ClearEndoclip Versus EZ Clip for the Hemostasis of Upper Gastrointestinal Ulcer Bleeding: an Open-label, Non-inferiority, Randomized, Multicenter Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Rebleeding rate after endoscopic hemostasis
研究概览
简要总结
We are going to conduct a comparative study to analyze the clinical effectiveness and user convenience of EZ clips that have been used in upper gastrointestinal ulcer bleeding and newly developed clip (ClearEndoclip, FineMedix, Taegu) in Korea.
1) Research hypothesis and purpose
- This study was designed to prove the hypothesis that the hemostatic effect of newly developed endoscopic clip (ClearEndoclip, FineMedix, Taegu, Korea) is not inferior to that of EZ clip (Olympus, Tokyo, Japan) in the treatment of hemostasis for patients who visited the upper gastrointestinal ulcer bleeding.
- This study was designed as a multi-center (9 institutions), open-labelled, randomized comparative clinical trial (1:1 ratio).
详细描述
-
Design of this study
-
Stratified randomization is performed, and the variable used for stratification is the patient's age (65 years or older, 65 years or less).
-
The existing clip (control) and the domestic clip (experimental group) are divided by the block size randomization method of size 4 for each floor.
-
Patients and Methods
-
inclusion criteria
- Men and women aged 20 to 80
- The patients who came to the emergency room due to upper gastrointestinal bleeding with as follows: peptic ulcer with acute bleeding or protruding vascular exposure (Forrest class Ia-IIa), anastomotic vascular ulcer bleeding, bleeding from endoscopic submucosal dissection or endoscopic mucosal resection site after 24 hours
- American Society of Anesthesiologist (ASA) Physical Status 1 - 3
- Patients with adequate patient compliance and adequate geographical distance for follow-up. character
- exclusion criteria
- Patients with gastrointestinal bleeding who are not recommended to clip Bleeding from a malignant tumor Hemorrhagic gastritis Angiodysplasia variceal bleeding
- Bleeding during endoscopic submucosal dissection or endoscopic mucosal resection
- Patients with insufficient clinical information
- Pregnant or lactating patients
- Patients or guardians who have not obtained informed consent
- The number of patients
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
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 20 to 80
- •The patients who came to the emergency room due to upper gastrointestinal bleeding with as follows: peptic ulcer with acute bleeding or protruding vascular exposure (Forrest class Ia-IIa), anastomotic vascular ulcer bleeding, bleeding from endoscopic submucosal dissection or endoscopic mucosal resection site after 24 hours
- •American Society of Anesthesiologist (ASA) Physical Status 1 - 3
- •Patients with adequate patient compliance and adequate geographical distance for follow-up. character
排除标准
- •Patients with gastrointestinal bleeding who are not recommended to clip Bleeding from a malignant tumor Hemorrhagic gastritis Angiodysplasia variceal bleeding
- •Bleeding during endoscopic submucosal dissection or endoscopic mucosal resection
- •Patients with insufficient clinical information
- •Pregnant or lactating patients
- •Patients or guardians who have not obtained informed consent
研究组 & 干预措施
ClearEndoclip
This arm is a group in whom ClearEndoclip would be used for the treatment of bleeding.
干预措施: Endoscopic hemostasis with clip (Device)
EZ clip
This arm is a group in whom EZ clip would be used for the treatment of bleeding.
干预措施: Endoscopic hemostasis with clip (Device)
结局指标
主要结局
Rebleeding rate after endoscopic hemostasis
时间窗: upto 7 days
The rate of rebleeding at the site of bleeding within 7 days after the first endoscopic hemostasis, which should be identified endoscopically.
次要结局
- Satisfaction scores of the operator and the assistant(during endoscopic procedure)
- Failure rate of clip installation(during endoscopic procedure)
研究者
Sun Gyo Lim, MD
Associate professor
Ajou University School of Medicine