Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction: study protocol for a randomized controlled trial
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 ma...
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| Published in | Current controlled trials in cardiovascular medicine Vol. 19; no. 1; pp. 108 - 6 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
London
BioMed Central
14.02.2018
BioMed Central Ltd Springer Nature B.V BMC |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1745-6215 1745-6215 |
| DOI | 10.1186/s13063-018-2473-2 |
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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. |
|---|---|
| AbstractList | 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. 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. 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).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).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.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.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.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.ClinicalTrials.gov, Identifier: NCT03172832 . Registered on 1 June 2017.TRIAL REGISTRATIONClinicalTrials.gov, Identifier: NCT03172832 . Registered on 1 June 2017. 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. 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). 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. 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. ClinicalTrials.gov, Identifier: NCT03172832 . Registered on 1 June 2017. |
| ArticleNumber | 108 |
| Audience | Academic |
| Author | Lang, Gabriel D. Banovac, Filip Foster, Lydia D. Tarnaksy, Paul Strife, Brian Wang, Andrew Y. Baillie, John McCarthy, Sean Singh, Vikesh K. Geller, Brian S. Spitzer, Rebecca L. Buscaglia, Jonathan M. Bayne Selby, J. Williams, April Chak, Amitabh Willingham, Field Draganov, Peter V. Al-Kawas, Firas Dua, Kulwinder Gardner, Timothy B. Keswani, Rajesh N. Chong, Bradford Law, Ryan Aslanian, Harry Yachimski, Patrick Jamil, Laith H. Durkalski, Valerie Elmunzer, B. Joseph Mullady, Daniel Nieto, Jose Lo, Simon K. Tokar, Jeffrey Jamidar, Priya Khashab, Mouen A. Lichtenstein, David Melo, Silvio Buxbaum, James Coté, Gregory A. Taylor, Jason R. |
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| Keywords | Endoscopic retrograde cholangiopancreatography Cholangiocarcinoma Percutaneous transhepatic biliary drainage Hilar stricture |
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| References_xml | – volume: 85 start-page: 32 year: 2017 ident: 2473_CR7 publication-title: Gastrointest Endosc. doi: 10.1016/j.gie.2016.06.051 – volume: 21 start-page: 789 year: 2010 ident: 2473_CR5 publication-title: J Vasc Interv Radiol. doi: 10.1016/j.jvir.2010.01.012 – volume: 69 start-page: 55 year: 2009 ident: 2473_CR1 publication-title: Gastrointest Endosc. doi: 10.1016/j.gie.2008.04.005 – volume: 28 start-page: 593 year: 2013 ident: 2473_CR4 publication-title: J Gastroenterol Hepatol. doi: 10.1111/jgh.12128 – volume: 14 start-page: 119 year: 2010 ident: 2473_CR2 publication-title: J Gastrointest Surg. doi: 10.1007/s11605-009-1009-1 – volume: 18 start-page: 400 year: 2016 ident: 2473_CR3 publication-title: HPB (Oxford). doi: 10.1016/j.hpb.2016.03.002 – volume: 47 start-page: 1124 year: 2015 ident: 2473_CR6 publication-title: Endoscopy. doi: 10.1055/s-0034-1392559 |
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The optimal approach to the drainage of malignant obstruction at the liver hilum remains uncertain. We aim to compare percutaneous transhepatic... The optimal approach to the drainage of malignant obstruction at the liver hilum remains uncertain. We aim to compare percutaneous transhepatic biliary... BackgroundThe optimal approach to the drainage of malignant obstruction at the liver hilum remains uncertain. We aim to compare percutaneous transhepatic... Abstract Background The optimal approach to the drainage of malignant obstruction at the liver hilum remains uncertain. We aim to compare percutaneous... |
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| SubjectTerms | 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 |
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| Title | Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction: study protocol for a randomized controlled trial |
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