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.

OTSC Proctology clip as appropriate treatment for complicated anorectal fistula.

PURPOSE: Evaluation of the effectiveness and tolerability of the application of an OTSC (Ovesco Endoscopy AG Tuebingen, Germany) Proctology clip as an innovative strategy of anorectal fistulae closure when established treatment strategies had already failed or were not feasible. METHODS: Retrospective single-center study including consecutive patients treated between March 2014 and March 2016 with the OTSC Proctology system for anorectal fistula closure, including one rectovaginal and one rectourethral fistula. The primary outcome was the healing rate with a minimum follow up of 6 months. Healing was defined as closure of the internal fistula ostium and absence of secretion or local inflammation during follow up. RESULTS: A total of 66 fistula closures by the OTSC Proctology clip were investigated, including cryptoglandular fistulas (45/66 patients, 68%), fistulas associated with CED (19/66 patients, 29%), and other non-cryptoglandular fistulas (2/66 patients, 4%). 47% (31/66 patients) had a failed previous therapy. In that selected collective, a successful fistula closure was achieved in 29/66 cases (44%) after a median follow up time of 40 months (6-61 months). Suprasphincteric and high transsphincteric fistulas showed healing in 63% and 42% in CD associated fistulas. CONCLUSION: Fistula closure by the OTSC Proctology clip is an innovative, sphincter protecting treatment strategy in anorectal fistulas that can achieve long-term cure in complex anorecta.

Efficacy of endoscopic over-the-scope clip fixation for preventing migration of self-expandable metal stents: a systematic review and meta-analysis.

BACKGROUND: Over-the-scope clips (OTSC), both conventional and Stentfix, are believed to anchor the self-expanding metal (SEMS) and prevent migration. We aimed to systematically study the efficacy of endoscopic OTSC fixation of SEMS in prevention of migration. METHODS: We searched electronic databases from inception to November 11, 2022 to identify studies reporting outcomes of OTSC fixation of metal stents. The primary outcome was to calculate the pooled migration rates following OTSC anchorage of SEMS and to compare it with controls (SEMS without any fixation). The secondary outcomes include technical and clinical success of OTSC anchorage of SEMS. Random effect models were used to determine pooled rates of migration and technical as well as clinical success rates of OTSC anchorage of metal stents. RESULTS: A total of 9 studies were included. The pooled rate of migration following OTSC anchorage of SEMS was 0.10 (95%CI, 0.04-0.20, I2 = 43%). The pooled rate of migration following OTSC anchorage of esophageal SEMS was 0.08 (95%CI, 0.04-0.15, I2 = 0%). The pooled risk ratio of SEMS migration following OTSC Stentfix was lower as compared to no fixation of SEMS [RR = 0.24 (95%CI,0.13- 0.43, I2 = 0)]. The pooled technical success rate of OTSC fixation following SEMS was 0.98 (95%CI, 0.81-1.00, I2 = 0%). The pooled clinical success rate of OTSC fixation following SEMS was 0.79 (95%CI, 0.64-0.88, I2 = 56%). All studies had valid and reliable methods to diagnose migration, technical and clinical success. CONCLUSIONS: The use of OTSC clips (conventional or Stentfix) for anchorage had a lower risk of migration of metal stents than no fixation. Future studies should look into prospective multicenter studies on their use to prevent the migration of SEMS.

Efficacy and safety of over-the-scope clips (OTSC®) for closure of gastrointestinal fistulas less than 2 cm.

