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

Not Applicable

Terminated

• Conditions: Cholangiocarcinoma; Hilar Lymphadenopathy; Biliary Stricture
• Interventions: Procedure: PTBD; Procedure: ERC

• Registration Number: NCT03172832
• Lead Sponsor: 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.

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approach over ERC for Bismuth type 3 \& 4 hilar strictures; 2) the generally quoted risks of PTBD are based on outdated studies and may be exaggerated; and 3) endoscopic diagnosis of indeterminate biliary strictures remains suboptimal despite the use of cholangioscopy and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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-26
• Study First Submitted QC: 2017-05-30
• Study First Posted: 2017-06-01
• Study Start: 2017-08-20
• Primary Completion: 2019-04-12
• Study Completion: 2019-04-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous Transhepatic Drainage	PTBD	Subjects randomized to this arm will undergo PTBD as the first drainage intervention.
Endoscopic Retrograde Cholangiography	ERC	Subjects randomized to this arm will undergo ERC as the first drainage intervention.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adequate tissue diagnosis	6 months	A definitive diagnosis of malignancy documented in the subject's medical record.
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.
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.
Quality of life measure	2-3 months after initial procedure	SF12 health survey

Trial Locations

Locations (25)

Sibley Memorial Hospital; 🇺🇸 Washington, District of Columbia, United States

Borland-Groover Clinic; 🇺🇸 Jacksonville, Florida, United States

University of Florida - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States

Dartmouth University; 🇺🇸 Lebanon, New Hampshire, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Methodist Hospital Dallas; 🇺🇸 Dallas, Texas, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Boston University; 🇺🇸 Boston, Massachusetts, United States

Stony Brook University; 🇺🇸 Stony Brook, New York, United States

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States