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Al-Kawas F , Aslanian H , Baillie J , Banovac F , Buscaglia JM , Buxbaum J , Chak A , Chong B , Cote GA , Draganov PV , Dua K , Durkalski V , Elmunzer BJ , Foster LD , Gardner TB , Geller BS , Jamidar P , Jamil LH , Keswani RN , Khashab MA , Lang GD , Law R , Lichtenstein D , Lo SK , McCarthy S , Melo S , Mullady D , Nieto J , Bayne Selby J , Singh VK , Spitzer RL , Strife B , Tarnaksy P , Taylor JR , Tokar J , Wang AY , Williams A , Willingham F , Yachimski P
Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction: study protocol for a randomized controlled trial
Trials. 2018 Feb 14;19(1) :108
PMID: 29444707    PMCID: PMC5813390   
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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. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT03172832 . Registered on 1 June 2017.
Notes
1745-6215 Al-Kawas, Firas Aslanian, Harry Baillie, John Banovac, Filip Buscaglia, Jonathan M Buxbaum, James Chak, Amitabh Chong, Bradford Cote, Gregory A Draganov, Peter V Dua, Kulwinder Durkalski, Valerie Elmunzer, B Joseph Foster, Lydia D Gardner, Timothy B Geller, Brian S Jamidar, Priya Jamil, Laith H Keswani, Rajesh N Khashab, Mouen A Lang, Gabriel D Law, Ryan Lichtenstein, David Lo, Simon K McCarthy, Sean Melo, Silvio Mullady, Daniel Nieto, Jose Bayne Selby, J Singh, Vikesh K Spitzer, Rebecca L Strife, Brian Tarnaksy, Paul Taylor, Jason R Tokar, Jeffrey Wang, Andrew Y Williams, April Willingham, Field Yachimski, Patrick In alphabetical order for the INTERCPT Study Group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE) Journal Article England Trials. 2018 Feb 14;19(1):108. doi: 10.1186/s13063-018-2473-2.