. 2018 Feb 14;19(1):108.

doi: 10.1186/s13063-018-2473-2.

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

Firas Al-Kawas¹, Harry Aslanian², John Baillie³, Filip Banovac⁴, Jonathan M Buscaglia⁵, James Buxbaum⁶, Amitabh Chak⁷, Bradford Chong⁶, Gregory A Coté⁸, Peter V Draganov⁹, Kulwinder Dua¹⁰, Valerie Durkalski¹¹, B Joseph Elmunzer¹², Lydia D Foster¹¹, Timothy B Gardner¹³, Brian S Geller¹⁴, Priya Jamidar², Laith H Jamil¹⁵, Rajesh N Keswani¹⁶, Mouen A Khashab¹⁷, Gabriel D Lang¹⁸, Ryan Law¹⁹, David Lichtenstein²⁰, Simon K Lo¹⁵, Sean McCarthy²¹, Silvio Melo²², Daniel Mullady¹⁸, Jose Nieto²³, J Bayne Selby²⁴, Vikesh K Singh¹⁷, Rebecca L Spitzer⁸, Brian Strife²⁵, Paul Tarnaksy²⁶, Jason R Taylor²⁷, Jeffrey Tokar²⁸, Andrew Y Wang²⁹, April Williams⁸, Field Willingham³⁰, Patrick Yachimski³¹; In alphabetical order for the INTERCPT Study Group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE)

Affiliations

¹ Division of Gastroenterology, Johns Hopkins Sibley Memorial Hospital, Washington, DC, USA.
² Division of Gastroenterology, Yale University, New Haven, CT, USA.
³ Division of Gastroenterology, Virginia Commonwealth University, Richmond, VA, USA.
⁴ Division of Interventional Radiology, Vanderbilt University, Nashville, TN, USA.
⁵ Division of Gastroenterology, Stony Brook University, Stony Brook, NY, USA.
⁶ Division of Gastroenterology, University of Southern California, Los Angeles, CA, USA.
⁷ Division of Gastroenterology, Case Western Reserve University, Cleveland, OH, USA.
⁸ Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, SC, USA.
⁹ Division of Gastroenterology, Hepatology, and Nutrition, University of Florida, Gainesville, FL, USA.
¹⁰ Division of Gastroenterology, Medical College of Wisconsin, Milwaukee, WI, USA.
¹¹ Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
¹² Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, SC, USA. elmunzer@musc.edu.
¹³ Division of Gastroenterology, Dartmouth University, Lebanon, NH, USA.
¹⁴ Division of Interventional Radiology, University of Florida, Gainesville, FL, USA.
¹⁵ Division of Gastroenterology, Cedars Sinai Medical Center, Los Angeles, CA, USA.
¹⁶ Division of Gastroenterology, Northwestern University, Chicago, IL, USA.
¹⁷ Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
¹⁸ Division of Gastroenterology, Washington University, St. Louis, MO, USA.
¹⁹ Division of Gastroenterology, University of Michigan, Ann Arbor, MI, USA.
²⁰ Division of Gastroenterology, Boston University, Boston, MA, USA.
²¹ Division of Gastroenterology, Ohio State University, Columbus, OH, USA.
²² Division of Gastroenterology, University of Florida-Jacksonville, Jacksonville, FL, USA.
²³ The Borland-Groover Clinic, Jacksonville, FL, USA.
²⁴ Division of Interventional Radiology, Medical University of South Carolina, Charleston, SC, USA.
²⁵ Division of Interventional Radiology, Virginia Commonwealth University, Richmond, VA, USA.
²⁶ Division of Gastroenterology, Methodist Dallas Medical Center, Dallas, TX, USA.
²⁷ Division of Gastroenterology, Saint Louis University, St. Louis, MO, USA.
²⁸ Division of Gastroenterology, Fox Chase Cancer Center, Philadelphia, PA, USA.
²⁹ Division of Gastroenterology, University of Virginia, Charlottesville, VA, USA.
³⁰ Division of Gastroenterology, Emory University, Atlanta, GA, USA.
³¹ Division of Gastroenterology, Vanderbilt University, Nashville, TN, USA.

PMID: 29444707
PMCID: PMC5813390
DOI: 10.1186/s13063-018-2473-2

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

Firas Al-Kawas et al. Trials. 2018.

. 2018 Feb 14;19(1):108.

doi: 10.1186/s13063-018-2473-2.