BACKGROUND AND AIM: Gastrointestinal (GI) fistula is a complication of surgery associated with potential morbidity and mortality. The aim of this study was to evaluate the efficacy and safety of over-the-scope clips (OTSC®) for closing GI fistulas. METHODS: Patients with GI fistula who underwent endoscopic closure using OTSC® were enrolled. The clinical date, duration, location and diameter of the fistula, technical success of the OTSC®, complications, follow-up periods and clinical success were recorded. RESULTS: A total of 98 patients with GI fistula underwent OTSC® closure. Their median age was 50 years (range 16-88 years), and the median duration of the fistula was 185.5 days (range 12-3129 days). The mean diameter of fistula was 4.64 ± 1.16 mm. Technical success was achieved in 100% of the patients, and clinical success was achieved in 55.10% (54/98) of the patients after a median follow-up of 168.5 days (range 36-424 days). Based on the location of the fistula, the clinical success rate of treating a fistula in the esophagus and small intestine was 100%, followed by the rectum (70%, 7/10), anastomotic stoma (61.90%, 13/21), duodenum (53.33%, 8/15), colon (47.06%, 8/17), stomach (43.47%, 10/23) and appendix stump (33.33%, 2/6). The duration of the fistula (HR 3.609, 95% CI 1.387-9.387, P = 0.009) was a risk factor for clinical success by multivariate analysis. CONCLUSION: OTSC® is a safe and efficient treatment for GI fistula and is a potential alternative to the surgical approach. Before OTSC® placement, the duration of the fistula should be assessed since it is related to the successful closures with OTSC®.

Guidewire-assisted over-the-scope clip delivery method into the distal intestine: a case series.

BACKGROUND: 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. MATERIAL AND METHODS: 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. RESULTS: 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. CONCLUSIONS: The GOD method is a feasible and safe technique for delivering OTSC toward the small and proximal large intestine.

OTSC assisted EFTR for the treatment of GIST: 40 cases analysis.

BACKGROUND AND AIMS: To verify the safety and efficacy of over-the-scope clip (OTSC)-assisted endoscopic full-thickness resection (EFTR) for the excision of stromal tumors. MATERIAL AND METHODS: Forty patients with gastric stromal tumors treated in the Department of Gastroenterology, Binzhou Medical University Hospital from December 2015 to March 2017 were included in this study. The surgical procedures included marking the lesion boundaries, cutting open the top surface of the lesion, installing an OTS, sucking the lesion into the transparent cap of the anatomical clip which was then released, application of an endoloop for EFTR, and confirming the complete resection and pathological examination of the lesion. Statistical analysis of the tumor site and size, operation time, success rates, complications, pathological examination results, and follow-up status was performed. RESULTS: The average operation duration was 38.40 ± 24.9 min. Three cases had an incomplete resection, but the lesion was later found to have fallen off together with the OTSC. Therefore, the treatment success rate was 100%. Postoperative pathological examination revealed leiomyomas in four cases and stromal tumors in the remaining 36 cases. CONCLUSIONS: OTSC-assisted EFTR is safe and effective for resection of gastrointestinal stromal tumors, especially for those <20 mm in size.

Over-the-scope clip-assisted endoscopic full-thickness resection has potential to treat complex nonampullary duodenal lesions: a single-center case series.

BACKGROUND AND AIMS: The duodenum is considered a challenging area for the endoscopic resection of lesions. This study aimed to evaluate the efficacy and safety of over-the-scope clip (OTSC)-assisted endoscopic full-thickness resection (EFTR) for complex nonampullary duodenal lesions unsuitable for conventional resection techniques. METHODS AND PATIENTS: We conducted a retrospective case review of 13 consecutive patients with complex nonampullary duodenal tumors that were unsuitable for conventional resection techniques; these patients underwent EFTR assisted with OTSC at Beijing Friendship Hospital, Capital Medical University from September 2015 to September 2020. The OTSC device was placed, and tumors were resected after the lesions were identified. Data were abstracted for demographics, lesion features, histopathologic diagnoses, technical success rates, complete resection (R0 resection) rates, and complications. RESULTS: Thirteen patients with duodenal lesions (6 adenomas and 7 submucosal tumors with nonlifting signs, incomplete lifting signs, difficult locations, failed ESD/EMR attempts or suspected origin in the muscularis propria) subjected to EFTR were included. The sizes of all the lesions evaluated by endoscopy were smaller than 20 mm, and most of them (84.6%, 11/13) were smaller than 12 mm. All 13 applications of the clips, endoscopic resection and full-thickness resection were successful (13/13, 100%). Complete resection was achieved in 12 patients (12/13, 92.3%). There were no immediate or delayed complications, including bleeding, infection and perforation. CONCLUSIONS: OTSC -assisted EFTR appears to be effective and safe for complex nonampullary duodenal lesions smaller than 20 mm (particularly those ≤ 10-12 mm) that are unsuitable for conventional resection techniques.

