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

Sponsor
Medical University of South Carolina (Other)
Overall Status
Terminated
CT.gov ID
NCT03172832
Collaborator
Yale University (Other), Virginia Commonwealth University (Other), Vanderbilt University (Other), Stony Brook University (Other), University of Southern California (Other), Case Western Reserve University (Other), Medical College of Wisconsin (Other), Dartmouth University (Other), University of Florida (Other), Northwestern University (Other), Johns Hopkins University (Other), Washington University School of Medicine (Other), University of Michigan (Other), Boston University (Other), Ohio State University (Other), Borland-Groover Clinic (Other), Methodist Health System (Other), St. Louis University (Other), Fox Chase Cancer Center (Other), Emory University (Other), Cedars-Sinai Medical Center (Other), Johns Hopkins Community Physicians (Other), University of Virginia (Other)
13
Enrollment
25
Locations
2
Arms
19.7
Actual Duration (Months)
0.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: PTBD
  • Procedure: ERC
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized comparative effectiveness trialRandomized 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 :
Aug 20, 2017
Actual Primary Completion Date :
Apr 12, 2019
Actual Study Completion Date :
Apr 12, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Successful biliary drainage [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 [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 [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 [6 months]

    A definitive diagnosis of malignancy documented in the subject's medical record.

  4. Quality of life measure [2-3 months after initial procedure]

    Promis Global Health Scale

  5. Quality of life measure [2-3 months after initial procedure]

    SF12 health survey

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Southern California Los Angeles California United States 90033
2 Cedars Sinai Medical Center Los Angeles California United States 90048
3 Yale University New Haven Connecticut United States 74085
4 Sibley Memorial Hospital Washington District of Columbia United States 20016
5 University of Florida Gainesville Florida United States 32608
6 University of Florida - Jacksonville Jacksonville Florida United States 32209
7 Borland-Groover Clinic Jacksonville Florida United States 32258
8 Emory University Atlanta Georgia United States 30322
9 Northwestern University Chicago Illinois United States 60611
10 Johns Hopkins University Baltimore Maryland United States 21287
11 Boston University Boston Massachusetts United States 02118
12 University of Michigan Ann Arbor Michigan United States 48109
13 Saint Louis University Saint Louis Missouri United States 63103
14 Washington University Saint Louis Missouri United States 63130
15 Dartmouth University Lebanon New Hampshire United States 02714
16 Stony Brook University Stony Brook New York United States 11790
17 Case Western Reserve University Cleveland Ohio United States 44106
18 Ohio State University Columbus Ohio United States 43210
19 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
20 Medical University of South Carolina Charleston South Carolina United States 29425
21 Vanderbilt University Nashville Tennessee United States 49795
22 Methodist Hospital Dallas Dallas Texas United States 75203
23 University of Virginia Charlottesville Virginia United States 22908
24 Virginia Commonwealth University Richmond Virginia United States 23219
25 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

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

  • Principal Investigator: B. Joseph Elmunzer, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Badih Elmunzer, Professor of Medicine, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT03172832
Other Study ID Numbers:
  • Pro00063825
First Posted:
Jun 1, 2017
Last Update Posted:
Mar 25, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cholangiocarcinoma
Lymphadenopathy

Study Results

No Results Posted as of Mar 25, 2020