Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction

Study protocol for a randomized controlled trial

INTERCPT Study Group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE)

Research output: Contribution to journalArticle

5 Citations (Scopus)

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.

Original languageEnglish (US)
Article number108
JournalTrials
Volume19
Issue number1
DOIs
StatePublished - Feb 14 2018
Externally publishedYes

Fingerprint

Drainage
Randomized Controlled Trials
Cholangiography
Cholestasis
Random Allocation
Decompression
Informed Consent
Hospitalization
Outcome Assessment (Health Care)
Physicians
Liver

Keywords

  • Cholangiocarcinoma
  • Endoscopic retrograde cholangiopancreatography
  • Hilar stricture
  • Percutaneous transhepatic biliary drainage

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction : Study protocol for a randomized controlled trial. / INTERCPT Study Group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE).

In: Trials, Vol. 19, No. 1, 108, 14.02.2018.

Research output: Contribution to journalArticle

INTERCPT Study Group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE). / Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction : Study protocol for a randomized controlled trial. In: Trials. 2018 ; Vol. 19, No. 1.
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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.",
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AU - Al-Kawas, Firas

AU - Aslanian, Harry

AU - Baillie, John

AU - Banovac, Filip

AU - Buscaglia, Jonathan M.

AU - Buxbaum, James

AU - Chak, Amitabh

AU - Chong, Bradford

AU - Coté, Gregory A.

AU - Draganov, Peter V.

AU - Dua, Kulwinder

AU - Durkalski, Valerie

AU - Elmunzer, B. Joseph

AU - Foster, Lydia D.

AU - Gardner, Timothy B.

AU - Geller, Brian S.

AU - Jamidar, Priya

AU - Jamil, Laith H.

AU - Keswani, Rajesh N.

AU - Khashab, Mouen A.

AU - Lang, Gabriel D.

AU - Law, Ryan

AU - Lichtenstein, David

AU - Lo, Simon K.

AU - McCarthy, Sean

AU - del Melo, Silvio

AU - Mullady, Daniel

AU - Nieto, Jose

AU - Bayne Selby, J.

AU - Singh, Vikesh K.

AU - Spitzer, Rebecca L.

AU - Strife, Brian

AU - Tarnaksy, Paul

AU - Taylor, Jason R.

AU - Tokar, Jeffrey

AU - Wang, Andrew Y.

AU - Williams, April

AU - Willingham, Field

AU - Yachimski, Patrick

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N2 - 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.

AB - 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.

KW - Cholangiocarcinoma

KW - Endoscopic retrograde cholangiopancreatography

KW - Hilar stricture

KW - Percutaneous transhepatic biliary drainage

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