Marine Camus1, Bertrand Napoléon2, Ariane Vienne3, Marc Le Rhun4, Sarah Leblanc1, Maximilien Barret1, Stanislas Chaussade1, Françoise Robin5, Nadira Kaddour6, Frederic Prat7. 1. Université Paris 5, INSERM U1016, Institut Cochin, Paris, France. 2. Ramsay Générale de Santé, Hôpital Privé Jean Mermoz, Lyon, France. 3. Ramsay Générale de Santé, Hôpital Privé d'Antony, Antony, Paris, France. 4. Institut des Maladies de l'Appareil Digestif, CHU Nantes, Nantes, France. 5. ARC SFED, Hépato-Gastroentérologie, HCL, Hôpital Edouard Herriot, Lyon, France. 6. URC/CIC Paris Descartes Necker-Cochin, Paris, France. 7. Université Paris 5, INSERM U1016, Institut Cochin, Paris, France; Service de Gastroentérologie, Hôpital Cochin, Assistance publique hôpitaux de Paris, Paris, France.
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.).
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.).
Authors: Enrique Pérez-Cuadrado-Robles; Hubert Piessevaux; Tom G Moreels; Ralph Yeung; Tarik Aouattah; Mina Komuta; Hélène Dano; Anne Jouret-Mourin; Pierre H Deprez Journal: United European Gastroenterol J Date: 2019-01-12 Impact factor: 4.623