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Video Video 1 Video of the prophylactic appendiceal retrograde intraluminal stent placement technique.

BACKGROUND Endoscopic full-thickness resection of adenomas or subepithelial tumors is a novel and promising endoscopic technique. There have been several recent studies of full-thickness resection device (FTRD) use in the colon, but data regarding its use and efficacy in the duodenum are still limited. CASE SUMMARY A 64-year-old female underwent resection of a recurrent adenoma of 7 mm in size in the duodenum after FTRD use for an adenoma eight months prior. The biopsies revealed a low-grade adenoma. The adenoma was removed using the gastroduodenal FTRD, and the pathology results revealed clear margins. Except for minor bleeding that was treated by argon plasma coagulation, no further complications occurred. CONCLUSION Repeat use of the FTRD appears to be a safe and efficacious approach for the treatment of recurrent duodenal lesions. Further prospective studies are needed to investigate the long-term safety and utility of repeat FTRD use after Endoscopic full-thickness resection.

Introduction Surgical resection of adenomas or subepithelial tumors in the duodenum has a high morbidity compared with endoscopic resection which also has a significant risk of complication. Endoscopic full-thickness resection has shown its feasibility and safety in the colorectum and in the upper gastrointestinal tract. Patient and Methods We present the new gastroduodenal full-thickness resection device (FTRD) for full-thickness resection in a patient with a recurrent nonlifting adenoma in the nonampullary duodenum. Results The procedure was successful with R0 resection without major complications. A control gastroscopy showed no recurrence of the adenoma. Conclusion The gastroduodenal FTRD seems to be a promising new technique for resecting nonlifting adenomas in the nonampullary duodenum.

Background and Aims Advanced adenomas and scarred lesions pose difficulties for the endoscopist because of the need for complete resection and accurate pathologic staging, which cannot be afforded by standard resection techniques. Endoscopic full-thickness resection, first described in Europe for treatment of early adenocarcinoma or scarred lesions in the colon, allows potentially curative en bloc resection in patients who may be at a high risk for surgery. We describe our endoscopic approach and histologic outcomes with use of a commercially available endoscopic full-thickness resection device (FTRD) (Ovesco Endoscopy, Tubingen, Germany). Methods We report our experience using the FTRD for advanced polyps in patients referred to our tertiary care center. Three patients were identified from a prospectively maintained database of patients undergoing FTRD from December 2018 to February 2019. Demographic, endoscopic, and histologic data were collected. Results All patients underwent successful full-thickness resection of the adenocarcinoma, and histopathologic examination showed negative lateral and deep margins. No immediate or delayed adverse events occurred during an average 2-month follow-up period. Conclusions Full-thickness resection with an over-the-scope fitted FTRD is safe and effective in the management of advanced colonic neoplastic lesions.

BACKGROUND AND AIMS: Endoscopic full thickness resection (eFTR) is a field of increasing interest that offers a minimally invasive resection modality for lesions that are not amenable for resection by conventional methods. Full-thickness resection device (FTRD) is a new device that was developed for a single-step eFTR using an over-the scope-clip (OTSC). In this meta-analysis, we aim to assess the efficacy and safety of FTRD for eFTR of colorectal lesions. METHODS: A Comprehensive literature review of different databases to identify studies reporting FTRD with outcomes of interest was performed. Studies with

Non‐exposed endoscopic full‐thickness resection (EFTR) has gained much momentum in streamlining the treatment of difficult‐to‐resect colorectal lesions. As a reiteration of the over‐the‐scope clip (OTSC) platform device‐assisted EFTR combines resection with defect closure, thus perforation and/or bleeding are uncommon complications., Non‐exposed endoscopic full‐thickness resection (EFTR) has gained much momentum in streamlining the treatment of difficult‐to‐resect colorectal lesions. As a reiteration of the over‐the‐scope clip (OTSC) platform device‐assisted EFTR combines resection with defect closure, thus perforation and/or bleeding are uncommon complications