Over-the-scope clip management of non-acute, full-thickness gastrointestinal defects.

BACKGROUND: Endoscopic management of full-thickness gastrointestinal tract defects (FTGID) has become an attractive management strategy, as it avoids the morbidity of surgery. We have previously described the short-term outcomes of over-the-scope clip management of 22 patients with non-acute FTGID. This study updates our prior findings with a larger sample size and longer follow-up period. METHODS: A retrospective analysis of prospectively collected data was conducted. All patients undergoing over-the-scope clip management of FTGID between 2013 and 2019 were identified. Acute perforations immediately managed and FTGID requiring endoscopic suturing were excluded. Patient demographics, endoscopic adjunct therapies, number of endoscopic interventions, and need for operative management were evaluated. Success was strictly defined as complete FTGID closure. RESULTS: We identified 92 patients with 117 FTGID (65 fistulae and 52 leaks); 27.2% had more than one FTGID managed simultaneously. The OTSC device (Ovesco Endoscopy, Tubingen, Germany) was utilized in all cases. Additional closure attempts were required in 22.2% of defects. With a median follow-up period of 5.5 months, overall defect closure success rate was 66.1% (55.0% fistulae vs. 79.6% leaks, p = 0.007). There were four mortalities from causes unrelated to the FTGID. Only 14.9% of patients with FTGID underwent operative management. There were no complications related to endoscopic intervention and no patients required urgent surgical intervention. CONCLUSIONS: Over-the-scope clip management of FTGID represents a safe alternative to potentially morbid operative intervention. When strictly defining success as complete closure of all FTGID, endoscopy was successful in 64.4% of patients with only a small minority of patients ultimately requiring surgery.

Endoscopic technique for closure of enterocutaneous fistulas.

BACKGROUND AND OBJECTIVES: Endoscopic over the scope clip (OTSC) closure represents a new technique for endoscopic management of enteric bleeding and tissue defects such as anastomotic leaks and enterocutaneous (EC) fistulas. We aim to describe our technical approach for OTSC closure of EC fistulas and convey our outcomes. METHODS AND PROCEDURES: This retrospective review includes ten patients who underwent OTSC application for EC fistulas by surgical endoscopists at a US tertiary care hospital from July 2015 to October 2017. Demographic data, along with type of defect, location, duration of lesion, success or failure of OTSC, and nutritional status were compiled. The ACS NSQIP surgical risk calculator was used to project the risk of mortality, complications, length of stay, and risk of readmission had our patients undergone surgical correction of their fistula. RESULTS: Overall success for EC fistula closure was 70%. Acute fistulas were closed with a success rate of 86%. Chronic fistulas were closed successfully in only 33% of cases. Of patients successfully closed, NSQIP-predicted rates of mortality, any complication, and median length of stay were 21.1%, 34.5%, and 9.5 days, respectively. With OTSC, these patients experienced 0 mortalities, 0 complications, and had a median length of stay of 4 days. CONCLUSION: OTSC is an effective adjunctive measure to improving rates of successful closure of EC fistulas and compromised anastomosis. OTSC conveys a markedly improved procedural risk profile as compared to standard surgical correction.

Over-the-scope clip for acute esophageal variceal bleeding.

