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:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
NCT ID:
NCT05307861
Eligibility Criteria:
Inclusion Criteria:
* Patient is scheduled for ERCP
* Patient is 18 years old or older
* Biliary tract disease presence
* Non-manipulated pancreatic papilla
* Written informed consent provided
Exclusion Criteria:
* Patient not requiring pancreatic stenting during ERCP
* Failed pancreatic stent placement
* Patients at risk of fluid overload
* Patients with cholangitis, sepsis, acute/flared up chronic pancreatitis
* Recent previous biliary tract manipulation (i.e., pancreatoscopy, wirsungoscopy, etc.)
* Hemodynamic instability
* Uncontrolled coagulopathy, kidney/liver failure, or any comorbidity with a meaningful impact on cardiac risk assessment (NHYA III/IV)
* Pregnancy or nursing
* Refuse to participate in the study or to sign corresponding informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05307861
Study Brief:
Protocol Section:
NCT05307861