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 @ 6:54 PM
Ignite Modification Date:
2025-12-24 @ 6:54 PM
NCT ID:
NCT02276157
Eligibility Criteria:
Inclusion Criteria:
* biliary disease requiring diagnostic and/or therapeutic direct POC
* distal common bile duct (CBD) dilation \> 8 mm
* previous sphincteroplasty, including major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation during a prior ERCP
* ability to provide informed consent
Exclusion Criteria:
* presence of any contraindication to ERCP
* bleeding tendency (international normalized ratio \> 1.5 or platelet count \< 50,000/ mm3)
* diffuse stricture of the distal CBD
* diagnosis of pancreatic cancer or tumor at the ampulla of Vater (AOV)
* altered gastrointestinal anatomy or significant duodenal obstruction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02276157
Study Brief:
Protocol Section:
NCT02276157