Clinical investigation of the safety of ALIMAXX-B biliary stent for bile duct obstruction

Clinical investigation of the safety of ALIMAXX-B biliary stent for bile duct obstruction - ALIMAXX-B* safety

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35349

Enrollment

Registered

2009-09-01

Start date

2009-12-04

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CBD obstruction malignant CBD obstruction

Interventions

An ALIMAXX-B biliary stent will be placed during ERCP.

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. Prior bilairy metal stent e Perforation of any duct within the biliary tree f. Life expectancy of 1.5 i. 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. 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) g. Assesment 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	—

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) g. Assesment 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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)