Indometacin with or without extra IV fluids to prevent pancreatitis after pancreatic stone shock-wave treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults scheduled for pancreatic extracorporeal shock wave lithotripsy (ESWL) are randomly assigned at multiple centers to receive either rectal indometacin alone or rectal indometacin plus aggressive intravenous hydration (lactated Ringer's or normal saline). The trial compares the two groups for the primary outcome of post-ESWL pancreatitis incidence. Key safety exclusions include significant heart or lung dysfunction and recent high-volume IV fluid use. The multicenter design aims to capture a broad and diverse patient population undergoing routine ESWL care.

Why it matters

Who can join: the full rules

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)

Where it's running

• The Second Affiliated Hospital of Baotou Medical College
  Baotou, China Recruiting
• Peking Union Medical College Hospital
  Beijing, China Recruiting
• Hangzhou First People's Hospital
  Hangzhou, China Recruiting
• The Third Xiangya Hospital of Central South University
  Hunan, China Recruiting
• Qilu Hospital of Shandong University
  Shandong, China Recruiting
• Changhai Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Liang-Hao Hu
• Email: lianghao-hu@hotmail.com
• Phone: +8613817593520

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.