Over-the-scope clip (OTSC) has been reported to control non-variceal bleeding; however, the use of this device for acute variceal hemorrhage (AVH) is very limited. We report our experience regarding the use of OTSC in patients with AVH in terms of technical success and safety. A retrospective clinical experience case series study was conducted from October 2017 to June 2019 at two tertiary care centers. Adult patients with AVH as a result of small varices managed with OTSC after endoscopic band ligation (EBL) failure were enrolled. Standard gastroscope and OTSC 'type a' with a cap of 11 mm in diameter were used in all procedures. Total of five patients with chronic liver disease (Child-Pugh score ≤8) and portal hypertension (hepatic venous pressure gradient, mean 14.4 ± 1.3 mmHg) were included. Four of them presented collapse of the bleeding varix, and one had wall disruption associated with fibrosis secondary to prior banding. We were able to stop AVH in all patients without clip-related adverse events during a 30-day follow-up period. Two patients developed solid food dysphagia after 3 months of clip deployment that resolved after removal using a bipolar cutting device. Twin grasper or anchor were not used to aid or facilitate the approximation of opposite edges in any patient. No additional local therapies or new endoscopic session for variceal eradication were required. This case series shows preliminary success controlling AVH with OTSC after EBL failure in patients with small varices. Esophageal dysphagia may appear as a complication during follow up but it can be resolved by clip removal.

Short-term outcomes of the over-the-scope clip proctology system for rectovaginal fistula repair: a prospective study.

BACKGROUND: The over-the-scope clip proctology system is rather new and information regarding its use for the closure of anorectal fistulas is scarce. No study has been designed to focus exclusively on its application in the treatment of rectovaginal fistulas. The aim of the study was to evaluate the feasibility, safety, and effectiveness of the clip for rectovaginal fistula repair. METHODS: From September 2014 to November 2017, consecutive patients underwent a rectovaginal fistula repair using the over-the-scope clip proctology system and were enrolled in a non-randomized prospective monocentric study. The primary outcome was fistula healing at 8 months. Secondary outcomes included assessment of morbidity and timing of rectovaginal fistula recurrence. RESULTS: There were 16 patients with a median age of 40.1 years. The most common causes of rectovaginal fistula were adverse events following proctectomy or pelvic radiotherapy (6 patients), obstetric trauma (5 patients) and inflammatory bowel disease (3 patients). Most participants had undergone at least two previous surgical interventions before the clipping procedure. 11 patients had a temporary diverting stoma at time of the clipping procedure. Successful primary healing of the fistula was observed in 7 (43.7%) patients. Short-term complications were rare and included pain, which occurred in 4 patients, and spontaneous clip detachment, which occurred in 2 patients. Most recurrences appeared shortly after the procedure, with a median delay of 45 days (range 16-217). CONCLUSIONS: We demonstrated the feasibility, safety, and reproducibility of the Over-The-Scope Clip Proctology system in rectovaginal fistula repair for the patients selected. Further trials should be designed, incorporating comparisons to well-established techniques, a longer follow-up period, and a larger cohort.

Minimally invasive surgical clip closure of anorectal fistulas: current status of OTSC Proctology.

OTSC Proctology is a minimally invasive sphincter-preserving technique for the surgical treatment of anorectal fistulas. It is based on a super-elastic Nitinol clip which closes the internal fistula opening to allow healing of the fistula tract. A systematic search of the literature was undertaken to identify publications about OTSC Proctology. All studies and reports identified were reviewed and evaluated to determine the feasibility, efficacy and safety of clip surgery. The assessment of all available studies with a total of more than 200 surgical cases strongly suggests that the clip procedure is safe and effective with a low rate of complications. The technique rendered convincing short and long term results with an overall healing rate of approximately 63%. Best results were achieved when OTSC Proctology was used as first-line treatment (healing rate 74%) and for cryptoglandular fistulas (healing rate 64%). However, its future clinical role for IBD-associated recurrent and anorecto-vaginal fistulas remains to be determined, due to a relatively low number of these patients in the evaluated studies. OTSC Proctology is part of the novel armamentarium for the treatment for anorectal fistulas, which is based on high-technology devices. They can be repeatedly used and even combined without causing irreversible sphincter damage.

Multicenter evaluation of first-line endoscopic treatment with the OTSC in acute non-variceal upper gastrointestinal bleeding and comparison with the Rockall cohort: the FLETRock study.

