Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction: study protocol for a randomized controlled trial

• Type of Material: Article
• Authors: Firas Al-Kawas, Johns Hopkins Sibley Memorial Hospital; Harry Aslanian, Yale University; John Baillie, Virginia Commonwealth University; Filip Banovac, Vanderbilt University; Jonathan M. Buscaglia, Stony Brook University; James Buxbaum, University of Southern California; Amitabh Chak, Case Western Reserve University; Bradford Chong, University of Southern California; Gregory A. Cote, Medical University of South Carolina; Peter V. Draganov, University of Florida; Kulwinder Dua, Medical College of Wisconsin; Valerie Durkalski, Medical University of South Carolina; B. Joseph Elmunzer, Medical University of South Carolina; Lydia D. Foster, Medical University of South Carolina; Timothy B. Gardner, Dartmouth College; Brian .S Geller, University of Florida; Priya Jamidar, Yale University; Laith H. Jamil, Cedars Sinai Medical Center; Rajesh N. Keswani, Northwestern University; Mouen A. Khashab, Johns Hopkins Medical Institutions; Gabriel D. Lang, Washington University; Ryan Law, University of Michigan; David Lichtenstein, Boston University; Simon K. Lo, Cedars Sinai Medical Center; Sean McCarthy, Ohio State University; Silvio Melo, University of Florida; Daniel Mullady, Washington University; Jose Nieto, The Borland-Groover Clinic; J. Bayne Selby, Medical University of South Carolina; Vikesh K. Singh, Johns Hopkins Medical Institutions; Rebecca L. Spitzer, Medical University of South Carolina; Brian Strife, Virginia Commonwealth University; Paul Tarnaksy, Methodist Dallas Medical Center; Jason R. Taylor, Saint Louis University; Jeffrey Tokar, Fox Chase Cancer Center; Andrew Y. Wang, University of Virginia; April Williams, Medical University of South Carolina; Field Willingham, Emory University; Patrick Yachimski, Vanderbilt University
• Language: English
• Date: 2018-02-14
• Publisher: BioMed Central
• Publication Version: Final Published Version
• Copyright Statement: © 2018 The Author(s).
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1186/s13063-018-2473-2
• Title of Journal or Parent Work: Trials
• ISSN: 1745-6215
• Volume: 19
• Issue: 1
• Start Page: 108
• End Page: 108
• Grant/Funding Information: None
• Keywords: Research & Experimental Medicine; Life Sciences & Biomedicine; Science & Technology; Cholangiocarcinoma; Percutaneous transhepatic biliary drainage; Hilar stricture; CHOLANGIOCARCINOMA; Endoscopic retrograde cholangiopancreatography; Medicine, Research & Experimental
• Research Categories: Health Sciences, General; Health Sciences, Medicine and Surgery

Abstract

Background: The optimal approach to the drainage of malignant obstruction at the liver hilum remains uncertain. We aim to compare percutaneous transhepatic biliary drainage (PTBD) to endoscopic retrograde cholangiography (ERC) as the first intervention in patients with cholestasis due to suspected malignant hilar obstruction (MHO). Methods: The INTERCPT trial is a multi-center, comparative effectiveness, randomized, superiority trial of PTBD vs. ERC for decompression of suspected MHO. One hundred and eighty-four eligible patients across medical centers in the United States, who provide informed consent, will be randomly assigned in 1:1 fashion via a web-based electronic randomization system to either ERC or PTBD as the initial drainage and, if indicated, diagnostic procedure. All subsequent clinical interventions, including crossover to the alternative procedure, will be dictated by treating physicians per usual clinical care. Enrolled subjects will be assessed for successful biliary drainage (primary outcome measure), adequate tissue diagnosis, adverse events, the need for additional procedures, hospitalizations, and oncological outcomes over a 6-month follow-up period. Subjects, treating clinicians and outcome assessors will not be blinded. Discussion: The INTERCPT trial is designed to determine whether PTBD or ERC is the better initial approach when managing a patient with suspected MHO, a common clinical dilemma that has never been investigated in a randomized trial.