopic and endoscopic cooperative surgery for gastric submucosal tumors preserve residual gastric motility? Results of a retrospective single-center study. PLoS ONE. 2014;9:1–5. https://doi.org/10.1371/journal.pone.0101337 . Granata A, Martino A, Amata M, Ligresti D, Tuzzolino F, Traina M. Efficacy and safety of gastric exposed endoscopic full-thickness resection without laparoscopic assistance: a systematic review. Endosc Int Open. 2020;08:E1173–82. https://doi.org/10.1055/a-1198-4357 . Wang C, Gao Z, Shen K, Cao J, Shen Z, Jiang K, Wang S, Ye Y. Safety and efficiency of endoscopic resection versus laparoscopic resection in gastric gastrointestinal stromal tumours: A systematic review and meta-analysis. Eur J Surg Oncol. 2020;46:667–74. https://doi.org/10.1016/j.ejso.2019.10.030 . Aslanian HR, Sethi A, Bhutani MS, Goodman AJ, Krishnan K, Lichtenstein DR, Melson J, Navaneethan U, Pannala R, Parsi MA, Schulman AR, Sullivan SA, Thosani N, Trikudanathan G, Trindade AJ, Watson RR, Maple JT. ASGE guideline for endoscopic full-thickness resection and submucosal tunnel endoscopic resection. VideoGIE. 2019;4:343–50. https://doi.org/10.1016/j.vgie.2019.03.010 . Zhou PH, Yao LQ, Qin XY, Cai MY, Xu MD, Zhong YS, Chen WF, Zhang YQ, Qin WZ, Hu JW, Liu JZ. Endoscopic full-thickness resection without laparoscopic assistance for gastric submucosal tumors originated from the muscularis propria. Surg Endosc. 2011;25:2926–31. https://doi.org/10.1007/s00464-011-1644-y . Shi Q, Chen T, Zhong YS, Zhou PH, Ren Z, Xu MD, Yao LQ. Complete closure of large gastric defects after endoscopic full-thickness resection, using endoloop and metallic clip interrupted suture. Endoscopy. 2013;45:329–34. https://doi.org/10.1055/s-0032-1326214 . Guo J, Liu Z, Sun S, Liu X, Wang S, Ge N, Wang G, Qi Y. Endoscopic full-thickness resection with defect closure using an over-the-scope clip for gastric subepithelial tumors originating from the muscularis propria. Surg Endosc. 2015;29:3356–62. https://doi.org/10.1007/s00464-015-4076-2 . Kobara H, Mori H, Nishiyama N, Fujihara S, Okano K, Suzuki Y, Masaki T. Over-the-scope clip system: A review of 1517 cases over 9 years. J Gastroenterol Hepatol. 2019;34:22–30. https://doi.org/10.1111/jgh.14402 . Kobara H, Nishiyama N, Fujihara S, Tada N, Kozuka K, Matsui T, Takata T, Chiyo T, Kobayashi N, Fujita K, Yachida T, Okano K, Suzuki Y, Nishiyama A, Mori H, Masaki T. Traction-assisted endoscopic full-thickness resection followed by O-ring and over-the-scope clip closure in the stomach: an animal experimental study. Endosc Int Open. 2021;09:E51–7. https://doi.org/10.1055/a-1287-7482 . Turnbull D, Webber S, Hamnegard CH, Mills GH. Intra-abdominal pressure measurement: Validation of intragastric pressure as a measure of intra-abdominal pressure. Br J Anaesth. 2007;98:628–34. https://doi.org/10.1093/bja/aem060 . Janssen P, Verschueren S, Giao Ly H, Vos R, Van Oudenhove L, Tack J. (2011) Intragastric pressure during food intake: A physiological and minimally invasive method to assess gastric accommodation. Neurogastroenterol Motil 23:. https://doi.org/10.1111/j.1365-2982.2011.01676.x . El-Serag HB, Tran T, Richardson PEG. (2006) Anthropometric correlates of intragastric pressure. Scand J Gastroenterol 41:. https://doi.org/10.1080/00365520500535402 . Iqbal A, Haider M, Stadlhuber RJ, Karu A, Corkill S, Filipi CJ. A study of intragastric and intravesicular pressure changes during rest, coughing, weight lifting, retching, and vomiting. Surg Endosc Other Interv Tech. 2008;22:2571–5. https://doi.org/10.1007/s00464-008-0080-0 . Ego M, Abe S, Nonaka S, Suzuki H, Yoshinaga S, Oda I, Saito Y. Endoscopic Closure Utilizing Endoloop and Endoclips After Gastric Endoscopic Submucosal Dissection for Patients on Antithrombotic Therapy. Dig Dis Sci. 2021;66:2336–44. Tera HAC. Tissue holding power to a single suture in different parts of the alimentary tract. Acta Chir Scand. 1976;142:343–8. Yeginsu A, Ergin M, Erkorkmaz U. Strength of esophageal closure techniques with and without tissue reinforcement. World J Surg. 2007;31:1445–8. https://doi.org/10.1007/s00268-007-9084-5 . Matthes K, Jung Y, Kato M, Gromski MA, Chuttani R. Efficacy of full-thickness GI perforation closure with a novel over-the-scope clip application device: An animal study. Gastrointest Endosc. 2011;74:1369–75. https://doi.org/10.1016/j.gie.2011.07.057 . Gonzalez J-M, Saito K, Kang C, Gromski M, Sawhney M, Chuttani R, Matthes K. Prospective randomized comparison of gastrotomy closure associating tunnel access and over-the-scope clip (OTSC) with two other methods in an experimental ex vivo setting. Endosc Int Open. 2015;03:E90–0. https://doi.org/10.1055/s-0035-1547013 . Cite Share Download PDF Status: Published Journal Publication published 26 Jan, 2023 Read the published version in BMC Surgery → Version 1 posted Reviewers agreed at journal 20 Aug, 2022 Reviewers invited by journal 29 Jul, 2022 Editor invited by journal 28 Jun, 2022 Editor assigned by journal 07 Jun, 2022 First submitted to journal 04 Jun, 2022 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. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-1642106","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":124828028,"identity":"148fac36-4c9a-4940-9c52-74324100c0a0","order_by":0,"name":"Takanori Matsui","email":"data:image/png;base64,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","orcid":"https://orcid.org/0000-0002-2517-1258","institution":"Kagawa University Hospital: Kagawa Daigaku Igakubu Fuzoku Byoin","correspondingAuthor":true,"prefix":"","firstName":"Takanori","middleName":"","lastName":"Matsui","suffix":""},{"id":124828029,"identity":"ed0a0b89-5dbd-4fa2-ad48-8a14d61b540d","order_by":1,"name":"Hideki Kobara","email":"","orcid":"","institution":"Kagawa University Hospital: Kagawa Daigaku Igakubu Fuzoku Byoin","correspondingAuthor":false,"prefix":"","firstName":"Hideki","middleName":"","lastName":"Kobara","suffix":""},{"id":124828030,"identity":"0cdc9261-8dfd-4e61-b291-b78674628af3","order_by":2,"name":"Noriko Nishiyama","email":"","orcid":"","institution":"Kagawa University Hospital: Kagawa Daigaku Igakubu Fuzoku Byoin","correspondingAuthor":false,"prefix":"","firstName":"Noriko","middleName":"","lastName":"Nishiyama","suffix":""},{"id":124828031,"identity":"79f67c00-6f76-4d3d-8889-12ba43192ef8","order_by":3,"name":"Kaho Nakatani","email":"","orcid":"","institution":"Kagawa University Hospital: Kagawa Daigaku Igakubu Fuzoku Byoin","correspondingAuthor":false,"prefix":"","firstName":"Kaho","middleName":"","lastName":"Nakatani","suffix":""},{"id":124828032,"identity":"c61ae89d-0813-494a-b59c-55e9c615c4ac","order_by":4,"name":"Tingting Shi","email":"","orcid":"","institution":"Kagawa University Hospital: Kagawa Daigaku Igakubu Fuzoku Byoin","correspondingAuthor":false,"prefix":"","firstName":"Tingting","middleName":"","lastName":"Shi","suffix":""},{"id":124828033,"identity":"d2011f9d-e8c7-4b2e-a3d8-01802d0f4fe0","order_by":5,"name":"Naoya Tada","email":"","orcid":"","institution":"Kagawa