Endoscopic submucosal dissection (ESD) is widely used to treat gastrointestinal mucosal and submucosal lesions. However, it may cause bleeding, perforation, and stricture. Although these complications can be avoided by introducing materials such as polyglycolic acid and carboxymethyl cellulose sheets, such approaches are expensive and time-consuming. Herein, we report a hydrogel prepared by combining a colloidal solution composed of konjac glucomannan (KGM) and sodium alginate (SA) and a fixative solution containing ε-poly-l-lysine (ε-PLL) and calcium chloride. The two solutions were mixed on the wound surface to form the KGM/SA/ε-PLL hydrogel through hydrogen bonds, coordination bonds, and electrostatic attraction. The effectiveness and convenience of applying the KGM/SA/ε-PLL hydrogel to promote wound healing in the esophagus and colon were assessed in vitro and in vivo. We found that the hydrogel stimulated epithelial proliferation, reduced inflammation, promoted recapillarization, and inhibited fibrosis in the esophagus and colon. Therefore, the KGM/SA/ε-PLL hydrogel is an effective and convenient agent that can promote post-ESD wound healing and is recommended for ulcer bed protection in daily clinical practice.

Post-polypectomy bleeding (PPB) remains a significant procedure-related complication, with multiple risk factors determining the risk including patient demographics, polyp characteristics, endoscopist expertise, and techniques of polypectomy. Immediate PPB is usually treated promptly, but management of delayed PPB can be challenging. Cold snare polypectomy is the optimal technique for small sessile polyps with hot snare polypectomy for pedunculated and large sessile polyps. Topical hemostatic powders and gels are being investigated for the prevention and management of PPB. Further studies are needed to compare these topical agents with conventional therapy.

Prophylactic closure with the over-the-scope clip (OTSC) after endoscopic submucosal dissection (ESD) of superficial non-ampullary duodenal epithelial tumors (SNADETs) has been reported to reduce postoperative adverse events (AEs). However, there are few evidences regarding AEs-associated factors and long-term outcomes of OTSCs.

From January 2011 to December 2020, 139 consecutive patients with SNADETs who underwent ESD followed by OTSC closure in five institutions were extracted in this retrospective study. The primary endpoint was the rate of postoperative AEs after prophylactic OTSC closure. The secondary endpoints were the complete closure rate, residual rate, and long-term AEs associated with residual OTSCs.

The rate of complete closure of the mucosal defect was 97.3% (142) in 146 SNADETs, which were completely resected by ESD. Postoperative AEs, including delayed bleeding, delayed perforation, and localized peritonitis, occurred in 6.2%, 3.4%, and 2.1% of patients, respectively; however, all of the cases improved without surgical treatment. In the multivariate logistic regression analysis, the use of two or more OTSCs was a significant independent risk factor for postoperative AEs (odds ratio, 2.94; 95% confidence interval, 1.02-8.46; P = 0.046). The residual OTSC rate was 46.4% at 1 year postoperatively, and long-term AEs included duodenal erosions and ulcers associated with residual OTSCs.

Prophylactic closure with OTSCs after duodenal ESD can provide acceptable short-and long-term outcomes for preventing postoperative AEs. However, multiple OTSCs were the independent risk factors of postoperative AEs due to the gaps between and near the OTSCs.

Endoscopic suturing enables full closure of large defects after endoscopic submucosal dissection (ESD). However, its use is limited by the need for a double-channel endoscope. A novel closure system, the OverStitch Sx (Apollo Endosurgery, Austin, Tex, USA), compatible with any single-channel endoscope, was introduced to address these shortcomings. The aim of this study was to assess the safety and feasibility of OverStitch Sx for the closure of large defects after ESD.

This is a prospective single-center feasibility study of patients who underwent closure of large defects after ESD using the OverStitch Sx system. Main outcomes of the study are technical and clinical success, same-day discharge rate, and adverse event rate.

Thirty-three patients were enrolled. The mean diameter of included lesions was 5.38 ± 2.52 cm. The defect occupied ≥50% of the lumen circumference in 70% of the cases. En-bloc resection, R0 resection, and curative resection were achieved in 97%, 87.5%, and 78.8% of patients, respectively. Technical success and clinical success were seen in 93.9% and 90.9% of the cases, respectively. Same-day hospital discharge was achieved in 77.4% of patients. Total adverse event rate was 35.7%, including delayed bleeding in 1 patient after rectal ESD that was managed conservatively, self-resolving rectal pain in 7 patients, rectal stricture requiring dilation in 1 patient, and temporary dysphagia in 1 patient. No immediate or delayed perforation was reported.

OverStitch Sx enabled safe and effective closure of large defects after ESD. Future trials are needed to determine its superiority over OverStitch for the closure of defects in challenging locations. (Clinical trial registration number: NCT04361227.).

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.

Endoscopic submucosal dissection (ESD) is a minimally invasive technique that is widely used to remove gastrointestinal tumors. However, because the walls of the duodenum and large intestine are thin, perforation can easily occur after ESD. We have previously reported that alkyl group-modified Alaska pollock gelatin-based microparticles (C10Ps) formed a colloidal gel that could adhere to defects and close perforations, driven by hydrophobic interactions. The present study focused on the effect of particle size on the colloidal gel properties and the floatation of C10Ps in the air in the delivery of C10Ps. We prepared C10Ps with different particle sizes from 0.1 to 100 µm. The storage modulus and adhesion strength of the C10P colloidal gel increased with decreasing particle size. All the C10Ps formed a colloidal gel layer on duodenum tissue after being sprayed from an endoscopic device. The underwater stability and burst strength of C10Ps with a particle size of 0.1 and 1 µm were higher than for larger C10Ps. Floating of the small-sized C10Ps in the air was observed. The results indicated that C10Ps with a size of 1 µm had suitable properties for use in endoscopic treatments. STATEMENT OF SIGNIFICANCE: We previously reported tissue adhesive microparticles as a spray-deliverable wound dressing in gastrointestinal tissues. However, their functions depending on particle size have not yet been clarified. In the present study, we prepared decyl group-modified Alaska pollock gelatin nano and microparticles (C10Ps) with different particle sizes from 0.1 to 100 µm and evaluated the effect of particle size on the colloidal gel properties (rheological property, underwater stability and perforation-closing ability) and the floatation of C10Ps in the air in the delivery of C10Ps.

