A Prospective Multicenter Cohort Study on the Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis
试验速览
- 阶段
- 不适用
- 入组人数
- 608
- 试验地点
- 1
- 主要终点
- six-week mortality rate
研究概览
简要总结
This study is a prospective, multi-center and observational clinical study. Investigators would like to explore the optimal emergency endoscopy timing in cirrhosis patients with esophagogastric variceal bleeding (EGVB) by evaluating and comparing the efficacy and safety of emergency endoscopy performed at different times ( within 6 hours or between 6 and 24 hours after gastroenterologic consultation ) and its impact on the short-term prognosis.
详细描述
Between July 2021 and April 2022, patients with cirrhosis undergoing emergency endoscopy due to EGVB are enrolled consecutively according to the following criteria: (1) age≥18 years; (2) A definite diagnosis of cirrhosis (confirmed by medical history, laboratory examination and imaging examination); (3) The cause of bleeding was identified as esophageal and/or gastric vein rupture. Exclusion criteria are as follows: (1) End-stage diseases of major organs (such as heart failure, chronic obstructive pulmonary disease, end-stage renal disease, and malignancies other than hepatocellular carcinoma); (2) The subject (or legal representative/guardian) refused to sign the informed consent.
Patients were divided into urgent-endoscopy group (< 6h) and early-endoscopy group (6h-24h) according to the time interval from gastroenterologic consultation to the start of emergency endoscopy.
Investigators will collect patients' data of baseline character, treatment, postoperative and follow-up. All patients will be followed up until death or the end of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •A definite diagnosis of cirrhosis (confirmed by medical history, laboratory examination and imaging examination)
- •The cause of bleeding was identified as esophageal and/or gastric vein rupture
排除标准
- •End-stage diseases of major organs (such as heart failure, chronic obstructive pulmonary disease, end-stage renal disease, and malignancies other than hepatocellular carcinoma)
- •The subject (or legal representative/guardian) refused to sign the informed consent
结局指标
主要结局
six-week mortality rate
时间窗: 6 weeks after treatment
Patients died in six weeks after emergency endoscopy due to rebleeding or other complications associated with cirrhosis.
次要结局
- mean operating time(during endoscopy)
- Immediate success hemostasis rate(within 24 hours after traetment)
- the needs of salvage treatment(6 weeks)
- detection rate of bleeding site(during endoscopy)
- five-day rebleeding rate(5 days after treatment)
研究者
ChenMingkai
Professor
Renmin Hospital of Wuhan University