Authors

Affiliations

¹ Division of Gastroenterology, Johns Hopkins Sibley Memorial Hospital, Washington, DC, USA.
² Division of Gastroenterology, Yale University, New Haven, CT, USA.
³ Division of Gastroenterology, Virginia Commonwealth University, Richmond, VA, USA.
⁴ Division of Interventional Radiology, Vanderbilt University, Nashville, TN, USA.
⁵ Division of Gastroenterology, Stony Brook University, Stony Brook, NY, USA.
⁶ Division of Gastroenterology, University of Southern California, Los Angeles, CA, USA.
⁷ Division of Gastroenterology, Case Western Reserve University, Cleveland, OH, USA.
⁸ Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, SC, USA.
⁹ Division of Gastroenterology, Hepatology, and Nutrition, University of Florida, Gainesville, FL, USA.
¹⁰ Division of Gastroenterology, Medical College of Wisconsin, Milwaukee, WI, USA.
¹¹ Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
¹² Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, SC, USA. elmunzer@musc.edu.
¹³ Division of Gastroenterology, Dartmouth University, Lebanon, NH, USA.
¹⁴ Division of Interventional Radiology, University of Florida, Gainesville, FL, USA.
¹⁵ Division of Gastroenterology, Cedars Sinai Medical Center, Los Angeles, CA, USA.
¹⁶ Division of Gastroenterology, Northwestern University, Chicago, IL, USA.
¹⁷ Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
¹⁸ Division of Gastroenterology, Washington University, St. Louis, MO, USA.
¹⁹ Division of Gastroenterology, University of Michigan, Ann Arbor, MI, USA.
²⁰ Division of Gastroenterology, Boston University, Boston, MA, USA.
²¹ Division of Gastroenterology, Ohio State University, Columbus, OH, USA.
²² Division of Gastroenterology, University of Florida-Jacksonville, Jacksonville, FL, USA.
²³ The Borland-Groover Clinic, Jacksonville, FL, USA.
²⁴ Division of Interventional Radiology, Medical University of South Carolina, Charleston, SC, USA.
²⁵ Division of Interventional Radiology, Virginia Commonwealth University, Richmond, VA, USA.
²⁶ Division of Gastroenterology, Methodist Dallas Medical Center, Dallas, TX, USA.
²⁷ Division of Gastroenterology, Saint Louis University, St. Louis, MO, USA.
²⁸ Division of Gastroenterology, Fox Chase Cancer Center, Philadelphia, PA, USA.
²⁹ Division of Gastroenterology, University of Virginia, Charlottesville, VA, USA.
³⁰ Division of Gastroenterology, Emory University, Atlanta, GA, USA.
³¹ Division of Gastroenterology, Vanderbilt University, Nashville, TN, USA.

PMID: 29444707
PMCID: PMC5813390
DOI: 10.1186/s13063-018-2473-2

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.

Keywords: Cholangiocarcinoma; Endoscopic retrograde cholangiopancreatography; Hilar stricture; Percutaneous transhepatic biliary drainage.

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Conflict of interest statement

Authors’ information

None

Ethics approval and consent to participate

Ethical approval has been obtained from the Institutional Review Board at the primary site (Medical University of South Carolina, Pro00063825) and several sub-sites. The remaining sites will only enroll subjects once local regulatory approval has been obtained.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

**Fig. 1**
Enrollment, intervention, and assessments in the INTERCPT trial

See this image and copyright information in PMC

References

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1. Kloek JJ, van der Gaag NA, Aziz Y, et al. Endoscopic and percutaneous preoperative biliary drainage in patients with suspected hilar cholangiocarcinoma. J Gastrointest Surg. 2010;14:119–125. doi: 10.1007/s11605-009-1009-1. - DOI - PMC - PubMed
1. Hameed A, Pang T, Chiou J, et al. Percutaneous vs. endoscopic pre-operative biliary drainage in hilar cholangiocarcinoma—a systematic review and meta-analysis. HPB (Oxford). 2016;18:400–410. doi: 10.1016/j.hpb.2016.03.002. - DOI - PMC - PubMed
1. Rerknimitr R, Angsuwatcharakon P, Ratanachu-ek T, et al. Asia-Pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma. J Gastroenterol Hepatol. 2013;28:593–607. doi: 10.1111/jgh.12128. - DOI - PubMed
1. Saad WE, Wallace MJ, Wojak JC, et al. Quality improvement guidelines for percutaneous transhepatic cholangiography, biliary drainage, and percutaneous cholecystostomy. J Vasc Interv Radiol. 2010;21:789–795. doi: 10.1016/j.jvir.2010.01.012. - DOI - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Authors’ information

Ethics approval and consent to participate

Consent for publication

Competing interests

Publisher’s Note

Figures

References

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