The INTERCPT Trial
Condition: Diagnostic, biliary hilar obstruction, percutaneous transhepatic biliary drainage, endoscopic retrograde cholangiopancreatography
Key Inclusion Criteria
- Patient with cholestasis (decrease in bile flow) due to suspected malignant hilar obstruction (tumors)
- Over 40 years old
- Evidence of a biliary hilar stricture (narrowing of bile duct) or intrahepatic but no extrahepatic biliary ductal dilation (duct dilation within the liver but not outside the liver)
Key Exclusion Criteria
- Evidence of a Bismuth-Corlette Type 1 biliary stricture
- Diagnosis of primary sclerosing cholangitis without suspicion of dominant hilar stricture (narrowing)
Full Study Name
A Multicenter, Randomized Trial of Percutaneous Transhepatic Biliary Drainage Versus Endoscopic Retrograde Cholangiography for Decompression of Suspected Malignant Biliary Hilar Obstruction (IRB no. 50643)
This study focuses on individuals who are over 40 years old and who have biliary hilar obstruction or intrahepatic biliary ductal dilation (a sign of a blockage in the biliary tree). The liver produces bile, a fluid that helps the body digest fats and transmits it to the small intestine through the “biliary tree.” The purpose of the study is to compare two methods of biliary drainage when malignant hilar obstruction (blockage) is suspected. The methods are called percutaneous transhepatic biliary drainage (PTBD) and endoscopic retrograde cholangiography (ERC).
Researchers aim to determine which of these two methods for collecting information about the blockage and providing relief (drainage) for the blockage is more effective. Researchers will also compare the safety, ease of procedure, and overall improvement in patient outcomes. Participants will be randomly assigned to undergo either the PTBD or ERC procedure.