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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,250
- 试验地点
- 12
- 主要终点
- Incidence of post-ESWL pancreatitis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with painful chronic pancreatitis eligible for P-ESWL treatment
- •Ages between 18-85 years
- •Providing informed consent
排除标准
- •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)
研究组 & 干预措施
Rectal indometacin alone
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.
干预措施: Indometacin suppository (Drug)
Rectal indometacin alone
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.
干预措施: Normal Saline (Drug)
Aggressive hydration with rectal Indometacin
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.
干预措施: Indometacin suppository (Drug)
Aggressive hydration with rectal Indometacin
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.
干预措施: Lactated ringers solution (Drug)
结局指标
主要结局
Incidence of post-ESWL pancreatitis
时间窗: 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.
次要结局
- 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)