CBD obstruction malignant biliary obstruction
Conditions
Sponsors
Alveolus, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: a. Malignant obstructive disease at the level of the extrahepatic CBD b. Willing and able to comply with study procedures and provide written informed consent c. > 18 years of age presenting with biliary obstruction
Exclusion criteria
Exclusion criteria: a. Benign obstruction of the CBD b. Malignancy involving intrahepatic ducts or duodenum c. Stricture >8cm in length d. Inability to pass a guidewire through the stricture area e. Prior biliary stent f. Perforation of any duct within the biliary tree g. Life expectancy of 1.5 j. Prior gastric bypass or biliroth type I or type II gastric resection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary endpoints of this trial will be as follows: a. Absence of clinically significant stent occlusion or migration within 6 month follow-up or prior to death, whichever occurs first. Clinically significant stent occlusion will be suggested by the development of symptoms including pruritis and/or cholangitis. Signs suggesting clinically significant occlusion include development of jaundice. Findings suggesting clinically significant stent occlusion include a 30% increase in bilirubin from its lowest point following stent placement. Migration of the stent by > 0.5 cm in association with any of the above defined Symptoms, Signs or Findings will be interpreted as clinically significant. These observations and/or additional findings of cholestasis (elevation of ALP, AST and ALT) with or without imaging defining ductal dilation may be interpreted to define clinically significant stent occlusion b. Device safety, including assessments of stent related complications and overall complication rate comparable to clinical literature | — |
Secondary
| Measure | Time frame |
|---|---|
| The secundary outcomes of the studie are as follows: a. Reduction in conjugated bilirubin >30% or return to normal range compared to baseline value at 1 week post stent placement. b. Independent review of cholangiographic and X-ray images confirming stent patency and position c. Assessment of stent position at all follow-up visits via X-ray d. Assessment of biliary re-intervention; defined as any endoscopic, percutaneous or surgical procedure to improve biliary drainage post stent placement. e. Assessment of patient survival post stent placement f. Occurrence of unanticipated adverse device effects (UADE) or serious adverse device effects (SADE) | — |
Countries
Netherlands
Outcome results
None listed