Abstract
BackgroundThe 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).MethodsThe 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.DiscussionThe 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 registrationClinicalTrials.gov, Identifier: NCT03172832. Registered on 1 June 2017.
Highlights
The optimal approach to the drainage of malignant obstruction at the liver hilum remains uncertain
endoscopic retrograde cholangiography (ERC) is generally favored on the basis of: (1) high technical and clinical success rates for other indications; (2) the perceived safety of ERC relative to percutaneous transhepatic biliary drainage (PTBD); (3) the perceived ability to perform more comprehensive tissue sampling at the time of ERC compared to PTBD; (4) the avoidance of external tubes which are often needed for PTBD; and (5) because patients with suspected malignant hilar obstruction (MHO) typically present to, and are managed by, gastroenterologists
: (1) observational data suggest that PTBD is superior for achieving complete drainage of MHO [1,2,3] and some guidelines recommend the percutaneous approach over ERC for Bismuth type 3 and 4 hilar strictures [4]; (2) the generally quoted risks of PTBD are based on outdated studies and may be exaggerated [5]; and (3) endoscopic diagnosis of indeterminate biliary strictures remains suboptimal despite the use of cholangioscopy and multi-modal sampling
Summary
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). : (1) observational data suggest that PTBD is superior for achieving complete drainage of MHO [1,2,3] and some guidelines recommend the percutaneous approach over ERC for Bismuth type 3 and 4 hilar strictures [4]; (2) the generally quoted risks of PTBD are based on outdated studies and may be exaggerated [5]; and (3) endoscopic diagnosis of indeterminate biliary strictures remains suboptimal despite the use of cholangioscopy and multi-modal sampling. Identifying patient and stricture characteristics that predict response to PTBD or ERC may be important for informing clinical decision-making and guidelines
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