Endoscopic suturing for GI applications: initial results from a prospective multicenter European registry.

BACKGROUND AND AIMS: OverStitch devices (OverStitch and OverStitch Sx; Apollo Endosurgery, Inc, Austin, Tex, USA) are used for a wide range of applications. A European registry was created to prospectively collect technical and clinical data regarding both systems to provide procedural outcomes and to find correlation between procedural characteristics and outcomes. This study shows the initial results of the first 3 years of the registry. METHODS: Patients who underwent endoscopic suturing from January 2018 to January 2021 at 9 centers were enrolled. Data regarding the disease treated,suturing pattern and outcomes were registered. Technical feasibility (success reaching the target area), technical success (success placing sutures), and clinical success (complete resolution of the clinical issue) were recorded and analyzed. RESULTS: During the study period, 137 patients (57.7% men) were enrolled with 100% technical feasibility rate. Endoscopic suturing was successfully performed in 136 cases (16.7% with OverStitch Sx), obtaining a technical success rate of 99.3%. No adverse events were recorded. Overall clinical success was 89%. Mucosal defects were sutured in 32 patients (100% clinical success). Leaks/fistulas were treated in 23 patients (64.7% clinical success). The clinical success of stent fixations (n = 38) was 85%. Perforations (n = 22) were repaired with a clinical success of 94.7%. No significant correlation between location, suture pattern or number, and the success was found, except in case of fistulas where fistulas <1 cm treated by a continuous suture were more likely to achieve clinical success in the follow-up (P < .001). CONCLUSIONS: OverStitch-based suturing is technically feasible regardless of site and method of suturing, with no cases of failure. The overall technical success rate of 99.3% and the clinical outcome success rate of 89% demonstrate that OverStitch technology provides reliable suturing with clinical advantages, especially with fistulas <1 cm.

Exposed endoscopic full-thickness resection for duodenal submucosal tumors: Current status and future perspectives.

Exposed endoscopic full-thickness resection (EFTR), with or without laparoscopic assistance, is an emergent natural orifice transluminal endoscopic surgery technique with promising safety and efficacy for the management of gastrointestinal submucosal tumors (SMTs) arising from the muscularis propria (MP), especially of the gastric wall. To date, evidence concerning duodenal exposed EFTR is lacking, mainly due to both the technical difficulty involved because of the special duodenal anatomy and concerns about safety and effectiveness of transmural wall defect closure. However, given the non-negligible morbidity and mortality associated with duodenal surgery, the recent availability of dedicated endoscopic tools for tissue-approximation capable to realize full-thickness defect closure could help in promoting the adoption of this endosurgical technique among referral centers. The aim of our study was to review the current evidence concerning exposed EFTR with or without laparoscopic assistance for the treatment of MP-arising duodenal SMTs.

Exposed endoscopic full-thickness resection without laparoscopic assistance for gastric submucosal tumors: A systematic review and pooled analysis.

BACKGROUND: Exposed endoscopic full-thickness resection (Eo-EFTR) is emerging as a promising minimally invasive alternative to surgery for the treatment of deep gastric submucosal tumors (G-SMTs). However, literature concerning this subject is heterogeneous and data mostly come from relatively small retrospective studies. AIMS: We aimed to perform a pooled analysis of published data with regard to gastric Eo-EFTR, providing a pooled estimate of technical and clinical outcomes. METHODS: The protocol was registered in PROSPERO. MEDLINE and EMBASE databases were searched for studies published from 1998 to 2020. The primary outcomes were complete resection and surgical conversion rates. The secondary outcomes were overall and selected major adverse events rates. The Forest plots on primary and secondary endpoints were produced based on fixed and random effect models. RESULTS: Nineteen studies including 952 Eo-EFTR-treated G-SMTs were included. The pooled estimate of the complete resection rate and surgical conversion rates was 99.3% and 0.09%, respectively. The pooled estimate of overall major adverse events, delayed bleeding, delayed perforation and peritonitis, abdominal abscess and/or abdominal infection was 0.29%, 0.14%, 0.14%, and 0.12%, respectively. CONCLUSION: Gastric Eo-EFTR has a high rate of complete resection with a low surgical conversion rate. It appears to be relatively safe and might represent a non-inferior minimally invasive alternative to surgery in selected cases.