University Hospital: Kagawa Daigaku Igakubu Fuzoku Byoin","correspondingAuthor":false,"prefix":"","firstName":"Naoya","middleName":"","lastName":"Tada","suffix":""},{"id":124828034,"identity":"19343f13-d85d-49fc-a13f-01ec670425c5","order_by":6,"name":"Kazuhiro Kozuka","email":"","orcid":"","institution":"Kagawa University Hospital: Kagawa Daigaku Igakubu Fuzoku Byoin","correspondingAuthor":false,"prefix":"","firstName":"Kazuhiro","middleName":"","lastName":"Kozuka","suffix":""},{"id":124828035,"identity":"41e95bad-c0f1-4abb-9642-a93d7e00c541","order_by":7,"name":"Nobuya Kobayashi","email":"","orcid":"","institution":"Kagawa University Hospital: Kagawa Daigaku Igakubu Fuzoku Byoin","correspondingAuthor":false,"prefix":"","firstName":"Nobuya","middleName":"","lastName":"Kobayashi","suffix":""},{"id":124828036,"identity":"8ef80aaa-178d-4df5-8c13-32b1bf9690f0","order_by":8,"name":"Taiga Chiyo","email":"","orcid":"","institution":"Kagawa University Hospital: Kagawa Daigaku Igakubu Fuzoku Byoin","correspondingAuthor":false,"prefix":"","firstName":"Taiga","middleName":"","lastName":"Chiyo","suffix":""},{"id":124828037,"identity":"5147bffe-1aff-4288-9079-197af5558204","order_by":9,"name":"Tatsuo Yachida","email":"","orcid":"","institution":"Kagawa University Hospital: Kagawa Daigaku Igakubu Fuzoku Byoin","correspondingAuthor":false,"prefix":"","firstName":"Tatsuo","middleName":"","lastName":"Yachida","suffix":""},{"id":124828038,"identity":"284343a2-f3f9-423b-9be2-cb3e1dea8d07","order_by":10,"name":"Akihiro Kondo","email":"","orcid":"","institution":"Kagawa University Hospital: Kagawa Daigaku Igakubu Fuzoku Byoin","correspondingAuthor":false,"prefix":"","firstName":"Akihiro","middleName":"","lastName":"Kondo","suffix":""},{"id":124828039,"identity":"da9ec6ac-a02c-481a-a34f-c7297f071421","order_by":11,"name":"Takayoshi Kishino","email":"","orcid":"","institution":"Kagawa University Hospital: Kagawa Daigaku Igakubu Fuzoku Byoin","correspondingAuthor":false,"prefix":"","firstName":"Takayoshi","middleName":"","lastName":"Kishino","suffix":""},{"id":124828040,"identity":"033ef0a2-aff7-4a70-b775-18211818f69e","order_by":12,"name":"Keiichi Okano","email":"","orcid":"","institution":"Kagawa University Hospital: Kagawa Daigaku Igakubu Fuzoku Byoin","correspondingAuthor":false,"prefix":"","firstName":"Keiichi","middleName":"","lastName":"Okano","suffix":""},{"id":124828041,"identity":"e2af1192-21d9-40c8-8d9d-99b0c4a89d8a","order_by":13,"name":"Shintaro Fujihara","email":"","orcid":"","institution":"Kagawa University Hospital: Kagawa Daigaku Igakubu Fuzoku Byoin","correspondingAuthor":false,"prefix":"","firstName":"Shintaro","middleName":"","lastName":"Fujihara","suffix":""},{"id":124828042,"identity":"b83a2c52-7fb9-4a68-8d3a-8214973298d6","order_by":14,"name":"Kunihisa Uchita","email":"","orcid":"","institution":"Kochi Red Cross Hospital: Kochi Sekijuji Byoin","correspondingAuthor":false,"prefix":"","firstName":"Kunihisa","middleName":"","lastName":"Uchita","suffix":""},{"id":124828043,"identity":"8fb21edb-9212-48a2-a701-4c881cfa7481","order_by":15,"name":"Kingo Hirasawa","email":"","orcid":"","institution":"Yokohama City University Medical Center: Yokohama Shiritsu Daigaku Fuzoku Shimin Sogo Iryo Center","correspondingAuthor":false,"prefix":"","firstName":"Kingo","middleName":"","lastName":"Hirasawa","suffix":""},{"id":124828044,"identity":"8d70960b-45a1-41ca-ac5e-dfe73d85d565","order_by":16,"name":"Tsutomu Masaki","email":"","orcid":"","institution":"Kagawa University Hospital: Kagawa Daigaku Igakubu Fuzoku Byoin","correspondingAuthor":false,"prefix":"","firstName":"Tsutomu","middleName":"","lastName":"Masaki","suffix":""}],"badges":[],"createdAt":"2022-05-10 13:15:21","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-1642106/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-1642106/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12893-023-01920-z","type":"published","date":"2023-01-26T18:28:54+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":24742535,"identity":"343b354a-8a1a-49d8-8f55-79872598c182","added_by":"auto","created_at":"2022-08-03 18:24:21","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":697252,"visible":true,"origin":"","legend":"\u003cp\u003eProcedure for creating full-thickness specimens of porcine stomach\u003c/p\u003e\u003cp\u003e(a) The porcine stomach was openly incised on the lesser curvature side (black lines).\u003c/p\u003e\u003cp\u003e(b) Three specimens of 8-cm length and 5-cm width were excised from the greater curvature of the body of the stomach (surrounding black).\u003c/p\u003e\u003cp\u003e(c) The full-thickness layers were disconnected at the center of the 8-cm-long side of the specimen, shown as dehiscence lines (black lines).\u003c/p\u003e\u003cp\u003e(d) The dehiscence line was sutured by each closure method. The left figure indicates the mucosal side, and the right figure indicates the serosal side.\u003c/p\u003e","description":"","filename":"Fig01.png","url":"https://assets-eu.researchsquare.com/files/rs-1642106/v1/80d911434b97f2ed4b18d81e.png"},{"id":24742533,"identity":"9b7e38ee-dfe8-4429-92ad-39c0e461e822","added_by":"auto","created_at":"2022-08-03 18:24:21","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":870175,"visible":true,"origin":"","legend":"\u003cp\u003eSix closure methods\u003c/p\u003e\u003cp\u003eLeft three specimens: mucosal side, Right three specimens: serosal side in each group\u003c/p\u003e\u003cp\u003eGroup A: hemoclip closure, Group B: purse-string suture (PSS) (mucosal closure), Group C: PSS (seromuscular closure), Group D: over-the-scope clip (OTSC) closure (mucosal closure), Group E: OTSC closure (seromuscular closure), Group F: surgical hand suture\u003c/p\u003e","description":"","filename":"Fig02.png","url":"https://assets-eu.researchsquare.com/files/rs-1642106/v1/84d77c526ac0886183aaeca7.png"},{"id":24744607,"identity":"17b658e4-3ae8-4c38-8ad3-698394a45b37","added_by":"auto","created_at":"2022-08-03 18:39:21","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":585187,"visible":true,"origin":"","legend":"\u003cp\u003eMeasurements of traction strength\u003c/p\u003e\u003cp\u003e(a) Traction machine (Autograph; Shimadzu Corporation, Kyoto, Japan)\u003c/p\u003e\u003cp\u003e(b) Both sides of each sutured specimen were fixed on the lower and upper arms. The upper arm automatically pulled the specimen toward the upper direction at the speed of 1 mm/s.\u003c/p\u003e\u003cp\u003e(c) Computer-generated waveform. Traction strength was measured in Newtons (N) when the dehiscence began, which correlated with the top of the first waveform.\u003c/p\u003e","description":"","filename":"Fig03.png","url":"https://assets-eu.researchsquare.com/files/rs-1642106/v1/09ecaf5987a6158b1a5d40c7.png"},{"id":24743144,"identity":"a815d8f3-bb9a-417c-89ed-7b819467c840","added_by":"auto","created_at":"2022-08-03 18:29:21","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":767873,"visible":true,"origin":"","legend":"\u003cp\u003eAir leak test\u003c/p\u003e\u003cp\u003e(a) The sealed stomach was inserted into a container filled with water using multiple surgical forceps.