PLASTIC STENTS VERSUS HEPARIN COATED PLASTIC STENTS FOR RELIEF OF MALIGNANT BILE-DUCT OBSTRUCTION

PLASTIC STENTS VERSUS HEPARIN COATED PLASTIC STENTS FOR RELIEF OF MALIGNANT BILE-DUCT OBSTRUCTION - The HEPCO trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32735

Enrollment

Registered

2008-11-22

Start date

2008-11-28

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

biliary obstruction jaundice

Interventions

Endoscopic implantation of a 5 cm, 7 cm, 9 cm, or 12 cm 10 fg plastic stent, either conventional or heparin mimetic coated

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients Age >= 18 years - diagnosed with malignant bile duct obstruction - referred for palliative stenting, or stent exchange - after written informed consent

Exclusion criteria

Exclusion criteria: candidate for surgical resection; clinical conditions that do not allow ERCP with sphincterotomy such as uncorrectable coagulopathies, pyloric or duodenal obstruction; stenosis extending into the left or right hepatic duct; periampullary lesions, within 2 cm from the papilla; patients with a history of heparin-induced thrombocytopenia

Design outcomes

Primary

Measure	Time frame
Stent patency at 3 months	—

Secondary

Measure	Time frame
1) procedural failure rate, 2) primary stent failure rate, 3) complications, major (requiring surgery) and minor (requiring endoscopic or medical intervention); 4) patient survival, 5) median stent patency	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)