Aggressive Intravenous Hydration With or Without Indometacin to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy
- Conditions
- Pancreatitis, ChronicPancreatitis, AcutePancreatic Duct Stones
- Interventions
- Registration Number
- NCT07202559
- Lead Sponsor
- Changhai Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1250
- Patients with painful chronic pancreatitis eligible for P-ESWL treatment
- Ages between 18-85 years
- Providing informed consent
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rectal indometacin alone Indometacin suppository 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. Rectal indometacin alone Normal Saline 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. Aggressive hydration with rectal Indometacin Indometacin suppository 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. Aggressive hydration with rectal Indometacin Lactated ringers solution 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.
- Primary Outcome Measures
Name Time Method Incidence of post-ESWL pancreatitis 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 Outcome Measures
Name Time Method Severity of pancreatitis 1 month Stratified as mild, moderate, or severe, mainly on the basis of length of hospitalization and need for invasive treatment.
Incidence of other post-ESWL complications 24 hours Including bleeding, infection, steinstrasse, and perforation.
Incidence of fluid overload 24 hours Including pulmonary or peripheral edema and congestive heart failure.
Transient adverse events related to ESWL 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.Length of hospitalisation 1 month
Trial Locations
- Locations (10)
The Second Affiliated Hospital of Baotou Medical College
🇨🇳Baotou, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Hangzhou First People's Hospital
🇨🇳Hangzhou, China
The Third Xiangya Hospital of Central South University
🇨🇳Hunan, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, China
Qilu Hospital of Shandong University
🇨🇳Shandong, China
Changhai Hospital
🇨🇳Shanghai, China
Ruijin Hospital
🇨🇳Shanghai, China
Shanghai Pudong New Area Gongli Hospital
🇨🇳Shanghai, China
Yunnan University Affiliated Hospital
🇨🇳Yunnan, China
The Second Affiliated Hospital of Baotou Medical College🇨🇳Baotou, ChinaTong DangContact+8613948823999