\u003c/p\u003e\u003cp\u003e(b) The stomach was slowly inflated using the air pump. Finally, the pressure gauge reading was recorded as the leak pressure when air bubbles appeared at the suture site.\u003c/p\u003e","description":"","filename":"Fig04.png","url":"https://assets-eu.researchsquare.com/files/rs-1642106/v1/0f38827bb98ddba92339399d.png"},{"id":24742541,"identity":"30674268-973a-4144-868a-9011b95fb871","added_by":"auto","created_at":"2022-08-03 18:24:21","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":50218,"visible":true,"origin":"","legend":"\u003cp\u003eOutcome results of traction test\u003c/p\u003e\u003cp\u003eThe mean ± standard deviation traction tension measured for the three samples in each group was 2.16 ± 0.11 N, 3.68 ± 0.70 N, 5.15 ± 0.61 N, 18.30 ± 2.16 N, 19.30 ± 0.34 N, and 62.40 ± 7.26 N for Groups A, B, C, D, E, and F, respectively. There were no significant differences among Groups A, B, and C. Compared with these three groups, Groups D, E, and F had significantly stronger traction tension. In addition, there was no significant difference between Groups D and E. However, the traction tension was significantly stronger in Group F than in Groups D and E.\u003c/p\u003e\u003cp\u003e\u0026nbsp;\u003c/p\u003e","description":"","filename":"Fig05.png","url":"https://assets-eu.researchsquare.com/files/rs-1642106/v1/4986b2fe3098b7e957980011.png"},{"id":24742539,"identity":"fdff2399-b5a8-4be9-91e0-55333d7123bb","added_by":"auto","created_at":"2022-08-03 18:24:21","extension":"png","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":543269,"visible":true,"origin":"","legend":"\u003cp\u003ePresence of complete inverted closure in traction test\u003c/p\u003e\u003cp\u003eUpper section: absence of complete inverted closure in Groups A, B, and D\u003c/p\u003e\u003cp\u003eLower section: presence of complete inverted closure in Groups C, E, and F\u003c/p\u003e","description":"","filename":"Fig06.png","url":"https://assets-eu.researchsquare.com/files/rs-1642106/v1/8680dd337ecd7590dd073d30.png"},{"id":24742536,"identity":"53d62e49-c4c4-40ed-80d1-d19247111169","added_by":"auto","created_at":"2022-08-03 18:24:21","extension":"png","order_by":7,"title":"Figure 7","display":"","copyAsset":false,"role":"figure","size":90391,"visible":true,"origin":"","legend":"\u003cp\u003eOutcome results of air leak test\u003c/p\u003e\u003cp\u003eThe mean ± standard deviation air leak pressure was 13.7 ± 3.35 mmHg in the PSS group and 24.8 ± 3.13 mmHg in the OTSC group (P \u0026lt; 0.01).\u003c/p\u003e","description":"","filename":"Fig07.png","url":"https://assets-eu.researchsquare.com/files/rs-1642106/v1/d6cfe7be78100e1303424968.png"},{"id":24743755,"identity":"c2cb1619-718a-45d1-9dfa-04505fdfcc76","added_by":"auto","created_at":"2022-08-03 18:34:21","extension":"png","order_by":8,"title":"Figure 8","display":"","copyAsset":false,"role":"figure","size":62557,"visible":true,"origin":"","legend":"\u003cp\u003eProcedure time of PSS versus OTSC in air leak test\u003c/p\u003e\u003cp\u003eThe mean ± standard deviation procedure time was significantly shorter in the OTSC group than in the PSS group (168.5 ± 25.1 vs. 540.8 ± 101 seconds, respectively) (P \u0026lt; 0.01).\u003c/p\u003e","description":"","filename":"Fig08.png","url":"https://assets-eu.researchsquare.com/files/rs-1642106/v1/670a36bea1c1aa4ac949f307.png"},{"id":24743147,"identity":"9f6f8156-ffe1-4d5e-8500-be0b50712789","added_by":"auto","created_at":"2022-08-03 18:29:21","extension":"png","order_by":9,"title":"Figure 9","display":"","copyAsset":false,"role":"figure","size":451769,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cspan class=\"ql-cursor\"\u003e\u003c/span\u003ePresence of complete inverted closure in air leak test\u003c/p\u003e\u003cp\u003eComplete inverted closure was observed only in the OTSC group; the PSS group exhibited absence of inverted closure [50% (3/6)] and partial closure [50% (3/6)].\u003c/p\u003e","description":"","filename":"Fig09.png","url":"https://assets-eu.researchsquare.com/files/rs-1642106/v1/d5838846facb24bd74f09bb5.png"},{"id":44717911,"identity":"d7126a59-c246-483e-969f-270743eb420c","added_by":"auto","created_at":"2023-10-16 18:40:42","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":6046022,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-1642106/v1/9a50aa99-2981-4341-9b61-e592f1946ae7.pdf"}],"financialInterests":"","formattedTitle":"Comparison of purse-string suture versus over-the-scope clip for gastric endoscopic full-thickness closure: traction and leak pressure testing in ex vivo porcine model","fulltext":[{"header":"Introduction","content":"\u003cp\u003eGastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors of the gastrointestinal tract[1], with a reported incidence of 10 to 15 per million people per year[2]. The stomach is the most common site of GISTs, accounting for 55.6% of cases[2]. The 5-year survival rate in patients with GISTs is 83%, and this rate increases to 93% when GISTs are organ-confined[3]. Therefore, it is important to treat GISTs when they are organ-confined.\u003c/p\u003e\n\u003cp\u003eSurgical intervention is the first therapeutic option for resectable GISTs, and partial gastrectomy or gastric wedge resection is the standard of care[4]. Laparoscopic and endoscopic cooperative surgery emerged in 2008[5]\u0026nbsp;as a minimally invasive treatment for GISTs. Because of its high reported efficacy and safety[6], this procedure has been widely performed in Japan and around the world.\u003c/p\u003e\n\u003cp\u003eIn 2001, endoscopic full-thickness resection (EFTR) was developed to achieve complete resection of gastrointestinal neuroendocrine tumors and defect closure using only a flexible endoscope[7]. EFTR without laparoscopic assistance has several advantages over conventional approaches. No scar occurs on the skin surface, leading to a reduction in patient complaints. Additionally, the nerves around the stomach are preserved, preventing postoperative gastric motility disorder[8]. Thus, EFTR is considered a more minimally invasive procedure. Although EFTR has already been clinically introduced in some countries[9]\u0026nbsp;[10], several issues remain unresolved[11]. The most important of these issues is reliable endoscopic closure of the full-thickness defect after EFTR. Major endoscopic closure methods include the use of hemoclips[12], the purse-string suture method (PSS)[13], and the over-the-scope clip (OTSC)[14][15]\u0026nbsp;, but sufficient evidence regarding these closure methods during EFTR is lacking. Accordingly, the suture strength of each method must be compared to establish the most appropriate closure technique. However, few reports have examined and compared the suture strength of these closure methods.