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

Cholangiocarcinoma Clinical Trial

— INTERCPT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03172832
• Other study ID #: Pro00063825
• Status: Terminated
• Phase: N/A
• Start date: August 20, 2017
• Est. completion date: April 12, 2019

Study information

• Verified date: March 2020
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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approach over ERC for Bismuth type 3 & 4 hilar strictures; 2) the generally quoted risks of PTBD are based on outdated studies and may be exaggerated; and 3) endoscopic diagnosis of indeterminate biliary strictures remains suboptimal despite the use of cholangioscopy and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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: April 12, 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Stricture
• Cholangiocarcinoma
• Hilar Lymphadenopathy
• Lymphadenopathy

Intervention

Procedure:
• PTBD
Percutaneous access and tube placement into the bile duct
• ERC
Endoscopic access and stent placement in the bile duct

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	Boston University	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Case Western Reserve University	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Methodist Hospital Dallas	Dallas	Texas
United States	University of Florida	Gainesville	Florida
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	University of Florida - Jacksonville	Jacksonville	Florida
United States	Dartmouth University	Lebanon	New Hampshire
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Vanderbilt University	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Saint Louis University	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	Stony Brook University	Stony Brook	New York
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (24)

Lead Sponsor

Collaborator

Medical University of South Carolina

Borland-Groover Clinic, Boston University, Case Western Reserve University, Cedars-Sinai Medical Center, Dartmouth University, Emory University, Fox Chase Cancer Center, Johns Hopkins Community Physicians, Johns Hopkins University, Medical College of Wisconsin, Methodist Health System, Northwestern University, Ohio State University, St. Louis University, Stony Brook University, University of Florida, University of Michigan, University of Southern California, University of Virginia, Vanderbilt University, Virginia Commonwealth University, Washington University School of Medicine, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful biliary drainage	50% reduction in bilirubin level within 2 weeks of the study intervention without additional ERC or PTBD	2 weeks
Secondary	Alternate definition of successful biliary drainage	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.	6 months
Secondary	Adverse events	Adverse events related to PTBD and ERC, defined according to standard consensus guideline documents published in the interventional radiology and gastroenterology literature respectively.	6 months
Secondary	Adequate tissue diagnosis	A definitive diagnosis of malignancy documented in the subject's medical record.	6 months
Secondary	Quality of life measure	Promis Global Health Scale	2-3 months after initial procedure
Secondary	Quality of life measure	SF12 health survey	2-3 months after initial procedure