Endoscopic full-thickness resection using an over-the-scope device: A prospective study

BACKGROUND: Endoscopic submucosal dissection to treat mucosal and submucosal lesions sometimes results in low rates of microscopically margin-negative (R0) resection. Endoscopic full-thickness resection (EFTR) has a high R0 resection rate and allows for the definitive diagnosis and treatment of selected mucosal and submucosal lesions that are not suitable for conventional resection techniques. AIM: To evaluate the efficacy and safety of EFTR using an over-the-scope clip (OTSC). METHODS: This prospective, single-center, non-randomized clinical trial was conducted at the endoscopy center of Shengjing Hospital of China Medical University. The study included patients aged 18-70 years who had gastric or colorectal submucosal tumors (SMTs) (≤ 20 mm in diameter) originating from the muscularis propria based on endoscopic ultrasound (EUS) and patients who had early-stage gastric or colorectal cancer (≤ 20 mm in diameter) based on EUS and computed tomography. All lesions were treated by EFTR combined with an OTSC for wound closure between November 2014 and October 2016. We analyzed patient demographics, lesion features, histopathological diagnoses, R0 resection (negative margins) status, adverse events, and follow-up results. RESULTS: A total of 68 patients (17 men and 51 women) with an average age of 52.0 ± 10.5 years (32-71 years) were enrolled in this study, which included 66 gastric or colorectal SMTs and 2 early-stage colorectal cancers. The mean tumor diameter was 12.6 ± 4.3 mm. The EFTR procedure was successful in all cases. The mean EFTR procedure time was 39.6 ± 38.0 min. The mean OTSC defect closure time was 5.0 ± 3.8 min, and the success rate of closure for defects was 100%. Histologically complete resection (R0) was achieved in 67 (98.5%) patients. Procedure-related adverse events were observed in 11 (16.2%) patients. The average post-procedure length of follow-up was 48.2 ± 15.7 mo. There was no recurrence during follow-up. CONCLUSION: EFTR combined with an OTSC is an effective and safe technique for the removal of select subepithelial and epithelial lesions that are not amenable to conventional endoscopic resection techniques.