\u003c/p\u003e\n\u003cp\u003eThis study was performed to examine the suture strengths of PSS and OTSC in an \u003cem\u003eex vivo\u003c/em\u003e porcine model and explore a closure method suitable for EFTR. \u0026nbsp;\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThis \u003cem\u003eex vivo\u003c/em\u003e study involved \u003cu\u003e18\u003c/u\u003e porcine stomachs isolated from pigs used for food. Fresh \u003cem\u003eex vivo\u003c/em\u003e stomachs were harvested from mixed-breed pigs weighing 100 to 120 kg at 6 months of age (Tokyo Shibaura Zouki, Tokyo, Japan). \u003cu\u003eThese pigs were raised on farms in Japan and euthanized for food while unconscious from CO2.\u003c/u\u003e The porcine stomachs were frozen and thawed immediately before use. We then washed the insides of the stomachs with tap water. A flexible endoscope and endoscopic instruments were prepared for performance of each endoscopic closure method. The \u003cem\u003eex vivo\u003c/em\u003e study consisted of traction and air leak pressure tests to evaluate the suture strength of each closure method for EFTR. Finally, all obtained data were compared among the suture methods.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTraction test\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStudy protocol\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eSix porcine stomachs were prepared, and for each porcine stomach, three specimens of 8-cm length and 5-cm width were excised from the greater curvature of the body of the stomach, resulting in a total of 18 specimens. The full-thickness layers were disconnected at the center of the 8-cm-long side of the specimen, and the dehiscence line was sutured by each closure method. Each stomach was sutured using the same method for each of the three specimens (Figure 1). All closure methods using endoscopic instruments were performed using a flexible endoscope. The closure methods were categorized into the six methods described below and shown in Figure 2.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eEndoscopic procedures\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eGroup A: Hemoclip closure (n = 3)\u003c/p\u003e\n\u003cp\u003eHemoclips (HX-610-090; Olympus, Tokyo, Japan) were used to suture the dehiscence line at 7-mm intervals.\u003c/p\u003e\n\u003cp\u003eGroup B: PSS (mucosal closure) (n = 3)\u003c/p\u003e\n\u003cp\u003eA detachable endoloop (MAJ-254; Olympus) was placed to cover both sides of the dehiscence line. After fixing it to the mucosal surface with eight hemoclips at 7-mm intervals, the dehiscence line was sutured while tightening the endoloop.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eGroup C: PSS (seromuscular closure) (n = 3)\u003c/p\u003e\n\u003cp\u003eAfter anchoring the endoloop on both the serosa and muscle using hemoclips, the above-described PSS method was applied.\u003c/p\u003e\n\u003cp\u003eGroup D: OTSC closure (mucosal closure) (n = 3)\u003c/p\u003e\n\u003cp\u003eA 12-mm OTSC (12-gc type; Ovesco Endoscopy AG, T\u0026uuml;bingen, Germany)[15]\u0026nbsp;was mounted on the tip of the endoscope (GIF-260QJ; Olympus). After only the mucosa of both edges on the dehiscence line was grasped with Twin Grasper forceps (TG forceps) (Ovesco Endoscopy AG), an OTSC was fired while pulling the TG forceps into the cap. Two OTSCs were used to suture the 5-cm dehiscence line.\u003c/p\u003e\n\u003cp\u003eGroup E: OTSC closure (seromuscular closure) (n = 3)\u003c/p\u003e\n\u003cp\u003eAfter the serosa as well as the muscle layers of both edges on the dehiscence line were grasped with the TG forceps, the above-described OTSC closure technique was used.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eGroup F: Surgical hand suture (n = 3)\u003c/p\u003e\n\u003cp\u003eUsing a 3-0 surgical nylon thread, the surgeon sutured the 5-cm dehiscence line from the serosal side with Albert-Lembert sutures at 7-mm intervals.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eMechanical measurement\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eA traction machine (Autograph; Shimadzu Corporation, Kyoto, Japan) was used to measure the traction strength. Both sides of each sutured specimen were fixed on the lower and upper arms. The upper arm automatically pulled the specimen toward the upper direction at the speed of 1 mm/s (Figure 3). The traction strength was measured in Newtons (N) based on the computer-generated waveform.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eOutcome measures\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe primary endpoint was comparison of the tension when the dehiscence began, which correlated with the top of the first waveform. The secondary endpoint was the presence or absence of complete inverted closure on the serosal surface. Complete inverted closure was defined as inversion of the whole suture line. The presence of complete inverted closure was evaluated by three specialized endoscopists.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAir leak test\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStudy protocol\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eA 15- \u0026times; 15-mm full-thickness defect was created with a surgical scalpel from the serosal side in the anterior wall of the gastric upper body. A 15- \u0026times; 15-mm circular paper was used to unify the size of all defects. The hole on the duodenal side was closed with surgical nylon to prevent other air leaks. An endoscope was inserted into the stomach via the hole on the esophageal side, and closure was then performed. Twelve porcine stomachs were randomly assigned to two groups for defect closure: the PSS group (n = 6) or OTSC group (n = 6). The defect was closed by PSS or OTSC without hand assistance.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eEndoscopic procedures\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIn the PSS group (n = 6), an endoloop was placed on the defect. After fixing it onto the full-thickness layer with six hemoclips at 5-mm intervals, the defect was sutured while tightening the endoloop. In the OTSC group (n = 6), the full-thickness layers of both edges of the defect were grasped with the TG forceps, and the above-described OTSC closure technique was then performed using a single OTSC.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eMechanical measurement\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAfter completion of the defect closure, two tubes of a blood pressure instrument were inserted into the stomach via the hole on the esophageal side of the endoscopic access route One of the tubes was connected to a pump that could be pressurized to inflate the porcine stomach, and the other tube was connected to a vacuum gauge calibrated in millimeters of mercury (mmHg) to measure the pressure in the stomach. The sealed stomach was inserted into a container filled with water using multiple surgical forceps. The stomach was slowly inflated using the air pump. Finally, the pressure gauge reading was recorded as the leak pressure when air bubbles were observed at the suture site (Figure 4).