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Background: Endoscopic closure techniques are effective and safe in the management of transmural gastrointestinal defects. However, there is a paucity of data regarding their comparative effectiveness. This study aimed to compare the efficacy and safety of several new-generation, endoscopic closure devices in a pre-clinical model., Methods: We evaluated five commercially available devices: a through-the-scope clip (TTSC), an anchor-pronged TTSC, a suturing device, helical tacking system, and over-the-scope clip. We tested closure strength using an ex-vivo porcine model. Next, live animals underwent 15 mm gastric and colonic perforations followed by immediate endoscopic closure with one of the devices. We assessed technical success, 7-day survival, time to complete closure, and National Aeronautical and Space Administration Task Load Index (NASA-TLX) task load index., Results: A total of 60 ex-vivo closures were conducted (12 per device). The suturing device achieved a higher closure strength than all other devices (P < 0.05 for all comparisons). Technical success was achieved in 80% of cases, and 9 of 10 animals (90%) survived to 7 days post-closure. The mean procedure time for the suturing device was longer than all other devices (P < 0.05 for all comparisons). The mean procedure time for the anchor-pronged TTSC was also faster than over-the-scope clip (P = 0.04). The total endoscopist NASA-TLX score for the suturing device and helical system were greater than all other devices (P < 0.05 for all comparisons)., Conclusion: Each closure device varies significantly in closure strength, closure time, and ease of use. Optimal device selection will depend on defect size, anatomic location, the viability of the surrounding tissue, and endoscopist/technician expertise., Competing Interests: Declarations. Disclosures: Trent Walradt, Daniel Szvarca, and Sheri Zarrella have nothing to disclose. Marvin Ryou has served as cofounder and consultant for EnteraSense and GI Windows Surgical; has served as consultant and received study support from Boston Scientific, Cook Medical and Olympus; has served as consultant and advisory board member for FujiFilm., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Per-oral plication of the (neo)esophagus (POPE) is an endoscopic procedure used to improve emptying of the defunctionalized esophagus or gastric conduit, with the hope of improving symptoms and quality of life. As this procedure has only been performed in the United States for the past 4 years, safety and efficacy have not been well established., Methods: This is a retrospective case series for patients who underwent POPE from a single institution between 2019 and 2023. Data collected included demographics, preoperative diagnoses and treatments, imaging, endoscopic data, operative intervention, 90-day complications, and response to treatment. Quality of life and patient satisfaction data were collected by phone survey., Results: Seventeen cases were identified, encompassing 13 primary procedures and 4 repeat POPEs (re-POPE). Eight patients had end-stage achalasia and 5 had impaired gastric emptying after esophagectomy with gastric conduits. Median age was 65 years and median ASA was 3, with 38.5% female patients. POPE was performed with 2-6 plication sutures in an average of 75 min. The majority of patients discharged home the same day. For the 17 procedures, there were 4 complications. Two patients required antibiotics for pneumonia, while 4 required procedural intervention. There were no deaths. Preoperative symptoms improved or resolved at initial follow up in 82.3% of patients. Four patients experienced symptom recurrence and required re-POPE, 1 with achalasia and 3 with gastric conduits. Although all achalasia patients had an "end-stage esophagus," none have required esophagectomy since the introduction of POPE., Conclusions: POPE is an endoscopic procedure that is efficacious in relieving emptying difficulties for the end-stage esophagus and gastric conduit. It may obviate the need for esophagectomy or conduit replacement. Also, it can be repeated in select patients. While the risk profile of complications is favorable compared to alternative operations, patients with gastric conduits are at higher risk., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Leaks following bariatric surgery, while rare, are potentially fatal due to risk of peritonitis and sepsis. Anastomotic leaks and gastro-gastric fistulae following Roux-En-Y gastric bypass (RYGB) as well as staple line leaks after sleeve gastrectomy have historically been treated multimodally with surgical drainage, aggressive antibiotic therapy, and more