Full-thickness Resection Device Research Articles

Adverse Events of the Over The Scope Endoscopic Clips and Cutters: A MAUDE Database Analysis

The OVESCO® clip system, including the Over-The-Scope Clip (OTSC) and Full-Thickness Resection Device (FTRD), has demonstrated efficacy in managing various gastrointestinal pathologies. However, real-world data on device malfunctions and patient complications are limited. This study aimed to analyze adverse events associated with OVESCO® clips and cutters reported to the FDA Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database was searched for reports related to OVESCO® clips and cutters from January 1, 2007, to August 30, 2024. Event date, device type and model, manufacturer, event type, device problem, and patient complications were extracted. Descriptive statistics were used to summarize the findings. Forty-two reports were identified, with 41 involving OVESCO® clips and one involving an OVESCO® cutter. The most common device problem for OVESCO® clips was failure to deploy (61.0%), followed by unintended deployment or misfiring (17.1%). Gastrointestinal perforation was the most frequently reported patient complication (60%). The OVESCO® cutter report described device component breakage and foreign body retention. No clear trends in adverse event reporting were observed over the study period. OVESCO® clips and cutters are associated with potential device malfunctions and patient complications, particularly gastrointestinal perforation. The findings highlight the need for careful patient selection, meticulous technique, and close post-procedural monitoring. Collaborative efforts among stakeholders are essential to optimize device safety and efficacy. Continued post-marketing surveillance and real-world data analysis are crucial for monitoring the performance of endoscopic devices and improving patient outcomes.

S4038 Novel Use of Full Thickness Resection Device to Ensure Complete Resection of Colonic MALT Lymphoma Post-Endoscopic Mucosal Resection

S4038 Novel Use of Full Thickness Resection Device to Ensure Complete Resection of Colonic MALT Lymphoma Post-Endoscopic Mucosal Resection

Unexpected clipping failure of a full-thickness resection device during endoscopic full-thickness resection

Unexpected clipping failure of a full-thickness resection device during endoscopic full-thickness resection

Clinical safety of a novel over-the-scope gastroduodenal full-thickness resection device for the treatment of upper GI tract lesions: a multicenter experience

BACKGROUND AND AIMSA novel gastroduodenal full-thickness resection device system was developed for resection of upper gastrointestinal (GI) tract lesions. Our study aimed to evaluate the efficacy and safety of the gastroduodenal full-thickness resection device system. METHODSConsecutive patients who received endoscopic resection of upper GI tract lesion (6/2020-8/2022) using gastroduodenal full-thickness resection device were evaluated from eight U.S. centers. Primary endpoints included technical success and R0 resection. Secondary endpoints were en bloc resection, residual lesions at follow-up endoscopy, and immediate/delayed adverse events. RESULTSForty-four patients (mean age 60.9±15.8 years) received 45 resections for gastric (35, 80%) and duodenal (9, 20%) leions. 34 (77%) were subepithelial and 10 (23%) were epithelial lesions. Technical success and en bloc resection were achieved in 43 (96%) and 41 (91%) patients, respectively. Furthermore, R0 resection was achieved in 32 (71%) patients including 24 (69%) of 35 with neoplastic lesions. Pathologic diagnosis included neuroendocrine tumor in 14 (32%), gastrointestinal stromal tumor in 10 (23%), and gastric cancer/high grade dysplasia in 7 (16%). Minor immediate and delayed bleeding occurred in 17 (38%) and 2 (4%) patients. One patient had delayed perforation, managed conservatively. On follow-up, 19 (90%) of 21 patients had no residual lesion. CONCLUSIONIn this multicenter series, gastroduodenal full-thickness resection device demonstrated high rates of technical success and acceptable rate of R0 resection. Immediate minor bleeding was common, while serious adverse events were rare. Gastroduodenal full-thickness resection device should be considered in patients with gastroduodenal subepithelial lesions as an alternative to long-term surveillance.

Selection of endoscopic resection technique for large colorectal lesion treatment.

