Adjunctive Cold Water Irrigation Added to Rectal Indomethacin for Prevention of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 950
- 试验地点
- 1
- 主要终点
- Incidence of Post-ERCP Pancreatitis (PEP) between the cold water and control groups
研究概览
简要总结
This study is designed to learn whether rinsing the papilla with cold water at the end of an ERCP procedure, in addition to standard medicine, can help lower the chance of developing pancreatitis, which is the most common major complication after ERCP.
详细描述
Study design:
This is an investigator-initiated, single-center, triple-blind, parallel-group, randomized controlled superiority trial. Participants will be randomized 1:1 to receive either (1) rectal indomethacin plus cold water irrigation or (2) rectal indomethacin plus room-temperature water irrigation. The study is designed to evaluate whether cold water irrigation provides additive benefit in reducing the incidence of post-ERCP pancreatitis (PEP) compared with standard therapy.
Eligible patients (≥20 years, native papilla) undergoing ERCP at University of Kansas Medical Center (KUMC) will be identified during pre-procedure evaluation. Written informed consent will be obtained prior to the procedure.
Baseline Data Collection: Demographic data, relevant medical history, ERCP indication, and risk factors for PEP will be recorded before the procedure.
All patients receive a 100 mg rectal indomethacin suppository at the completion of ERCP.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Native papilla present.
- •Undergoing ERCP for diagnostic or therapeutic indications.
- •Able to provide informed consent.
排除标准
- •Post-operative reconstructed intestinal tract other than Billroth I reconstruction.
- •Acute pancreatitis at the time of ERCP.
- •Chronic pancreatitis.
- •Pancreatic head cancer with occlusion of the main pancreatic duct.
- •Existing pancreatic duct stent or need for prophylactic pancreatic duct stenting during the index ERCP.
- •Known contraindications or allergy to indomethacin or other NSAIDs.
- •Significant renal impairment (eGFR < 30 mL/min/1.73m²).
- •Active peptic ulcer disease or history of NSAID-induced gastrointestinal bleeding.
研究组 & 干预措施
Cold Water
• Cold Water Irrigation of the Papilla: Participants randomized to the experimental arm will receive 250 mL of refrigerated water (target temperature 4-8 °C) in five 50 mL aliquots directed toward the papilla, with duodenal aspiration after each aliquot.
干预措施: Cold water (Procedure)
Warm water
• Control Intervention: Participants randomized to the control group will receive 250 mL of room-temperature water in identical increments and delivery.
干预措施: Warm water (Procedure)
结局指标
主要结局
Incidence of Post-ERCP Pancreatitis (PEP) between the cold water and control groups
时间窗: approximately 24-36 months.
The incidence of post-ERCP pancreatitis (PEP) is defined according to established consensus criteria as new or worsened abdominal pain persisting for at least 24 hours after ERCP, accompanied by serum amylase or lipase levels ≥3 times the upper limit of normal at approximately 24 hours post-procedure, and necessitating hospital admission or prolongation of planned observation.
次要结局
- Severity of post-ERCP pancreatitis(Up to 7 days post-ERCP)
研究者
Reza Hejazi
Associate Professor
University of Kansas Medical Center