Epinephrine Sprayed on the Papilla and Rectal Indomethacin Versus Sterile Water Sprayed on the Papilla and Rectal Indomethacin for Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 548
- 试验地点
- 1
- 主要终点
- Number of participants with pancreatitis after endoscopic retrograde cholangiopancreatography, used consensus definition
研究概览
简要总结
This multicentre randomised controlled trial included patients aged >18 years with an indication for ERCP and naive major papilla. All patients received 100 mg of rectal indomethacin and 10 ml of either sterile water or a 1:10,000 epinephrine dilution. Patients were asked about PEP symptoms via telephone 24 hours and 7 days after the procedure.
详细描述
This multicentre randomised placebo-controlled trial was conducted in two hospitals in Mexico: the National Institute of Medical Sciences and Nutrition "Salvador Zubirán" (INCMNSZ) in Mexico City, and Bernardette Hospital in Jalisco. The study was approved by both institutional review boards. All patients provided written informed consent.
All patients were given a dose of rectal indomethacin (100 mg) at the beginning of the ERCP. Depending on the experimental group, either 10 ml of sterile water or 10 ml of a 1:10,000 epinephrine dilution (0.1 mg/ml) was sprayed on the ampulla through a biliary balloon or a sphincterotome, avoiding any direct contact with the papilla during irrigation at the end of the procedure.
After the procedure, patients were monitored in the recovery room for 2 hours and then discharged. Symptoms of acute pancreatitis or any other complication were interrogated at baseline while in the recovery room, and then by telephone 24 hours and 7 days after the procedure. Serum levels of pancreatic enzymes were determined only if the patient developed abdominal pain after 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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
As the two solutions are colourless, the endoscopist, nurse and patient were all blinded to the intervention. Investigators who participated in the evaluation of post-ERCP complications were also blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Patient with an indication for endoscopic retrograde cholangiopancreatography
- •Patient without prior endoscopic retrograde cholangiopancreatography
- •Patient who accept contact by telephone
排除标准
- •Previous sphincterotomy
- •Allergy to epinephrine or indomethacin
- •NSAIDs use in the prior week
- •Pancreatic cancer located in the head
- •Chronic pancreatitis
- •Renal failure (Cr >1.4 mg / dl)
- •Indication for endotracheal intubation independent of endoscopic retrograde cholangiopancreatography
- •Biliodigestive derivation
- •Pregnant patients
研究组 & 干预措施
Epinephrine sprayed on the papilla and rectal indomethacin
Epinephrine 1 mg/1 mL + 9 mL of sterile water are sprayed on the papilla at the end of the endoscopic retrograde cholangiopancreatography and 100 mg of indomethacin rectal suppository is administered at the beginning of the procedure
干预措施: Epinephrine (Drug)
Epinephrine sprayed on the papilla and rectal indomethacin
Epinephrine 1 mg/1 mL + 9 mL of sterile water are sprayed on the papilla at the end of the endoscopic retrograde cholangiopancreatography and 100 mg of indomethacin rectal suppository is administered at the beginning of the procedure
干预措施: Sterile water (Other)
Epinephrine sprayed on the papilla and rectal indomethacin
Epinephrine 1 mg/1 mL + 9 mL of sterile water are sprayed on the papilla at the end of the endoscopic retrograde cholangiopancreatography and 100 mg of indomethacin rectal suppository is administered at the beginning of the procedure
干预措施: Indomethacin Rectal Suppository (Drug)
Sterile water sprayed on the papilla and rectal indomethacin
10 mL of sterile water are sprayed on the papilla at the end of the endoscopic retrograde cholangiopancreatography and 100 mg of indomethacin rectal suppository is administered at the beginning of the procedure
干预措施: Sterile water (Other)
Sterile water sprayed on the papilla and rectal indomethacin
10 mL of sterile water are sprayed on the papilla at the end of the endoscopic retrograde cholangiopancreatography and 100 mg of indomethacin rectal suppository is administered at the beginning of the procedure
干预措施: Indomethacin Rectal Suppository (Drug)
结局指标
主要结局
Number of participants with pancreatitis after endoscopic retrograde cholangiopancreatography, used consensus definition
时间窗: 7 days
Consensus definition for post endoscopic retrograde cholangiopancreatography pancreatitis is: (1) new or worsened abdominal pain, (2) new or prolongation of hospitalization for at least 2 days, and (3) serum amylase or lipase 3 times or more the upper limit of normal, measured more than 24 hours after the procedure
次要结局
- Risk factors associated with the development of pancreatitis after endoscopic retrograde cholangiopancreatography assessed by relative risk(7 days)
研究者
FELIX IGNACIO TELLEZ AVILA
M.D., M.Sc., Ph. D.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran