To explore feasibility and efficacy of endoscopic unilateral drainage of patients with presumed perihilar cholangiocarcinoma eligible for major liver resection using a novel fully covered metal stent with a retrieval string.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: number of severe drainage related complications between
inclusion and exploratory laparotomy. In patients who will not undergo
exploratory laparotomy, the number of drainage-related complications will be
measured until 7 days after the decision to cancel exploratory laparotomy or 90
days after inclusion, whichever comes first.
Secondary outcome
Secondary outcome will include technical and therapeutic success of biliary
drainage, individual components of primary endpoints and quality of life.
Background summary
Pre-operative biliary drainage is advised to treat obstructive jaundice and
optimize the clinical condition of patients with presumed resectable perihilar
cholangiocarcinoma who are expected to be eligible to major liver resection.
However, stent related complications such as cholangitis (37%) and stent
dysfunction (19%) occur frequently. Creating the need for numerous
re-inventions, re-admissions, delay of diagnostic work-up and surgery. Biliary
drainage could be optimized by the use of a novel design short fully covered
self-expanding metal stent (FCSEMS) with a retrieval string, which makes
removal possible although the stent does not reach into the duodenum.
Study objective
To explore feasibility and efficacy of endoscopic unilateral drainage of
patients with presumed perihilar cholangiocarcinoma eligible for major liver
resection using a novel fully covered metal stent with a retrieval string.
Study design
Prospective cohort pilot study.
Intervention
Unilateral endoscopic drainage of the future liver remnant using a removable
FCSEMS (length 4 cm; diameter 8 mm).
Study burden and risks
The relatively large diameter of the stent presumably leads to less stent
occlusion and reduction in re-interventions. Furthermore, because the stent
does not bridge the papilla, risk of ascending cholangitis might be lower.
Besides the use of a different stent patients receive standard of care.
Additionally, patients are requested to fill out questionnaires concerning
their quality of life at baseline, 7 days, 28 days and 90 days after inclusion
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with presumed perihilar cholangiocarcinoma that are judged eligible
for major liver resection and require endoscopic biliary drainage of the future
liver remnant.
Exclusion criteria
- Incompletely recovered from any side effects of previous biliary drainage
procedures
- Any contra-indication for major liver surgery
- Technical contra-indications for endobiliary drainage
- Requirement of multiple stents for adequate drainage of the future liver
remnant
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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 | NL76466.018.21 |