Background The aim of our retrospective study is to compare the efficacy and indications of transanal endoscopic microsurgery (TEM), endoscopic submucosal dissection (ESD), and endoscopic full-thickness resection device (FTRD) with Over-The-Scope Clip (OTSC®) System for en-bloc resection of rectal lesions. Methods This study collected 76 cases of rectal neoplasms from a single hospital institution. Primary endpoints were complete en-bloc resection, intraprocedural adverse events, R0 en-bloc resection and an early discharge of the patient. Secondary endpoints included procedure-related adverse events. Results Mean tumor sizes were statistically significant smaller among patients treated with FTRD rather than TEM and ESD. TEO and FTRD treated patients experienced a higher en-bloc resection rate, with a shorter procedure time and hospital stay. No significant difference concerning the R0 resection was found. TEO and FTRD recorded lower perforation rates as compared to ESD, whereas no difference emerged concerning the bleeding rate and the post-polypectomy syndrome rate. Conclusions Our study showed that each technique has specific features, so that each one offers advantages and disadvantages. Nevertheless, all of them ensure high en-bloc resection rates, whereas no difference exists for R0 resection rate. TEO provides the possibility to remove low rectal large lesions as compared to ESD and FTRD.

Endoscopic full-thickness resection device (FTRD) is a new and promising device for endoscopic full-thickness resection of gastrointestinal lesions. Limited data is available regarding its role in endoscopic full-thickness resection of upper gastrointestinal lesions compared with its well-studied role in colorectal lesions. Colonic FTRD is a preloaded device with a large cap which limits peroral insertion. A 49-year-old woman was referred to us for submucosal gastric lesion resection. Gradual dilatation of the upper esophagus was performed before successful advancement of the endoscope mounted with a FTRD system into the stomach. The lesion was successfully resected with no complications.

Verfeinerte endoskopische Methoden ersetzen heute viele chirurgische Eigriffe — oft mit weniger Belastung und Komplikationen. Eine deutsche Innovation verbessert nun die Versorgung von oberen gastrointestinalen Blutungen und kolorektalen Adenomen.

Background Endoscopic full thickness resection (EFTR) by the Full Thickness Resection Device (FTRD) has recently been introduced as a method to allow resection of certain lesions such as adenomatous polyps that would not be resectable by standard polypectomy techniques. We report our clinical experience with FTRD procedures, assessing technical success, completeness of resection (R0 status), rate of histologically proven FTR and safety. Patients and methods We conducted a retrospective analysis of 33 consecutive patients with colonic polyps treated with FTRD from May 2015 to November 2016. Results Indications mainly were adenoma recurrence or residual adenoma with nonlifting sign after previous polypectomy. In the 31 cases amenable to EFTR, resection was en bloc and histologically complete (R0) in 87.9% (29/33) of patients. Histologically confirmed complete full thickness resection (FTR) was achieved in 80.6% (25/31). Three post-procedure bleedings and one perforation were seen. Conclusion FTRD offers an additional endoscopic approach to treat nonlifting colorectal lesions. EFTR by FTRD appears to be feasible and efficacious in the resection of benign neoplasms of up to 30 mm in diameter and may be an alternative to surgery in selected patients. Given a significant rate of complications, safety is a concern and needs to be assessed in larger prospective studies.

Background and study aims Treatment of colorectal polyps in patients undergoing permanent anticoagulation is associated with a significantly increased risk of peri-interventional bleeding. This specifically applies to polyps > 1 cm where endoscopic full-thickness resection (EFTR) with the full-thickness-resection device (FTRD) can be taken into consideration as an alternative approach to classical snare polypectomy.For these indications, EFTR appears to be superior to conventional techniques especially in terms of sufficient hemostasis due to the mechanical tissue compression achieved by the FTRDʼs integrated Over-The-Scope Clip (OTSC). This is demonstrated in the following case report of a 59-year-old male with a left ventricular assist device (LVAD) implanted due to congestive heart failure. He presented with intermittent hemorrhage from a large polyp in the ascending colon that was successfully treated via EFTR with the FTRD. A video is included.

