NCT07202559

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,250

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Oct 2025Dec 2027

First Submitted

Initial submission to the registry

September 30, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

October 13, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

September 30, 2025

Last Update Submit

April 8, 2026

Conditions

Pancreatitis, AcutePancreatic Duct StonesPancreatitis, Chronic

Outcome Measures

Primary Outcomes (1)

  • Incidence of post-ESWL pancreatitis

    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.

    24 hours

Secondary Outcomes (5)

  • Severity of pancreatitis

    1 month

  • Incidence of other post-ESWL complications

    24 hours

  • Incidence of fluid overload

    24 hours

  • Transient adverse events related to ESWL

    24 hours

  • Length of hospitalisation

    1 month

Study Arms (2)

Rectal indometacin alone

ACTIVE COMPARATOR

Participants in this arm will receive a rectal administration of 100mg indometacin 30 minutes prior to ESWL. This group will not undergo aggressive hydration and will instead receive restricted hydration measures.

Drug: Indometacin suppositoryDrug: Normal Saline

Aggressive hydration with rectal Indometacin

EXPERIMENTAL

Participants in this arm will also receive a rectal administration of 100mg indometacin 30 minutes before ESWL. In addition, they will undergo aggressive intravenous hydration using lactated Ringer's solution.

Drug: Indometacin suppositoryDrug: Lactated ringers solution

Interventions

Indometacin suppositoryDRUG

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

Aggressive hydration with rectal IndometacinRectal indometacin alone
Lactated ringers solutionDRUG

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.

Aggressive hydration with rectal Indometacin
Normal SalineDRUG

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

Rectal indometacin alone

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with painful chronic pancreatitis eligible for P-ESWL treatment
  • Ages between 18-85 years
  • Providing informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

The Second Affiliated Hospital of Baotou Medical College

Baotou, China

RECRUITING

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Hangzhou First People's Hospital

Hangzhou, China

RECRUITING

The Third Xiangya Hospital of Central South University

Hunan, China

RECRUITING

The First Hospital of Lanzhou University

Lanzhou, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Shandong, China

RECRUITING

Changhai Hospital

Shanghai, China

RECRUITING

Ruijin Hospital

Shanghai, China

RECRUITING

Shanghai Pudong New Area Gongli Hospital

Shanghai, China

RECRUITING

Yunnan University Affiliated Hospital

Yunnan, China

NOT YET RECRUITING

MeSH Terms

Conditions

Pancreatitis, ChronicPancreatitis

Interventions

Ringer's LactateSaline Solution

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Liang-Hao Hu

CONTACT

+8613817593520lianghao-hu@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 30, 2025

First Posted

October 2, 2025

Study Start

October 13, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

CN(10)