Large mucosal defects following gastric endoscopic submucosal dissection (ESD) cause postoperative bleeding. To address this limitation and ensure closure of large mucosal defects, we developed the reopenable clip-over-the-line method (ROLM) using a reopenable clip and nylon line. The purpose of this study was to evaluate the feasibility of the ROLM for closure of large mucosal defects following gastric ESD in a prospective, consecutive series of cases.

We performed the ROLM on 50 consecutive patients with gastric mucosal defects at the Ise Red Cross Hospital and Mie Prefectural Shima Hospital. The time to complete the ROLM, numbers of clips and lines required, size of defect, and closure success rate were measured, and postoperative adverse events were recorded.

In all, 50 lesions were included in this study period between July 2021 and March 2022. The success rates of defect closure and defect closure without submucosal dead space of the ROLM were both 100% (50/50), with a median ROLM time of 30 (range, 14-35) min and a median resected specimen major axis of 45 (range, 31-73) mm. The median number of reopenable clips used was 31 (range, 10-93). Following gastric ESD, two cases of post-ESD bleeding were observed during the follow-up periods.

Our results suggest that ROLM is a feasible strategy for complete closure of mucosal defects post-ESD without submucosal dead space. Future comparative studies with post-ESD bleeding rate as the main outcome are desirable to evaluate the efficacy of ROLM.

No study has focused on the safety and feasibility of our previously developed open-window suturing technique to close mucosal defects on the pancreatic side after endoscopic submucosal dissection from the opened duodenal wall. This study aimed to evaluate the safety and usefulness of laparoscopic endoscopic cooperative surgery for duodenal tumors for treating superficial non-ampullary duodenal epithelial tumors on the pancreatic side of the duodenum.

This retrospective study included 61 consecutive patients who underwent surgery during August 2014-November 2021. After dissection when the tumor was on the pancreatic side, we sutured the mucosal defect from the opened duodenal wall. A preoperative endoscopic pancreatic stent was placed for tumors within 1 cm of the ampulla of Vater. The surgical outcomes were compared between tumors on the pancreatic and non-pancreatic sides.

There were 27 and 34 patients with tumors on the pancreatic and non-pancreatic sides, respectively. The patient characteristics were similar. Preoperative pancreatic stents were placed in four patients in the pancreatic side group. The median operative time was significantly longer on the pancreatic side than in the non-pancreatic side group (241 vs. 209 min, P = 0.02). In one patient in the pancreatic side group, an intraoperative injury of the ampulla of Vater was successfully treated with intraoperative management. There were no significant differences in the incidence of postoperative grade II or higher complications between the groups.

Laparoscopic endoscopic cooperative surgery for duodenal tumors for treating superficial non-ampullary duodenal epithelial tumors on the pancreatic side is safe and feasible.

Over-the-scope clips (OTSCs) are now becoming popular in endoscopy performed in adults for indications such as acute nonvariceal GI bleeding, anastomotic bleeding, and for closure of gastrocutaneous and postgastrostomy fistulae. Varied sizes of clip are available, but even the smallest, 8.5 to 9.8 mm in diameter with its loading device on the tip of the endoscope, increases device and endoscope intubation diameters up to 14.65 mm. This may present challenges in terms of the size of the patient in whom it might be used. OTSCs appear to be effective and safe in the hands of those who are trained appropriately in endoscopy on adult patients; however, the experience of OTSC application in children is not reported. Here we present results of a service evaluation of this technology at 2 regional/national referral pediatric endoscopy units in the United Kingdom and the United States.

Two tertiary centers' databases were searched to identify cases in which OTSCs were used. Demographics, presentation, anthropometry, comorbidities, efficacy, adverse events, and postprocedure follow-up were recorded, with identification of resolution or recurrence.

OTSC procedures were performed on 24 occasions in 20 patients (11 girls) between February 2018 and February 2021. Patients had a mean age of 12 years (range, 5-17) and a mean weight of 44.42 kg (range, 18.2-70.3). Indications were nonhealing PEG site fistulae (n = 7), acute nonvariceal upper GI bleeding (ANUGIB) from gastric ulcers (5), ANUGIB from duodenal ulcers (3), nonhealing bleeding anastomotic ulcer (3), esophageal mucocutaneous fistula (1), and gastric perforation (1). Technical success was achieved in all but 1 case (95%), and clinical success was achieved in 18 cases (90%).

The OTSC device appears to be effective in children (minimum age 5 years and minimum weight 18 kg) in a limited number of situations including anastomotic ulcer, closure of leaking PEG site, gastric perforation, and bleeding peptic ulcers. The operator should be an experienced endotherapeutic endoscopist with specific OTSC training, and the type and size of the OTSC device should be carefully considered, along with any comorbidities of the patient that may preclude success and/or lead to potential adverse events such as esophageal perforation.

The over-the-scope clip (OTSC) is an innovative device and has been successfully used in endoscopic treatment, however, there is a lack of clinical data from China. The aim of this study is to investigate the OTSC applications in the treatment of upper non-variceal gastrointestinal bleeding (UNVGIB), perforations, and fistulas in China.

In total, 80 patients were treated with one OTSC respectively as first-line therapy in our endoscopy center between January 2016 and November 2020. Among them, 41 patients had UNVGIB, 34 patients had perforations, and five patients had fistulas. The technical and clinical success rates were used to assess the efficacy of OTSC on the above diseases. In addition, we compared the hemostatic efficacy of OTSC with the standard endoscopic therapy in ulcer bleeding and Dieulafoy's lesion by propensity score matching analysis.

