To investigate feasibility, safety, and effectiveness of covered expandable stents with a proximal lasso to resolve benign post-surgical strictures.
ID
Source
Brief title
Condition
- Bile duct disorders
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Successful removal of covered expandable stent using the proximal lasso.
Secondary outcome
Stricture resolution, ease of stent removal, stent patency, migration rate,
integrity of the covering membrane after stent removal, number of endoscopic
procedures, removability of covered expandable stent at surgery (if surgery is
indicated)
Background summary
Endoscopic therapy is regarded as the initial therapy of choice to treat benign
biliary strictures. Based on the intensity of the treatment with plastic
stents, efforts continue to improve the endoscopic treatment of benign
strictures. The use of a removable coated expandable metal stent may be
promising in this respect. Removal of the expandable metal stent is however
complicated in some cases. Snare techniques and a distal lasso have been used
anecdotally, but in both the whole surface area of the stent must detach from
the common bile duct at the same time. This problem could be overcome by using
a proximal lasso; thereby the stent is removed inside-out and level by level.
Study objective
To investigate feasibility, safety, and effectiveness of covered expandable
stents with a proximal lasso to resolve benign post-surgical strictures.
Study design
Non-randomised prospective follow-up study with 3 sequential groups of 8
patients each.
Intervention
In all patients a covered expandable biliary stent with a proximal lasso will
be placed to resolve benign post-surgical strictures. In the first group of 8
patients the stent will be removed after 2 months, in the second group after 3
months and in the third group after 4 months.
Study burden and risks
Risks of the endoscopic intervention inserting the covered expandable stent is
comparable with placement of plastic stents. However, current plastic stent
therapy implies far more endoscopic procedures (ERCP*s) than treatment with a
covered expandable stent. Consequently the risk of complications of ERCP and
cumbersomeness for patients will be relatively low. Although the covered
expandable stent with proximal lasso is designed to be easily removable and
experience with removal has been obtained in esophageal stenting, the
possibility remains that a covered expandable stent can not be retrieved from
the bile duct. In such a case the patient will be referred for surgery.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
* Benign biliary stricture due to a surgical injury
* Proximal extend of the stricture limited to 2 cm below the liver hilum
Exclusion criteria
* More than 1 plastic stent traversing the stenosis
* Refusal to sign informed consent
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 | NL16620.018.07 |