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

Aggressive Intravenous Hydration With Lactated Ringer's Solution Plus Rectal Indometacin Versus Rectal Indometacin Alone to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy: A Multicentre, Superiority, Randomised, Controlled Trial

This study will test whether giving aggressive intravenous fluids in addition to rectal indometacin reduces the chance of pancreatitis after ESWL for pancreatic stones.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1250 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Changhai Hospital (other)
• Locations: 10 sites (Baotou and 9 other locations)
• Trial ID: NCT07202559 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–85 with painful chronic pancreatitis who are scheduled for pancreatic ESWL and can give informed consent are ideal candidates.

Not a fit: People with significant heart failure, respiratory insufficiency, or who recently received large volumes of IV fluids (or other listed exclusions) may not be eligible or likely to benefit from the aggressive hydration approach.

Why it matters

Potential benefit: If successful, the combined treatment could lower post-ESWL pancreatitis rates, reduce complications, and shorten hospital stays.

How similar studies have performed: Similar strategies combining rectal NSAIDs and aggressive IV hydration have shown benefit for preventing pancreatitis after ERCP in some studies, but applying this combined approach to ESWL is relatively novel.

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)

Where this trial is running

Baotou and 9 other locations

• 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)
• The First Hospital of Lanzhou University — Lanzhou, China (NOT_YET_RECRUITING)
• Qilu Hospital of Shandong University — Shandong, China (RECRUITING)
• Changhai Hospital — Shanghai, China (RECRUITING)
• Ruijin Hospital — Shanghai, China (RECRUITING)
• Shanghai Pudong New Area Gongli Hospital — Shanghai, China (RECRUITING)
• Yunnan University Affiliated Hospital — Yunnan, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Liang-Hao Hu

Conditions: Pancreatitis, Chronic, Pancreatitis, Acute, Pancreatic Duct Stones