Comparison of Hemostatic Efficacy for Argon Plasma Coagulation vs Hemoclipping Following Distilled Water Injection in Treating High-risk Bleeding Ulcers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Number of Participants With Rebleeding
研究概览
简要总结
Endoscopic treatment is recommended for initial hemostasis in nonvariceal upper gastrointestinal bleeding. However, the additional hemostatic efficacy of argon plasma coagulation (APC) has not been widely investigated. We designed a randomized trial comparing APC plus injection therapy vs hemoclipping plus injection therapy for peptic ulcer bleeding.
详细描述
【Goals and Background 】 Endoscopic treatment is recommended for initial hemostasis in nonvariceal upper gastrointestinal bleeding. Many endoscopic devices have been demonstrated to be effective in the hemostasis of bleeding ulcers. However, the additional hemostatic efficacy of argon plasma coagulation (APC) after endoscopic injection therapy has not been widely investigated.
【Study】 From Feb. 2012 to April 2016, consecutive patients with high-risk bleeding ulcers, characterized by active bleeding, non-bleeding visible vessels and adherent clots, were admitted to our hospital. They prospectively randomly underwent either APC therapy plus distilled water injection or Hemoclipping plus distilled water injection. Pantoprazole infusion was conducted during the fasting period after endoscopy and orally for 8 weeks to encourage ulcer healing. Episodes of rebleeding were retreated with endoscopic combination therapy. Patients who did not benefit from retreatment underwent emergency surgery or arterial embolization.
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
- •． high-risk peptic ulcer bleeding. High-risk bleeding ulcers were defined as participants with stigmata of a bleeding visible vessels (eg, spurting, oozing), a non-bleeding visible vessels (NBVV) or adherent clot.4 A NBVV at endoscopy was defined as a raised red, red-blue or pale hemispheric vessel protruding from the ulcer bed, without active bleeding. An adherent clot was defined as an overlying blood clot that was resistant to vigorous irrigation.
排除标准
- •the presence of another possible bleeding site (eg, gastroesophageal varix, gastric cancer, reflux esophagitis)
- •coexistence of actively severe ill diseases (eg, septic shock, stroke, myocardial infarction, surgical abdomen)
- •treatment with an anticoagulant (eg, warfarin)
- •pregnancy
- •the presence of operated stomach
- •refusal to participate in the study
结局指标
主要结局
Number of Participants With Rebleeding
时间窗: up to 30 days
Rebleeding was observed for a 30-day study period. One or more the following criteria were considered as evidence of recurrent bleeding: aspiration of fresh blood from a nasogastric or orogastric tube; pulse rate over 100 beats per minute; a drop in systolic blood pressure exceeding 30 mmHg; or continue coffee ground emesis or melena with a decline in hemoglobin of at least 2g/dL.
次要结局
- Surgery or Arterial Embolization(up to 30 days)
- Mortality(up to 30 days)
研究者
Huay-Min Wang
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Kaohsiung Veterans General Hospital.