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Recruiting NCT07202559

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

No phase Interventional Pancreatitis, Chronic Pancreatitis, Acute Pancreatic Duct Stones

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indometacin suppository, Lactated ringers solution, Normal Saline.
Who it may be relevant to
Registry conditions: Pancreatitis, Chronic, Pancreatitis, Acute, Pancreatic Duct Stones. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • Drug Indometacin suppository
    Administration of a 100mg indometacin suppository rectally 30 minutes prior to ESWL
  • Drug Lactated ringers solution
    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.
  • Drug Normal Saline
    Intravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h)

Primary outcome measures

  • Incidence of post-ESWL pancreatitis [Time frame: 24 hours]
Secondary outcome measures (5)
  • Severity of pancreatitis [Time frame: 1 month]
  • Incidence of other post-ESWL complications [Time frame: 24 hours]
  • Incidence of fluid overload [Time frame: 24 hours]
  • Transient adverse events related to ESWL [Time frame: 24 hours]
  • Length of hospitalisation [Time frame: 1 month]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 10 centers
  • The Second Affiliated Hospital of Baotou Medical College — Baotou
  • Peking Union Medical College Hospital — Beijing
  • Hangzhou First People's Hospital — Hangzhou
  • The Third Xiangya Hospital of Central South University — Hunan
  • The First Hospital of Lanzhou University — Lanzhou
  • Qilu Hospital of Shandong University — Shandong
  • Changhai Hospital — Shanghai
  • Ruijin Hospital — Shanghai
  • … and 2 more centers

Identifiers

NCT: NCT07202559 · PANDA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