Closure techniques in exposed endoscopic full-thickness resection: Overview and future perspectives in the endoscopic suturing era.

Exposed endoscopic full-thickness resection (EFTR) without laparoscopic assistance is a minimally invasive natural orifice transluminal endoscopic surgery technique that is emerging as a promising effective and safe alternative to surgery for the treatment of muscularis propria-originating gastric submucosal tumors. To date, various techniques have been used for the closure of the transmural post-EFTR defect, mainly consisting in clip- and endoloop-assisted closure methods. However, the recent advent of dedicated tools capable of providing full-thickness defect suture could further improve the efficacy and safety of the exposed EFTR procedure. The aim of our review was to evaluate the efficacy and safety of the different closure methods adopted in gastric-exposed EFTR without laparoscopic assistance, also considering the recent advent of flexible endoscopic suturing.

Gastrointestinal exposed endoscopic full-thickness resection in the era of endoscopic suturing: a retrospective single-center case series.

INTRODUCTION: Exposed endoscopic full thickness resection (EFTR) is a minimally invasive technique that has shown promising efficacy and safety in the removal of both gastrointestinal (GI) submucosal tumors (SMTs) arising from the muscularis propria (MP) and select epithelial tumors (ETs) unsuitable for conventional resection techniques. Given the chance of realizing endosurgical full-thickness suturing, the Endoscopic Suturing System (ESS) can be used to close wall defects in this setting. However, data concerning its use in EFTR are still limited. AIM: This study was conducted to evaluate the safety and efficacy of exposed EFTR with defect closure using the ESS for the removal of both GI SMTs and select ETs unsuitable for conventional resection techniques. MATERIAL AND METHODS: This was a retrospective, single-center, observational cohort study of patients who underwent GI exposed EFTR. RESULTS: Seven patients (M : F 6 : 1) with a mean age of 56 ±14.5 years were identified. The indications were MP-originating SMTs of the stomach (n = 2) and duodenum (n = 2), and from submucosa of the rectum (n = 1), and 2 ETs of the rectum. Exposed EFTR and defect closure were successfully performed in 6/7 patients. One case was converted to laparoscopic gastric wedge resection due to technical unfeasibility. We performed an R0 resection in all cases, with the exception of 1 case of rectal EFTR. No macroscopic recurrence was detected at 6-month endoscopic follow-up. CONCLUSIONS: GI exposed EFTR with defect closure by the ESS appears to be feasible, effective, and safe in referral centers. Further studies are necessary to clarify the role of the ESS for post-EFTR wall defect closure.

Management of intra-abdominal hypertension during ECMO: Total water-assisted colonoscopy as a step-up minimally invasive treatment, and a literature review.

Background and study aims During extracorporeal membrane oxygenation (ECMO), intra-abdominal hypertension (IAH) can impair ECMO venous drainage, reducing its ability to provide an adequate oxygenated blood flow. When medical therapy is ineffective in managing IAH, guidelines recommend a decompressive laparotomy (DL), though the procedure is associated with several complications and poor outcomes. Patients and methods This was a case series of IAH in patients affected with acute respiratory distress syndrome (ARDS) on veno-venous (V-V) ECMO, in whom we performed total water-assisted colonoscopy (t-WAC) to treat IAH. Results In three patients who underwent t-WAC, we report a real-time intra-procedural reduction of IAH, normalization of ECMO blood flow, and a reduction of vasopressors and lactates. t-WAC was performed in the context of evident abdominal compartment syndrome with multiorgan failure, and in one case was performed because of IAH and ECMO impairment. One patient was discharged alive, while the other two died of multiorgan failure, although the cause of death was apparently not secondary to IAH. Conclusions During ECMO, in select cases,T-WAC may represent a first-line non-invasive approach.

Novel 1-L polyethylene glycol + ascorbate versus high-volume polyethylene glycol regimen for colonoscopy cleansing: a multicenter, randomized, phase IV study.