INTRODUCTION: The over-the-scope clip (OTSC) overcomes limitations of standard clips and achieves a more efficient and reliable hemostasis in non-variceal upper gastrointestinal bleeding (NVUGIB). The study aims to evaluate mortality, rebleeding, and mortality after rebleeding of patients in whom the OTSC was used as the first-line endoscopic treatment (FLET) of NVUGIB. PATIENTS AND METHODS: In total, 118 patients (FLET cohort) with a median age of 73.5 years (range 29-93 years; mean (±SD) 71.39 ± 12.39 years) were included. The distribution of patients with respect to risk category revealed a median Rockall score of 7 (range 3-10). For hypothesis testing, the FLET cohort was categorized into three risk groups taking into account the Rockall score: low risk [Rockall risk category (RRC ≤3)], moderate risk (RRC 4-7), and high risk (RRC ≥8). Event rates (mortality, rebleeding, and mortality after rebleeding) observed per risk group were compared to predicted event rates (Rockall cohort) using Fisher's Exact Test. RESULTS: Primary successful hemostasis (PSH) was achieved in 92.4% either by FLET alone or in combination with an additional hemostasis technique in 1.7% (SCS = secondary clinical success). In 7.5% of the FLET cohort PSH could not be achieved. Compared to RRC prediction, mortality after rebleeding was significantly reduced from 27.9 to 10.9% in the high-risk group (RRC ≥8) treated with FLET (p < 0.011). Furthermore, the occurrence of rebleeding or continued bleeding was significantly lower in the moderate risk group (RRC 4-7) with 4.9% as well as in the high-risk group (RRC ≥8) with 21.4% compared to the Rockall cohort 24.0 and 53.2%, respectively (p < 0.001). CONCLUSIONS: This study shows that OTSC is superior to standard care and FLET reduces significantly rebleeding and rebleeding-associated mortality in NVUGIB. For this reason, OTSC could be the treatment of choice as the first-line treatment as an alternative to standard hemostasis techniques in high-risk patients.

Efficacy and safety of the remOVE System for OTSC® and FTRD® clip removal: data from a PMCF analysis.

INTRODUCTION: The remOVE System (Ovesco Endoscopy AG, Tuebingen, Germany) is a medical device for the endoscopic removal of OTSC or FTRD clips (Ovesco Endoscopy AG, Tuebingen, Germany). The aim of this paper is to assess the efficacy and safety of this system. MATERIAL AND METHODS: A total of 74 patients underwent clip extraction. The standard removal procedure comprises fragmenting the clip by applying an electrical direct current pulse at two opposing sides of the clip. RESULTS: Clip fragmentation was successful in 72 of 74 patients (97.3%). In two cases (2.7%) clip fragmentation was not possible. In nine cases (12.2%) a clip fragment could not be removed and was left in place. Complications occurred in three cases (4.1%): two minor bleedings near the clip removal site (2.7%), and one superficial mucosal tear resulting from clip fragment extraction (1.4%). DISCUSSION: Based on this study, the use of the remOVE System for OTSC or FTRD clip removal can be considered safe and effective.

Outcome, comorbidity, hospitalization and 30-day mortality after closure of acute perforations and postoperative anastomotic leaks by the over-the-scope clip (OTSC) in an unselected cohort of patients.

BACKGROUND: Acute gastrointestinal (GI) wall defects contain a high risk of morbidity and mortality and may be closed endoscopically by a full-thickness over-the-scope clip (OTSC). METHODS: Unselected consecutive patients presenting with acute non-surgical perforations or postoperative anastomotic leaks or perforations underwent attempted OTSC placement as primary closure method after interdisciplinary consensus in three tertiary referral centres. Their clinical data and intervention characteristics were evaluated in an intention to treat analysis during a 24-month period to assess closure rates, 30-day mortality, hospitalization and comorbidity. RESULTS: In total, 34 patients (16 females, 18 males, 69.5 years) were included with 22 non-surgical perforations and 12 postoperative anastomotic leaks or perforations. Definitive closure of the perforations and leaks was achieved in 26/34 patients (76.5 %). Successful closure of the GI wall defect resulted in a significantly shorter hospital stay (8 days, p = 0.03) and was significantly correlated with comorbidity (r = 0.56, p = 0.005). In the group with OTSC failure, hospitalization was 18 days and 6 of 8 patients (75 %) required immediate surgery. Three deaths occurred in the group with successful OTSC closure due to comorbidity, while one death in the OTSC failure group was related to a refractory perforation. Favourable indications and locations for a successful OTSC procedure were identified as PEG complications, endoscopic or postoperative leaks of stomach, colon or rectum, respectively. CONCLUSIONS: In unselected patients, OTSC was effective for closure of acute GI wall defects in more than 75 % of all patients. Clinical success and short hospitalization were best achieved in patients without comorbidity, but closure of the perforation or the anastomotic leak was found to be not the only parameter relevant for patient outcome and mortality.