Introduction of the full-thickness resection device (FTRD) has allowed endoscopic resection of difficult lesions such as those with deep wall origin/infiltration or those located in difficult anatomic locations. The aim of this study is to assess the outcomes of the FTRD among its early users in the USA. Patients who underwent endoscopic full-thickness resection (EFTR) for lower gastrointestinal tract lesions using the FTRD at 26 US tertiary care centers between 10/2017 and 12/2018 were included. Primary outcome was R0 resection rate. Secondary outcomes included rate of technical success (en bloc resection), achievement of histologic full-thickness resection (FTR), and adverse events (AE). A total of 95 patients (mean age 65.5 ± 12.6 year, 38.9% F) were included. The most common indication, for use of FTRD, was resection of difficult adenomas (non-lifting, recurrent, residual, or involving appendiceal orifice/diverticular opening) (66.3%), followed by adenocarcinomas (22.1%), and subepithelial tumors (SET) (11.6%). Lesions were located in the proximal colon (61.1%), distal colon (18.9%), or rectum (20%). Mean lesion diameter was 15.5 ± 6.4 mm and 61.1% had a prior resection attempt. The mean total procedure time was 59.7 ± 31.8 min. R0 resection was achieved in 82.7% while technical success was achieved in 84.2%. Histologically FTR was demonstrated in 88.1% of patients. There were five clinical AE (5.3%) with 2 (2.1%) requiring surgical intervention. Results from this first US multicenter study suggest that EFTR with the FTRD is a technically feasible, safe, and effective technique for resecting difficult colonic lesions.

Introduction Endoscopic resection of adenomas involving the appendiceal base is challenging and often technically impossible with resultant necessity for surgery. Endoscopic full thickness resection (eFTR) using the full thickness resection device (FTRD) is a novel technique for removing lesions in the colo-rectum unresectable by conventional methods. We report use of this technique and outcomes for adenomas involving the appendiceal base. Methods Data was collected and analysed on patients who underwent eFTR of adenomas involving the appendix base in the UK from April 2015 – January 2019. Main outcome measures were technical success, procedural time, specimen size, R0 resection, endoscopic clearance, and adverse events including appendicitis, and need for surgery. Results 10 cases were identified across 4 sites where eFTR was attempted for adenoma at the appendix base. Mean patient age was 68 years (range 57–78). 3/10 had previous attempts at EMR and 2/10 had prior appendicectomy. In 9/10 patients the lesion was reached with the FTRD, with failure of insertion in 1/10 due to sigmoid diverticulosis. The procedure was technically successful in 9/9 patients. Median procedure time was 72 minutes (50–97) and median resection time 6 minutes (4–17). Antibiotics were given in all cases. Median hospital stay was 1 day (1–3). Median specimen size was 26 mm (15–35), and full thickness resection was achieved in 7/9 and R0 resection in 6/9. In those where R0 resection was not achieved, 2/3 had residual lesion at follow up; one residual lesion removed by snare, one had clip still in situ and awaiting use of clip cutter to facilitate residual polyp removal. Overall endoscopic clearance rate to date is 89% (8/9). One patient developed appendicitis at day 6 which required surgery to remove a gangrenous appendix. The patient made an uneventful recovery. Appendicitis rates for this cohort was therefore 14.2% (1/7) when those with prior appendicectomy were excluded. No other complications occurred. Conclusions Removal of adenomas at the appendix base by eFTR is technically feasible and can avoid the need for surgery. Rates of appendicitis in our cohort are significant and similar to published data1, suggesting the need for careful consent and close observation post procedure. Reference Schmidt A, et al. Gut 2018; 67: 1280–1289.

