F. Banovac

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

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.

Evaluating the Costs of IR in Health Care Delivery: Proceedings from a Society of Interventional Radiology Research Consensus Panel

From the Division of Va of Radiology, Beth Israe WCC 308-B, 1 Deacone and Imaging Sciences ( Georgia; Department o tiveness, Cost, and O Washington, Seattle, Institute for Healthcare Health System, Ann Ar ical University of Sou Research, and Policy T Herndon, Virginia; Fre Department of Radiolo Medical School, Bosto IBM Watson Health, C (C.E.R.), University of I Radiology (F.B.), Vande 27, 2017; final revision respondence to A.S.; E

Are prophylactic antibiotics necessary prior to transarterial chemoembolization for hepatocellular carcinoma in patients with native biliary anatomy

Prophylactic antibiotics are frequently administered for transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC). In patients without previous biliary instrumentation, infection risk from TACE is low. We hypothesized that there is a negligible rate of infection in these patients without prophylactic antibiotics.