Actively Recruiting
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
Led by Changhai Hospital · Updated on 2026-04-13
1250
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
R
Ruijin Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether combining aggressive intravenous hydration with indometacin is more effective at preventing pancreatitis after pancreatic Extracorporeal Shock Wave Lithotripsy (ESWL) compared to using indometacin alone. This multicenter, randomized, controlled trial focuses on patients with painful chronic pancreatitis who are scheduled for ESWL to treat pancreatic duct stones. The study aims to improve understanding of pancreatitis prevention following ESWL and reduce related complications. Participants will be randomly assigned to one of two groups. One group will receive a rectal administration of 100mg indometacin 30 minutes before ESWL along with aggressive intravenous hydration using lactated Ringer's solution, delivered as 20 mL/kg within 60 minutes from the start of ESWL followed by 3 mL/kg per hour for 8 hours. The other group will receive the same indometacin dose but only restricted hydration measures without aggressive intravenous fluids. Both interventions are carefully monitored during the procedure. During the trial, researchers will measure the incidence of pancreatitis within 24 hours after ESWL as the primary outcome. Additional assessments include severity of pancreatitis, incidence of other post-ESWL complications, fluid overload, transient adverse events within 24 hours, and length of hospitalization over one month. Participants will be evaluated at multiple time points, with careful monitoring of safety and treatment effects throughout the study period, which extends up to December 2027.
CONDITIONS
Brief Title
Indometacin With or Without Aggressive Intravenous Hydration to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with painful chronic pancreatitis eligible for pancreatic ESWL treatment
- Aged between 18 and 85 years
- Able to provide informed consent
You will not qualify if you...
- Patients readmitted for ESWL during the study period
- Contraindications to ESWL
- Signs of congestive heart failure or NYHA class greater than I; for patients aged 70 or older, abnormal BNP or ejection fraction below 50%
- Respiratory insufficiency or for patients aged 70 or older, FEV1 below 70%
- Receiving more than 1.5 mL/kg/h or 3 L/24 h of intravenous fluids before ESWL
- Hypotension (systolic blood pressure below 90 mmHg or mean arterial pressure below 70 mmHg)
- Low or high serum sodium levels (below 130 or above 150 mmol/L)
- Severe liver disease such as cirrhosis with ascites or liver abscess
- NSAID use within 7 days prior to ESWL
- Contraindications to rectal NSAIDs including renal dysfunction, allergy, active gastrointestinal bleeding, ulcer disease, or NSAID use for other reasons besides cardioprotective aspirin
- Coagulopathy or anticoagulation therapy within 3 days
- Acute pancreatitis within 3 days
- Known active cardiovascular or cerebrovascular disease
- Pregnant or breastfeeding women
- Absence of a rectum due to total proctocolectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of ESWL procedure
Participants receive a rectal administration of 100mg indometacin 30 minutes prior to pancreatic ESWL. Depending on the assigned group, participants either undergo aggressive intravenous hydration with lactated Ringer's solution during and after ESWL or receive restricted hydration measures.
1 treatment visit (in-person)
Duration - Up to 1 month
Participants are monitored for the incidence and severity of post-ESWL pancreatitis and other complications, including fluid overload and transient adverse events, over a period of 1 month after treatment.
Follow-up visits up to 1 month after treatment
Trial Site Locations
Total: 10 locations
1
The Second Affiliated Hospital of Baotou Medical College
Baotou, China
Actively Recruiting
2
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
3
Hangzhou First People's Hospital
Hangzhou, China
Actively Recruiting
4
The Third Xiangya Hospital of Central South University
Hunan, China
Actively Recruiting
5
The First Hospital of Lanzhou University
Lanzhou, China
Not Yet Recruiting
6
Qilu Hospital of Shandong University
Shandong, China
Actively Recruiting
7
Changhai Hospital
Shanghai, China
Actively Recruiting
8
Ruijin Hospital
Shanghai, China
Actively Recruiting
9
Shanghai Pudong New Area Gongli Hospital
Shanghai, China
Actively Recruiting
10
Yunnan University Affiliated Hospital
Yunnan, China
Not Yet Recruiting
Research Team
L
Liang-Hao Hu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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