NCT03172832

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

25 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 20, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2019

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

May 26, 2017

Last Update Submit

March 23, 2020

Conditions

CholangiocarcinomaHilar LymphadenopathyBiliary Stricture

Outcome Measures

Primary Outcomes (1)

  • Successful biliary drainage

    50% reduction in bilirubin level within 2 weeks of the study intervention without additional ERC or PTBD

    2 weeks

Secondary Outcomes (5)

  • Alternate definition of successful biliary drainage

    6 months

  • Adverse events

    6 months

  • Adequate tissue diagnosis

    6 months

  • Quality of life measure

    2-3 months after initial procedure

  • Quality of life measure

    2-3 months after initial procedure

Study Arms (2)

Percutaneous Transhepatic Drainage

ACTIVE COMPARATOR

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

Procedure: PTBD

Endoscopic Retrograde Cholangiography

ACTIVE COMPARATOR

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

Procedure: ERC

Interventions

PTBDPROCEDURE

Percutaneous access and tube placement into the bile duct

Percutaneous Transhepatic Drainage
ERCPROCEDURE

Endoscopic access and stent placement in the bile duct

Endoscopic Retrograde Cholangiography

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Yale University

New Haven, Connecticut, 74085, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

University of Florida - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Borland-Groover Clinic

Jacksonville, Florida, 32258, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Boston University

Boston, Massachusetts, 02118, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Saint Louis University

St Louis, Missouri, 63103, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Dartmouth University

Lebanon, New Hampshire, 02714, United States

Location

Stony Brook University

Stony Brook, New York, 11790, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University

Nashville, Tennessee, 49795, United States

Location

Methodist Hospital Dallas

Dallas, Texas, 75203, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • 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.

    PMID: 29444707DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

perfluoro-2,2,2',2'-tetramethyl-4,4'-bis(1,3-dioxolane)

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • B. Joseph Elmunzer

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized comparative effectiveness trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

May 26, 2017

First Posted

June 1, 2017

Study Start

August 20, 2017

Primary Completion

April 12, 2019

Study Completion

April 12, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(25)