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Author Notes:

Correspondence: elmunzer@musc.edu

BJE conceived the project, helped design the study, drafted the manuscript, and approved the final submission.

FA, HA, JB, FB, JB, JB, AC, BC, GC, PD, KD, TG, BG, PJ, RK, MK, GL, RL, DL, SM, SM, DM, JN, JBS, VS, BS, PT, JT, JT, AW, FW, and PY helped design the study, revised the manuscript, and approved the final submission.

RS and AW are the project managers, helped design the study, revised the manuscript, and approved the final submission.

LF and VD are the study statisticians, helped design the study, revised the manuscript, and approved the final submission.

All authors read and approved the manuscript.

The authors declare that they have no competing interests.

Subjects:

Research Funding:

None

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Medicine, Research & Experimental
  • Research & Experimental Medicine
  • Cholangiocarcinoma
  • Hilar stricture
  • Endoscopic retrograde cholangiopancreatography
  • Percutaneous transhepatic biliary drainage
  • CHOLANGIOCARCINOMA

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

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Journal Title:

Trials

Volume:

Volume 19, Number 1

Publisher:

, Pages 108-108

Type of Work:

Article | Final Publisher PDF

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.

Copyright information:

© 2018 The Author(s).

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
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