Large nonpedunculated colorectal polyps ≥ 20 mm (LNPCPs) comprise 1% of all colorectal lesions. LNPCPs are more likely to contain advanced histology such as high-grade dysplasia and submucosal invasive cancer (SMIC). Endoscopic resection is the first-line approach for management of these lesions. Endoscopic resection options include endoscopic mucosal resection (EMR), cold-snare EMR (EMR), endoscopic submucosal dissection (ESD) and endoscopic full-thickness resection (EFTR). This review aimed to critically evaluate current endoscopic resection techniques. Evidence-based selective resection algorithms should inform the most appropriate endoscopic resection technique. Most LNPCPs are removed by conventional EMR but there has been a trend toward C-EMR for endoscopic resection of LNPCPs. More high-quality trials are required to better define the limitations of C-EMR. Advances in our understanding of ESD technique, has clarified its role within the colorectum. More recently, the development of a full thickness resection device (FTRD) has allowed the curative endoscopic resection of select lesions. Endoscopic resection should be regarded as the principle approach for all LNPCPs. Underpinned by high-quality research, endoscopic resection has become more nuanced, leading to improved patient outcomes.

Endoscopic Full-Thickness Resection of Proximal Ascending Colonic Intramucosal Carcinoma by FTRD Device: Saving the Colon

AbstractThe full-thickness resection device (FTRD) allows for endoscopic full-thickness resection of gastrointestinal lesions up to 3 cm. This transluminal endoscopic minimally invasive technique allows safe closure after full-thickness resection, thereby providing an en-bloc specimen for histological examination and resection with minimal thermal damage. Using the device for lesions in the proximal ascending colon and cecum is technically challenging. Herein, we describe a case of JNET 2A/2B proximal ascending colonic polyp on both sides of the fold, which was resected safely by the FTRD device, and the en-bloc resected specimen turned out to be intramucosal carcinoma.

Hybrid endoscopic approaches for complex colorectal polyps with a non-lifting sign: the Greek experience.

Hybrid approaches combining endoscopic full-thickness resection (EFTR) with conventional techniques (endoscopic mucosal resection [EMR], endoscopic submucosal dissection [ESD]) have enabled the resection of difficult fibrotic colorectal adenomas exhibiting a "non-lifting" sign, and polyps in difficult positions. We present our cohort treated with either EMR+EFTR or ESD+EFTR as salvage hybrid endoscopic approaches for complex colorectal polyps not amenable to conventional techniques. Retrospective analysis included technical success, histological confirmation of margin-free resection, assessment of adverse events and follow up with histological assessment. All patients underwent follow-up endoscopy at least 6 and 12 months post-resection. Fourteen patients underwent hybrid EFTR procedures (11 EMR+EFTR and 3 ESD+EFTR). Technical success was achieved in all cases where the full-thickness resection device (FTRD) was advanced to the site of the resection (100%). In 2 cases, the FTRD system could not be passed through the sigmoid colon because of severe chronic diverticulitis, subsequent fibrosis and stiffness. The mean lesion size in the EMR+EFTR group (41.7 mm; range 20-50 mm) was larger than the ESD+EFTR group (31.7 mm; range 30-35 mm). Six patients (42.9%) were histologically diagnosed with T1 carcinoma. The mean duration of hospitalization was 1.4 days. Follow-up endoscopy was available in all patients and no recurrence was observed with histological confirmation during a mean follow-up period of 15.4 months. Hybrid procedures appear to be safe and effective treatments for complex colorectal lesions not amenable to EMR, ESD or EFTR alone, because of the lesion size, positive non-lifting sign, and difficult positions.

Safety and Efficacy of Endoscopic Full Thickness Resection of Upper Gastrointestinal Lesions Using a Full Thickness Resection Device: A Systematic Review and Meta-analysis.

Endoscopic full-thickness resection (EFTR) is a promising technique that allows for a minimally invasive resection of mucosal and submucosal lesions in the gastrointestinal (GI) tract. The data regarding the efficacy and safety of performing EFTR of upper GI lesions using a full-thickness resection device (FTRD) is limited. Hence, we performed a systematic review and meta-analysis of the studies that evaluated this technique. We performed a comprehensive systematic search of multiple electronic databases and conference proceedings that reported outcomes of EFTR using the FTRD system. The weighted pooled rates of technical success, complete (R0) resection, adverse events (AE), and residual or recurrent lesions were analyzed with 95% CI using the random effects model. Eight studies with a total of 139 patients who underwent EFTR of upper GI lesions were included in the study. The pooled, weighted rate of technical success was 88.2% (95% CI: 81.4-92.7%, I2 : 0). The R0 resection rate was 70.7% (95% CI: 62.5-77.8%, I2 : 0). Overall AE rates were 22.1% (95% CI: 15.8-30.1%, I2 : 0), however, most of the AEs were minor. Of the patients who had follow-up endoscopies, the residual and/or recurrent lesion rate was 6.1% (95% CI: 2.4-14.4%, I2 : 0). Heterogeneity in the analysis was low. EFTR using the FTRD seems to be effective and safe with acceptable R0 resection rates and low recurrence rates. Further prospective studies are required to validate our results and to compare various modalities of endoscopic resection with this single-step EFTR device.

