clinical symptoms of biliary obstruction and inoperable extrahepatic biliary obstruction by any malignant process
Conditions
Interventions
None listed
Sponsors
Medinol Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 or older. 2. Clinical symptoms of biliary obstruction. 3. Presence of inoperable extrahepatic distal biliary obstruction by any malignant process (the subject not being a surgical candidate based on the finding of a pancreatic mass >2.0cm or a severe medical illness). Malignancy is defined as: • A tissue diagnosis (biliary brushing or percutaneous biopsy, EUS, FNA), or • Elevated serum tumor markers (CEA, CA19-9, AFP), or • Presence of liver metastasis per CT scan or MRI. 4. .Subject is willing and able to comply with the study procedures and provide written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: The subject must not meet any of the following exclusion criteria: 1. Participation in an Investigational Study within 30 days prior to date of subject consent. 2. Perforation of any duct within the biliary tree. 3. Presence of more than three previously implanted plastic stent. 4. Plastic stent implantation less than 2 weeks prior to current procedure. 5. Presence of a metal biliary stent. 6. Presence of any esophageal or duodenal stent. 7. Previous Bilroth II or Roux-en-Y gastric resection, a significant duodenal obstruction or any other altered anatomy which could prevent access to ampulla. 8. Subjects for whom endoscopic procedures are contraindicated. 9. Subjects with known sensitivity to any components of the stent or delivery system. 10. Subjects with active hepatitis or other hepatic diseases that may cause jaundice. 11. Subjects with a WHO performance score of 4- Bedbound (completely disabled, cannot carry on any self-care, totally confined to bed or chair). 12. Pregnant women and breast-feeding women. 13. Subjects considered to be vulnerable i.e. prisoners and individuals with impaired consent capacity and/or lack or loss of autonomy.;Cholangiographic exclusion criterion: 14. Strictures that cannot be passed by the guide wire or the delivery system.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 2 Secondary Endpoints 2.1 Performance assessment 1) Technical success: • Successful deployment of the stent in a satisfactory position across the stricture, resulting in immediate drainage of the stented bile duct, as demonstrated by a total serum bilirubin level of 30% if baseline value was greater than 3.0 mg/dL. • The placement of the stent in an adequate position without migration, as determined via visual assessment by the Investigator. 2) Clinical success: • Reduction of the total number of biliary obstruction symptoms at 2 weeks, 1, 3 and 6 months compared to these symptoms at baseline. The presence or absence of the total number of symptoms, which include jaundice, itching, nausea, vomiting, fever and dark urine, will be assessed at baseline and at each follow-up visit. Additionally, total serum bilirubin and liver enzyme levels (ALP, GGT, ALT, AST) will be assessed at baseline for comparison with levels recorded at each follow-up visit. • Rate of stent patency at 2 weeks, 1, 3 and 6 months. Stent patency is defined as the number of subjects without recurrent biliary obstruction at the designated time points, divided by the number of evaluable subjects at the designated time points, and expressed as a percentage. Stent patency will be measured by the maintenance of a total serum bilirubin level of 3.0 mg/dL), the stent will be assumed to be obstructed) and the absence of clinical signs and symptoms of cholangitis, such as fever, worsening abdominal pain or worsening liver enzymes. Liver enzymes (ALP, GGT, ALT, AST), including serum bilirubin, will be measured at 2 weeks, 1, 3 and 6 months. • Time to recurrent biliary obstruction: period in days between insertion of stent and the time of stent occlusion in subjects experiencing recurrent biliary obstruction. 2.2 Safety assessment 1) Number of stent-related complications. These include cholecystitis, ascending cholangitis, stent migration, and pancreatitis. 2) Total number of ad | — |
Primary
| Measure | Time frame |
|---|---|
| 1 Primary Endpoint The primary outcome measured will be the adequate clinical palliation of the biliary obstruction, as demonstrated by: • The maintenance of a total serum bilirubin level 30% if baseline value was greater than 3.0 mg/dL, and • The absence of recurrent biliary obstruction, defined as the absence of clinical signs and symptoms of cholangitis (such as fever, worsening abdominal pain), or absence of worsening liver enzymes, at 6 months follow-up or prior to death, whichever comes first. | — |
Countries
Netherlands
Outcome results
None listed