In general, the OTSCs were applied successfully in all patients and achieved 100% (80/80) technical success. The clinical success of all patients was 91.3% (73/80). Among 41 patients with UNVGIB, the clinical success was 85.4% (35/41); 6 patients presented with recurrence. For patients of Dieulafoy's lesion and under antithrombotic therapy, we found that OTSC treatment had both efficient and reliable hemostasis effects. In addition, according to the characteristics of ulcers, site of bleeding lesion, and Blatchford score, all patients received similar and reliable clinical success rates. After propensity score matching, we found that OTSC treatment had low rebleeding rates when compared with standard endoscopic therapy in both Dieulafoy's lesion (15.0 vs 30.0%) and ulcer bleeding (17.6 vs 29.4%). Among 34 patients with perforations, the clinical success was 100% (34/34). Among five patients with fistulas, only one patient failed in maintaining the OTSC before esophageal fistula healing, and the clip achieved an overall clinical success of 80% (4/5).

The OTSC represents a safe and effective endoscopic therapy for UNVGIB, perforations, and fistulas as first-line treatment, especially for Dieulafoy's lesion or patients under antithrombotic therapy for UNVGIB, etc. However, OTSC application in these specific lesions or patients lacks adequate evidence as first-line treatment. Therefore, further larger sample and multi-center clinical trials are required to improve its indications in clinical treatment.

Closure of endoscopic resection defects can be achieved with through-the-scope clips, over-the-scope clips, or endoscopic suturing. However, these devices are often limited by their inability to close large, irregular, and difficult-to-reach defects. Thus, we aimed to assess the feasibility and safety of a novel through-the-scope, suture-based closure system developed to overcome these limitations.

This was a retrospective multicenter study involving 8 centers in the United States. Primary outcomes were feasibility and safety of early use of the device. Secondary outcomes were assessment of need for additional closure devices, prolonged procedure time, and technical feasibility of performing the procedure with an alternative device(s).

Ninety-three patients (48.4% women) with mean age 63.6 ± 13.1 years were included. Technical success was achieved in 83 patients (89.2%), and supplemental closure was required in 24.7% of patients (n = 23) with a mean defect size of 41.6 ± 19.4 mm. Closure with an alternative device was determined to be impossible in 24.7% of patients because of location, size, or shape of the defect. The use of the tack and suture device prolonged the procedure in 8.6% of cases but was considered acceptable. Adverse events occurred in 2 patients (2.2%) over a duration of follow-up of 34 days (interquartile range, 13-93.5) and were mild and moderate in severity. No serious adverse events or procedure-related deaths occurred.

The novel endoscopic through-the-scope tack and suture system is safe, efficient, and permits closure of large and irregularly shaped defects that were not possible with established devices.

BEST PRACTICE ADVICE 1: For all procedures, especially procedures carrying an increased risk for perforation, a thorough discussion between the endoscopist and the patient (preferably together with the patient's family) should include details of the procedural techniques and risks involved. BEST PRACTICE ADVICE 2: The area of perforation should be kept clean to prevent any spillage of gastrointestinal contents into the perforation by aspirating liquids and, if necessary, changing the patient position to bring the perforation into a non-dependent location while minimizing insufflation of carbon dioxide to avoid compartment syndrome. BEST PRACTICE ADVICE 3: Use of carbon dioxide for insufflation is encouraged for all endoscopic procedures, especially any endoscopic procedure with increased risk of perforation. If available, carbon dioxide should be used for all endoscopic procedures. BEST PRACTICE ADVICE 4: All endoscopists should be aware of the procedures that carry an increased risk for perforation such as any dilation, foreign body removal, any per oral endoscopic myotomy (Zenker's, esophageal, pyloric), stricture incision, thermal coagulation for hemostasis or tumor ablation, percutaneous endoscopic gastrostomy, ampullectomy, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), endoluminal stenting with self-expanding metal stent (SEMS), full-thickness endoscopic resection, endoscopic retrograde cholangiopancreatography (ERCP) in surgically altered anatomy, endoscopic ultrasound (EUS)-guided biliary and pancreatic access, EUS-guided cystogastrostomy, and endoscopic gastroenterostomy using a lumen apposing metal stent (LAMS). BEST PRACTICE ADVICE 5: Urgent surgical consultation should be highly considered in all cases with perforation even when endoscopic repair is technically successful. BEST PRACTICE ADVICE 6: For all upper gastrointestinal perforations, the patient should be considered to be admitted for observation, receive intravenous fluids, be kept nothing by mouth, receive broad-spectrum antibiotics (to cover Gram-negative and anaerobic organisms), nasogastric tube (NGT) placement (albeit some exceptions), and surgical consultation. BEST PRACTICE ADVICE 7: For upper gastrointestinal tract perforations, a water-soluble upper gastrointestinal series should be considered to confirm the absence of continuing leak at the perforation site before initiating a clear liquid diet. BEST PRACTICE ADVICE 8: Endoscopic closure of esophageal perforations should be pursued when feasible, utilizing through-the-scope clips (TTSCs) or over-the-scope clips (OTSCs) for perforations <2 cm and endoscopic suturing for perforations >2 cm, reserving esophageal stenting with SEMS for cases where primary closure is not possible. BEST PRACTICE ADVICE 9: Endoscopic closure of gastric perforations should be pursued when feasible, utilizing TTSCs or OTSCs for perforations <2 cm and endoscopic suturing or combination of TTSCs and endoloop for perforations >2 cm. BEST PRACTICE ADVICE 10: For large type 1 duodenal perforations (lateral duodenal wall tear >3 cm), being cognizant of the difficulty in closing them endoscopically, urgent surgical consultation should be made while the feasibility of endoscopic closure is assessed. BEST PRACTICE ADVICE 11: Because type 2 periampullary (retroperitoneal) perforations are subtle and can be easily missed, the endoscopist should carefully assess the gas pattern on fluoroscopy to avoid delays in treatment and request a computed tomography scan if there is a concern for such a perforation; identified perforations of this type at the time of ERCP may be closed with TTSCs if feasible and/or by placing a fully covered SEMS into the bile duct across the ampulla. BEST PRACTICE ADVICE 12: For the management of large duodenal polyps, endoscopic mucosal resection (EMR) should only be performed by experienced endoscopists and endoscopic submucosal dissection (ESD) only by experts because both EMR and ESD in the duodenum require proficiency in resection and mucosal defect closure techniques to manage immediate and/or delayed perforations (caused by the proteolytic enzymes of the pancreas). BEST PRACTICE ADVICE 13: Endoscopists should be aware that colon perforations occurring during diagnostic colonoscopy are most commonly located in the sigmoid colon due to direct trauma from forceful advancement of the colonoscope. Such tears recognized at the time of colonoscopy may be closed by TTSCs or OTSCs if the bowel preparation is good and the patient is stable. BEST PRACTICE ADVICE 14: Although colon perforation is responsive to various endoscopic tools such as TTSC, OTSC, and endoscopic suturing, perforations in the right colon, especially in the cecum, have been relegated to using only TTSCs because of inability to reach the site of the perforation with an endoscopic suturing device or OTSC if the colon is tortuous or unclean. Recently a new suture-based device for defect closure has been introduced allowing deep submucosal and intramuscular enhanced fixation through a standard gastroscope or colonoscope. BEST PRACTICE ADVICE 15: Patients with perforations who are hemodynamically unstable or who have suffered a delayed perforation with peritoneal signs or frank peritonitis should be surgically managed without any attempt at endoscopic closure. BEST PRACTICE ADVICE 16: In any adverse event including perforation, it is paramount to ensure accurate documentation, prompt discussion with the patient and family, and swift reporting to the quality officer (or equivalent) and risk management team of the institution (in major adverse events).