recently, endoscopically. Endoscopic clipping using over-the-scope clips and endoscopic suturing are two of the most common approaches used to achieve full thickness closure., Methods: A systematic literature search was performed in PubMed to identify articles on the use of endoscopic clipping or suturing for the treatment of leaks and fistulae following bariatric surgery. Studies focusing on stents, and those that incorporated multiple closure techniques simultaneously, were excluded. Literature review and meta-analysis were performed with the PRISMA guidelines., Results: Five studies with 61 patients that underwent over-the-scope clip (OTSC) closure were included. The pooled proportion of successful closure across the studies was 81.1% (95% CI 67.3 to 91.7). The successful closure rates were homogeneous (I 2  = 39%, p = 0.15). Three studies with 92 patients that underwent endoscopic suturing were included. The weighted pooled proportion of successful closure across the studies was shown to be 22.4% (95% CI 14.6 to 31.3). The successful closure rates were homogeneous (I 2  = 0%, p = 0.44). Three of the studies, totaling 34 patients, examining OTSC deployment reported data for reintervention rate. The weighted pooled proportion of reintervention across the studies was 35.0% (95% CI 11.7 to 64.7). We noticed statistically significant heterogeneity (I 2  = 68%, p = 0.04). One study, with 20 patients examining endoscopic suturing, reported rate of repeat intervention 60%., Conclusion: Observational reports show that patients managed with OTSC were more likely to experience healing of their defect than those managed with endoscopic suturing. Larger controlled studies comparing different closure devices for bariatric leaks should be carried out to better understand the ideal endoscopic approach to these complications., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing., Methods: The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices., Results: We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity., Conclusions: The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background and Aim: Endoscopic closure of chronic gastrointestinal fistulas (CGFs) is challenging due to their epithelialized surfaces. The aim of this study was to assess the efficacy and long-term closure rate of endosuturing for CGFs with an Apollo Overstitch device., Patients and Methods: Consecutive CGF patients undergoing endosuturing for fistula closure from April 2018 to January 2020 at the First Affiliated Hospital of Nanjing Medical University were enrolled for retrospective review. Demographics, fistula characteristics, details of the suturing procedures and outcomes were collected for analysis., Results: Twenty patients (mean age 59.8 ± 9.1 years; 85% males) with a total of 23 CGFs underwent sutured fistula closure. Esophagotracheal fistulas were the most common CGFs (12/23, 52.2%), and prior cancer surgery was the most common fistulization etiology (14/20, 70%). Twelve patients (12/20, 60%) had undergone failed endoscopic attempts at fistula closure before suturing. Additional endoscopic therapies used during suturing were 100% argon plasma coagulation, 50% clip fixation, and 10% stent placement. Although all patients undergoing suturing achieved immediate technical success of fistula closure, sustained fistula closure was observed in only 5 patients (5/20, 25.0%) on surveillance endoscopy 3 months after suturing with a mean follow-up of 19.5 months. Esophagotracheal fistula patients were predisposed to shorter dehiscence-free survival than those with other fistulas (HR 3.378; 95% CI 1.127-10.13)., Conclusions: Endosuturing is safe and should be considered for use as the first-line or salvage therapy for CGF closure, primarily for patients with fistulas not involving the trachea. However, the long-term healing of CGFs by suturing is challenging, and CGF patients might not benefit from repeated suturing., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background and Aims: Endoscopic stenting is the standard of care for full thickness esophageal wall defects. The aim of this study is to evaluate outcomes of endoscopic closure of esophageal defects using stenting, with or without endoscopic suturing., Methods: This is a single-center retrospective study of patients with esophageal wall defects who underwent endoscopic interventions. Outcomes of stenting with or without endoscopic suturing of the defect were assessed. Univariate and multivariate logistic regression models were used to examine factors associated with successful defect closure., Results: One hundred and fourteen patients with esophageal wall defects underwent 254 endoscopies with an overall complete