in this project we will compare conventional 10fg plastic endoprosthesis with similar stents covalently coated with heparin
ID
Source
Brief title
Condition
- Bile duct disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Stent patency at 3 months
Secondary outcome
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
Background summary
Endoscopic placement of a biliary endoprosthesis is the primary palliative
treatment for patients with obstructive jaundice to provide adequate drainage
of bile. Two types of stents are inserted: polyethylene plastic stents and
self-expandable metal stents. The major drawback of permanent biliary
prosthesis is their short life span. Average stent patency of conventional
plastic endoprosthesis is approximately 3 months. In conventional plastic
stents clogging remains the predominant problem, occurring in 21 to 31% of
cases. Several variables contribute to this clogging phenomenon, including bile
viscosi¬ty, bacterial infection, stent surface, stent diameter and stent
design. To date, only the stent diameter has been manipulated successful¬ly in
numerous attempts to decrease stent-clogging rate. Various drug coatings have
been successfully used to delay clogging in other endoprosthesis (e.g.
vascular, urinary tract).
Study objective
in this project we will compare conventional 10fg plastic endoprosthesis with
similar stents covalently coated with heparin
Study design
This is a single center prospective randomized study carried out in the Erasmus
MC Rotterdam. Patients with biliary obstruction caused by a non-resectable
neoplasm involving the common bile duct will be randomized for placement of a
10 fg conventional endoprothesis or a 10 fg heparin mimetic coated
endoprosthesis
Intervention
Endoscopic implantation of a 5 cm, 7 cm, 9 cm, or 12 cm 10 fg plastic stent,
either conventional or heparin mimetic coated
Study burden and risks
Burden: informed consent procedure, sampling of venous blood at t=5 to 8 days,
telphone interview at t=3 months
Risks: the relative risk of stent occlusion of the heparin coated stents is
subject of this study. The risks of venous blood sampling is negectable
Postbus 2040
3000 CA Rotterdam
Nederland
Postbus 2040
3000 CA Rotterdam
Nederland
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24805.078.08 |