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Endoscopic drainage of presumed resectable perihilar cholangiocarcinoma using a novel design short fully covered self-expanding metal stent with retrieval string (CHORDA)

Recruiting
Conditions
(Potentially) resectable perihilar cholanhiocarcinoma
Registration Number
NL-OMON22954
Lead Sponsor
Amsterdam UMC
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
20
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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