closure rate of 75.8%. Twenty-three (20.2%) patients underwent primary closure using endoscopic suturing and subsequent esophageal stenting, while 91 (79.8%) underwent esophageal stenting only. The dual modality group (versus the stent-only group) had similar defect closure rates (84.2 vs. 73.8%, p = 0.55) and time to stent migration (37 vs. 12.5 days, p = 0.07), but was associated with longer procedure times (60 vs. 36 min, p < 0.01) and fewer additional endoscopic procedures (13.6 vs. 43.2%, p = 0.01). Stent suturing significantly decreased migration (35.5 vs. 58.5%, p = 0.04), was associated with fewer additional endoscopies (15.4 vs. 50%, p < 0.01) and reduced need for additional stents (7.7 vs. 34.3%, p < 0.01). On multivariate analysis, chronic defects (> four weeks old) were 81% less likely to close compared to acute (≤ 4 weeks) defects (OR 0.19, CI 0.04-0.77, p = 0.02), and large diameter stents (23 mm) were associated with higher odds of defect closure (OR 3.36, CI 1.02-11.4, p = 0.04)., Conclusion: Endoscopic treatment of esophageal wall defects is safe, effective, and more likely to be successful in acute defects using larger caliber stents. Stent suturing reduces migration, need for additional endoscopic procedures, and stent exchanges. Further comparative studies with larger cohorts are needed to validate our results., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Management of upper gastrointestinal leaks is challenging. A new potential treatment option for this complication is endoscopic suturing with the OverStitch system (Apollo Endosurgery, Texas, USA), which is today mainly used for endoscopic sleeve gastroplasty. The aim of this study was to analyze the efficacy and feasibility of this new treatment option in patients with leaks in the upper gastrointestinal tract., Methods: We performed a retrospective, single-center study of all patients who underwent endoscopic suturing with OverStitch of leaks in the upper gastrointestinal tract., Results: Endoscopic suturing was performed on 13 patients (mean age, 59.62 ± 16.29 years; mean leak size, 22.31 ± 22.6 mm) over a period of 8 months. Postoperative leaks were detected in 10 patients (76.9%) after foregut surgery. Interventional success was achieved in all endoscopic attempts (n = 16, 100%) with a mean closure time of 28.0 ± 12.36 min per patient. Follow-up technical success rate for each suture was (n = 8, 50.0%). Clinical success, including repeated suture attempts was achieved in 8 of the 13 patients (61.5%). These 8 patients had not received prior treatment for the leak. No immediate or delayed serious complications occurred as a result of OverStitch. The mean follow-up was 95 ± 91.07 days., Conclusions: Endoscopic suturing with OverStitch for leaks in the upper gastrointestinal tract is feasible and effective in patients who have not received prior treatment. This minimally invasive technique seems to be a promising option especially for patients with large leaks and significant comorbidities.

Background: Peptic ulcers are a frequent cause of upper G.I. bleeding. Since endoscopic methods may be unsuccessful, we have studied the feasibility of a new laparoscopic approach on a porcine model to control the bleeding of these ulcers with transgastric suturing.Methods: After approval of the Animal Ethics Committee, 20 pigs (20 kg) were anticoagulated with intravenous sodium heparin (400 U/kg), and anesthetized. A nasogastric tube was inserted and a 15 mmHg pneumoperitoneum was created. Two 10-mm trocars and one 5-mm trocar were inserted through the abdominal cavity for laparoscopic guidance of three 7-mm endoluminal trocars inside the stomach through the anterior wall. Two posterior gastric ulcers were mechanically made on each pig by a "lift and cut technique." Ulcers were observed for at least 1 min for evidence of continued bleeding. First, bleeding ulcers were treated with sclerosing agents (epinephrine and ethanolmine oleate 5%); following sclerotherapy, ulcers were sutured intraluminaly with 2-0 silk, with intracorporeal knots.Results: Ulcers created extended into the vascular submucosa and averaged 7 mm in diameter. Bleeding rate was variable, but significant (2 cm3/min) in 40%. It was technically possible to suture these ulcers in 80%. Bleeding was controlled in 95% of cases with sclerotherapy and intraluminal sutures. One perforation of the posterior gastric wall occurred and four endoluminal trocars had to be reinserted after dislodgement.Conclusions: It is possible to technically control bleeding ulcers in most cases with a laparoscopic transgastric technique using sclerosing agent and intraluminal sutures. This approach is promising for future human application; also, the intragastric suturing skills developed may be useful for other surgical interventions. [ABSTRACT FROM AUTHOR]

