A Randomized Trial of Hemostatic Forceps Versus Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Comparing hemostatic rate between hemostatic forceps and bipolar electrocautery probes
研究概览
简要总结
A randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patient with high risk bleeding gastroduodenal ulcers.
详细描述
This is a prospective randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patients with high-risk bleeding gastroduodenal ulcers. The primary outcome is comparing the hemostatic rates of the devices. Secondary outcomes are rebleeding rate at 7 and 30 days after index intervention, survival rate after intervention, procedure time for achieving hemostasis, number of units of infused blood, duration of hospitalization, and complications.
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)
盲法说明
The participants will be randomized for each intervention using sequentially numbered, opaque sealed envelopes after recruitment in the study. The care provider who uses the devices cannot be blinded.
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
- •The patient with upper gastrointestinal hemorrhage age ≥ 18 years old
- •The patient with gastroduodenal ulcer with indication for hemostatic intervention including 2.1 Forrest classification 1a (Active spurting) 2.2 Forrest classification 1b (Active oozing) 2.3 Forrest classification 2a (Non-bleeding visible vessel; NBVV) 2.4 Forrest classification 2b (Adherent clot) with lesion underneath clot which need hemostatic intervention including active spurting, active oozing or non-bleeding visible vessel
排除标准
- •Uncorrectable hemostasis laboratory including serum platelet < 50000 /mm3 or International Normalized Ratio (INR) >1.5
- •Bleeding from cancerous gastroduodenal ulcer
- •The patient with history of gastric surgery
- •The patient with history of bleeding gastroduodenal ulcer within 30 days prior to enrollment
- •The patient with history of proton pump inhibitor allergy
- •The patient deny to participate in the study
研究组 & 干预措施
Hemostatic forceps
Hemostatic forceps will be used for control bleeding with electrocautery unit setting: 80 W, effect 4, soft coagulation mode for 1-2 seconds.
干预措施: Hemostatic Forceps (Device)
Bipolar electrocautery probes
Bipolar electrocautery probes will be used for control bleeding with electrocautery unit setting: effect 2, soft coagulation bipolar mode for 8-10 seconds.
干预措施: Bipolar Electrocautery Probes (Device)
结局指标
主要结局
Comparing hemostatic rate between hemostatic forceps and bipolar electrocautery probes
时间窗: During esophagogastroduodenoscopy
When the bleeding stopped for at least 2 minutes, it is defined as successful hemostasis.
次要结局
- Rebleeding rate at 7 days and 30 days after index intervention(30 days)
- Survival rate after intervention(30 days)
- Procedure time for achieving hemostasis(During esophagogastroduodenoscopy)
- Duration of hospitalization(30 days)
- Number of units of infused blood(30 days)
- Complications of hemostatic interventions(30 days)
研究者
Uayporn
Assistant professor
Mahidol University