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eOutcome measures\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe primary endpoint was comparison of the mean leak pressure (mmHg) between PSS and OTSC. The secondary endpoints were the procedure time and presence of complete inverted closure. The procedure time was the duration between the start and completion of each closure method. The criterion for the start was deployment of the endoloop around the defect in the PSS group or the grasping of one side of the defect with the TG forceps in the OTSC group. In both groups, completion of a closure method was defined as the confirmation of complete closure.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical analyses\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll statistical analyses were performed with GraphPad Prism 7.0 (GraphPad Software, San Diego, CA, USA). Comparisons between each group were performed by one-way analysis of variance and the Mann-Whitney U test. A \u003cem\u003eP\u003c/em\u003e-value of \u0026lt;0.05 was considered significant. This study did not require IRB approval.\u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eTraction test\u003c/h2\u003e \u003cp\u003eThe mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation (SD) traction tension measured for three samples in each group was 2.16\u0026thinsp;\u0026plusmn;\u0026thinsp;0.11 N, 3.68\u0026thinsp;\u0026plusmn;\u0026thinsp;0.70 N, 5.15\u0026thinsp;\u0026plusmn;\u0026thinsp;0.61 N, 18.30\u0026thinsp;\u0026plusmn;\u0026thinsp;2.16 N, 19.30\u0026thinsp;\u0026plusmn;\u0026thinsp;0.34 N, and 62.40\u0026thinsp;\u0026plusmn;\u0026thinsp;7.26 N for Groups A, B, C, D, E, and F, respectively (Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThere were no significant differences among Groups A, B, and C. Compared with these three groups, Groups D, E, and F had significantly stronger traction tension. In addition, there was no significant difference between Groups D and E. However, the traction tension was significantly stronger in Group F than in Groups D and E (Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eComplete inverted closure was observed in Groups C, E, and F (Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eAir leak test\u003c/h2\u003e \u003cp\u003eThe mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD air leak pressure by the suture method was 13.7\u0026thinsp;\u0026plusmn;\u0026thinsp;3.35 mmHg in the PSS group and 24.8\u0026thinsp;\u0026plusmn;\u0026thinsp;3.13 mmHg in the OTSC group (Fig.\u0026nbsp;\u003cspan refid=\"Fig7\" class=\"InternalRef\"\u003e7\u003c/span\u003e). In the statistical analysis, the OTSC group showed a significantly higher leak pressure than the PSS group (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.01). The mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD procedure time was significantly shorter in the OTSC group than in the PSS group (168.5\u0026thinsp;\u0026plusmn;\u0026thinsp;25.1 vs. 540.8\u0026thinsp;\u0026plusmn;\u0026thinsp;101 seconds, respectively) (Fig.\u0026nbsp;\u003cspan refid=\"Fig8\" class=\"InternalRef\"\u003e8\u003c/span\u003e). Complete inverted closure was observed only in the OTSC group; the PSS group showed absence of complete inverted closure [50% (3/6)] as well as partial closure [50% (3/6)] (Fig.\u0026nbsp;\u003cspan refid=\"Fig9\" class=\"InternalRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis is the first study to compare the suture strength of endoscopic closure methods for gastric full-thickness defects using traction force and air leak pressure testing. In this basic study, we found that an OTSC suitable for inverted closure produced a higher suture strength than PSS.\u003c/p\u003e \u003cp\u003eEFTR is still challenging, and several issues regarding its establishment have been raised. Among these issues, the most important is the development of a reliable endoscopic closure method for full-thickness defects. Inadequate closure can cause dehiscence of the suture line, leading to serious complications such as peritonitis and sepsis. Therefore, the suture strength of current closure methods should be fundamentally acknowledged. In our comparative study, we selected conventional hemoclip closure, PSS[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e], and OTSC[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e], all of which have been reported as the main endoscopic closure methods after EFTR. We then performed two tests, namely mechanical traction and air leak pressure tests, that have been traditionally evaluated in the surgical field.\u003c/p\u003e \u003cp\u003eThe traction test showed no significant difference in traction strength between hemoclip closure and PSS; however, the traction strength of OTSC was significantly stronger than that of hemoclip closure and PSS. The air leak test also showed that the intragastric pressure required to cause an air leak was significantly higher in OTSC than in PSS, indicating that OTSC has greater suture strength. The procedure time was shorter in OTSC than in PSS. Whereas anchoring several hemoclips around the endoloop requires a longer time in PSS, TG forceps-assisted OTSC enables closure of a large defect in a single step.\u003c/p\u003e \u003cp\u003eThese two tests concluded that the suture strength was greater in the OTSC group than in the PSS group. Meanwhile, both the traction strength and air leak pressure were lower in the OTSC group than in the surgical suture group. In clinical practice, the degree of leak pressure needed for durable closure after EFTR should be discussed. The intragastric pressure during physiological fasting is considered to be 6.6 mmHg[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e], and the pressure does not increase even with food intake[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. The mean leak pressures in this study, which were 13.7 mmHg in the PSS group and 24.8 mmHg in the OTSC group, were higher than the previously reported pressure of 6.6 mmHg. Therefore, both PSS and OTSC may be acceptable means of closing the suture line after EFTR under usual conditions. However, because the intragastric pressure increases with obesity[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e] and markedly increases during coughing and vomiting[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e], a tighter suture is preferable in these situations.