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.
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based on outdated studies and may be exaggerated; and 3) endoscopic diagnosis of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
Name | Type | Description | Interventions |
---|
Percutaneous Transhepatic Drainage | Active Comparator | Subjects randomized to this arm will undergo PTBD as the first drainage intervention. | |
Endoscopic Retrograde Cholangiography | Active Comparator | Subjects 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: | Terminated |
Lead Sponsor: | Medical University of South Carolina |
Last Updated
March 25, 2020