Endoscopic transmural resection as an alternative to colorectal surgery after high-risk (non-curative) endoscopic resection.

Endoscopic full-thickness resection (eFTR) is an emerging technique that enables effective and safe management of complex colorectal lesions. The full-thickness resection device (FTRD®, Ovesco, Germany) has primarily been used for non-exposed transmural resection of challenging subepithelial or epithelial lesions, where conventional methods may be limited. This technique represents an alternative to surgery in selected patients, and its applications are rapidly expanding. In recent years, eFTR has been described as an alternative to surgery for scars aiming to exclude residual tumors after non-curative endoscopic resection. We present a case of a 41-year-old woman with Lynch syndrome (dMLH1) with rectal adenocarcinoma at the age of 20 underwent anterior resection of the rectum and adjuvant chemoradiotherapy. At the age of 39, during endoscopic surveillance, she presented with a suspicious lesion (Paris 0-Is+IIa, NICE2, JNET2B) measuring 16mm in the hepatic angle, and underwent en bloc endoscopic mucosal resection (EMR). Histopathological analysis revealed a low-grade invasive adenocarcinoma with lymphoid stroma with deep invasion of the submucosa and resection margin involvement (vertical R1). After a multidisciplinary team discussion, complementary surgery was proposed but the patient refused, opting for close endoscopic and imaging surveillance. Two subsequent colonoscopies plus computed tomography (CT) scans showed no signs of macro or microscopic residual or recurrent tumor, even after extensive biopsies of the colonic scar. However, a CT scan 20months post-resection showed a de novo 2cm thickening of the parietal wall in the hepatic angle, consistent with the location of the previous endoscopic resection. Suspecting deep parietal tumor recurrence without superficial endoscopic findings, a transmural endoscopic resection using FTRD® of the EMR scar was performed, whose histology revealed no transparietal tumor recurrence.

Clip Dislodgement After Full-Thickness Endoscopic Resection Device Removal of Scarred Gastric Subepithelial Lesion Leading to Delayed Perforation

ABSTRACT Endoscopic full-thickness resection using a full-thickness resection device is a newer technique for endoscopic removal of submucosal lesions not amenable to endoscopic mucosal resection or endoscopic submucosal dissection. There is a low rate of complications reported, although we report 2 cases of delayed perforation caused by dislodgement of a full-thickness resection device clip after removal of scarred gastric lesions. Both were managed endoscopically with good outcomes. However, special attention and consideration of alternative closure techniques should be considered with scarred gastric lesions and possible changes to the clip design could be considered.

S1238 Using an Endoscopic Full Thickness Resection Device to Obtain Histologically Complete Resection or Formal Staging in Patients With Previous Piecemeal Resection of Malignant Colon Polyps

S1238 Using an Endoscopic Full Thickness Resection Device to Obtain Histologically Complete Resection or Formal Staging in Patients With Previous Piecemeal Resection of Malignant Colon Polyps

Full-thickness resection device for management of lesions involving the appendiceal orifice: Systematic review and meta-analysis.

Background and study aims Endoscopic resection of lesions involving the appendiceal orifice is technically challenging and is commonly referred for surgical resection. However, post-resection appendicitis is a concern. Many studies have varying rates of post-procedure appendicitis. We aim to report the rate of post-resection appendicitis by performing a systematic review and meta-analysis. Methods Studies that involved the use of a full-thickness resection device (FTRD) for management of appendiceal polyps were included. The primary outcome was appendicitis after FTRD and a subgroup analysis was performed on studies that only included FTRD performed at the appendiceal orifice. Results Appendicitis was encountered in 15% (95%CI: [11-21]) of the patients with 61% (95% CI: [44-76]) requiring surgical management. Pooled rates of technical success, histologic FTR, and histologic R0 resection in this sub-group (n=123) were 92% (95% CI: [85-96]), 98% (95% CI: [93-100]), and 72% (95% CI: [64-84%]), respectively. Post-resection histopathological evaluation revealed a mean resected specimen size of 16.8 ± 5.4 mm, with non-neoplastic pathology in 9 (7%), adenomas in 103 (84%), adenomas + high-grade dysplasia (HGD) in nine (7%), and adenocarcinoma in two (2%). The pooled rate for non-appendicitis-related surgical management (technical failure and/or high-risk lesions) was 11 % (CI: 7-17). Conclusions FTRD appears to be an effective method for managing appendiceal lesions. However, appendicitis post-resection occurs in a non-trivial number of patients and the R0 resection rate in appendiceal lesions is only 72%. Therefore, caution should be employed in the use of this technique, considering the relative risks of surgical intervention in each patient.

