CAN PROPHYLACTIC APC REDUCE DELAYED POST-PAPILLECTOMY BLEEDING? A PROSPECTIVE RANDOMIZED MULTICENTER TRIAL

Abstract

Background and Aims Endoscopic post-papillectomy bleeding occurs in 3 to 20% of cases and delayed bleeding within one week is also problematic. However, there was no definite guideline or consensus for prevention or reduction of delayed post-papillectomy bleeding. Submucosal injection of dilute epinephrine before endoscopic papillectomy may not aid in reducing the risk of delayed bleeding. The aim of this study was to evaluate the efficacy of prophylactic argon plasma coagulation (APC) to prevent or reduce delayed post-papillectomy bleeding.

Patients and Methods A prospective randomized study was performed at six tertiary referral centers in Korea. Patients with benign papillary tumors were enrolled from January 2015 to August 2017 and were randomized to either the prophylactic APC group or non-APC group. Endoscopic papillectomy was performed using a conventional snaring papillectomy method. Then, APC on the resection margin was performed in the prophylactic APC group. On the day after papillectomy, all patients underwent follow-up duodenoscopy to identify post-papillectomy bleeding and were followed up with duodenoscopy at 1 month later. The main outcome measures were delayed (>24 h) post-papillectomy bleeding rate and remnant tissue ablation effects.

Results In total, 48 patients underwent endoscopic papillectomy. Delayed bleeding rates in the prophylactic APC and non-APC groups were 33.3% (8/24) and 16.7% (4/24), respectively (p=0.336). Tumor persistence at 1 month did not differ between the two groups (12.5% vs. 8.3%, p=0.628). The mean tumor length and width were 11 and 12 mm in the prophylactic APC group, and 13.6 and 12.7 mm in the non-APC group. En-bloc resection rates in the prophylactic APC and non-APC groups were 83.3% (20/24) and 95.8% (23/24), respectively. Positive resection margin rates in the prophylactic APC and non-APC groups were 66.7% (16/24) and 33.3% (8/24), respectively (p=0.076). Post-procedure pancreatitis rates were 20.7% (5/24) in the prophylactic APC and 37.5% (9/24) in the non-APC groups, respectively (p=0.295). The severity of pancreatitis did not differ between the two groups. There were no procedure-related mortalities or serious complications.

Conclusions Prophylactic APC may not be effective in reducing delayed post-papillectomy bleeding or remnant tumor ablation. The prophylactic APC group seemed to have a higher tendency of delayed post-papillectomy bleeding without statistical difference and might be also ineffective on remnant tumor ablation during short-term follow-up.