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A Trial of Percutaneous vs. Endoscopic Drainage of Suspected Klatskin Tumors (INTERCPT)

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ClinicalTrials.gov Identifier: NCT03172832
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : April 17, 2018
Sponsor:
Collaborators:
Yale University
Virginia Commonwealth University
Vanderbilt University
Stony Brook University
University of Southern California
Case Western Reserve University
Medical College of Wisconsin
Dartmouth University
University of Florida
Northwestern University
Johns Hopkins University
Washington University School of Medicine
University of Michigan
Boston University
Ohio State University
Borland-Groover Clinic
Methodist Health System
St. Louis University
Fox Chase Cancer Center
Emory University
Cedars-Sinai Medical Center
Johns Hopkins Community Physicians
University of Virginia
Information provided by (Responsible Party):
Badih Elmunzer, Medical University of South Carolina

Brief Summary:
The optimal approach to the drainage of malignant obstruction at the biliary hilum remains uncertain. This is a randomized comparative effectiveness study of percutaneous transhepatic biliary drainage (PTBD) vs. endoscopic retrograde cholangiography (ERC) as the first intervention in patients with cholestasis due to suspected malignant hilar obstruction.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Hilar Lymphadenopathy Biliary Stricture Procedure: PTBD Procedure: ERC Not Applicable

Detailed Description:

Both percutaneous transhepatic biliary drainage (PTBD) and endoscopic retrograde cholangiography (ERC) are accepted approaches in the management of patients with malignant obstruction at the biliary hilum. In routine clinical practice, ERC is generally favored on the basis of: 1) high technical and clinical success rates for other (non-hilar) indications; 2) the perceived safety of ERC relative to 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. However: 1) observational data suggest that PTBD is superior for achieving complete drainage of MHO1 and some guidelines recommend the percutaneous approach over ERC for Bismuth type 3 & 4 hilar strictures; 2) the generally quoted risks of PTBD are based on outdated studies and may be exaggerated; and 3) endoscopic diagnosis of indeterminate biliary strictures remains suboptimal despite the use of cholangioscopy and multi-modal sampling.

Although many patients who undergo initial ERC require subsequent PTBD for adequate drainage, no randomized trials comparing the two modalities for suspected MHO have been published. The main hypothesis is that even though PTBD will be more effective than ERC for decompression of suspected MHO, this advantage will be offset by the favorable safety profile and superior diagnostic capability of ERC. If, however, PTBD is found to be substantially superior (by a pre-specified margin) in terms of drainage, or if the potential advantages of ERC are not realized, then the existing clinical approach to MHO must be reappraised. Moreover, 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized comparative effectiveness trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Trial of Percutaneous Transhepatic Biliary Drainage vs. Endoscopic Retrograde Cholangiography for Decompression of Suspected Malignant Biliary Hilar Obstruction - the INTERCPT Trial
Actual Study Start Date : August 20, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: Percutaneous Transhepatic Drainage
Subjects randomized to this arm will undergo PTBD as the first drainage intervention.
Procedure: PTBD
Percutaneous access and tube placement into the bile duct

Active Comparator: Endoscopic Retrograde Cholangiography
Subjects randomized to this arm will undergo ERC as the first drainage intervention.
Procedure: ERC
Endoscopic access and stent placement in the bile duct




Primary Outcome Measures :
  1. Successful biliary drainage [ Time Frame: 2 weeks ]
    50% reduction in bilirubin level within 2 weeks of the study intervention without additional ERC or PTBD


Secondary Outcome Measures :
  1. Alternate definition of successful biliary drainage [ Time Frame: 6 months ]
    improvement in the serum bilirubin level to ≤2.5 mg/dL as a result of the index (randomization) intervention without the need for additional procedures.

  2. Adverse events [ Time Frame: 6 months ]
    Adverse events related to PTBD and ERC, defined according to standard consensus guideline documents published in the interventional radiology and gastroenterology literature respectively.

  3. Adequate tissue diagnosis [ Time Frame: 6 months ]
    A definitive diagnosis of malignancy documented in the subject's medical record.

  4. Quality of life measure [ Time Frame: 2-3 months after initial procedure ]
    Promis Global Health Scale

  5. Quality of life measure [ Time Frame: 2-3 months after initial procedure ]
    SF12 health survey



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥40 (to reduce the likelihood of enrolling patients with obstruction due to primary sclerosing cholangitis)
  2. Cholestatic liver function tests, including serum alkaline phosphatase level ≥ 300 IU/L and bilirubin level ≥ 3.7 mg/dL
  3. Radiographic evidence of a biliary hilar stricture OR intrahepatic but no extrahepatic biliary ductal dilation

Exclusion Criteria:

  1. Known radiographic evidence of a Bismuth-Corlette type 1 biliary stricture
  2. Known diagnosis of primary sclerosing cholangitis without suspicion of dominant hilar stricture
  3. Recent gallbladder/biliary surgery within 12 months
  4. Known Mirizzi syndrome
  5. Known IgG4-mediated cholangiopathy
  6. Significant liver metastatic disease interfering with safe/effective PTBD
  7. Significant ascites interfering with safe/effective PTBD
  8. Known regional malignant-appearing adenopathy or extra-biliary mass, indicating the need for concurrent EUS-FNA
  9. Prior ERCP or PTBD for hilar obstruction
  10. Surgically altered luminal anatomy other than prior Billroth reconstruction or Whipple resection
  11. Standard general contraindications to ERCP or PTBD (e.g. hemodynamic instability, uncorrected coagulopathy, etc.)
  12. Inability or unwillingness to follow study protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172832


Contacts
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Contact: B. Joseph Elmunzer 843 876 4261 elmunzer@musc.edu
Contact: Rebecca Spitzer 843 876 4261 spitzer@musc.edu

  Show 25 Study Locations
Sponsors and Collaborators
Medical University of South Carolina
Yale University
Virginia Commonwealth University
Vanderbilt University
Stony Brook University
University of Southern California
Case Western Reserve University
Medical College of Wisconsin
Dartmouth University
University of Florida
Northwestern University
Johns Hopkins University
Washington University School of Medicine
University of Michigan
Boston University
Ohio State University
Borland-Groover Clinic
Methodist Health System
St. Louis University
Fox Chase Cancer Center
Emory University
Cedars-Sinai Medical Center
Johns Hopkins Community Physicians
University of Virginia
Investigators
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Principal Investigator: B. Joseph Elmunzer Medical University of South Carolina

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Badih Elmunzer, Professor of Medicine, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03172832     History of Changes
Other Study ID Numbers: Pro00063825
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cholangiocarcinoma
Lymphadenopathy
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases