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:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
NCT ID:
NCT03629600
Eligibility Criteria:
Inclusion Criteria:
* All patients aged 18 to 70 years undegoingt ERCP for the first time
* Patients undergoing ERCP for standard clinical indications
Exclusion Criteria:
* Ongoing acute pancreatitis
* Known chronic calcific pancreatitis
* Pancreatic head mass
* Any malignancy
* Standard contraindications to ERCP
* Unwillingness or inability to consent for the study
* Ongoing hypotension including those with sepsis
* Cardiac insufficiency (CI, \>NYHA Class II heart failure)
* Renal insufficiency (RI, creatinine clearance \<40mL/min)
* Severe liver dysfunction (albumin \< 3mg/dL)
* Respiratory insufficiency (defined as oxygen saturation \< 90%)
* Greater than 70 years of age
* Pregnancy
* Breastfeeding mother
* Allergy/hypersensitivity to aspirin or NSAIDs
* Received NSAIDs in prior 7 days (aspirin 325mg or less ok)
* Active or recurrent (within 4 weeks) gastrointestinal hemorrhage
* Hyponatremia (Na+ levels \< 135mEq/L))
* Hypernatremia (Na+ levels \> 150mEq/L) will be excluded.
* Edema or anasarca
* Ascites
* Procedure performed on major papilla/ventral pancreatic duct in patient with pancreas divisum (dorsal duct not attempted on injected)
* ERCP for biliary stent removal or exchange without anticipated pancreatogram
* Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
* Anticipated inability to follow protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03629600
Study Brief:
Protocol Section:
NCT03629600