\u003c/p\u003e \u003cp\u003eWhether mucosal closure or seromuscular closure is suitable for full-thickness closure remains unclear. The PSS technique[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e] principally anchors the circumferential mucosa around the defect, whereas clip anchoring of the seromuscular layer of both defect edges is expected to be better for inverted closure. In OTSC, the areas grasped by the TG forceps were also divided into mucosa or serosa-muscle. We therefore conducted two patterns of mucosal closure or seromuscular closure. In this comparison in the PSS group, although not significant, the traction strength tended to be slightly stronger in seromuscular closure than in mucosal closure. In the traction test, complete inverted closure of the serosa-muscle layer was observed only in seromuscular closure in both the PSS and OTSC groups. In the air leak test, complete inverted closure was observed only in the OTSC group. The principle of surgical suturing is traditionally based on inverted suturing of the serosa-muscle layer, such as the Albert-Lembert suture technique[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]\u003csup\u003e,\u003c/sup\u003e[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. However, even if endoscopic closure using hemoclips (as in PSS) appears endoluminally to be complete defect closure, the state of the serosal side is not well known. The present study clarified that mucosal closure does not satisfy the criterion for inverted closure being suitable for surgical suture. Thus, anchoring hemoclips on the serosa-muscle or full-thickness layer seems mandatory in PSS, and grasping these layers with TG forceps is also favorable in OTSC.\u003c/p\u003e \u003cp\u003eA previous \u003cem\u003eex vivo\u003c/em\u003e porcine study showed that gastric OTSC closure of 15-mm full-thickness defects sustained a higher mean (\u0026plusmn;\u0026thinsp;SD) air leak pressure (74.9\u0026thinsp;\u0026plusmn;\u0026thinsp;17.5 mmHg) than surgical stapling (64.6 mmHg)[\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. Moreover, gastric OTSC closure of mean 16.29 -mm full-thickness defects sustained a similar air leak pressure (72.5 mmHg) in the porcine stomach in natural orifice transluminal endoscopic surgery (NOTES)[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. These leak pressures were higher than that obtained in the present study (24.8 mmHg). The difference may be explained by technical aspects, such as pulling the defect into the OTSC cap using TG forceps, as well as the difference in the gastric wall thickness of the porcine models. In a previous study, the mean leak pressures at the gastric closure sites were 32.5 mmHg for 5-mm defects, 111.9 mmHg for 10-mm defects, 74.9 mmHg for 15-mm defects, 49.3 mmHg for 20-mm defects, and 15.2 mmHg for 25-mm defects[\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. Thus, the closure pressure decreased as the defect size increased. As addressed below in the description of the third limitation of this study, the leak pressure for a 30-mm defect that meets the defect size suitable for EFTR should be further investigated.\u003c/p\u003e \u003cp\u003eA recent meta-analysis revealed that the clinical complication rate of EFTR was 1.6%, including a 0.1% rate of delayed suture dehiscence and a 0.9% rate of intra-abdominal infection[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Three studies demonstrated that intra-abdominal infection occurred in either hemoclip closures or PSS, whereas none occurred in OTSC use[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThis study has three limitations. First, the experiment was conducted using a porcine stomach. The thickness of the mucosa and muscular layer and the expansion and contraction of the gastric wall differ from those of a human stomach. Nevertheless, different endoscopic closure methods were compared under the same conditions to examine the suture strength. Second, the durability and wound healing after suturing were not considered because of the nature of the \u003cem\u003eex vivo\u003c/em\u003e experiments. The healing process may differ depending on the closure method used. \u003cem\u003eIn vivo\u003c/em\u003e studies are ongoing to investigate this issue. Third, the defect size in the leak test was not substantially large (15 mm). EFTR is indicated for gastric GISTs of \u0026le;\u0026thinsp;3 cm; thus, we plan to perform measurement of leak pressure in 3-cm defects.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis \u003cem\u003eex vivo\u003c/em\u003e experimental study demonstrated that OTSC closure, which facilitates complete inverted closure, has greater strength than PSS in full-thickness layer suturing. A clinical study is required to determine whether the basic data obtained in this study are associated with post-EFTR leakage.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eGISTs: Gastrointestinal stromal tumors\u003c/p\u003e\n\u003cp\u003eEFTR: endoscopic full-thickness resection\u003c/p\u003e\n\u003cp\u003ePSS: purse-string suture\u003c/p\u003e\n\u003cp\u003eOTSC: over-the-scope clip\u003c/p\u003e\n\u003cp\u003eTG forceps: Twin Grasper forceps\u003c/p\u003e\n\u003cp\u003eSD: standard deviation\u003c/p\u003e\n\u003cp\u003eNOTES: natural orifice transluminal endoscopic surgery\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u003c/strong\u003e \u003cu\u003eThe need for ethics approval was waived by the Animal Care and Use Committee for Kagawa University.\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u003c/strong\u003e Not applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials:\u0026nbsp;\u003c/strong\u003eAll data generated or analysed during this study are included in this published article\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u003c/strong\u003e The authors declare that they have no competing interests\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e No funding was received.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003cstrong\u003e:\u003c/strong\u003e \u003cu\u003eT. M.1\u003c/u\u003e and H.K. were responsible for the study concept and design. N.N., K.N., T.S., N.T., K.K., N.K., T.C., T.Y., A.K., and T.K. were responsible for acquisition of the data. H.K., N.N., K.U., and K.H. were responsible for analysis and interpretation of the data. K.O. and S.F. supplied the materials. \u003cu\u003eT. M.1\u003c/u\u003e and S.F. were responsible for the statistical analysis. H.K. was responsible for revision of the manuscript. \u003cu\u003eT. M.2\u003c/u\u003e was responsible for study supervision\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements:\u0026nbsp;\u003c/strong\u003eThe authors are grateful to Okura Industrial Co. Ltd., Kagawa, Japan for supporting the traction test using the Autograph device. The authors also thank Angela Morben, DVM, ELS, from Edanz (https://jp.edanz.com/ac) for editing a draft of this manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eRubin BP, Heinrich MC, Corless CL. Gastrointestinal stromal tumour. Lancet. 2007;369:1731\u0026ndash;41. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/S0140-6736(07)60780-6\u003c/span\u003e\u003cspan address=\"10.1016/S0140-6736(07)60780-6\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eS\u0026oslash;reide K, Sandvik OM, S\u0026oslash;reide JA, Giljaca V, Jureckova A, Bulusu VR. Global epidemiology of gastrointestinal stromal tumours (GIST): A systematic review of population-based cohort studies. Cancer Epidemiol. 