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New combo approach aims to stop pancreatitis after stone treatment

NCT ID NCT07202559

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 1,250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 85 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Changhai Hospital

    RECRUITING

    Shanghai, China

  • Hangzhou First People's Hospital

    RECRUITING

    Hangzhou, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Shandong, China

  • Ruijin Hospital

    RECRUITING

    Shanghai, China

  • Shanghai Pudong New Area Gongli Hospital

    RECRUITING

    Shanghai, China

  • The First Hospital of Lanzhou University

    NOT_YET_RECRUITING

    Lanzhou, China

  • The Second Affiliated Hospital of Baotou Medical College

    RECRUITING

    Baotou, China

  • The Third Xiangya Hospital of Central South University

    RECRUITING

    Hunan, China

  • Yunnan University Affiliated Hospital

    NOT_YET_RECRUITING

    Yunnan, China

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