Endoscopic submucosal dissection (ESD) is a method of en-bloc resection of neoplastic colorectal lesions which is less invasive compared to surgical resection. Lesion stratification, architecture recognition and estimation of depth of invasion are crucial for patient selection. Expert endoscopists have integrated a variety of classification systems including Paris, lateral spreading tumor (LST), narrow band imaging (NBI), international colorectal endoscopic (NICE) and Japanese NBI expert team (JNET) in their day-to-day practice to enhance lesion detection accuracy. Major societies recommend ESD for LST-non granular (NG), Kudo-VI type, large depressed and protruded colonic lesions with shallow submucosal invasion. Chance of submucosal invasion enhances with increased depth as well as tumor location and size. In comparison to endoscopic mucosal resection (EMR), ESD has a lowerl recurrence rate and higher curative resection rate, making it superior for larger colonic lesions management. Major complications such as bleeding and perforation could be seen in up to 11% and 16% of patients, respectively. In major Western countries, performing ESD is challenging due to limited number of expert providers, lack of insurance coverage, and unique patient characteristics such as higher BMI and higher percentage of previously manipulated lesions.

Management of iatrogenic gastrointestinal (GI) defects traditionally required surgical interventions. Recently, the over-the-scope-clip system (OTSC) has been reported to be effective for GI defects. So we aimed to conduct an updated systematic review to evaluate the clinical safety and efficacy of the OTSC system for the management of iatrogenic GI defects.

Studies published in PubMed, Embase and Cochrane library from January 2006 to December 2018 were searched. The literature was selected independently by two reviewers according to inclusion and exclusion criteria. The statistical analysis was carried out using Comprehensive Meta-Analysis software version 3.0.

A total of 12 studies including 191 patients with iatrogenic GI defects were identified. The major causes for iatrogenic GI defects were endoscopic submucosal dissection (n = 79) and endoscopic mucosal resection (n = 31). Pooled technical success was achieved in 182 patients (89.1%; 95% confidence interval (CI), 81.6%-93.8%, I2 =41.06%), and the pooled clinical success was achieved in 170 patients (85.2%; 95% CI, 71.9%-92.8%, I2=58.92%). Two patients (1%) suffered complications after OTSC system procedures.

Our study revealed that endoscopic closure of iatrogenic GI defects by the OTSC system was a safe and effective approach. Further randomized controlled trials are warranted to compare the OTSC system to other treatment modalities.

Although various procedures have been used to prevent serious adverse events after endoscopic resection of the duodenum, their effectiveness has not been determined. In this study, we conducted a systematic review and meta-analysis to determine whether endoscopic preventive procedures reduce delayed adverse events.

Studies on endoscopic treatment for superficial nonampullary duodenal tumors were selected. We compared the following 2 groups: the closure group, which underwent mucosal sutures and coverage of mucosal defects after resection, and the unclosed group, which did not. The primary outcome was the rate of delayed adverse events, including perforation and bleeding. The pooled risk ratios (RRs) of all outcomes investigated, the 95% confidence intervals (CIs), and P values were calculated.

A total of 438 patients from 4 studies were included in the meta-analysis. The pooled overall adverse event rates in the closure group and unclosed group were 3.6% and 21.1%, respectively. This rate was significantly lower in the closure group (RR, 0.19; 95% CI, 0.10-0.38; P < .01; I2 = 0%), and the rate of delayed bleeding was significantly lower in the closure group (RR, 0.14; 95% CI, 0.06-0.33; P < .01; I2 = 0%). Regarding delayed perforation, the RR in the closure group was 0.39 (95% CI, 0.12-1.32; P = .13; I2 = 0%).

Preventive procedures significantly reduced the risk of delayed adverse events by more than 80%. After endoscopic resection of the duodenum, the implementation of preventive procedures, including mucosal sutures and coverage of mucosal defects, to delay adverse events is strongly recommended.

The Over-The-Scope Clip (OTSC) can effectively treat refractory gastrointestinal diseases. However, most reports have focused on short-term effectiveness. We examined clinical outcomes of the deployed clips and long-term characteristics.

Of 47 patients with OTSC treatment, 35 with follow-up periods of ≥3 months were retrospectively examined. The indications were 11 bleedings, 17 perforations, and seven fistulas. The observation period was defined as medium-term (3 to <12 months) or long-term (≥12 months). The primary outcome was the clinical success rate without disease recurrence. The secondary outcomes were the complication rate, survival duration, and clip retention rate.

The medium- and long-term clinical success rates were 100% during the observation period (median, 44 months; range, 3-78 months). The complication rate was 2.9% (n = 1). The median survival time was 1,634 days for bleeding, 1,757 days for perforation, and 444 days for fistulas. The overall clip retention rates were 56.4%, 38.1%, 30.9%, and 25.9% after one, six, and 12 months and at the final follow-up, respectively. The average clip retention duration was 244 days in bleeding, 656 days in perforations, and 188 days in fistulas.

Regardless of clip detachment, the OTSC can be effective in long-term.

