NL-OMON22954
Recruiting
Not Applicable
Endoscopic drainage of presumed resectable perihilar cholangiocarcinoma using a novel design short fully covered self-expanding metal stent with retrieval string (CHORDA)
Amsterdam UMC0 sites20 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- (Potentially) resectable perihilar cholanhiocarcinoma
- Sponsor
- Amsterdam UMC
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years or older.
- •\- Capable of providing written and oral informed consent.
- •\- Presumed perihilar cholangiocarcinoma.
- •\- Biliary obstruction in the future liver remnant.
- •\- Drainage naïve patients: total bilirubin \>50 umol/L
- •\- Patients with previous endobiliary drainage procedures: persistently rising total bilirubin \>50 umol/L (i.e. no stent placed or insufficient draining stent) or persistent biliary dilatation in the future liver remnant on imaging (i.e. previous stent placed in contralateral side of the liver).
Exclusion Criteria
- •\- Incompletely recovered from any side effects of previous biliary drainage procedures. Patients are required to be off antibiotic treatment for at least 5 days.
- •\- Any contra\-indication for major liver surgery (e.g. ECOG/WHO score 3 or higher).
- •\- Technical contra\-indications for endobiliary drainage (e.g. previous gastrojejunostomy).
- •\- Refusal to provide informed consent.
- •\- Requirement of multiple stents for adequate drainage of the future liver remnant (e.g. involvement of segmental bile ducts).
- •\- In case it is not feasible to prevent blockage of one or more large segmental branches.
Outcomes
Primary Outcomes
Not specified
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