Clinical Trials /

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

NCT03172832

Description:

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.

Related Conditions:
  • Cholangiocarcinoma
  • Hepatobiliary Neoplasm
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: A Trial of Percutaneous vs. Endoscopic Drainage of Suspected Klatskin Tumors
  • 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 IDs

  • ORG STUDY ID: Pro00063825
  • NCT ID: NCT03172832

Conditions

  • Cholangiocarcinoma
  • Hilar Lymphadenopathy
  • Biliary Stricture

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Percutaneous Transhepatic DrainageActive ComparatorSubjects randomized to this arm will undergo PTBD as the first drainage intervention.
    Endoscopic Retrograde CholangiographyActive ComparatorSubjects randomized to this arm will undergo ERC as the first drainage intervention.

      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
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:40 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Successful biliary drainage
      Time Frame:2 weeks
      Safety Issue:
      Description:50% reduction in bilirubin level within 2 weeks of the study intervention without additional ERC or PTBD

      Secondary Outcome Measures

      Measure:Alternate definition of successful biliary drainage
      Time Frame:6 months
      Safety Issue:
      Description: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.
      Measure:Adverse events
      Time Frame:6 months
      Safety Issue:
      Description:Adverse events related to PTBD and ERC, defined according to standard consensus guideline documents published in the interventional radiology and gastroenterology literature respectively.
      Measure:Adequate tissue diagnosis
      Time Frame:6 months
      Safety Issue:
      Description:A definitive diagnosis of malignancy documented in the subject's medical record.
      Measure:Quality of life measure
      Time Frame:2-3 months after initial procedure
      Safety Issue:
      Description:Promis Global Health Scale
      Measure:Quality of life measure
      Time Frame:2-3 months after initial procedure
      Safety Issue:
      Description:SF12 health survey

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Medical University of South Carolina

      Last Updated

      August 31, 2017