Rectal Indomethacin Alone Versus Rectal Indomethacin Plus Post-procedural Papillary Ice Water Irrigation for Prevention of Post-ERCP Pancreatitis (N-ICE Trial): A Randomized, Patient- and Assessor-Blinded, Superiority Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Incidence of Post-ERCP Pancreatitis
研究概览
简要总结
Post-endoscopic retrograde cholangiopancreatography pancreatitis (post-ERCP pancreatitis, or PEP) is inflammation of the pancreas that can occur after an ERCP procedure. Rectal indomethacin is commonly given around the time of ERCP to help reduce this risk, but pancreatitis can still occur despite this treatment.
The purpose of this randomized clinical trial is to determine whether adding ice water irrigation of the papilla at the end of ERCP further reduces the risk of post-ERCP pancreatitis compared with rectal indomethacin alone. The papilla is the small opening in the intestine where the bile duct and pancreatic duct drain.
Participants will be randomly assigned to one of two groups. Both groups will receive rectal indomethacin 100 mg. In the intervention group, the doctor will also irrigate the papilla with a total of 250 mL of ice water immediately after the ERCP. Participants and the study team members who assess study outcomes will not know which treatment group the participant was assigned to. Participants will be assessed after ERCP and followed for up to 30 days for pancreatitis and other complications.
详细描述
The N-ICE Trial is a prospective, randomized, patient- and assessor-blinded, parallel-group superiority trial evaluating whether post-procedural papillary ice water irrigation provides additional protection against post-ERCP pancreatitis (PEP) when added to standard rectal indomethacin prophylaxis.
Eligible adults undergoing ERCP with a native papilla will be randomized in a 1:1 ratio to receive either rectal indomethacin 100 mg alone or rectal indomethacin 100 mg plus post-procedural papillary ice water irrigation. In the intervention group, immediately following completion of ERCP and before withdrawal of the endoscope, the duodenal papilla will be irrigated with a total of 250 mL of ice water delivered in five 50 mL aliquots under direct endoscopic visualization. The endoscopist cannot be blinded to treatment assignment; participants and outcome assessors will remain blinded.
The primary objective is to determine whether adding papillary ice water irrigation to rectal indomethacin reduces the incidence of PEP. Participants will undergo clinical and biochemical assessment following ERCP, including measurement of serum amylase and/or lipase within 24 hours, with subsequent follow-up for delayed adverse events and health care utilization through 30 days.
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)
盲法说明
Participants and outcome assessors will remain blinded to treatment allocation. Data analysts will also remain blinded. The endoscopist performing the ERCP cannot be blinded because they must either perform or omit post-procedural papillary ice water irrigation. Procedural documentation available to blinded outcome assessors will use neutral or standardized language where feasible to minimize inadvertent unblinding.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older. Undergoing ERCP with a native papilla. Eligible to receive rectal indomethacin. Able to provide informed consent. Willing and able to complete the required follow-up and post-procedure bloodwork.
排除标准
- •Known allergy, hypersensitivity, or contraindication to indomethacin or rectal NSAIDs.
- •Active acute pancreatitis at the time of ERCP. Prior sphincterotomy or absent native papilla. Prediction of papilla inaccessibility. Pregnancy. Inability or unwillingness to provide informed consent. Any clinical circumstance in which the treating endoscopist judges study participation to be unsafe or inappropriate.
- •Chronic pancreatitis. Pancreatic head malignancy with complete main pancreatic duct obstruction. Altered luminal anatomy, other than Billroth I.
研究组 & 干预措施
Rectal Indomethacin Plus Papillary Ice Water Irrigation
Participants will receive rectal indomethacin 100 mg administered peri-procedurally. Immediately after completion of ERCP, while the participant remains sedated and before withdrawal of the endoscope, the duodenal papilla will be irrigated with a total of 250 mL of ice water delivered in five 50 mL aliquots under direct endoscopic visualization.
干预措施: Papillary Ice Water Irrigation (Procedure)
Rectal Indomethacin Alone
Participants will receive rectal indomethacin 100 mg administered peri-procedurally according to standard institutional practice. No post-procedural papillary ice water irrigation will be performed.
干预措施: Rectal Indomethacin (Drug)
Rectal Indomethacin Plus Papillary Ice Water Irrigation
Participants will receive rectal indomethacin 100 mg administered peri-procedurally. Immediately after completion of ERCP, while the participant remains sedated and before withdrawal of the endoscope, the duodenal papilla will be irrigated with a total of 250 mL of ice water delivered in five 50 mL aliquots under direct endoscopic visualization.
干预措施: Rectal Indomethacin (Drug)
结局指标
主要结局
Incidence of Post-ERCP Pancreatitis
时间窗: Within 24 hours after ERCP
Post-ERCP pancreatitis will be defined as new abdominal pain after ERCP with serum amylase or lipase at least three times the upper limit of normal.
次要结局
- Incidence of Post-ERCP Pancreatitis in Participants With Difficult Cannulation(Within 24 hours after ERCP)
- Incidence of Post-ERCP Pancreatitis in Participants With Pancreatic Duct Cannulation(Within 24 hours after ERCP)
- Incidence of Post-ERCP Pancreatitis in Participants With High-Risk Features(Within 24 hours after ERCP)
- Severity of Post-ERCP Pancreatitis(Up to 30 days after ERCP)
- Post-ERCP Hyperamylasemia and/or Hyperlipasemia Without Pancreatitis(Within 24 hours after ERCP)
- Bleeding(Up to 30 days after ERCP)
- Cholangitis(Up to 30 days after ERCP)
- Perforation(Up to 30 days after ERCP)
- Mortality(Up to 30 days after ERCP)
- ICU Admission(Up to 30 days after ERCP)
- Hospital Admission or Prolonged Hospitalization(Up to 30 days after ERCP)
- Need for Rescue Interventions(Up to 30 days after ERCP)
- 30-Day Readmission(Within 30 days after ERCP)
研究者
Sunil Gupta
Assistant Professor
Unity Health Toronto