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 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT06671418
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent must be given according to ICH/GCP and national/local regulations.
* MHBO on imaging with histopathological confirmation or high clinical suspicion.
* Ineligible for surgical resection.
* Hyperbilirubinemia (a combination of a total bilirubin level \>50 mmol/l.
Exclusion Criteria:
* Fluctuation or spontaneous decrease of a total bilirubin level before start of any treatment suggesting a potential non-malignant diagnosis.
* Patients who underwent previous biliary drainage procedures endoscopically or percutaneously. Patients who underwent an attempted but failed ERCP are eligible only when no papillotomy or cannulation was performed.
* Clinical signs of cholangitis. Cholangitis is defined as the presence of both fever (i.e. body temperature \>38.5°C) and leucocytosis (i.e. ≥10 \*109/L) without clinical or radiological evidence of acute cholecystitis (22).
* Uncorrectable coagulation disorder.
* Uncorrectable contrast allergy.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06671418
Study Brief:
Protocol Section:
NCT06671418