Efficacy and safety of endobiliary radiofrequency ablation for the eradication of residual neoplasia after endoscopic papillectomy: a multicenter prospective study.

ABSTRACT

BACKGROUND AND AIMS: Endobiliary dysplasia may persist after endoscopic papillectomy. Intraductal radiofrequency ablation (ID-RFA) is a potential alternative to complementary surgery. The aim of this study was to evaluate the efficacy and safety of ID-RFA for the treatment of adenomatous intraductal residue after endoscopic papillectomy. METHODS: A prospective open-label multicenter study included patients with histologically proven endobiliary adenoma remnant (ductal extent <20 mm) after endoscopic papillectomy for ampullary tumor. RFA (effect 8, power 10 W, 30 seconds) was performed during ERCP. Biliary ± pancreatic stent was placed at the end of the procedure. Endpoints were (1) the rate of residual neoplasia (ie, low-grade dysplasia [LGD], high-grade dysplasia [HGD], or invasive carcinoma) at 6 and 12 months, (2) rate of surgery, and (3) adverse events. RESULTS: Twenty patients (67 ± 11 years of age, 12 men) were included. The endobiliary adenoma was in LGD in 15 patients and HGD in 5 patients. All underwent 1 successful ID-RFA session with biliary stent placement and recovered uneventfully. Five (25%) received a pancreatic stent. The rates of residual neoplasia were 15% and 30% at 6 and 12 months, respectively. Only 2 patients (10%) were referred for surgery. Eight patients (40%) experienced at least 1 adverse event between ID-RFA and 12 months of follow-up. No major adverse event occurred. HGD at inclusion was associated with higher dysplasia recurrence at 12 months (P = .01). CONCLUSIONS: ID-RFA of residual endobiliary dysplasia after endoscopic papillectomy can be offered as an alternative to surgery, with a 70% chance of dysplasia eradication at 12 months after a single session and a good safety profile. Patient follow-up remains warranted after ID-RFA. (Clinical trial registration number NCT02825524.).