Single-center Experience on the Efficacy and Safety of a Dedicated Endoscopic Full Thickness Resection Device

Aims Endoscopic full-thickness resection (EFTR) is a potential treatment option for lesions that are not amenable to conventional resection techniques. A dedicated, over-the-scope, full-thickness resection device (FTRD, Ovesco Endoscopy, Tuebingen, Germany) is commercially available, with outcomes data derived primarily from multicenter studies. Our aim is to describe the efficacy and safety of the FTRD in a high-volume, tertiary referral center.

Methods Patients who underwent the FTRD procedure between April 2019 and March 2024 were identified using a prospectively maintained electronic database. Data were abstracted for patient demographics, clinical history, indications for FTRD, technical success, histopathologic findings, rates of complete or R0 resection, and adverse events.

Results A total of 130 patients (59.4% men; mean age 63.3±13.3 years) underwent 133 attempted or completed FTRD procedures under monitored anaesthesia care (56%) or general anaesthesia (44%). The more common indications for FTRD were nonlifting adenomas from prior treatment (24.1%), subepithelial lesions (21.1%), and treatment-naive early cancer (15%). Lesions targeted with FTRD were primarily located in the colon and rectum (79%). Technical success was achieved in 85% (113/133) of procedures. Failures were due to device malfunction (e.g., snare breakage) or inability to grasp the lesion in 13.5% (18/133), and inability to safely advance the FTRD to the target site in 1.5% of cases. The mean size of the resected specimens was 17.6±6.1 mm, and the more common histopathologic diagnoses were adenoma (30.1%), adenocarcinoma (18.2%), scar tissue (12.7%) and neuroendocrine tumors (9.5%). Complete or R0 resection was achieved in 89.7% of cases. Adverse events (AEs) occurred in 15% of patients, including perforation (4.5%), transmural burn syndrome (3.7%), and bleeding (2.2%). The majority of AEs occurred post-procedurally (62%). Management of AEs was predominantly conservative (66.7%), with repeat colonoscopy within 7 days in 1.5% and surgery in 3.8% of patients. The first follow-up endoscopy was performed at a median of 6.9 months (IQR 6.3); recurrence was observed in 4% of cases during follow-up. Overall, 14.6% (19/130) patients ultimately required surgery, primarily due to non-curative resections. The median time from FTRD to surgery was 42 days (IQR 50.7).

Conclusions EFTR via FTRD is relatively safe and efficacious for the removal of lesions deemed not suitable to conventional resection techniques.

Publication History

Article published online:
27 March 2025