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 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT07202559
Eligibility Criteria:
Inclusion Criteria:
* Patients with painful chronic pancreatitis eligible for P-ESWL treatment
* Ages between 18-85 years
* Providing informed consent
Exclusion Criteria:
* Patients readmitted to the hospital for ESWL during the study period
* contraindications to ESWL
* Signs of congestive heart failure, such as pitting edema or a New York Heart Association classification greater than class I heart failure. For patients ≥ 70 years old, brain natriuretic peptide (BNP) and cardiac ultrasound would be performed before ESWL. Patients with BNP\>100pg/ml or Ejection Fraction value\<50% should be excluded
* Respiratory insufficiency (pO2 \< 60 mmHg or saturation \< 90% despite FiO2 of 30% or requiring mechanical ventilation). For patients ≥ 70 years old, pulmonary function tests would be performed before ESWL. Patients with Forced Expiratory Volume in the first second (FEV1) \<70% are excluded
* Patients receiving more than 1.5 mL/kg/h or 3 L/24 h of intravenous fluids in the 24 h before ESWL
* Hypotension (systolic blood pressure \<90 mmHg or mean arterial pressure \<70 mmHg)
* Hypo- or hypernatremia (serum Na+ levels \< 130 or \> 150 mmol/L)
* Severe liver disease (cirrhosis with ascites, liver abscess)
* receiving NSAIDs within 7 days
* Contraindications for rectal use of NSAIDs (renal dysfunction with serum creatinine \>120 μmol/L, allergy, active gastrointestinal bleeding, ulcer disease, and NSAID use for other indications \[other than cardioprotective aspirin\])
* presence of coagulopathy or received anticoagulation therapy within 3 days
* acute pancreatitis within 3 days
* known active cardiovascular or cerebrovascular disease
* pregnant or breastfeeding women
* without a rectum (ie, status post-total proctocolectomy)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07202559
Study Brief:
Protocol Section:
NCT07202559