Background: Obesity is a leading cause of morbidity and healthcare utilization. At the moment, the best treatment for obesity has shown to be laparoscopic gastric bypass. However, about a quarter of the patients experience substantial weight regain, which is difficult to treat, as revision surgery has higher risks than primary procedures. Endoscopic procedures, such as endoscopic suturing, are effective, safe and less invasive in addressing weight regain., Methods: We conducted a retrospective analysis on 22 consecutive patients operated between 2011 and 2013 who had a significant weight regain after RYGB (mean follow-up 22 months), in order to evaluate the long-term outcomes of endoscopic gastro-jejunal revision after weight regain post-bypass surgery. Mucosal ablation around the anastomosis was performed in all patients, and the endoscopic suturing device was used to perform suture stoma reduction. We also evaluated, in a group of 11 patients, the effect of combining sclerotherapy and endoscopic suturing., Results: We showed good efficacy of the endoluminal procedure, with 100 % of patients achieving weight loss. Maximum weight loss was noted at a mean of 18-month follow-up (average of 60.3 % excess weight loss; n = 19), while the mean weight loss regained percentage was 5 % ± 39. 4/22 patients (all four in non-sclerotherapy group, all of them had an anastomosis >10 mm) regained some of this lost weight by the time of the longest follow-up. There was an actual correlation between final stoma diameter (<10 mm) and weight loss., Conclusions: A larger randomized sample of patients with a longer follow-up would be needed to support the effectiveness of the combination of the two therapies. Although almost 20 % of the patients regained weight during the follow-up period, the endoluminal approach offers the advantage of being repeatable after weight regain without adding morbidity risks.

Introduction: Obtaining an adequate mucosal closure is one of the crucial steps in per-oral endoscopic myotomy (POEM). Thus far, there have been no objective data comparing the various available closure techniques. This case-controlled study attempts to compare the application of endoscopic clips versus endoscopic suturing for mucosotomy closure during POEM cases., Methods: A retrospective review of our prospective POEM database was performed. All cases in which endoscopic suturing was used to close the mucosotomy were matched to cases in which standard endoclips were used. Overall complication rate, closure time and mucosal closure costs between the two groups were compared., Results: Both techniques offer good clinical results with good mucosal closure and the absence of postoperative leak. Closure time was significantly shorter (p = 0.044) with endoscopic clips (16 ± 12 min) when compared to endoscopic suturing (33 ± 11 min). Overall, the total closure cost analysis showed a trend toward lower cost with clips (1502 ± 849 USD) versus endoscopic suturing (2521 ± 575 USD) without reaching statistical significance (p = 0.073)., Conclusion: The use of endoscopic suturing seems to be a safe method for mucosal closure in POEM cases. Closure time is longer with suturing than conventional closure with clips, and there is a trend toward higher overall cost. Endoscopic suturing is likely most cost-effective for difficult cases where conventional closure methods fail.

Background and Study Aims: Endoscopic suturing reduces stent migration, but is challenging and time-consuming. We compare endoscopic suturing versus anchoring with a novel over-the-scope clip (Padlock) to fix esophageal stents. Additionally, the first clinical case of Padlock stent fixation is reported., Materials and Methods: A fully covered esophageal stent was placed in 11 pigs and fixed with one figure-of-eight suture (n = 5) or with a Padlock (n = 4) or not fixed (controls; n = 2). The force required to mobilize the stent was recorded., Clinical Case: an esophageal stent was fixed with a Padlock and endoscopically removed 1 month later, in an 82-year-old patient., Results: Mean force (newton) to mobilize the stent was similar after suturing and Padlock fixation (23.99 ± 14.91 vs. 19.97 ± 7.62; p = 0.32). In controls was 7 and 11 Newtons. Suturing time (seconds) was longer than Padlock application (455.4 ± 144.83 vs. 155 ± 12.9; p = 0.002)., Clinical Case: stent fixation was feasible and uncomplicated. Removal was easy, and only mild bleeding occurred., Conclusions: Padlock is faster than endoscopic suturing and achieves similar stent fixation. The first clinical case confirms the feasibility of the method.