Retrospective study of 189 cases of acute perforated peptic ulcer: safety and efficacy of over-the-scope-clip based endoscopic closure.

BACKGROUND: To compare the clinical outcomes in patients with acute perforated peptic ulcer (PPU) treated with over-the-scope clip (OTSC), non-surgical, and surgical interventions, and to explore the effectiveness and safety of OTSC closure. METHODS: Hospital stay, antibiotic use, diet resumption time, and mortality rate were analyzed retrospectively. Binary Logistic regression analysis was used to identify the risk factors influencing PPU complicated with sepsis. RESULTS: Patients were divided into three treatment groups: OTSC (n = 62), non-surgical (n = 72), and surgical (n = 55) groups. The median time (IQR) from symptom onset to admission was 9.0 (4-23) h. 88.71% (55/62) of the patients in In the OTSC group underwent OTSC closure within 24 h (median [IQR] time: 14.5 [7.00-30.25] h). The perforation diameters in the OTSC and surgical groups were 9.87 mm ± 5.97 mm and 8.55 mm ± 6.17 mm, respectively. The median (IQR) hospital stays in the OTSC (9.50 [7.00-12.25] days) and non-surgical group (9.00[7.00-13.00]days) were similar (p > 0.05), but shorter than that in surgical group (12.00[10.00-16.00]days), (p < 0.05). The median duration of antibiotic use was shorter in the OTSC group (7.00[3.00-10.00]) than in the non-surgical group (9.00[7.00-11.00]) and surgical group (11.00[9.00-13.00]) ( p < 0.05); and the time to resume oral feeding was shorter in the OTSC group (4.00[2.00-5.25]) than in the non-surgical group (7.00[6.13-9.00]) and surgical group (8.00[6.53-10.00]), respectively ( p < 0.05). No mortality difference among groups (p = 0.109) was found. Lower albumin level at admission, older age, and elevated creatinine levels were associated with increased sepsis risk, with OR(95%CI) of 0.826 (0.687-0.993), 1.077 (1.005-1.154), and 1.025 (1.006-1.043), respectively (all p < 0.05). CONCLUSION: OTSC closure improves clinical outcomes of acute PPU patients without sepsis. Age, hypoalbuminemia, and baseline renal dysfunction increase the risk of sepsis, while mortality was associated with sepsis and multiorgan dysfunction.

Use of Over-the-Scope Clips in the Management of Refractory Postbanding Ulcer Bleed in a Patient After Liver Transplant.

Postbanding ulcer bleeds (PBUBs) are an uncommon complication of variceal band ligation. They are often treated with proton pump inhibitors in addition to endoscopic interventions such as epinephrine injections, hemostatic clips, electrothermal cautery, or further band ligation. Over-the-scope clips are being increasingly used for the management of acute nonvariceal upper gastrointestinal bleeds, but their use in the management of PBUBs has been reported only once before. We present a 24-year-old man with alcohol-associated decompensated cirrhosis with recurrent PBUB, despite multiple endoscopic interventions, transjugular intrahepatic portosystemic shunt, and liver transplant, treated successfully with an Ovesco clip.

Management of aero-digestive fistulas: the gastroenterologist's perspective, a narrative review.

Background and Objective: Esophagorespiratory fistulas (ERFs) are pathologic communications between the esophagus and respiratory tract that may be congenital or acquired, and benign or malignant. ERFs can lead to significant respiratory compromise and increased mortality through recurrent respiratory infections. As the condition spans multiple organ systems, ERFs pose unique diagnostic and management challenges to pulmonologists, gastroenterologists, and thoracic surgeons. The aim of this manuscript is to provide an up-to-date review of the management of aero-digestive fistulas from the gastroenterologist's perspective. Methods: Relevant studies regarding the management of ERFs through August 2022 were identified and data was extracted based on the relevance to the topic of the manuscript. Key Content and Findings: Endoscopy has a pivotal role in the management of these patients. Multiple endoscopic options are currently available that involve either closure, covering, or draining techniques. Studies evaluating strategies for the management of ERFs are limited to small retrospective studies while head-to-head studies comparing different endoscopic options are lacking. Therefore, a standardized evidence-based algorithm for the management of this challenging pathology is not available. Selection of the management strategy depends on operator preference, location and size of the fistula, viability of the surrounding tissue, and patient's comorbidities. Conclusions: Successful management of ERFs requires a tailored and multidisciplinary approach including surgery, pulmonology, gastroenterology, and oncology. Future studies comparing the effectiveness of different endoscopic strategies for the management of ERFs could help standardize management and potentially improve patient outcomes.