Efficacy and safety of combined EMR and endoscopic full-thickness resection (hybrid EFTR) for large nonlifting colorectal adenomas.

Endoscopic full-thickness resection (EFTR) with a full-thickness resection device (FTRD) has become the standard technique for selected nonlifting colorectal adenomas, but tumor size is the major limitation. However, large lesions might be approached in combination with EMR. Herein, we report the largest single-center experience to date of combined EMR and EFTR (hybrid EFTR) in patients with large (≥25mm) nonlifting colorectal adenomas not amenable to EMR or EFTR alone. This is a single-center retrospective analysis of consecutive patients who underwent hybrid EFTR of large (≥25mm) nonlifting colorectal adenomas. Outcomes of technical success (successful advancement of the FTRD with consecutive successful clip deployment and snare resection), macroscopic complete resection, adverse events, and endoscopic follow-up were evaluated. Seventy-five patients with nonlifting colorectal adenomas were included. Mean lesion size was 36.5mm (range, 25-60mm), and 66.6% were located in the right side of the colon. Technical success was 100% with macroscopic complete resection in 97.3%. Mean procedure time was 83.6 minutes. Adverse events occurred in 6.7%, leading to surgical therapy in 1.3%. Histology revealed T1 carcinoma in 16%. Endoscopic follow-up was available in 93.3% (mean follow-up time, 8.1 months; range, 3-36) and showed no signs of residual or recurrent adenoma in 88.6%. Recurrence (11.4%) was treated endoscopically. Hybrid EFTR is safe and effective for advanced colorectal adenoma that cannot be approached by EMR or EFTR alone. Hybrid EFTR expands the indication of EFTR substantially in selected patients.

Recent advances and current challenges in endoscopic resection with the full-thickness resection device.

Endoscopic full-thickness resection (EFTR) has emerged as a viable technique in the management of mucosal and subepithelial lesions of the gastrointestinal tract (GIT) not amenable to conventional therapeutic approaches. While various devices and techniques have been described for EFTR, a single, combined full-thickness resection and closure device (full-thickness resection device, FTRD system, Ovesco Endoscopy AG, Tuebingen, Germany) has become commercially available in recent years. Initially, the FTRD system was limited to use in the colorectum only. Recently, a modified version of the FTRD has been released for EFTR in the upper GIT as well. This review provides a broad summary of the FTRD, highlighting recent advances and current challenges.

Endoscopic resection of upper gastrointestinal lesions using the colonic Ovesco full-thickness resection device: Retrospective observational case series of 22 cases

Background and study aims The endoscopic full-thickness resection (EFRT) device (FTRD) has been shown to have acceptable outcomes in regard to efficacy and safety in the resection of colorectal lesions. Data on its use in the upper gastrointestinal tract are limited to small case series. Patients and methods All consecutive patients undergoing endoscopic full-thickness resection of gastric or duodenal lesions at our institutions were analyzed retrospectively for a primary endpoint of technical success. Results A total of 22 patients with duodenal and gastric lesions underwent EFTR between June 2018 and February 2022. Technical success was achieved in 20 of 22 (91 %) of the procedures. Indications for EFTR were: subepithelial tumor (n = 14), mucosal lesion (n = 5), scar resection (n = 2), and EFTR of endoscopic submucosal dissection (ESD) resection base (n = 1). The FTRD could be advanced to the lesion in all 22 cases (100 %). No dilation of the upper esophageal sphincter (UES) or pylorus was required to pass the device. There were 14 cases of gastric lesions and eight duodenal. One subepithelial lesion was too big for the cap and one scar could not be sucked into the cap. One lesion (gastrointestinal stromal tumor) was removed at second procedure with the ESD technique, including over-the-scope clip. The R0 resection rate for deployed clips was 90 % (18 of 20). There were two superficial esophageal tears from FTRD insertion that required no therapy. No bleeding occurred during the postoperative period. Conclusions Upper gastrointestinal EFTR using the colonic Ovesco FTRD is feasible without pre-dilation of the upper esophageal sphincter or pylorus. This study further confirms acceptable efficacy and safety in upper gastrointestinal use.

