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

• Published in: Current controlled trials in cardiovascular medicine Vol. 19; no. 1; pp. 108 - 6
• Main Authors: Al-Kawas, Firas, Aslanian, Harry, Baillie, John, Banovac, Filip, Buscaglia, Jonathan M., Buxbaum, James, Chak, Amitabh, Chong, Bradford, Coté, 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
• Format: Journal Article
• Language: English
• Published: London BioMed Central 14.02.2018; BioMed Central Ltd; Springer Nature B.V; BMC
• Subjects: Bile Duct Neoplasms - complications; Bile Duct Neoplasms - diagnostic imaging; Biomedicine; Cancer therapies; Cholangiocarcinoma; Cholangiopancreatography, Endoscopic Retrograde - adverse effects; Cholangitis; Cholestasis - diagnostic imaging; Cholestasis - etiology; Cholestasis - therapy; Clinical medicine; Comparative analysis; Comparative Effectiveness Research; Consent; Contraindications; Decision making; Drainage - adverse effects; Drainage - methods; Endoscopic retrograde cholangiopancreatography; Endoscopy; Enrollments; Equivalence Trials as Topic; Health Sciences; Hilar stricture; Humans; Intervention; Liver; Medical records; Medical referrals; Medicine; Medicine & Public Health; Multicenter Studies as Topic; Patient outcomes; Patients; Percutaneous transhepatic biliary drainage; Physicians; Regulatory approval; Statistics for Life Sciences; Study Protocol; Time Factors; Treatment Outcome; Ultrasonic imaging; United States; United States; Endoscopic retrograde cholangiopancreatography; Cholangiocarcinoma; Percutaneous transhepatic biliary drainage; Hilar stricture
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-018-2473-2

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.