2016;40:39\u0026ndash;46. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.canep.2015.10.031\u003c/span\u003e\u003cspan address=\"10.1016/j.canep.2015.10.031\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWilms C, Be T, Early F, Stages WT. (2018) Wilms Tumor Early Detection, Diagnosis, and Staging Can Wilms Tumors Be Found Early ? Am Cancer Soc 1\u0026ndash;15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGrignani G, Boccone P, Varetto T, Cirillo S. (2012) Gastrointestinal stromal tumors. Imaging Tumor Response to Ther 41\u0026ndash;60. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/978-88-470-2613-1_3\u003c/span\u003e\u003cspan address=\"10.1007/978-88-470-2613-1_3\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHiki N, Yamamoto Y, Fukunaga T, Yamaguchi T, Nunobe S, Tokunaga M, Miki A, Ohyama S, Seto Y. Laparoscopic and endoscopic cooperative surgery for gastrointestinal stromal tumor dissection. Surg Endosc Other Interv Tech. 2008;22:1729\u0026ndash;35. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s00464-007-9696-8\u003c/span\u003e\u003cspan address=\"10.1007/s00464-007-9696-8\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMatsuda T, Nunobe S, Kosuga T, Kawahira H, Inaki N, Kitashiro S, Abe N, Miyashiro I, Nagao S, Nishizaki M, Hiki N. Laparoscopic and luminal endoscopic cooperative surgery can be a standard treatment for submucosal tumors of the stomach: a retrospective multicenter study. Endoscopy. 2017;49:476\u0026ndash;83. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1055/s-0043-104526\u003c/span\u003e\u003cspan address=\"10.1055/s-0043-104526\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSuzuki H, Ikeda K. Endoscopic mucosal resection and full thickness resection with complete defect closure for early gastrointestinal malignancies. Endoscopy. 2001;33:437\u0026ndash;9. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1055/s-2001-14269\u003c/span\u003e\u003cspan address=\"10.1055/s-2001-14269\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWaseda Y, Doyama H, Inaki N, Nakanishi H, Yoshida N, Tsuji S, Takemura K, Yamada S, Okada T. Does laparoscopic and endoscopic cooperative surgery for gastric submucosal tumors preserve residual gastric motility? Results of a retrospective single-center study. PLoS ONE. 2014;9:1\u0026ndash;5. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1371/journal.pone.0101337\u003c/span\u003e\u003cspan address=\"10.1371/journal.pone.0101337\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGranata A, Martino A, Amata M, Ligresti D, Tuzzolino F, Traina M. Efficacy and safety of gastric exposed endoscopic full-thickness resection without laparoscopic assistance: a systematic review. Endosc Int Open. 2020;08:E1173\u0026ndash;82. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1055/a-1198-4357\u003c/span\u003e\u003cspan address=\"10.1055/a-1198-4357\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang C, Gao Z, Shen K, Cao J, Shen Z, Jiang K, Wang S, Ye Y. Safety and efficiency of endoscopic resection versus laparoscopic resection in gastric gastrointestinal stromal tumours: A systematic review and meta-analysis. Eur J Surg Oncol. 2020;46:667\u0026ndash;74. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.ejso.2019.10.030\u003c/span\u003e\u003cspan address=\"10.1016/j.ejso.2019.10.030\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAslanian HR, Sethi A, Bhutani MS, Goodman AJ, Krishnan K, Lichtenstein DR, Melson J, Navaneethan U, Pannala R, Parsi MA, Schulman AR, Sullivan SA, Thosani N, Trikudanathan G, Trindade AJ, Watson RR, Maple JT. ASGE guideline for endoscopic full-thickness resection and submucosal tunnel endoscopic resection. VideoGIE. 2019;4:343\u0026ndash;50. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.vgie.2019.03.010\u003c/span\u003e\u003cspan address=\"10.1016/j.vgie.2019.03.010\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhou PH, Yao LQ, Qin XY, Cai MY, Xu MD, Zhong YS, Chen WF, Zhang YQ, Qin WZ, Hu JW, Liu JZ. Endoscopic full-thickness resection without laparoscopic assistance for gastric submucosal tumors originated from the muscularis propria. Surg Endosc. 2011;25:2926\u0026ndash;31. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s00464-011-1644-y\u003c/span\u003e\u003cspan address=\"10.1007/s00464-011-1644-y\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShi Q, Chen T, Zhong YS, Zhou PH, Ren Z, Xu MD, Yao LQ. Complete closure of large gastric defects after endoscopic full-thickness resection, using endoloop and metallic clip interrupted suture. Endoscopy. 2013;45:329\u0026ndash;34. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1055/s-0032-1326214\u003c/span\u003e\u003cspan address=\"10.1055/s-0032-1326214\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGuo J, Liu Z, Sun S, Liu X, Wang S, Ge N, Wang G, Qi Y. Endoscopic full-thickness resection with defect closure using an over-the-scope clip for gastric subepithelial tumors originating from the muscularis propria. Surg Endosc. 2015;29:3356\u0026ndash;62. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s00464-015-4076-2\u003c/span\u003e\u003cspan address=\"10.1007/s00464-015-4076-2\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKobara H, Mori H, Nishiyama N, Fujihara S, Okano K, Suzuki Y, Masaki T. Over-the-scope clip system: A review of 1517 cases over 9 years. J Gastroenterol Hepatol. 2019;34:22\u0026ndash;30. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1111/jgh.14402\u003c/span\u003e\u003cspan address=\"10.1111/jgh.14402\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKobara H, Nishiyama N, Fujihara S, Tada N, Kozuka K, Matsui T, Takata T, Chiyo T, Kobayashi N, Fujita K, Yachida T, Okano K, Suzuki Y, Nishiyama A, Mori H, Masaki T. Traction-assisted endoscopic full-thickness resection followed by O-ring and over-the-scope clip closure in the stomach: an animal experimental study. Endosc Int Open. 2021;09:E51\u0026ndash;7. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1055/a-1287-7482\u003c/span\u003e\u003cspan address=\"10.1055/a-1287-7482\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTurnbull D, Webber S, Hamnegard CH, Mills GH. Intra-abdominal pressure measurement: Validation of intragastric pressure as a measure of intra-abdominal pressure. Br J Anaesth. 2007;98:628\u0026ndash;34. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1093/bja/aem060\u003c/span\u003e\u003cspan address=\"10.1093/bja/aem060\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJanssen P, Verschueren S, Giao Ly H, Vos R, Van Oudenhove L, Tack J. (2011) Intragastric pressure during food intake: A physiological and minimally invasive method to assess gastric accommodation. Neurogastroenterol Motil 23:. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1111/j.1365-2982.2011.01676.x\u003c/span\u003e\u003cspan address=\"10.1111/j.1365-2982.2011.01676.x\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEl-Serag HB, Tran T, Richardson PEG. (2006) Anthropometric correlates of intragastric pressure. Scand J Gastroenterol 41:. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1080/00365520500535402\u003c/span\u003e\u003cspan address=\"10.1080/00365520500535402\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIqbal A, Haider M, Stadlhuber RJ, Karu A, Corkill S, Filipi CJ. A study of intragastric and intravesicular pressure changes during rest, coughing, weight lifting, retching, and vomiting. Surg Endosc Other Interv Tech. 2008;22:2571\u0026ndash;5. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s00464-008-0080-0\u003c/span\u003e\u003cspan address=\"10.1007/s00464-008-0080-0\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEgo M, Abe S, Nonaka S, Suzuki H, Yoshinaga S, Oda I, Saito Y. Endoscopic Closure Utilizing Endoloop and Endoclips After Gastric Endoscopic Submucosal Dissection for Patients on Antithrombotic Therapy. Dig Dis Sci. 2021;66:2336\u0026ndash;44.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTera HAC. Tissue holding power to a single suture in different parts of the alimentary tract. Acta Chir Scand. 1976;142:343\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYeginsu A, Ergin M, Erkorkmaz U. Strength of esophageal closure techniques with and without tissue reinforcement. World J Surg. 2007;31:1445\u0026ndash;8. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s00268-007-9084-5\u003c/span\u003e\u003cspan address=\"10.1007/s00268-007-9084-5\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMatthes K, Jung Y, Kato M, Gromski MA, Chuttani R. Efficacy of full-thickness GI perforation closure with a novel over-the-scope clip application device: An animal study. Gastrointest Endosc. 2011;74:1369\u0026ndash;75. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.gie.2011.07.057\u003c/span\u003e\u003cspan address=\"10.1016/j.gie.2011.07.057\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGonzalez J-M, Saito K, Kang C, Gromski M, Sawhney M, Chuttani R, Matthes K. Prospective randomized comparison of gastrotomy closure associating tunnel access and over-the-scope clip (OTSC) with two other methods in an experimental ex vivo setting. Endosc Int Open. 2015;03:E90\u0026ndash;0. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1055/s-0035-1547013\u003c/span\u003e\u003cspan address=\"10.1055/s-0035-1547013\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\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":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bsur","sideBox":"Learn more about [BMC Surgery](http://bmcsurg.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bsur/default.aspx","title":"BMC Surgery","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Endoscopic closure, Endoscopic full-thickness resection, Purse-string suture, Over-the-scope clip","lastPublishedDoi":"10.21203/rs.3.rs-1642106/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-1642106/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBackground \u003c/em\u003e\u003c/strong\u003eThe recently developed\u003cstrong\u003e \u003c/strong\u003eendoscopic full-thickness resection technique requires reliable closure. The main closure methods are the purse-string suture (PSS) technique and over-the-scope clip (OTSC) technique; however, basic data on the suture strength of each technique are lacking. This study was performed to compare the suture strengths of these two methods in an \u003cem\u003eex vivo\u003c/em\u003e porcine model. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003e\u003cem\u003eMethods \u003c/em\u003e\u003c/strong\u003eIn the traction test, a virtual 5-cm full-thickness suture line was closed by the following six methods three times each: conventional hemoclips, mucosal PSS, seromuscular PSS, mucosal OTSC, seromuscular OTSC, and surgical suture. The primary endpoint was the tension at the starting point of dehiscence, measured in Newtons (N) by an automatic traction machine.\u003cstrong\u003e \u003c/strong\u003eIn the\u003cstrong\u003e \u003c/strong\u003eleak test, a 15-mm gastric full-thickness defect was closed by PSS or OTSC six times each, and the sutured stomach was then pressurized in a water container. The primary endpoint was the leak pressure when air bubbles appeared. The secondary endpoints were the procedure time and presence of complete inverted closure.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003e\u003cem\u003eResults\u003c/em\u003e \u003c/strong\u003eThe mean tension was 2.16, 3.68, 5.15, 18.30, 19.30, and 62.40 N for conventional hemoclips, mucosal PSS, seromuscular PSS, mucosal OTSC, seromuscular OTSC, and surgical suture, respectively. Complete inverted closure was observed for seromuscular PSS, seromuscular OTSC, and surgical suture. The mean leak pressure was 13.7 and 24.8 mmHg in the PSS and OTSC group, respectively (P \u0026lt; 0.01). The mean procedure time was 541 and 169 seconds in the PSS and OTSC group, respectively (P \u0026lt; 0.01). Complete inverted closure was observed in OTSC alone.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003e\u003cem\u003eConclusion \u003c/em\u003e\u003c/strong\u003eThe OTSC, which allows complete inverted closure, showed greater suture strength than PSS.\u0026nbsp;\u003c/p\u003e","manuscriptTitle":"Comparison of purse-string suture versus over-the-scope clip for gastric endoscopic full-thickness closure: traction and leak pressure testing in ex vivo porcine model","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2022-08-03 18:24:19","doi":"10.21203/rs.3.rs-1642106/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2022-08-20T19:56:58+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2022-07-29T04:22:36+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"BMC Surgery","date":"2022-06-28T09:59:08+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2022-06-07T14:56:13+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Surgery","date":"2022-06-04T06:33:11+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bsur","sideBox":"Learn more about [BMC Surgery](http://bmcsurg.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bsur/default.aspx","title":"BMC Surgery","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"0b80b60d-519d-4936-9707-ffe1a0330e7e","owner":[],"postedDate":"August 3rd, 2022","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2023-10-16T18:38:51+00:00","versionOfRecord":{"articleIdentity":"rs-1642106","link":"https://doi.org/10.1186/s12893-023-01920-z","journal":{"identity":"bmc-surgery","isVorOnly":false,"title":"BMC Surgery"},"publishedOn":"2023-01-26 18:28:54","publishedOnDateReadable":"January 26th, 2023"},"versionCreatedAt":"2022-08-03 18:24:19","video":"","vorDoi":"10.1186/s12893-023-01920-z","vorDoiUrl":"https://doi.org/10.1186/s12893-023-01920-z","workflowStages":[]},"version":"v1","identity":"rs-1642106","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-1642106","identity":"rs-1642106","version":["v1"]},"buildId":"B-jG_2CBjPDmsCi4Wdhf-","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}