Scope-induced duodenal perforation is a life-threatening complication and surgery remains the standard of care. With the advent of over-the-scope clip (OTSC), scope-induced perforations are increasingly managed conservatively, though there is no study comparing this form of non-surgical treatment with surgery. We aimed to compare OTSC and surgery in the management of scope-induced perforation of the duodenum.

We retrospectively collected data of scope-induced duodenal perforation patients. Perforations identified and treated within 24 h of procedure were analyzed. Factors analyzed were spectrum, etiology, baseline parameters, perforation size, outcome, comorbidities, and duration of hospital stay.

A total of 25 patients had type I duodenal perforations, out of whom five were excluded due to delayed diagnosis and treatment. Of the twenty, eight were treated with OTSC placement while the rest underwent surgery. Age was comparable and the majority were females. Baseline parameters and comorbidities were similar in both the groups. The median size of perforation was 1.5 cm in both the OTSC group and the surgical group. All patients were treated with standard of care according to institutional protocols. Patients in the OTSC group were started orally after 48 h of OTSC placement, while in the surgery group median time to oral intake was 7 days. Two patients in the surgical group died while there was no mortality in the OTSC group (p = 0.48). Median hospital stay was shorter in the OTSC group (2 days vs. 22 days, p = 0.003).

OTSC is a feasible and better option in type I duodenal perforations with a shorter hospital stay.

This study aimed to assess the safety and feasibility of endoscopic submucosal dissection (ESD) using a scissors-type knife with prophylactic closure using over-the-scope clip (OTSC) for superficial non-ampullary duodenal epithelial tumors (SNADETs).

Consecutive patients who underwent ESD for SNADETs >10 mm between January 2009 and July 2019 were retrospectively enrolled. We performed ESD using either a needle-type knife (Flush Knife-ESD) or a scissors-type knife (Clutch Cutter-ESD). Mucosal defects were prophylactically closed using three methods: conventional clip, laparoscopic closure, or OTSC.

A total of 84 lesions were resected using the Flush Knife-ESD and the Clutch Cutter-ESD (37 and 47 patients, respectively), and conventional clip, laparoscopic closure, and OTSC for mucosal defect closure after ESD were applied in 13, 13, and 56 lesions, respectively. The R0 resection rate was significantly higher in the Clutch Cutter-ESD than that in the Flush Knife-ESD (97.9% vs 83.8%, respectively, P = 0.040). The intraoperative perforation rate was significantly lower in the Clutch Cutter-ESD than in the Flush Knife-ESD (0% vs 13.5%, respectively, P = 0.014). Complete closure rates of conventional clip, laparoscopic closure, and OTSC were 76.9%, 92.3%, and 98.2%, respectively (P = 0.021); and delayed perforation rates were 15.4%, 7.7%, and 1.8%, respectively (P = 0.092).

Endoscopic submucosal dissection using a scissors-type knife with prophylactic OTSC closure is safe and feasible for the low-invasive treatment of SNADETs.

1:  ESGE recommends that each center implements a written policy regarding the management of iatrogenic perforations, including the definition of procedures that carry a higher risk of this complication. This policy should be shared with the radiologists and surgeons at each center. 2 : ESGE recommends that in the case of an endoscopically identified perforation, the endoscopist reports its size and location, with an image, and statement of the endoscopic treatment that has been applied. 3:  ESGE recommends that symptoms or signs suggestive of iatrogenic perforation after an endoscopic procedure should be rapidly and carefully evaluated and documented with a computed tomography (CT) scan. 4 : ESGE recommends that endoscopic closure should be considered depending on the type of the iatrogenic perforation, its size, and the endoscopist expertise available at the center. Switch to carbon dioxide (CO2) endoscopic insufflation, diversion of digestive luminal content, and decompression of tension pneumoperitoneum or pneumothorax should also be performed. 5 : ESGE recommends that after endoscopic closure of an iatrogenic perforation, further management should be based on the estimated success of the endoscopic closure and on the general clinical condition of the patient. In the case of no or failed endoscopic closure of an iatrogenic perforation, and in patients whose clinical condition is deteriorating, hospitalization and surgical consultation are recommended.

The Over-the-scope clip (OTSC) has been recently introduced for multiple purposes, including refractory bleeding, perforation, fistula, and anastomotic dehiscence of the gastrointestinal tract. However, no easy access techniques for delivering OTSCs to distant sites have been described. Therefore, we have developed a simple and safe guidewire-assisted OTSC delivery (GOD) method for use on the distal intestine. This study aimed to investigate the technical feasibility and safety of the method.

Between June 2018 and April 2019, all eight patients who underwent the GOD method were retrospectively examined. The primary outcome was the successful rate of OTSC delivery to the lesion without complications. The secondary outcomes were GOD procedure time, total procedure time, technical and clinical OTSC success rates, and GOD- and OTSC-associated complications.

The rate of successful OTSC delivery was 100%. The median procedure time of GOD was 21 min (range 8-29). The median total procedure time was 38.5 min (range 26-41). The technical and clinical success rates of OTSC were 100% and 75% (6/8), respectively. No GOD- or OTSC-associated complications occurred.

The GOD method is a feasible and safe technique for delivering OTSC toward the small and proximal large intestine.

The over-the-scope clip (OTSC) system has been increasingly utilized as a non-surgical option to endoscopically manage refractory gastrointestinal (GI) hemorrhage, perforations/luminal defects and fistulas. Limited data exist evaluating the efficacy and safety of OTSC.

To determine the clinical success and adverse event (AE) rates of OTSC across all GI indications.

A PubMed search was conducted for eligible articles describing the application of the OTSC system for any indication in the GI tract. Any article or case series reporting data for less than 5 total patients was excluded. The primary outcome was the rate of clinical success. Secondary outcomes included: Technical success rate, OTSC-related AE rate and requirement for surgical intervention despite-OTSC placement. Pooled rates (per-indication and overall) were calculated as the number of patients with the event of interest divided by the total number of patients.

