Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT05874934
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).
* Technical contra-indications for endobiliary drainage (e.g. previous gastrojejunostomy).
* Distance between stricture and sphincter less than 2 cm.
* Refusal to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05874934
Study Brief:
Protocol Section:
NCT05874934