Evaluation of the Benefit of Lidocaine on the Prevention of the Risk of Post Endoscopic Retrograde Cholangio-pancreatography Pancreatitis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Plasma lipase level
研究概览
简要总结
The goal of this study is, in a population of patients undergoing ERCP surgery, treated preventively with NSAIDs and divided into two groups according to the absence (group 1) or presence (group 2) of intravenous lidocaine in the general anesthesia protocol.
The main objective of this study is to compare the incidence of post-ERCP pancreatitis between the two groups.
type of study: clinical trial participant population/health conditions: Patients with ERCP surgery
详细描述
This is a single-center, prospective, randomized, single-blind study of two parallel groups of patients undergoing ERCP surgery
- Group 1 (n=900): General anesthesia without IV lidocaine administration
- Group 2 (n=900): General anesthesia with IV lidocaine administration
Randomization Patients who have given written informed consent and received confirmation of eligibility will be randomized into the study according to a randomization list. According to the randomization, patients will be divided into two equal groups of 900 patients (anesthesia with and without lidocaine). The randomization list will be established by a centralized computer procedure.
PAP prevention protocols Treatment with indomethacin (100mg intrarectally), which is the reference preventive treatment, will be administered systematically in both groups just before anesthesia (or during anesthesia if ERCP is preceded by an echo-endoscopy). The endoscopic techniques to prevent PAP (pancreatic prosthesis, double guide wire technique, infundibulotomy, needle pre-cutting ...) will be used by the operator according to his procedural habits and will be reported in the CRF.
Anesthesia protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patient over 18 years of age
- •Patient who has read and signed the consent form for participation in the study
- •Patient candidate for ERCP with virgin papilla
排除标准
- •Patient with sphincterotomized papilla
- •Patient under court protection, guardianship or curatorship
- •Pregnant woman or woman of childbearing age without highly effective contraception for the duration of the study (surgically sterile, intrauterine device (> 14 days), hormonal contraception (same dose and formulation for at least 6 months), sexual abstinence. Women after menarche and until they become postmenopausal, unless they are permanently infertile or have undergone surgical sterilization, are considered to be of childbearing age, i.e. fertile. A postmenopausal condition is defined as the absence of menstruation for 12 months without any other medical cause
- •Patient not affiliated with the French social security system
- •Patient participating in another clinical research protocol
- •Impossibility to give the subject informed information and/or written informed consent: dementia, psychosis, disorders of consciousness, non-French speaking patient
- •Contraindication to the use of NSAIDs
- •Contraindication to anesthesia or to the administration of any of the products used in anesthesia protocols (including lidocaine)
研究组 & 干预措施
General anesthesia with intravenous lidocaine administration
干预措施: Intravenous lidocaine administration (Drug)
结局指标
主要结局
Plasma lipase level
时间窗: Hour 24
A plasma lipase level greater than or equal to 3N, considered to be indicative of a PAP, is the primary endpoint of the study
次要结局
- Pancreatic ultrasound or CT scan data(Hour 24)
- Severity of pancreatitis(Hour 24)
- Abdominal pain intensity(Hour 24)