BACKGROUND AND AIMS: Adequate bowel cleansing is critical to ensure quality and safety of a colonoscopy. A novel 1-L polyethylene glycol plus ascorbate (1L-PEG+ASC) regimen was previously validated against low-volume regimens but was never compared with high-volume regimens. METHODS: In a phase IV study, patients undergoing colonoscopy were randomized 1:1 to receive split-dose 1L PEG+ASC or a split-dose 4-L PEG-based regimen (4L-PEG) in 5 Italian centers. Preparation was assessed with the Boston Bowel Preparation Scale (BBPS) by local endoscopists and centralized reading, both blinded to the randomization arm. The primary endpoint was noninferiority of 1L-PEG+ASC in colon cleansing. Secondary endpoints were superiority of 1L-PEG+ASC, patient compliance, segmental colon cleansing, adenoma detection rate, tolerability, and safety. RESULTS: Three hundred eighty-eight patients (median age, 59.8 years) were randomized between January 2019 and October 2019: 195 to 1L-PEG+ASC and 193 to 4L-PEG. Noninferiority of 1L-PEG+ASC was demonstrated for cleansing in both the entire colon (BBPS ≥ 6: 97.9% vs 93%; relative risk [RR], 1.03; 95% confidence interval [CI], 1.001-1.04; P superiority = .027) and in the right-sided colon segment (98.4% vs 96.0%; RR, 1.02; 95% CI, .99-1.02; P noninferiority = .013). Compliance was higher with 1L-PEG+ASC than with 4L-PEG (178/192 [92.7%] vs 154/190 patients [81.1%]; RR, 1.10; 95% CI, 1.05-1.12), whereas no difference was found regarding safety (moderate/severe side effects: 20.8% vs 25.8%; P = .253). No difference in adenoma detection rate (38.8% vs 43.0%) was found. CONCLUSIONS: One-liter PEG+ASC showed noninferiority compared with 4L-PEG in achieving adequate colon cleansing and provided a higher patient compliance. No differences in tolerability and safety were detected. (Clinical trial registration number: NCT03742232.).

The role of endoscopy as non-invasive procedure to manage gastrointestinal complications during extracorporeal membrane oxygenation.

INTRODUCTION: Gastrointestinal bleeding is a life-threatening complication in patients undergoing extracorporeal membrane oxygenation support. Despite data on increased mortality due to gastrointestinal bleeding, there is little data on the treatment of such conditions under extracorporeal membrane oxygenation, and on the possibilities of advanced endoscopic therapy to non-invasively solve these bleeding complications. No clear treatment in the case of extracorporeal membrane oxygenation support is recommended in the guidelines. METHODS: Retrospective observational cohort study including 134 veno-venous extracorporeal membrane oxygenation patients for acute respiratory failure from 2009 to 2018 at IRCCS-ISMETT (Italy). Patients were divided into two groups according to gastrointestinal bleeding episodes and reviewed for type of endoscopic therapy. Gastrointestinal bleeding group was characterized for pre-extracorporeal membrane oxygenation characteristics, management variables-including amount of transfusions and clinical outcomes. RESULTS: Fourteen (14) patients (10.4%) experienced upper (n = 13) or lower (n = 1) gastrointestinal bleeding. Gastrointestinal bleeding and no-gastrointestinal bleeding group had similar characteristics apart from higher creatinine in the gastrointestinal bleeding group (1.9 mg/dL (1.3-4.9) vs 1.2 mg/dL (0.7-1.8), p = 0.03). In 3 of the 14 patients (21%), endoscopy showed no signs of active bleeding (nasogastric or feeding tube decubitus), and no specific intervention was performed. Active bleeding was recognized in 11 of the 14 patients (79 %). No patients died of fatal bleeding in the gastrointestinal bleeding group. Endoscopic therapy was feasible, with a complete bleeding control in all the cases: five Hemospray®, two fibrin glue, two metallic clips, one combined approach metallic clips with epinephrine, and one cyanoacrylate. The extracorporeal membrane oxygenation course was significantly longer in the gastrointestinal bleeding group: 19.5 (15-36) days vs 13.5 (8-25) days, p = 0.01. No significant differences in mortality were found between the two groups (all p values > 0.05). CONCLUSION: Advanced endoscopic therapy during veno-venous extracorporeal membrane oxygenation may contribute to reducing the negative effects on mortality for gastrointestinal bleeding episodes.

