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

NCT ID: NCT03172832

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-20
• Study Completion Date: 2019-04-12

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approach over ERC for Bismuth type 3 & 4 hilar strictures; 2) the generally quoted risks of PTBD are based on outdated studies and may be exaggerated; and 3) endoscopic diagnosis of indeterminate biliary strictures remains suboptimal despite the use of cholangioscopy and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

Conditions

Cholangiocarcinoma; Hilar Lymphadenopathy; Biliary Stricture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous Transhepatic Drainage

Subjects randomized to this arm will undergo PTBD as the first drainage intervention.

Group Type: ACTIVE_COMPARATOR

PTBD

Intervention Type: PROCEDURE

Percutaneous access and tube placement into the bile duct

Endoscopic Retrograde Cholangiography

Subjects randomized to this arm will undergo ERC as the first drainage intervention.

Group Type: ACTIVE_COMPARATOR

ERC

Intervention Type: PROCEDURE

Endoscopic access and stent placement in the bile duct

Interventions

PTBD

Percutaneous access and tube placement into the bile duct

Intervention Type: PROCEDURE

ERC

Endoscopic access and stent placement in the bile duct

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

Stony Brook University

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: collaborator

Dartmouth University

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

Borland-Groover Clinic

OTHER

Sponsor Role: collaborator

Methodist Health System

OTHER

Sponsor Role: collaborator

St. Louis University

OTHER

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: collaborator

Johns Hopkins Community Physicians

OTHER

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Badih Elmunzer

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

B. Joseph Elmunzer

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

University of Southern California

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Yale University

New Haven, Connecticut, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

University of Florida

Gainesville, Florida, United States

University of Florida - Jacksonville

Jacksonville, Florida, United States

Borland-Groover Clinic

Jacksonville, Florida, 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

University of Michigan

Ann Arbor, Michigan, United States

Saint Louis University

St Louis, Missouri, United States

Washington University

St Louis, Missouri, United States

Dartmouth University

Lebanon, New Hampshire, 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

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt University

Nashville, Tennessee, United States

Methodist Hospital Dallas

Dallas, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

Al-Kawas F, Aslanian H, Baillie J, Banovac F, Buscaglia JM, Buxbaum J, Chak A, Chong B, Cote GA, Draganov PV, Dua K, Durkalski V, Elmunzer BJ, Foster LD, Gardner TB, Geller BS, Jamidar P, Jamil LH, Keswani RN, Khashab MA, Lang GD, Law R, Lichtenstein D, Lo SK, McCarthy S, Melo S, Mullady D, Nieto J, Bayne Selby J, Singh VK, Spitzer RL, Strife B, Tarnaksy P, Taylor JR, Tokar J, Wang AY, Williams A, Willingham F, Yachimski P; In alphabetical order for the INTERCPT Study Group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE). Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction: study protocol for a randomized controlled trial. Trials. 2018 Feb 14;19(1):108. doi: 10.1186/s13063-018-2473-2.

Reference Type: DERIVED

PMID: 29444707 (View on PubMed)

Other Identifiers

Pro00063825

Identifier Type: -

Identifier Source: org_study_id