New combo approach aims to stop pancreatitis after stone treatment
NCT ID NCT07202559
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving extra IV fluids along with a standard anti-inflammatory suppository can better prevent pancreatitis after a procedure to break up pancreatic stones. About 1250 adults with chronic pancreatitis will be randomly assigned to receive either the combination or the suppository alone. The main goal is to see if the combination reduces the number of people who develop pancreatitis after the procedure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lactated Ringer's solution and indometacin suppository
- What this could lead to
- If it works, this could become a standard way to prevent pancreatitis after pancreatic stone treatment, reducing serious complications.
- What could go wrong
- This is an early-stage trial without a phase designation, so results are uncertain. Adding IV fluids may not improve outcomes and could cause fluid overload in some patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Changhai Hospital
RECRUITINGShanghai, China
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Hangzhou First People's Hospital
RECRUITINGHangzhou, China
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Peking Union Medical College Hospital
RECRUITINGBeijing, China
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Qilu Hospital of Shandong University
RECRUITINGShandong, China
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Ruijin Hospital
RECRUITINGShanghai, China
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Shanghai Pudong New Area Gongli Hospital
RECRUITINGShanghai, China
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The First Hospital of Lanzhou University
NOT_YET_RECRUITINGLanzhou, China
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The Second Affiliated Hospital of Baotou Medical College
RECRUITINGBaotou, China
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The Third Xiangya Hospital of Central South University
RECRUITINGHunan, China
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Yunnan University Affiliated Hospital
NOT_YET_RECRUITINGYunnan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could fasting ease the misery of pancreatitis?
- Can an arthritis drug quiet the pain of chronic pancreatitis?
- Chilled water may curb pancreatitis risk after Bile-Duct procedure
- Fungal enzymes could replace pig enzymes for digestive aid in pancreatitis
- Basket or balloon: which tool best clears pancreatic stones?
- Blood test software could spot pancreatic cancer early in High-Risk groups