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 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT04671095
Eligibility Criteria:
Inclusion Criteria:
* • Patients who are at high risk of post ERCP infection such as
* Jaundice (Bilirubin \>21)
* Primary sclerosing cholangitis
* Post liver transplant anastomotic stricture
* Inpatients
* Combined procedures (Ex: ERCP+ spy glass cholangioscopy)
* Previous inadequate biliary drainage.
* Biliary stricture
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Grade 1-3 ERCP on complexity grading (ASGE grading)
* Able (in the Investigators opinion) and willing to comply with all study requirements.
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion Criteria:
* Patients with CBD stones and no jaundice
* Sphincter of Oddi manometry.
* Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
* Patients who are unable to consent for the study.
* ERCP for Pancreatic pathology.
* Grade 4 complex ERCP (ASGE grading)
* Participant who is terminally ill /ECOG 4
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04671095
Study Brief:
Protocol Section:
NCT04671095