Over-the-scope clip closure for treatment of post-pancreaticogastrostomy pancreatic fistula: A case series.

BACKGROUND AND AIM: 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. METHODS: 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. RESULTS: 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. CONCLUSION: In consideration of clinical and technical success, OTSC placement in POPF seems to be effective, safe and technically relatively easy to carry out.

A randomized comparative trial of OTSC and Padlock for upper GI hemostasis in a standardized experimental setting.

INTRODUCTION: Upper gastrointestinal bleeding (UGIB) is the key emergency situation in clinical endoscopy and is traditionally treated with injection, thermal or through the scope clipping therapy. Mortality rates are in the range of 8-10% and demand new treatment approaches. The Over-The-Scope Clip (OTSC®) has been described as a very effective hemostatic device in UGIB. We compared OTSC with the Padlock™ device in an established pre-clinical setting. MATERIAL AND METHODS: Our test-bed consisted of the biohybrid EASIE model using soft silicone tubes, tunneled into the gastric wall and surfacing at a mucosa defect, representing the bleeding site. After successful deployment of the OTSC and Padlock devices on the spurting ulcer bleed (Forrest Ia) the vessel tubes were pressurized with a manometer to 120 mmHg. Tight closure at this pressure was defined as successful hemostasis (primary endpoint). N = 11 procedures were done with each device. Statistical testing was done using Fisher's exact test. Sample size was adjusted to an assumed α-error of 5% (two-sided test) and a power of 80%. RESULTS: Technically correct placement of the respective hemostatic device was achieved in all procedures. A statistically significant difference was found in the primary endpoint. In OTSC the success proportion was 100%; 11/11 (95% KI 74.1% to 100%); in Padlock it was 0%; 0/11 (95% KI 0%-25.8%). This means that no bleeding was stopped by Padlock. The mean value of perfusion pressure resistance was 300 mmHg (cut-off) for OTSC and 9.2 ± 8.4 mmHg for Padlock. DISCUSSION: Our data on hemostatic function of OTSC coincide with the clinical literature and earlier pre-clinical studies in the EASIE model, which is widely accepted as a realistic and effective simulation system for clinical conditions. The inability of Padlock to stop hemorrhage may be due to design differences and, thus, its limitation in providing tight sealing of the clipped tissue. CONCLUSION: Different types of endoscope-tip mounted clips have different performances. OTSC consistently stops simulated spurting bleeding, Padlock fails to do so. These differences are statistically significant.

Management of non-acute gastrointestinal defects using the over-the-scope clips (OTSCs): a retrospective single-institution experience.

INTRODUCTION: Advanced endoscopic techniques provide novel therapies for complications historically treated with surgical interventions. Over-the-scope clips (OTSCs) have recently been shown to be effective at endoscopic closure of gastrointestinal (GI) defects. We hypothesize that by following classic surgical principles of fistula management, a high rate of long-term success can be achieved with endoscopic closure of non-acute GI tract defects. METHODS: A retrospective review of a single-institution prospectively maintained database (2012-2015) of all patients referred for the management of GI leaks or fistulae who underwent attempted closure with the OTSC system (Ovesco, Germany) was performed. Acute perforations were excluded. The primary endpoint was long-term success defined by the absence of radiographic or clinical evidence of leak or fistula during follow-up. Patients were stratified by success or failure of OTSC closure and compared with Fisher's exact and Mann-Whitney U tests. RESULTS: We identified 22 patients with 28 defects (22 fistulae and 6 leaks). Most patients were female (59 %) with a mean age of 54 years (±14), median BMI of 29, and prior bariatric procedure (55 %). Comorbidities included smoking history (68 %) and diabetes (23 %). The majority of defects were solitary (64 %), involved the upper GI tract (82 %), and had been present for >30 days (50 %). Multiple therapeutic interventions were necessary in 46 % of defects. There were no adverse outcomes related to OTSC placement or misfiring. Endoscopic adjuncts were used in 61 % of cases. Overall success rate was 82 % (100 % for leaks and 76 % for fistulae) at a median follow-up of 4.7 months (IQR 2.1-8.4 months). Predictors of success and failure could not be distinguished due to limited sample size. CONCLUSIONS: Over-the-scope clips can be safely and effectively used in patients presenting with GI leaks and fistulae. Further research is required to characterize the determinants of long-term success and risk factors for failure.