Improvement of Rectal Prolapse Using an Over-the-scope Clip System.

Rectal prolapse is typically treated surgically, and internal therapy has not been reported. We encountered a case of rectal prolapse that improved with an over-the-scope clip system (OTSC). An 81-year-old woman complaining of anorectal pain underwent colonoscopy, and rectal prolapse was observed prior to colonoscopy. Unfortunately, rectal perforation occurred while attempting endoscopic reversal. The OTSC system was used to close the rectal perforation and subsequently improved her rectal prolapse, probably because the rectal wall was anchored to the retroperitoneum. This is the first report to show that rectal prolapse can be endoscopically improved and that an OTSC system might be a viable alternative method for managing inoperable rectal prolapse.

Outcomes of Endoscopic Intervention Using Over-the-Scope Clips for Anastomotic Leakage Involving Secondary Fistula after Gastrointestinal Surgery: A Japanese Multicenter Case Series.

BACKGROUND: The over-the-scope clip (OTSC) is a highly effective clipping device for refractory gastrointestinal disease. However, Japanese data from multicenter studies for anastomotic leakage (AL) involving a secondary fistula after gastrointestinal surgery are lacking. Therefore, this study evaluated the efficacy and safety of OTSC placement in Japanese patients with such conditions. METHODS: We retrospectively collected data from 28 consecutive patients from five institutions who underwent OTSC-mediated closure for AL between July 2017 and July 2020. RESULTS: The AL and fistula were located in the esophagus (3.6%, n = 1), stomach (10.7%, n = 3), small intestine (7.1%, n = 2), colon (25.0%, n = 7), and rectum (53.6%, n = 15). The technical success, clinical success, and complication rates were 92.9% (26/28), 71.4% (20/28), and 0% (0/28), respectively. An age of <65 years (85.7%), small intestinal AL (100%) and colonic AL (100%), defect size of <10 mm (82.4%), time to OTSC placement > 7 days (84.2%), and the use of simple suction (78.9%) and anchor forceps (80.0%) were associated with higher clinical success rates. CONCLUSION: OTSC placement is a useful therapeutic option for AL after gastrointestinal surgery.

Endoscopic Resection with One-Port Placement: A Newly Developed Technique for the Safe Management of Advanced Endoscopic Resection for Gastric Gastrointestinal Stromal Tumors.

INTRODUCTION: Endoscopic full-thickness resection (EFTR) without laparoscopic assistance (pure EFTR) is an emerging, less invasive treatment for gastrointestinal stromal tumors (GISTs). However, the technique has seldom been performed outside China because of concerns regarding pneumoperitoneum, maintenance of endoscopic view, and endoscopic suturing. This study aimed to evaluate the efficacy and safety of endoscopic resection with one-port placement (EROPP) for gastric GISTs. METHODS: This retrospective study included 17 patients with gastric GISTs originating from the muscularis propria who underwent EROPP between 2019 and 2022. One camera port was inserted in the umbilicus before initiating the endoscopic procedure to maintain intra-abdominal pressure, which was monitored and adjusted via this port. While allowing for conversion to laparoscopic surgery if needed, EFTR was performed as follows: (1) circumferential incision of the mucosal and submucosal layers around the lesion was performed by typical endoscopic submucosal dissection; (2) an intentional perforation and subsequent seromuscular resection was made using dental floss and an endo-clip for traction; and (3) closure of the gastric full-thickness defect was performed with an over-the-scope clip (OTSC) after peroral retrieval of the specimen. We retrospectively assessed the short-term outcomes and safety. RESULTS: All procedures were completed successfully without conversion to laparoscopic surgery. The median size of the resected tumors was 23 mm (range, 8-35 mm), the median resection time was 36 min (range, 22-95 min), and closure time was 18 min (range, 10-45 min). The rates of en bloc and complete resection were 100% and 88%, respectively. In 2 cases, another port was added to aspirate the leaking fluid or check the condition of the endoscopic closure. All gastric defects were endoscopically closed, mainly using OTSCs. The recovery course for all patients was uneventful, and no adverse events were reported. CONCLUSIONS: EROPP is a safe and minimally invasive treatment for gastric GISTs and appears to be suitable for introducing EFTR procedures.

Prophylactic clipping using the over-the-scope clip (OTSC) system after complex ESD and EMR of large colon polyps.