A total of 85 articles met our inclusion criteria (n = 3025 patients). OTSC was successfully deployed in 94.4% of patients (n = 2856/3025). The overall rate of clinical success (all indications) was 78.4% (n = 2371/3025). Per-indication clinical success rates were as follows: (1) 86.0% (1120/1303) for GI hemorrhage; (2) 85.3% (399/468) for perforation; (3) 55.8% (347/622) for fistulae; (4) 72.6% (284/391) for anastomotic leaks; (5) 92.8% (205/221) for defect closure following endoscopic resection (e.g., following endoscopic mucosal resection or endoscopic submucosal dissection); and (6) 80.0% (16/20) for stent fixation. AE's related to the deployment of OTSC were only reported in 64 of 85 studies (n = 1942 patients), with an overall AE rate of 2.1% (n = 40/1942). Salvage surgical intervention was required in 4.7% of patients (n = 143/3025).

This systematic review demonstrates that the OTSC system is a safe and effective endoscopic therapy to manage GI hemorrhage, perforations, anastomotic leaks, defects created by endoscopic resections and for stent fixation. Clinical success in fistula management appears limited. Further studies, including randomized controlled trials comparing OTSC with conventional and/or surgical therapies, are needed to determine which indication(s) are the most effective for its use.

Iatrogenic perforation is a known and feared complication of diagnostic and therapeutic colonoscopy. Specific locations in the gastrointestinal tract, such as the jejunum, have a higher risk of perforation owing to its difficult anatomical position. Over-the-scope clips have recently been used for the management of these perforations. We present the case of a 40-year-old male patient treated with over-the-scope (Ovesco®, Ovesco Endoscopy AG, Tübingen, Germany) clips for an iatrogenic postpolypectomy perforation with subsequent anal pain and inability to evacuate stool occurring as a result of the migration of the clip, followed by a review of the literature.

Upper gastrointestinal bleeding is defined as the bleeding originating from the esophagus to the ligament of Treitz and further classified into variceal and non-variceal gastrointestinal bleeding. Non-variceal upper gastrointestinal bleeding remains a common clinical problem globally. It is associated with high mortality, morbidity, and cost of the health care system. Despite the continuous improvement of therapeutic endoscopy, the 30-d readmission rate secondary to rebleeding and associated mortality is an ongoing issue. Available Food and Drug Administration approved traditional or conventional therapeutic endoscopic modalities includes epinephrine injection, argon plasma coagulation, heater probe, and placement of through the scope clip, which can be used alone or in combination to decrease the risk of rebleeding. Recently, more attention has been paid to the novel advanced endoscopic devices for primary treatment of the bleeding lesion and as a secondary measure when conventional therapies fail to achieve hemostasis. This review highlights emerging endoscopic modalities used in the management of non-variceal upper gastrointestinal related bleeding such as over-the-scope clip, Coagrasper, hemostatic sprays, radiofrequency ablation, cryotherapy, endoscopic suturing devices, and endoscopic ultrasound-guided angiotherapy. In this review article, we will also discuss the technical aspects of the common procedures, outcomes in terms of safety and efficacy, and their advantages and limitations in the setting of non-variceal upper gastrointestinal bleeding.

Historically, the gold standard management of esophageal perforations, leaks, and fistulae has been traditional open surgery, but it is associated with significant morbidity and mortality. Minimally invasive approaches offer alternatives to surgery in treating hemodynamically stable patients with such defects. In this review article, we will discuss the recent advancements in the minimally invasive management of esophageal perforations, leaks, and fistulas.

This review includes information from case reports, case series, and clinical trials on minimally invasive management of esophageal perforations, leaks, and fistulas. The focus is on the devices, outcomes, and application of the technology.

Minimally invasive treatment represents significant progress in the management of esophageal perforations, leaks, and fistulas. Based on current evidence, it seems safe and effective but it is evolving and more studies are needed to help draw definitive conclusions.

Background and study aims  It is unclear if the clinical success rate of the over-the-scope-clip (OTSC) in peptic ulcer bleeding (PUB) is comparable when it is used in the first- or in the second-line of treatment. Patients and methods  Data on endoscopic treatment (first- vs. second-line) in PUB with OTSC and clinical data were analyzed. The primary outcome was the clinical success of hemostasis, defined as the absence of recurrent bleeding or further intervention. Secondary outcomes were factors associated with OTSC failure. Results  From April 2014 to March 2018, 100 patients (age 72 [20 - 98] y, female 36 %) with PUB in the stomach or the duodenum were treated endoscopically with the OTSC. The OTSC was used as a first-line procedure (primary-OTSC) in 66 pts. Successful hemostasis could be achieved in 90.9 %. After failure of an initial endoscopic treatment, 34 patients were treated with the OTSC (secondary-OTSC) and the treatment was successful in 94.1 %. Recurrent bleeding occurred in n = 10 for primary-OTSC (16.7 %) and in n = 7 pts in the secondary-OTSC (21.9 %) ( P  = 0.81). Clinical success in the primary-OTSC was 75.8 % and 73.5 % in the secondary-OTSC respectively. Conclusions  The OTSC has a high rate of initial bleeding control in first- and second line treatment of PUB. OTSC failure occurs more often in the duodenum than in the stomach and results in longer intensive care unit stay, higher amount of transfusions, and a higher reimbursement per case.

Since its market launch in 2007, the endoscopic OTSC clipping system has been the object of intensive clinical research. These data were systematically collected for post-market clinical follow-up (PMCF). The aim of the study was the systematic review of the efficacy and safety of the OTSC System. The PMCF database was systematically searched for clinical data on OTSC therapy of GI hemorrhage (H), acute leaks/perforations (AL) and chronic leaks/fistulae (CL). Major outcomes were successful clip application and durable hemostasis/closure of defects. Comprehensive pooled success proportions were established by meta-analytical methods. Four-hundred-fifty-seven publications were reviewed. Fifty-eight articles comprising 1868 patients fulfilled criteria to be included in the analysis. These consisted of retrospective analyses, prospective observational trials, one randomized-controlled trial (STING) and one quasi-controlled study (FLETRock). The pooled proportion analysis revealed high overall proportions of technical success: H - mean 93.0% [95%CI 90.2-95.4], AL-mean 89.7% [95%CI 85.9-92.9] and CL-mean 83.8% [95%CI 76.9-89.7]. Pooled durable clinical success proportions were: H-mean 87.5% [95%CI 80.5-93.2], AL-mean 81.4% [95%CI 77.0-85.3] and CL-mean 63.0% [95%CI 53.0-72.3]. By pooling all clinical data gained, we conclude that OTSC application in GI hemorrhage and closure of GI lesions is safe and effective in real clinical use.

