The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD: an Endoscopist-blinded Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- The total bleeding rate according to grading of intraoperative bleeding during ESD procedure
研究概览
简要总结
This will be a single-centre, randomised, endoscopist-blind, parallel-group study in patients who are scheduled endoscopic submucosal dissection (ESD) for gastric mucosal lesion. The primary objective is to observe whether a regimen of 7-day oral esomeprazole premedication can alleviate intraoperative bleeding in patients scheduled for ESD due to gastric mucosal lesions.
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
- Single (Outcomes Assessor)
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
- •Ability to understand and the willingness to sign a written informed consent document.
- •Female or male aged ≥18 years.
- •Patients must have gastric mucosal lesion that are eligible for ESD indications (Japanese Gastric Cancer Association 2011), including early gastric cancer, polyps, adenoma, and precancerous/suspected lesions diagnosed by endoscopy.
排除标准
- •Malignancy or other advanced disease with a life expectancy of < 6 months as judged by the investigator.
- •The ASA classification of physical status ≥ 4 as judged by the investigator.
- •Severe hepatic disease or renal disease
- •Ability to understand and the willingness to sign a written informed consent document.
- •Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator.
- •Haemorrhagic disorder.
- •Patients who had a history of gastrectomy or a recurrent lesion.
- •Known or suspected hypersensitivity to any component of any PPI .
- •Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine.
- •Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator.
- •Known or suspected alcohol, drug or medication abuse.
- •Any condition associated with poor compliance as judged by the investigator.
- •Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment.
- •Involvement in the planning and conduct of the study. Previous enrollment in the present study.
研究组 & 干预措施
Control group
No PPI treatment should given after the initial allocation. Patient will be admitted, and ESD will be performed. Then a 3-day i.v. treatment of esomeprazole will be initiated after ESD procedure and followed by a 26 days oral treatment with esomeprazole tablets 40 mg.
干预措施: No PPI treatment (Drug)
Esomeprazole group
Esomeprazole should start as soon as possible after the initial allocation. During the 7 days of p.o. treatment, patient will be admitted, and ESD will be performed as soon as completing the p.o. treatment. Then a 3-day i.v. treatment of esomeprazole will be initiated after ESD procedure and followed by a 26 days oral treatment with esomeprazole tablets 40 mg.
干预措施: Esomeprazole (Drug)
结局指标
主要结局
The total bleeding rate according to grading of intraoperative bleeding during ESD procedure
时间窗: 1 day
≥grade 1 means bleeding
次要结局
- The frequency of coagrasper usage which reflects grade of major bleeding(1 day)
- Post-ESD ulcer quality as indicated in description(1 day)
- Intra-procedure injury to muscularis propria including perforation.(1 day)
- Mean haemoglobin reduction between intervention and control group.(1 day)
- Delayed bleeding rate as indicated by haematemesis and melaena(30 days)
- The mean percentage of mucosal defect reduction at follow-up endoscopy on 28 days after ESD procedure.(30 days)
研究者
Zhiguo Liu
Associate Professor
Xijing Hospital of Digestive Diseases