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 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
NCT ID:
NCT03075592
Eligibility Criteria:
Inclusion Criteria:
1. All people presenting for ERCP procedures.
2. Males and females of 14 years of age and older.
3. Willingness to participate in the study and sign the informed consent. (Children will require a representative to sign the informed consent).
4. People in whom therapeutic pancreatic interventions are planned during the ERCP procedure.
5. Intact papilla
Exclusion Criteria:
1. Persons unwilling to sign the informed consent
2. Disorientation secondary to irreversible organic brain damage.
3. Hemoglobin of less than 11 gm/dl in children of 10 years of age to puberty and hemoglobin of 12 gm/dl in pubertal males and females.
4. Mean corpuscular volume (MCV) of less than 77 in all children of 18 years or younger.
5. ERCP scheduled for stent change
6. Previous diagnosis of pancreatic cancer or cholangiocarcinoma
7. History of chronic pancreatitis
8. Active Acute Pancreatitis prior to ERCP (typical pain and amylase or lipase \>3 times UNL)or smoldering pancreatitis
9. History of Recurrent Acute Pancreatitis with chronic pain between acute attacks of \>5/10 more than 3 days per week.
10. Previous sphincterotomy
11. Post surgical anatomy
12. History of organ transplant
13. On medications for the treatment of HIV
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT03075592
Study Brief:
Protocol Section:
NCT03075592