To investigate the effectiveness of over-the-scope-clip (OTSC)-based endoscopic closure in patients with perforated peptic ulcer (PPU).

One hundred six patients diagnosed with PPU were treated with either OTSC (n = 26) or conservative treatments (n = 80), respectively. The outcome assessments included technical success rate, clinical success rate, post-treatment complications after 1 month, mortality rate, time to resume oral feeding, length of hospital stay, and the administration of antibiotics.

In the OTSC group, technical and clinical success was achieved in 100% of patients without any complications, including death, incomplete closure, duodenal obstruction, and gastrointestinal bleeding, with a median operation time of 10 min. All patients in the OTSC group were discharged, while the mortality rate in the control group was 13.8%. Subsequent surgeries were required in 30% of patients in the control group. The median times to resume oral feeding were 3.5 (interquartile range [IQR] 2.0-5.25) days in the OTSC group and 7.0 (IQR 5.0-9.0) days in the control group (p < 0.001). One month post-procedure, 30% (24/80) of patients in the control group and 0 (0/26) in the OTSC group required additional operations (p < 0.001). No significant difference was found in the length of the hospital stay and the administration of antibiotics between the two groups (p > 0.05).

OTSC-based endoscopic technique, with a high clinical success rate and a shorter time to resume oral feeding, was effective in achieving closure of PPU with a diameter < 15 mm.

Endoscopic retrograde cholangiopancreatography (ERCP)-related duodenal perforation is a rare complication associated with significant morbidity and mortality. This study evaluated endoscopic management experience and outcomes of ERCP-related duodenal perforations.

Between March 2005 and March 2017, a total of 19,468 ERCP procedures were performed in three endoscopy units of three hospitals in China. Diagnoses, management, and outcomes were identified and retrospectively reviewed in 58 of these patients.

According to the classification system, 58 patients included 8 with type I, 44 with type II, 4 with type III, and 2 with type IV perforation. Of type I perforations, 7 patients underwent endoscopic closure with endoclips, and 1 patient was treated with surgical repair. Of type II perforations, 11 patients were actively managed using the fully covered self-expandable metallic stents (SEMS) to seal the perforation, and 33 patients were passively managed using nose-biliary drainage, in which 13 cases had retroperitoneal abscess formation and were successfully treated by abdominal computed tomography (CT)-guided percutaneous external drainage, but 1 patient died due to sepsis. One patient with type III perforation (pancreatic duct perforation) underwent endoscopic pancreatic duct stent placement after surgery failure. The mean hospital stay of 11 cases with type II perforation treated actively by endoscopy (26.5 ± 3.3 days) was lower compared with 33 cases who received passive conservative treatment (34.6 ± 3.9 days).

Many (especially type I and II) ERCP-related duodenal perforations can be successfully treated with endoscopic management. Active endoscopic therapy may be better than passive conservative treatment for type II perforations.

Rescue therapy for gastrointestinal (GI) refractory bleeding, perforation, and fistula has traditionally required surgical interventions owing to the limited performance of conventional endoscopic instruments and techniques. An innovative clipping system, the over-the-scope clip (OTSC), may play an important role in rescue therapy. This innovative device is proposed as the final option in endoscopic treatment. The device presents several advantages including having a powerful sewing force for closure of GI defects using a simple mechanism and also having an innovative feature, whereby a large defect and fistula can be sealed using accessory forceps. Consequently, it is able to provide outstanding clinical effects for rescue therapy. This review clarifies the current status and limitations of OTSC according to different indications of GI refractory disease, including refractory bleeding, perforation, fistula, and anastomotic dehiscence. An extensive literature search identified studies reported 10 or more cases in which the OTSC system was applied. A total of 1517 cases described in 30 articles between 2010 and 2018 were retrieved. The clinical success rates and complications were calculated overall and for each indication. The average clinical success rate was 78% (n = 1517) overall, 85% for bleeding (n = 559), 85% (n = 351) for perforation, 52% (n = 388) for fistula, 66% (n = 97) for anastomotic dehiscence, and 95% (n = 122) for other conditions, respectively. The overall and severe OTSC-associated complications were 1.7% (n = 23) and 0.59% (n = 9), respectively. This review concludes that the OTSC system may serve as a safe and productive device for GI refractory diseases, albeit with limited success for fistula.

Esophageal perforation has historically been a devastating condition resulting in high morbidity and mortality. The use of endoluminal therapies to treat esophageal leaks and perforations has grown exponentially over the last decade and offers many advantages over traditional surgical intervention in the appropriate circumstances. New interventional endoscopic techniques, including endoscopic clips, covered metal stents, and endoluminal vacuum therapy, have been developed over the last several years to manage esophageal perforation in an attempt to decrease the related morbidity and mortality.

Endoscopic hemostasis in patients with non-variceal bleeding (NVGIB) with standard therapy has improved outcomes. However, persistent bleeding and re-bleeding continues to drive morbidity and mortality. Use of over-the-scope clips (OTSC) is an emerging treatment modality for managing gastrointestinal (GI) bleeding. We performed a systematic review and meta-analysis to evaluate the ability of OTSC to achieve primary hemostasis and re-bleeding rates as primary therapy and rescue endoscopic interventions in patients with NVGIB.

We searched articles in PubMed, Ovid Medline In- Process & Other Non-Indexed Citations, Embase, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus from inception to July 2017 using keywords such as "OTSC" and "NVGIB."

A total of 16 studies which involved 475 patients met the inclusion criteria. 288 patients were treated with OTSC as primary therapy while 187 patients were treated with OTSC as rescue therapy. Primary hemostasis rate achieved with primary endoscopic therapy with OTSC was 0.93 (95% CI: 0.89-0.96). Similarly, primary hemostasis rate achieved with rescue endoscopic therapy with OTSC was 0.91 (95% CI: 0.84-0.95). Re-bleeding rates after primary endoscopic therapy with OTSC was 0.21 (95% CI:0.08-0.43) and 0.25 (95% CI:0.17-0.34) with rescue therapy. There was a decreased risk of re-bleeding in patients treated with OTSC as primary therapy versus rescue therapy. RR=0.52 (95% CI: 0.31-0.89).

