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

Abstract

BackgroundThe 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).MethodsThe 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.DiscussionThe 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 registrationClinicalTrials.gov, Identifier: NCT03172832. Registered on 1 June 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2473-2) contains supplementary material, which is available to authorized users.

ASGE guideline on the role of endoscopy in the management of malignant hilar obstruction

“…We only included comparative data from 11 studies. 21,[27][28][29][30][31][32][33][34][35][36] Three RCTs 27,32,36 assessed the use EBD versus PTBD. The RCT by Coelen et al 27 was stopped early because of higher early mortality in the PTBD group.…”

Efficacy and safety of EUS biliary drainage in malignant distal and hilar biliary obstruction: A comprehensive review of literature and algorithm

“…[ 74 ] Currently, a RCT is still being conducted to compare PTBD and ERCP in the management of MHBO. [ 75 ] At this juncture, the Asia-Pacific Consensus and ESGE guidelines recommend PTBD over ERCP in MHBO of Bismuth type III–IV disease and ERCP over PTBD in Bismuth type II disease. [ 70 76 ]…”

Biliary Drainage Before and After Liver Resection for Perihilar Cholangiocarcinoma

“…Regardless, they acknowledge their findings leave several questions unanswered, which they plan to address in the ongoing INTERCPT trial. 47…”