A Trial of Percutaneous vs. Endoscopic Drainage of Suspected Klatskin Tumors (INTERCPT)
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|ClinicalTrials.gov Identifier: NCT03172832|
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma Hilar Lymphadenopathy Biliary Stricture||Procedure: PTBD Procedure: ERC||Not Applicable|
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approach over ERC for Bismuth type 3 & 4 hilar strictures; 2) the generally quoted risks of PTBD are based on outdated studies and may be exaggerated; and 3) endoscopic diagnosis of indeterminate biliary strictures remains suboptimal despite the use of cholangioscopy and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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||184 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized comparative effectiveness trial|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 20, 2017|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||April 2020|
Active Comparator: Percutaneous Transhepatic Drainage
Subjects randomized to this arm will undergo PTBD as the first drainage intervention.
Percutaneous access and tube placement into the bile duct
Active Comparator: Endoscopic Retrograde Cholangiography
Subjects randomized to this arm will undergo ERC as the first drainage intervention.
Endoscopic access and stent placement in the bile duct
- Successful biliary drainage [ Time Frame: 2 weeks ]50% reduction in bilirubin level within 2 weeks of the study intervention without additional ERC or PTBD
- Alternate definition of successful biliary drainage [ Time Frame: 6 months ]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.
- Adverse events [ Time Frame: 6 months ]Adverse events related to PTBD and ERC, defined according to standard consensus guideline documents published in the interventional radiology and gastroenterology literature respectively.
- Adequate tissue diagnosis [ Time Frame: 6 months ]A definitive diagnosis of malignancy documented in the subject's medical record.
- Quality of life measure [ Time Frame: 2-3 months after initial procedure ]Promis Global Health Scale
- Quality of life measure [ Time Frame: 2-3 months after initial procedure ]SF12 health survey
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172832
|Contact: B. Joseph Elmunzer||843 876 email@example.com|
|Contact: Rebecca Spitzer||843 876 firstname.lastname@example.org|
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|Principal Investigator:||B. Joseph Elmunzer||Medical University of South Carolina|