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

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.

TRIAL REGISTRATION:

ClinicalTrials.gov, Identifier: NCT03172832 . Registered on 1 June 2017.

• Authors: Firas Al-Kawas, Harry Aslanian, John Baillie, Filip Banovac, Jonathan M Buscaglia, James Buxbaum, Amitabh Chak, Bradford Chong, Gregory A Coté, Peter V Draganov, Kulwinder Dua, Valerie Durkalski, B Joseph Elmunzer, Lydia D Foster, Timothy B Gardner, Brian S Geller, Priya Jamidar, Laith H Jamil, Rajesh N Keswani, Mouen A Khashab, Gabriel D Lang, Ryan Law, David Lichtenstein, Simon K Lo, Sean McCarthy, Silvio Melo, Daniel Mullady, Jose Nieto, J Bayne Selby, Vikesh K Singh, Rebecca L Spitzer, Brian Strife, Paul Tarnaksy, Jason R Taylor, Jeffrey Tokar, Andrew Y Wang, April Williams, Field Willingham, Patrick Yachimski, In alphabetical order for the INTERCPT Study Group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE)
• Journal: Trials (Trials) Vol. 19 Issue 1 Pg. 108 (Feb 14 2018) ISSN: 1745-6215 [Electronic] England
• PMID: 29444707 (Publication Type: Clinical Trial Protocol, Journal Article)

Topics

• Bile Duct Neoplasms (complications, diagnostic imaging)
• Cholangiopancreatography, Endoscopic Retrograde (adverse effects)
• Cholestasis (diagnostic imaging, etiology, therapy)
• Comparative Effectiveness Research
• Drainage (adverse effects, methods)
• Equivalence Trials as Topic
• Humans
• Multicenter Studies as Topic
• Time Factors
• Treatment Outcome
• United States