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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07329803
Eligibility Criteria:
Inclusion Criteria:
\- Age \> 18 years.
* Valid indication for ERCP (benign or malignant obstruction).
* Native papilla (no prior sphincterotomy).
* Difficult Biliary Cannulation (DBC) defined by ESGE "5-5-2" criteria:
* \> 5 minutes of cannulation attempts.
* \> 5 contacts with the papilla.
* \> 1 inadvertent pancreatic duct cannulation.
Exclusion Criteria:
* Ampullary mass or tumor preventing standard cannulation view.
* Surgically altered anatomy (e.g., Billroth II, Roux-en-Y).
* Uncorrectable coagulopathy (INR \> 1.5 or Platelets \< 50,000).
* Acute pancreatitis present prior to ERCP.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07329803
Study Brief:
Protocol Section:
NCT07329803