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 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07417020
Eligibility Criteria:
Inclusion Criteria:
* Patients aged between 18 to 70 years.
* Both males and females.
* Patients undergoing their first Endoscopic Retrograde Cholangiopancreatography (ERCP) for choledocholithiasis, bile duct leak, or biliary obstruction.
Exclusion Criteria:
* Patients who have previously undergone an ERCP, endoscopic sphincterectomy, or endoscopic papillary balloon dilatation.
* Individuals with a known history of chronic pancreatitis, ongoing acute pancreatitis, or patients with gallstone pancreatitis or active cholangitis.
* Patients with coagulopathy or those on anticoagulation therapy.
* Pregnant or lactating women.
* Substance abuse: Individuals with a history of alcohol or other substance abuse disorders.
* Patients having hypernatremia or hyponatremia (Na \<130 or Na \>150 mEq/L) or Hyperkalemia (\>5.1 mEq/dL).
* Specific organ dysfunctions:
* Patients with organ dysfunctions including cardiac insufficiency (New York Heart Association Class II or above), respiratory insufficiency (oxygen saturation \<90%), renal insufficiency (creatinine clearance \<40 mL/min), or liver dysfunction.
* Clinical signs of fluid overload, specifically peripheral or pulmonary edema, and ongoing hypotension, including those with sepsis.
* Patients undergoing sphincterotomy as it reduces the risk of pancreatitis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07417020
Study Brief:
Protocol Section:
NCT07417020