Natural orifice transluminal endoscopic surgery in humans: feasibility and safety of transgastric closure using the OTSC system.

BACKGROUND: NOTES is a technique in which an operation is performed within the body without a skin incision by using a natural body orifice to provide access. The principal challenge of transgastric NOTES procedures is still the feasibility and safety of access closure. Currently, there are very limited data regarding the closure of transgastric NOTES in humans, and the standard method and device for closure has not been defined. Herein, we evaluate the feasibility and safety of gastric closure after NOTES procedures in humans with the over-the-scope clip (OTSC). METHODS: Review of collected data of patients underwent transgastric NOTES in prospective clinical studies between April 2010 and March 2014 focused on the gastric closure with the OTSC. RESULTS: A total of 43 patients underwent transgastric NOTES: 36 patients with an acute appendicitis, six patients with a prophylactic bilateral salpingo-oophorectomy, and one patient with uterus myomatosus. In all 43 cases, the incision of the gastric wall and the endoscopic access to the abdominal cavity succeeded without any difficulty. After performing transgastric procedures, it was possible to close the access by OTSC in all cases. There were all in all three adverse events: one major (Clavien-Dindo Grade III) and two minor (Clavien-Dindo Grades I and II). CONCLUSION: Even if we could show for the first time in more than 40 consecutive patients that there is a safe approach for closing the transgastric access, it is absolutely necessary that further investigation in clinical settings has to be done to establish clear indications and guidelines for the use of transgastric NOTES.

A comparison of two endoscopic closures: over-the-scope clip (OTSC) versus KING closure (endoloop + clips) in a randomized long-term experimental study.

BACKGROUND: Both over-the-scope clip (OTSC) and KING (endoloop + clips) closures provide reliable and safe full-thickness endoscopic closure. Nevertheless, OTSC clip demonstrated significantly inferior histological healing in the short-term follow-up. AIM: To compare OTSC versus KING closure of a perforation with regard to long-term effectiveness and macroscopic and histological quality of healing. METHODS: We performed a randomized experimental study with 16 mini-pigs (mean weight 43.2 ± 11.2 kg). A standardized perforation was performed on the anterior sigmoid wall. KING closure (n = 8) was attained by approximation of an endoloop fixed to the margins of a perforation with endoclips. OTSC closure (n = 8) was performed by deploying OTSC (OVESCO) over the defect. Pigs underwent a control sigmoidoscopy 8 months after the closure to assess the macroscopic quality of healing. Then, autopsy was performed and the rectosigmoid was sent for histopathological assessment. RESULTS: All closures were completed successfully without air leaks. The duration of closure was similar in both techniques (OTSC 17.8 ± 7.6 min vs. KING 19.6 ± 8.8 min). At autopsy, all KING closures (100 %) were healed with a flat scar without signs of leakage. Microscopically, no inflammatory changes were observed after KING closure. In the OTSC group, microscopic ulcers were present in two pigs (25 %), cryptal abscesses in three pigs (38 %) and significant neutrophil accumulation in all eight pigs (P < 0.01). Giant cell granulomas, dysplasia or abundant scarification was not observed in either group. CONCLUSIONS: Both OTSC and KING closures offer a long-term reliable seal of a gastrointestinal perforation without stenosis or fistulas. KING closure provides long-term histologically superior healing.