BACKGROUND: Delayed bleeding is the most frequent complication after endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) of large colon polyps. Today, prophylactic clipping with through-the-scope clips (TTSCs) is commonly used to reduce the risk of bleeding. However, the over-the-scope clip (OTSC) system might be superior to TTSCs in achieving hemostasis. This study aims to evaluate the efficacy and safety of prophylactic clipping using the OTSC system after ESD or EMR of large colon polyps. METHODS: This is a retrospective analysis of a prospective collected database from 2009 until 2021 of three endoscopic centers. Patients with large (≥ 20 mm) colon polyps were enrolled. All polyps were removed by either ESD or EMR. After the resection, OTSCs were prophylactically applied on parts of the mucosal defect with a high risk of delayed bleeding or/and perforation. The main outcome measurement was delayed bleeding. RESULTS: A total of 75 patients underwent ESD (67%, 50/75) or EMR (33%, 25/75) in the colorectum. The mean resected specimen diameter was 57 mm ± 24.1 (range 22-98 mm). The mean number of OTSCs placed on the mucosal defect was 2 (range 1-5). None of the mucosal defects were completely closed. Intraprocedural bleeding occurred in 5.3% (ESD 2.0% vs. EMR 12.0%; P = 0.105), and intraprocedural perforation occurred in 6.7% (ESD 8% vs. EMR 4%; P = 0.659) of the patients. Hemostasis was achieved in 100% of cases of intraprocedural bleeding, whereas two patients required surgical conversion due to intraprocedural perforation. Among the remaining 73 patients who received prosphylactic clipping, delayed bleeding occurred in 1.4% (ESD 0% vs. EMR 4.2%; P = 0.329), and delayed perforation occurred in 0%. CONCLUSIONS: The prophylactic partial closure of large post-ESD/EMR mucosal defects using OTSCs could serve as an effective strategy to reduce the risk of delayed bleeding and perforation. The prophylactic partial closure of large complex post-ESD/EMR mucosal defects using OTSCs could serve as an effective strategy to reduce the risk of delayed bleeding and perforation.

Effective and Secure Closure after Duodenal Endoscopic Submucosal Dissection: Combination of Endoscopic Ligation with O-Ring Closure and Over-the-Scope Clip.

Duodenal endoscopic submucosal dissection (ESD) is associated with high incidences of intraoperative complications and delayed adverse events (AEs). Delayed AEs can be reduced by closing the post-ESD defects. We developed a new method of closure after duodenal ESD, combining endoscopic ligation with O-ring closure (E-LOC) with an over-the-scope clip (OTSC) (Band OTSC; B-OTSC). Here, we conducted a single-center, retrospective, observational study to investigate the efficacy and safety of the B-OTSC method for preventing delayed AEs in patients undergoing duodenal ESD. The study included nine patients with superficial nonpapillary duodenal epithelial tumors who underwent ESD and were closed with B-OTSC from February 2021 to February 2023. There were no delayed AEs (0%), the mean (± standard deviation) closure time was 53 ± 21.6 min, the complete closure rate was 100%, and the mean hospital stay was 7.8 ± 1.8 days. The sustained closure rates at postoperative days 3 and 7 were 88.9% and 88.9%, respectively. The historical analysis indicated a significant difference in cost between B-OTSC and conventional OTSC (p < 0.01). In conclusion, B-OTSC was a safe, secure, and cost-effective method of closure after duodenal ESD, even in patients with post-ESD defects of more than half the circumference.

Successful Closure of a Tracheoesophageal Fistula Using an Over-The-Scope Clip.

