Plastic or metal stent for malignant biliary obstructions

Plastic or metal stents for primary or recurrent inoperable malignant extrahepatic biliary obstruction: a multicenter randomised trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25796

Enrollment

460

Registered

2008-06-27

Start date

2008-07-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Malignant biliary obstruction, stent, cost/cost effectiveness, quality of life, prognosis

Interventions

a. Plastic stent b. Covered self-expandable metal stent c. Uncovered self-expandable metal stent

Eligibility

Inclusion criteria

Inclusion criteria: 1. Obstructive malignancy at the level of the extrahepatic CBD 2. Inoperability due to a poor medical condition, local irresectability or distant metastases 3. Serum bilirubin >50 micromol/L 4. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Malignancy involving intrahepatic bile ducts and duodenum 2. Known history of cholecystitis (unless cholecystectomy has been performed) 3. WHO performance score of 4 (100% of ime in bed) 4. Unable to fill out quality of life questionnaires 5. Known history of operation of the bile ducts (unless cholecystectomy has been perfromed).

Design outcomes

Primary

Measure	Time frame
- Medical effects	—

Secondary

Measure	Time frame
- Quality of life - Cost/Cost effectiveness	—

Contacts

Public ContactP. Boeckel, van

Universitair Medisch Centrum Utrecht Postbus 85500 3508 GA Utrecht

p.g.a.vanboeckel@umcutrecht.nl+31 (0)88 7551057

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)