Dong Wan Seo1, Stuart Sherman2, Kulwinder S Dua3, Adam Slivka4, Andre Roy5, Guido Costamagna6, Jacques Deviere7, Joyce Peetermans8, Matthew Rousseau8, Yousuke Nakai9, Hiroyuki Isayama9, Richard Kozarek10. 1. Internal Medicine, Asan Medical Center University of Ulsan, Seoul, South Korea. 2. Division of Gastroenterology and Hepatology Indiana University School of Medicine, Indianapolis, Indiana, USA. 3. Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA. 4. Gastroenterology, Hepatology and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA. 5. Surgery, Centre hospitalier de l'Université de Montréal, Montreal, Quebec, Canada. 6. Fondazione Policlinico A. Gemelli - IRCCS, Digestive Endoscopy Unit; Università Cattolica del S. Cuore, Rome, Italy. 7. Gastro-Entérologie et d'Hépato-Pancréatologie, Université Libre de Bruxelles Hôpital Erasme, Brussels, Belgium. 8. Boston Scientific Corporation, Marlboro, Massachusetts, USA. 9. Gastroenterology, University of Tokyo, Tokyo, Japan. 10. Digestive Disease Institute, Virginia Mason Medical Center, Seattle, Washington, USA.
Abstract
BACKGROUND AND AIMS: Preoperative biliary drainage with self-expanding metal stents (SEMSs) brings liver function within an acceptable range in preparation for neoadjuvant therapy (NATx) and provides relief of obstructive symptoms in patients with pancreatic cancer. We compared fully-covered SEMSs (FCSEMSs) and uncovered SEMSs (UCSEMSs) for sustained biliary drainage before and during NATx. METHODS:Patients with pancreatic cancer and planned NATx who need treatment of jaundice and/or cholestasis before pancreaticoduodenectomy were randomized to FCSEMSs versus UCSEMSs. The primary endpoint was sustained biliary drainage, defined as the absence of reinterventions for biliary obstructive symptoms, and was assessed from SEMS placement until curative intent surgery or at 1 year. RESULTS: The intention-to-treat population included 119 patients (59 FCSEMSs, 60 UCSEMSs). Sustained biliary drainage was equally successful with FCSEMSs and UCSEMSs (72.2% vs 72.9%, noninferiority P = .01). Reasons for FCSEMS and UCSEMS failure differed significantly between the groups and included tumor ingrowth in 0% versus 16.7% (P < .01), and stent migration in 6.8% versus 0% (P = .03), respectively. Serious adverse event rates related to stent placement were not significantly different in both groups (23.7% [14/59] vs 20.0% [12/60], P = .66), as were acute cholecystitis rates when the gallbladder was in situ (9.3% [4/43] vs 4.8% [2/42], P = .68) for FCSEMSs and UCSEMSs, respectively. In our study, independent of stent type, predictors of reinterventions were 4-cm stent length and presence of the gallbladder. CONCLUSION: FCSEMSs and UCSEMSs provide similar preoperative management of biliary obstruction in patients with pancreatic cancer receivingNATx, but mechanisms of stent dysfunction depend on stent type, stent length, and presence of the gallbladder. (Clinical trial registration number: NCT02238847.).
RCT Entities:
BACKGROUND AND AIMS: Preoperative biliary drainage with self-expanding metal stents (SEMSs) brings liver function within an acceptable range in preparation for neoadjuvant therapy (NATx) and provides relief of obstructive symptoms in patients with pancreatic cancer. We compared fully-covered SEMSs (FCSEMSs) and uncovered SEMSs (UCSEMSs) for sustained biliary drainage before and during NATx. METHODS:Patients with pancreatic cancer and planned NATx who need treatment of jaundice and/or cholestasis before pancreaticoduodenectomy were randomized to FCSEMSs versus UCSEMSs. The primary endpoint was sustained biliary drainage, defined as the absence of reinterventions for biliary obstructive symptoms, and was assessed from SEMS placement until curative intent surgery or at 1 year. RESULTS: The intention-to-treat population included 119 patients (59 FCSEMSs, 60 UCSEMSs). Sustained biliary drainage was equally successful with FCSEMSs and UCSEMSs (72.2% vs 72.9%, noninferiority P = .01). Reasons for FCSEMS and UCSEMS failure differed significantly between the groups and included tumor ingrowth in 0% versus 16.7% (P < .01), and stent migration in 6.8% versus 0% (P = .03), respectively. Serious adverse event rates related to stent placement were not significantly different in both groups (23.7% [14/59] vs 20.0% [12/60], P = .66), as were acute cholecystitis rates when the gallbladder was in situ (9.3% [4/43] vs 4.8% [2/42], P = .68) for FCSEMSs and UCSEMSs, respectively. In our study, independent of stent type, predictors of reinterventions were 4-cm stent length and presence of the gallbladder. CONCLUSION: FCSEMSs and UCSEMSs provide similar preoperative management of biliary obstruction in patients with pancreatic cancer receiving NATx, but mechanisms of stent dysfunction depend on stent type, stent length, and presence of the gallbladder. (Clinical trial registration number: NCT02238847.).
Authors: Muhammad Nadeem Yousaf; Hamid Ehsan; Ahsan Wahab; Ahmad Muneeb; Fizah S Chaudhary; Richard Williams; Christopher J Haas Journal: World J Gastrointest Endosc Date: 2020-10-16