Erratum: Efficacy and safety of gastric exposed endoscopic full-thickness resection without laparoscopic assistance: a systematic review.

[This corrects the article DOI: 10.1055/a-1198-4357.].

Endoscopic management of post-surgical GI wall defects with the overstitch endosuturing system: a single-center experience.

BACKGROUND AND AIMS: Post-GI surgical wall defects are frequent and life-threatening complications, with limited literature regarding current treatment. This case series aims to assess the safety, feasibility, and outcomes of endoluminal therapy with the overstitch endoscopic suturing system (Apollo Endosurgery Inc, Austin). MATERIALS AND METHODS: All patients who underwent endoscopic suturing for post-surgical wall defect management at IRCCS-ISMETT Palermo from October 2017 until January 2019 were retrospectively enrolled. Stratification therapy was applied according to the clinical scenario, time from surgery to endoscopic intervention, and structural condition of the wall defect layers (tissue status and suture feasibility). The therapeutic endoscopic strategy was divided into three groups (A: pure endoscopic direct suture; B: combined therapy with endoscopic direct suture + FC-SEMS placement + anchoring; C: FC-SEMS placement + anchoring). Success was considered the resolution of symptoms and the presence of a regular intestinal transit after a period of 4-6 weeks. RESULTS: Twenty (20) patients (male/female 7/13; mean age 54 ± 13.43 years) were included in the study (group A: 9 patients, group B: 7 patients, group C: 4 patients). The types of operative procedures were bariatric (9/20), post-tracheostomy (3/20), post-operative GI surgery (8/20). The post-surgical defects were predominantly intermediate and chronic (24-72 h: 1/20; 3-30 days: 13/20; > 30 days: 6/20). The overall clinical success was 80% (17/20 patients), with a success of 94% (16/17 patients) when excluding the three cases of tracheo-esophageal fistula. No evidence of migration was detected. The only complication was short stenosis of the distal esophagus, present in 4 patients (19%) and successfully treated with a novel lumen-apposing metal stent. CONCLUSIONS: In our experience, considering the absence of clear guidelines, the endoluminal approach with the overstich endoscopic suturing system is a valid alternative to conventional therapy, offering mini-invasiveness, and presenting promising opportunities in terms of technical feasibility and clinical efficacy.

Sequential multistenting protocol in biliary stenosis after liver transplantation: a prospective analysis.

BACKGROUND: Biliary complications are a serious source of morbidity after orthotopic and living-related liver transplantation. Endoscopic retrograde cholangiography (ERC) is the gold standard for patients with duct-to-duct anastomosis because it allows a direct approach for interventional procedures. A retrospective study showed results of a sequential multistenting protocol, without stent removal/exchange, with promising results. We conducted a prospective analysis to assess the clinical success, recurrence rate, and adverse event rate related to this protocol. METHODS: From May 2012 to April 2018, all consecutive patients with a diagnosis of anastomotic stenosis following liver transplantation were enrolled in the study, and were followed for a period of at least 6 months after the last ERC. During the first ERC, a maximum number of plastic stents (10 Fr) were placed. In subsequent ERCs, scheduled every 3 months up to a maximum of 1 year, additional stents were inserted, as many as possible, without removing the previously placed stents. RESULTS: From May 2012 to May 2018, 87 patients were included in the study and treated with a sequential multistenting protocol. The mean number of stents placed was 3.7 (SD 1.0). Clinical success (stricture resolution and normalization of cholestasis) was achieved in 86 patients (98.9 %). Seven patients (8.0 %) developed complications. Recurrence was recorded in seven patients (8.0 %) after a mean of 992.7 days (SD 622.1). CONCLUSIONS: This study represents the first prospective demonstration of the efficacy and safety of a sequential multistenting protocol. A key limitation of the study is the lack of a comparative group treated according to the traditional stent exchange approach.