Papillary Undiluted Epinephrine Injection vs Rectal Indomethacin in Preventing Post-ERCP Pancreatitis (PEIR-PEP): A Prospective, Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 504
- 试验地点
- 2
- 主要终点
- Overall post-ERCP pancreatitis rate
研究概览
简要总结
Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is the most common and one of the most undesirable major adverse events after endoscopic retrograde cholangiopancreatography (ERCP), causing significant morbidity and even mortality. The incidence rate is almost 15% in high-risk patients and no less than 3% in average-risk patients.
Many factors contribute to PEP, such as patient-related and endoscopist-related factors, but mainly two mechanisms are considered in terms of physiopathology: papillary edema caused by mechanical trauma during cannulation and thermal injury with electrocautery current.
Rectal NSAIDs and pancreatic stent placement are the two proven methods of PEP prophylaxis included in the guideline recommendations, but despite their frequent use, the incidence rates remain unacceptably high. There is a need for additional methods that are easy to implement, preferably low-cost, and safe to reduce the risk of PEP.
Topical epinephrine applied submucosally can meet these goals. Ampullary epinephrine injection is an effective method for post-sphincterotomy bleeding. Still, to our knowledge, no study has examined its efficacy in PEP prophylaxis, except for the retrospective study we reported.
There are conflicting reports on epinephrine spraying onto the papilla for PEP, but these trials are largely heterogeneous, with different dose regimens. It should also be noted that spraying epinephrine onto the papilla has a duration of action of about 1 to 5 minutes, whereas epinephrine injection has a duration of roughly 120 minutes.
Given this information, a large-scale, prospective, double-blind, randomized, controlled trial is designed.
详细描述
Patients will be randomized into two groups: rectal indomethacin (Group A) and epinephrine injection (Group B), by computer-generated, numbered, sealed envelopes for treatment assignments. The envelopes will be opened before the procedure without the knowledge of the endoscopists to enable blinding in the randomization process
The patients in Group A will receive 100mg of rectal indomethacin alone, just before the procedure. The patients in Group B will receive a peripapillary injection of 4mg undiluted epinephrine, divided into 1mg in each quadrant of the peripapillary region, 1 to 2 cm from the papillary orifice
ERCP procedures will be performed under endoscopist-directed deep sedation. Blood pressure, pulse rate, and electrocardiography will be monitored in all patients during and after the procedure. Demographic data, laboratory values, procedure parameters, and adverse events will be recorded. All patients will be hospitalized for at least 24 hours.
Total procedure time is defined as the interval between esophageal intubation and duodenoscope extubation. Difficult biliary cannulation is defined as ≥5 contacts with the papilla and more than five minutes spent attempting cannulation after the first papillary contact. Cannulation time is defined as the interval between the initial contact of the sphincterotome with the ampullary mound and successful biliary cannulation. Post-ERCP adverse events will be recorded according to the American Society for Gastrointestinal Endoscopy (ASGE) ERCP lexicon. Serum samples will be obtained before the procedure and at four and 24 hours post-ERCP to measure complete blood cell counts, C-reactive protein (CRP), amylase, lipase, bilirubin, and liver enzymes. All patients will be invited for follow-up at 1 week and 1 month after the procedure.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with a naïve papilla that required ERCP for treatment of biliary obstruction, aged between 18 and 80.
排除标准
- •Pregnancy
- •Inability to provide written informed consent
- •Previous history of ERCP
- •Ampulla of Vater cancer
- •Surgically altered anatomy
结局指标
主要结局
Overall post-ERCP pancreatitis rate
时间窗: 30 days
The rate of post-ERCP pancreatitis
次要结局
- Overall post-ERCP hyperamylasemia(30 days)
- Overall post-ERCP pancreatitis rate in high risk patients(30 days)
- Post sphincterotomy bleeding(30 days)
- Overall ERCP complications(30 days)
- Length of hospital stay(30 days)