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NCT Number: NCT07202559

Indometacin With or Without Aggressive Intravenous Hydration to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy

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.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Baotou Medical College, Baotou, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Indometacin suppository

Drug

Administration of a 100mg indometacin suppository rectally 30 minutes prior to ESWL

Lactated ringers solution

Drug

Intravenous 20 mL/kg Ringer's lactate solution within 60 min from the start of ESWL, directly followed by 3 mL/kg per h for 8 h.

normal saline

Drug

Intravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h)

Primary outcomes

  1. Incidence of post-ESWL pancreatitis

    Time frame: 24 hours

    Post-ESWL pancreatitis is defined according to the 2012 Atlanta criteria. A diagnosis of post-ESWL pancreatitis is made if two of three of the following criteria are met: pain consistent with pancreatitis; amylase or lipase of at least three times the upper normal limit within 24 h of the procedure; or characteristic findings on imaging.

Secondary outcomes

  1. Severity of pancreatitis

    Time frame: 1 month

    Stratified as mild, moderate, or severe, mainly on the basis of length of hospitalization and need for invasive treatment.

  2. Incidence of other post-ESWL complications

    Time frame: 24 hours

    Including bleeding, infection, steinstrasse, and perforation.

  3. Incidence of fluid overload

    Time frame: 24 hours

    Including pulmonary or peripheral edema and congestive heart failure.

  4. Transient adverse events related to ESWL

    Time frame: 24 hours

    Transient adverse events were defined as transient injuries caused by shock waves that required no medical intervention and did not prolong hospitalisation, including asymptomatic hyperamylasaemia, haematuria, and acute gastrointestinal mucosal injury (eg, haematemesis, melena, or haem atochezia) caused by ESWL.

    Asymptomatic hyper amylasaemia was defined as an increase in serum amylase compared with pre ESWL levels and beyond the upper limit of the normal range but showing no related symptoms.

  5. Length of hospitalisation

    Time frame: 1 month

Study contacts

Contact information is provided by the study sponsor or research team.

Liang-Hao Hu

CONTACT

[email protected]

+8613817593520

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • Affiliated Hospital of Yunnan University
  • First People's Hospital of Hangzhou
  • LanZhou University
  • Peking Union Medical College Hospital
  • Qilu Hospital of Shandong University
  • Ruijin Hospital
  • Shanghai Pudong New Area Gongli Hospital
  • The Second Affiliated Hospital of Baotou Medical College
  • The Third Xiangya Hospital of Central South University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 2, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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