Background Endoscopic full-thickness resection (EFTR) using the full-thickness resection device (FTRD®) is an invasive treatment for colorectal lesions not resectable by conventional endoscopic techniques. This study presents the first Greek experience of the FTRD® procedure, assessing the efficacy and safety of EFTR. Methods We conducted a retrospective analysis of 17 consecutive patients treated with the FTRD® at 2 referral centers from October 2015 through December 2018. The indications included difficult adenomas (non-lifting and/or at difficult locations), early adenocarcinomas and subepithelial tumors. Primary endpoints were technical success and R0 resection. Results Technical success and R0 resection were achieved in 82.3% procedures (14/17) and in 87.5% of those with difficult adenomas (8 patients). In the subgroup with carcinomas (n=3), the rate of technical success and R0 resection was 66.6%, while in the subgroup with subepithelial tumors (n=6) the rate was 83.3%. Technical success and R0 resection were significantly lower for lesions >20 mm vs. ≤20 mm (P=0.0429). In the 17 patients a total of 3 adverse events occurred (17.6%) and one of the patients underwent laparoscopic appendectomy because of EFTR around the appendix. Conclusions Our study showed favorable results concerning EFTR feasibility, efficacy and safety, especially for lesions ≤20 mm, non-lifting adenomas, and subepithelial tumors. Technical success, R0 resection, and adverse events rates were comparable with previously published data. Larger randomized studies are needed to better define the clinical benefit and long-term outcomes of EFTR in selected patients.

Eine Vollwandresektion im Kolon und Rektum ist einer endoskopischen Submukosadissektion (ESD) im Hinblick auf Kuration, En-bloc-Resektion und R0-Status uberlegen. Das Full-Thickness-Device (FTRD, Ovesco, Germany) ist das erste kommerziell erhaltliche endoskopische System, das eine peritoneale Verschlusstechnik mit nachfolgender Vollwandresektion in einem Schritt realisiert. In dieser Studie wurde das FTRD in Bezug auf die Effektivitat einer histologisch nachgewiesenen Vollwandresektion, den R0-Status und die Sicherheit im Rektum und Kolon uberpruft. Zwischen November 2014 und Juni 2015 wurden in unserer interdisziplinaren Endoskopie 20 Patienten am Rektum und Kolon mit dem FTRD behandelt und retrospektiv ausgewertet. Folgende Indikationen wurden im Rektum (n = 11) und Kolon (n = 9) behandelt: endoskopisch inkomplett abgetragene T1-Karzinome (n = 6) und neuroendokrine Tumoren (n = 2), inkomplett abgetragene tubulovillose, villose und serratierte Adenome mit niedrigen und hochgradigen intraepithelialen Neoplasien (n = 9), primare Adenome (n = 3) ohne Vorbiopsie. Der technische Erfolg lag bei 75 %. Drei technische Versager indizierten in zwei Fallen eine konventionelle und in einem Fall eine operative Nachresektion der duplizierten Darmwand. Eine konventionell beendete Resektion fuhrte zu einer thermischen Spatperforation, die eine Segmentresektion indizierte. In einem Fall konnte die Lasion im Zokum zwar erreicht, aber nicht abgetragen werden. Die histologisch gesicherte Vollwandresektion betrug 60 % (85,7 % im Kolon, 54,6 % im Rektum). R0-Resektionen wurden in 80 % der Patienten erreicht. Zwei Patienten wurden onkologisch reseziert. Die mediane Grose der Resektate betrug 5 cm2 (1,6–12,9 cm2). Das FTRD ermoglicht es dem interventionellen Endoskopiker erstmals, Vollwandresektionen des unteren Gastrointestinaltrakts standardisiert, sicher und effektiv durchzufuhren. Limitierende Faktoren sind die Grose der Ziellasion, Gewebefibrosierung und die Wandstarke des zu behandelnden Darmabschnitts. Aus diesen Grunden empfiehlt es sich, bereits im Rahmen der Screeningkoloskopie mithilfe spezieller Aufsatzkappen, die dem FTRD entsprechend dimensioniert sein sollten, eine Simulation der Resektion durchzufuhren.