This meta-analysis demonstrates success on the use of OTSC as primary and rescue therapy in the management of NVGIB. Further trials should clarify the ideal setting for the use of OTSC and assess the cost of these devices as compared to standard therapy.

Endoscopic hemostasis is effective in treatment of bleeding peptic ulcers. However, rebleeding is difficult to treat and associated with substantial morbidity and mortality. We performed a prospective randomized trial to determine whether over-the-scope clips (OTSCs) are more effective than standard treatment of severe recurrent upper gastrointestinal bleeding.

We performed our study at 9 academic referral centers (in Germany, Switzerland, and Hong Kong) from March 2013 through September 2016. Adult patients with recurrent peptic ulcer bleeding following initially successful hemostasis (66 patients in the intent-to-treat analysis) were randomly assigned to groups (1:1) that underwent hemostasis with either OTSC or standard therapy. Standard therapy was defined as hemostasis with through-the-scope clips (TTSC, n = 31) or thermal therapy plus injection with diluted adrenaline (n = 2). The primary endpoint was further bleeding (a composite endpoint of a persistent bleeding despite endoscopic therapy according to the protocol or recurrent bleeding within 7 days after successful hemostasis). Patients with further bleeding were allowed to cross over to OTSC therapy. Main secondary endpoints were mortality, necessity of surgical or angiographic salvage therapy, duration of stay in the hospital or intensive care, number of blood units transfused, and complications associated with endoscopic therapy.

Persistent bleeding after per-protocol hemostasis was observed in 14 patients (42.4%) in the standard therapy group and 2 patients (6.0%) in the OTSC group (P = .001). Recurrent bleeding within 7 days occurred in 5 patients (16.1%) in the standard therapy group vs 3 patients (9.1%) in the OTSC group (P = .468). Further bleeding occurred in 19 patients (57.6%) in the standard therapy group and in 5 patients (15.2%) in the OTSC group (absolute difference 42.4%; 95% confidence interval 21.6-63.2; P = .001) Within 30 days of follow-up, 1 patient in the standard therapy group (3.0%) and 1 patient in the OTSC group (3.0%) required surgical therapy (P = .999). Within 30 days of the procedure, 2 patients died in the standard therapy group (6.3%) and 4 patients died in the OTSC group (12.1%) (P = .672). There were no significant differences in the other secondary endpoints.

In prospective randomized trial, we found endoscopic treatment with OTSCs to be superior to standard therapy with TTSCs for patients with recurrent peptic ulcer bleeding. STING Study, Clinicaltrials.gov no: NCT1836900.

Esophageal perforation is a medical emergency associated with high morbidity and mortality. There is no consensus on the optimal treatment of this life-threatening condition. Conventional treatment of esophageal perforation is surgical. However, more recently, endoscopic treatment has become the treatment of choice given its less invasive nature compared to surgical treatment. This includes endoscopic clip administration, endoscopic stent placement, endoscopic suturing, endoscopic vacuum therapy and tissue sealants which are all administered via the endoluminal route. Whilst small defects (<2 cm) may be closed with endoscopic clips, larger defects require stent placement or suturing. Removable esophageal stent is an effective method of treatment in cases with esophageal perforation as they allow minimal invasive repair of perforation and rapid nutrition. Endoscopic suturing can be used both to fix the stent to prevent migration and to primarily close the perforation. If perforation is associated with a mediastinal collection, drainage is mandatory and this procedure can be performed by computed tomography guided percutaneous drainage, thoracoscopy or endoscopic vacuum therapy. In some cases, a combination of these minimally invasive methods is required. Since endoscopic methods provide better quality of life and outcomes and shorten length of hospitalization, such methods have become the treatment of choice for esophageal perforation.

Crohn's disease (CD) leads to the development of complications through progressive uncontrolled inflammation and the transmural involvement of the bowel wall. Most of the available literature on penetrating CD focuses on the perianal phenotype. The management of nonperianal penetrating complications poses its own set of challenges and can result in significant morbidity and an increased risk of mortality. Few controlled trials have been published evaluating this subgroup of patients for clinicians to use for guidance. Utilizing the available evidence, we review the epidemiology, presentation, and modalities used to diagnosis and assess intestinal fistulas, phlegmons, and abscesses. The literature regarding the medical, endoscopic, and surgical management options are reviewed providing physicians with a therapeutic framework to comprehensively treat these nonperianal penetrating complications. Through a multidisciplinary evidence-based approach to the complex sequela of CD outcomes can be improved and patient's quality of life enhanced.10.1093/ibd/izx108_video1izx108_Video5754037501001.

The over-the-scope clip (OTSC) system is a recently developed endoscopic device. In the last few years, it has been successfully used for severe bleeding or deep wall lesions, or perforations of the gastrointestinal (GI) tract. We hereby report a series of patients with post-pancreaticogastrostomy pancreatic fistula in whom OTSC were used as endoscopic treatment.

From January 2012 to July 2015, we prospectively collected data on cases of postoperative pancreatic fistula. These patients underwent pancreaticoduodenectomy in a high-volume center of hepatobiliopancreatic surgery. After conservative management, OTSC closure was done by single skilled operators in anesthesiologist-assisted deep sedation.

A total of seven patients were enrolled. According to the International Study Group of Pancreatic Surgery criteria, we observed grade B postoperative pancreatic fistula in all cases. All patients were treated with 12/6 t-type OTSC. In two cases, a second clip was successfully applied to a second site adjacent to the original closure site. In all cases, subsequent fluoroscopy showed no contrastographic spreading through the wall. There were no complications related to the procedure itself, not from the endoscopy point of view, nor from the anesthesiological perspective. There were no device malfunctions. Further clinical and endoscopic evaluation was made 8 weeks later and showed no fistula or anastomotic defect recurrence. No patients required additional endoscopic or interventional procedures.

In consideration of clinical and technical success, OTSC placement in POPF seems to be effective, safe and technically relatively easy to carry out.