A tracheoesophageal fistula (TEF) is a pathological connection between the trachea and esophagus, which can either occur congenitally or be acquired. An acquired TEF may occur secondary to malignancy, chemoradiotherapy, infection, or trauma. Hallmark symptoms typically associated with TEF include choking with food intake, productive cough, pneumonia, or failure to thrive. The management of TEF has predominantly involved surgical or endoscopic intervention such as esophageal or airway stenting, suturing, or ablation. More recently, the endoscopic over-the-scope clip (OTSC) has emerged as an effective method of TEF management. The OTSC grasps the mucosa overlaying lesion and seals the defect, thus making it an effective treatment option for the endoscopic closure of various GI defects such as fistulas, bleeding ulcers, and perforations. We report a case of a TEF, acquired secondary to underlying malignancy, and its successful treatment with the use of an OTSC placement. A 79-year-old female with a significant history of diffuse large B-cell lymphoma (DLBCL) currently undergoing chemotherapy was admitted to the hospital for aspiration pneumonia. She presented with persistent productive cough and subsequent limited oral intake ability while initially presenting for DLBCL six months prior with an enlarging right-sided neck mass. Her positron emission tomography-computed tomography (PET-CT) imaging showed a cavitary lesion in the superior mediastinum with increased fluorodeoxyglucose (FDG) lymphatic uptake. She had an esophagogram followed by an esophagogastroduodenoscopy (EGD), due to aspiration concerns, which demonstrated a fistula site with tracheal secretions about 20 cm from the incisors. An OTSC was used to close the esophageal opening and successful closure was confirmed using real-time fluoroscopic imaging by the unimpeded passage of contrast in the stomach without leakage. At follow-up, she was able to tolerate an oral diet without any significant difficulty or symptom recurrence. We present a case of successful endoscopic management of TEF with an OTSC that resulted in immediate fistula closure and improvement in the patient's quality of life. This particular case highlights the ability of OTSC to provide more durable and long-term closure than other management techniques due to its mechanism of grasping more tissue for approximation and its association with less morbidity compared to alternative surgical interventions. Although previous reports describing the technical feasibility and utility of OTSC in TEF repair support its use, there is still a paucity of data exploring the long-term efficacy of OTSC in TEF management; therefore, additional prospective studies are necessary.

A Case of Successful Endoscopic Extraction of Common Bile Duct Stones After Closing a Duodenal Perforation Using Over-The-Scope Clip.

A 57-year-old man visited our hospital for acute cholangitis due to common bile duct (CBD) stones in March 2021. Biliary stenting was performed without any complications. The cholangitis improved rapidly. He was re-hospitalized to treat the CBD stones in May 2021. Although endoscopic retrograde cholangiopancreatography was performed, endoscopy caused a perforation of the duodenal bulb. We successfully performed endoscopic closure of the duodenal defect using an over-the-scope clip (OTSC®). Considering that mild CBD dilatation of 10 mm can carry an increased risk of stenosis after surgery, we decided to avoid surgery and perform a follow-up endoscopic treatment. He was re-hospitalized in July 2021. The endoscopy revealed OTSC® in the anterior wall of the duodenal bulb and complete healing of the perforation. We carefully advanced the scope to the second portion of the duodenum while avoiding OTSC®, and the ampulla of Vater was identified. We were then able to remove the stones without any complications. OTSC® was effective in closing a duodenal perforation and enabled us to carry out the retreatment safely and successfully.

Don't be afraid of black holes: Vacuum sponge and vacuum stent treatment of leaks in the upper GI tract-a case series and mini-review.

The treatment of leaks in the upper gastrointestinal tract has been revolutionized by the advent of covered self-expanding metal stents (cSEMS), endoscopic vacuum therapy (EVT), and recently, vacuum stent therapy (VST). In this retrospective study, we report the experiences with EVT and VST at our institution. Patients and methods: Twenty-two patients (15 male, 7 female) with leaks in the esophagus, at the esophago-gastric junction or anastomotic leaks underwent EVT by placing a sponge connected to a negative pressure pump into or near the leak. VST was applied in three patients. Results: EVT led to closure of the leak in 18 of 22 Patients (82%). In 9 patients (41%), EVT was followed by application of a cSEMS. One patient (5%) died during the hospital stay due to an aorto-esophageal fistula near the leak, four others (18%) due to underlying disease. The stricture rate was 3/22 (14%). All three patients in whom VST was applied had closure of the leak and recovered. Reviewing the literature, we identified sixteen retrospective series of ten or more patients (n = 610) with an overall closure rate for EVT of 84%. In eight additional retrospective observations, a comparison between the efficacy of EVT and cSEMS therapy was performed that revealed a success rate of 89% and 69%, respectively (difference not significant, chi-square test). For VST, two small series show that closure is possible in the majority of patients. Conclusion: EVT and VST are valuable options in the treatment of leaks in the upper gastrointestinal tract.

Over-the-scope clip to the rescue: solution for duodenal perforation from migrated biliary stent.

Video 1Over-the-scope clip to the rescue: solution for duodenal perforation from migrated biliary stent.

Over-the-Scope-Clips Can Be Fired Safely Over a Guidewire: Proof of Concept in an Ex-Vivo Porcine Model.