Endoscopic full-thickness resection for upper gastrointestinal tract lesions: a systematic review and meta-analysis.

Endoscopic full-thickness resection (EFTR) is used to resect difficult superficial mucosal lesions and sub-epithelial lesions (SELs). We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of EFTR for upper gastrointestinal tract (GIT) lesions. We conducted a comprehensive literature search of MEDLINE, EMBASE, Cochrane, ClinicalTrials.gov, and Scopus databases for studies published in the English language that addressed outcomes of EFTR for upper GIT lesions through November 2021. The weighted pooled rates with the 95% confidence interval (CI) were calculated. Cochran Q test and I statistics were used to calculate heterogeneity. We identify 740 articles on the initial search and six studies met the inclusion criteria. 140 patients (45.7% females) with 142 lesions were analyzed. Four studies used the full-thickness resection device (FTRD®). EFTR was performed for 26 adenomas, 97 SELs, six adenocarcinomas, and ten full-thickness biopsies. The overall technical success rate was 86.9% (CI 79.8-94%, I 2 = 38.9%), R0 resection was 80% (CI 67.6-92.3%, I 2 = 75.6%), and the overall adverse events rate was 18.6% (9.8-27.2%, I 2 = 49.4%). Major adverse events includedsix episodes of major bleeding, three micro-perforations, one large duodenal perforation, and one case of mucosal damage from FTRD®. At 3-6months follow-up, there were only two cases of recurrence (R0 was not achieved in both). EFTR has a high technical and clinical success rate in managing upper GIT lesions with an acceptable safety profile. Large prospective studies comparing EFTR with conventional endoscopic resection techniques are needed.

Endoscopic resection of GI stromal tumor using full-thickness resection device: tips and tricks

Video 1R0 endoscopic resection of gastric GI stromal tumor using a dedicated gastroduodenal full-thickness resection device.

Adverse events of endoscopic full-thickness resection: results from the German and Dutch nationwide colorectal FTRD registry

Endoscopic full-thickness resection (eFTR) is emerging as a minimally invasive alternative to surgery for complex colorectal lesions. Previous studies have demonstrated favorable safety results; however, large studies representing a generalizable estimation of adverse events (AEs) are lacking. Our aim was to provide further insight in AEs after eFTR. Data from all registered eFTR procedures in the German and Dutch colorectal full-thickness resection device registries between July 2015 and March 2021 were collected. Safety outcomes included immediate and late AEs. Of 1892 procedures, the overall AE rate was 11.3% (213/1892). No AE-related mortality occurred. Perforations occurred in 2.5% (47/1892) of all AEs, 57.4% (27/47) of immediate AEs, and 42.6% (20/47) of delayed AEs. Successful endoscopic closure was achieved in 29.8% of cases (13 immediate and 1 delayed), and antibiotic treatment was sufficient in 4.3% (2 delayed). The appendicitis rate for appendiceal lesions was 9.9% (13/131), and 46.2% (6/13) could be treated conservatively. The severe AE rate requiring surgery was 2.2% (42/1892), including delayed perforations in .9% (17/1892) and immediate perforations in .7% (13/1892). Delayed perforations occurred between days 1 and 10 (median, 2) after eFTR, and 58.8% (10/17) were located on the left side. Other severe AEs were appendicitis (.4%, 7/1892), luminal stenosis (.1%, 2/1892), delayed bleeding (.1%, 1/1892), pain after eFTR close to the dentate line (.1%, 1/1892), and grasper entrapment in the clip (.1%, 1/1892). Colorectal eFTR is a safe procedure with a low risk for severe AEs in everyday practice and without AE-related mortality. These results further support the position of eFTR as an established minimally invasive technique for complex colorectal lesions.

Endoscopic full-thickness resection of gastric ulceration with persistent low-grade dysplasia using full-thickness resection device.

Video 1Endoscopic full-thickness resection of gastric ulceration with persistent low-grade dysplasia using full-thickness resection device.

Hybrid resection of GI stromal tumor with endoscopic submucosal dissection and the full-thickness resection device

Video 1Hybrid resection of gastric GI stromal tumor with endoscopic submucosal dissection and the Full-Thickness Resection Device.