Actively Recruiting
Indometacin With or Without Aggressive Intravenous Hydration to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy
Led by Changhai Hospital · Updated on 2026-04-13
1250
Participants Needed
10
Research Sites
111 weeks
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
R
Ruijin Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to determine whether combining aggressive intravenous hydration with indometacin is more effective at preventing pancreatitis after a Extracorporeal Shock Wave Lithotripsy (ESWL) than using indometacin alone. The study will involve patients who are scheduled to undergo ESWL for pancreatic stones. Participants will be randomly assigned to one of two groups: one will receive both the intravenous hydration and the rectal indometacin, while the other will receive only the rectal indometacin. The trial will be conducted at multiple centers, ensuring a broad and diverse patient population. The primary outcome of the study will be the incidence of pancreatitis after the ESWL procedure. This study is important because it could lead to a better understanding of how to prevent pancreatitis after ESWL, potentially improving patient outcomes and reducing the risk of serious complications.
CONDITIONS
Official 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 P-ESWL treatment
- Ages between 18-85 years
- Providing informed consent
You will not qualify if you...
- Patients readmitted for ESWL during the study period
- Contraindications to ESWL
- Signs of congestive heart failure, including pitting edema or NYHA class greater than I; for patients aged 70 or older, elevated BNP (>100 pg/ml) or ejection fraction below 50%
- Respiratory insufficiency defined as low oxygen levels or FEV1 below 70% for patients aged 70 or older
- Receiving more than 1.5 mL/kg/h or 3 L/24 h of IV fluids before ESWL
- Hypotension with systolic blood pressure below 90 mmHg or mean arterial pressure below 70 mmHg
- Abnormal sodium levels (serum Na+ <130 or >150 mmol/L)
- Severe liver disease such as cirrhosis with ascites or liver abscess
- Use of NSAIDs within 7 days before ESWL
- Contraindications for rectal NSAIDs including renal dysfunction, allergy, active gastrointestinal bleeding, ulcer disease, or NSAID use for other reasons except cardioprotective aspirin
- Coagulopathy or recent anticoagulation therapy within 3 days
- Acute pancreatitis within 3 days
- Known active cardiovascular or cerebrovascular disease
- Pregnancy or breastfeeding
- Absence of a rectum (post-total proctocolectomy)
AI-Screening
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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
CONTACT
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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