Background and Objectives: To assist in achieving optimal position when deploying over-the-scope (OTS)-clips, the concept of cannulating the defect with a guidewire, backloading the endoscope onto the wire, and firing the OTS-clip over the wire with subsequent wire removal has been demonstrated. The safety of this technique has not been evaluated. Methods: An ex-vivo porcine foregut model was utilized. Biopsy punches were used to create 3-mm diameter full-thickness gastrointestinal tract defects through which a guidewire was threaded. An endoscope was backloaded over the wire and OTS-clips (OVESCO, Tuebingen, Germany) were fired over the mucosal defect and wire. The wire was removed through the endoscope and the removal difficulty was graded using a Likert scale. This process was repeated for each unique combination of nine OTS-clip types, two wire types, four wire angles, and three tissue types. Statistical analysis included t test and ANOVA. Results: Two hundred sixteen OTS-clip firings with wire removal attempts were performed with the following Likert score breakdown: 1 - No difficulty (80.6%), 2 - mild difficulty (16.2%), 3 - moderate difficulty (2.3%), 4 - extreme difficulty (0.9%), and 5 - unable to remove (0%). Statistically significant differences were noted in removal difficulty between OTS-clip sizes (p < 0.05). No differences were identified between clip teeth types, wire types, tissue types, and wire angles (p > 0.05). Conclusion: In this ex-vivo model, the guidewire was successfully removed through the endoscope in all cases. This technique can be employed to facilitate OTS-clip closure of gastrointestinal tract defects, but further study is indicated before wide clinical implementation.

Successful management of a duodenal perforation using a through-the-scope suturing device after failed attempt at closure with an over-the-scope clip.

Video 1Endoscopic closure of a duodenal perforation using a through-the-scope helix tacking suture-based system.

Successful closure of a duodenal perforation caused by endoscopic ultrasound with an over-the-scope clip: a case report and literature review.

Duodenal perforation is a rare but severe complication during endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) and typically requires surgical intervention. With the widespread clinical use of over-the-scope clips (OTSCs), we aimed to evaluate their efficacy and safety for the closure of a duodenal perforation caused by EUS-FNA. A 79-year-old woman underwent EUS-FNA for a suspected low-density nodule in the head of the pancreas. However, duodenal perforation occurred during EUS-FNA. To minimize the patient's pain postoperatively compared with surgical intervention, we used an OTSC to close the perforation immediately and administered drug treatment for 2 weeks. The patient was discharged after complete recovery. OTSC is considered an effective and safe choice for closing a perforation at the upper corner of the duodenal bulb without surgical intervention.

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.

BACKGROUND: The recently developed endoscopic 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 closure strength of each technique are lacking. This study was performed to compare the closure strengths of these two methods in an ex vivo porcine model. METHODS: In the traction test, a virtual 5-cm full-thickness closure 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 closed 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 s 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 closure strength than PSS. Considering the size limitation suitable for single OTSC, a therapeutic strategy for closing the larger size is further warranted.

Efectividad del sistema over-the-scope-clip (OTSC®) como tratamiento de rescate en la hemorragia digestiva alta secundaria a úlcera péptica / Over-the-scope-clip (OTSC®) as a rescue treatment for gastrointestinal bleeding secondary to peptic ulcer disease

Introducción: el clip OTSC® (over-the-scope-clip) se ha postulado como tratamiento de rescate de la hemorragia digestiva alta por úlcera péptica, aunque su efectividad no ha sido evaluada en nuestro medio. Métodos: en este estudio retrospectivo y unicéntrico (enero 2018-diciembre 2021) se evaluaron el éxito técnico, el éxito clínico y la seguridad del dispositivo a 30 días. Se incluyeron todos los pacientes con hemorragia digestiva alta por úlcera péptica en los que se utilizó el clip OTSC® como tratamiento de rescate. Resultados: se incluyeron once pacientes (nueve por resangrado y dos por sangrado persistente). El éxito técnico fue del 81,9 % (9/11, intervalo de confianza [IC] 95 %: 52-95 %). El éxito clínico por protocolo y por intención de tratar fue del 88,9 % (8/9, IC 95 %: 57-98 %) y del 72,7 % (8/11, IC 95 %: 43-90 %) (8/11), respectivamente. No se registraron efectos adversos relacionados con el dispositivo. Conclusiones: el clip OTSC® fue un tratamiento de rescate efectivo y seguro de la hemorragia digestiva por úlcera péptica (AU)

Two cases of endoscopic closure using an over-the-scope clip for endoscopy-related duodenal perforation: How to handle the over-the-scope clip.

Yamamoto et al. report two cases of endoscopic closure using an over-the-scope clip for scope-induced perforation encountered during endoscopic ultrasound and endoscopic retrograde cholangiopancreatography, respectively. In a supporting video, they explain how to prepare the over-the-scope clip and clearly show how the actual procedures were performed.