Prospective, Randomized Trial of Hemospray Plus Epinephrine Injection Versus Endoscopic Hemoclip Plus Epinephrine Injection in Nonvariceal Upper Gastrointestinal Bleeding
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 主要终点
- Initail hemostasis after endoscopic hemostatic procedure
研究概览
简要总结
The non-variceal upper gastrointestinal bleeding is defined as gastrointestinal bleeding located proximal to the angle of Treitz, whose cause is not related to esophagogastric varices or gastropathy of portal hypertension.
Animal studies showed no absorption in the GIT and disposal within 48 hours of application, and no reported cases of obstruction. Recently, a prospective study involving 20 patients with upper gastrointestinal bleeding, showed that the application of hemospray ® promoted hemostasis in 95% of cases, confirmed by endoscopic revision 72h after application without any complication.
详细描述
The non-variceal upper gastrointestinal bleeding is defined as gastrointestinal bleeding located proximal to the angle of Treitz, whose cause is not related to esophagogastric varices or gastropathy of portal hypertension.
Despite all therapeutic guidelines and innovations introduced in recent decades, the incidence varies between 50 and 160 cases/100000 inhabitants / year and recent data show a mortality rate of approximately 10% in hospitalized patients. In the United States the upper gastrointestinal bleeding (HDA) promotes 300,000 hospitalizations per year.
The etiologies of non-variceal, HDA remains virtually unchanged over the past 20 years, peptic ulcer disease accounts for 40-50% of cases. Other less common causes are vascular ectasia, Mallory-Weiss lacerations, acute gastroduodenal mucosal lesions, Dieulafoy lesions, tumors and other rarer.
The HDA is manifested most often by hematemesis and / or melena. In a smaller proportion of patients can only be observed a drop in hemoglobin levels, and hemodynamic instability possible, without externalization of blood. There is also a smaller chance of rectal bleeding occur, which should indicate a bleeding of major consequence.
The management of patients with HDA should be systematized and as early as possible. Due to the unpredictability of the evolution of bleeding, all patients should be kept in the hospital environment and in the presence of hemodynamic and / or comorbidities should be considered high risk instability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical diagnosis of upper gastrointestinal bleeding and that during endoscopy revealed to non-varicose bleeding lesions in the endoscopic treatment being necessary.
排除标准
- •Pregnancy and History of endoscopic haemostatic procedure in the previous seven days
研究组 & 干预措施
Group 1
Patients with a clinical diagnosis of upper gastrointestinal bleeding and that during endoscopy revealed to non-varicose bleeding lesions in the endoscopic treatment being necessary. The group will be submitted to injection of adrenaline at a proportion of 1: 10,000 in the four quadrants of the lesion associated with application of metal clips. The patients will be submitted to endoscopy exam in 12 to 24 hours after the therapeutic procedure to confirm the success of the therapy and measure if there the presence of rebleeding.
干预措施: Metal clips (Device)
Group 1
Patients with a clinical diagnosis of upper gastrointestinal bleeding and that during endoscopy revealed to non-varicose bleeding lesions in the endoscopic treatment being necessary. The group will be submitted to injection of adrenaline at a proportion of 1: 10,000 in the four quadrants of the lesion associated with application of metal clips. The patients will be submitted to endoscopy exam in 12 to 24 hours after the therapeutic procedure to confirm the success of the therapy and measure if there the presence of rebleeding.
干预措施: Endoscopy Exam (Procedure)
Group 1
Patients with a clinical diagnosis of upper gastrointestinal bleeding and that during endoscopy revealed to non-varicose bleeding lesions in the endoscopic treatment being necessary. The group will be submitted to injection of adrenaline at a proportion of 1: 10,000 in the four quadrants of the lesion associated with application of metal clips. The patients will be submitted to endoscopy exam in 12 to 24 hours after the therapeutic procedure to confirm the success of the therapy and measure if there the presence of rebleeding.
干预措施: Adrenaline (Drug)
Group 2
Patients with a clinical diagnosis of upper gastrointestinal bleeding and that during endoscopy revealed to non-varicose bleeding lesions in the endoscopic treatment being necessary. The group will be submitted to injection of adrenaline at a proportion of 1: 10,000 in the four quadrants of the lesion associated with application adsorption powder, marketed under the name Hemospray. The patients will be submitted to endoscopy exam in 12 to 24 hours after the therapeutic procedure to confirm the success of the therapy and measure if there the presence of rebleeding.
干预措施: Hemospray (Drug)
Group 2
Patients with a clinical diagnosis of upper gastrointestinal bleeding and that during endoscopy revealed to non-varicose bleeding lesions in the endoscopic treatment being necessary. The group will be submitted to injection of adrenaline at a proportion of 1: 10,000 in the four quadrants of the lesion associated with application adsorption powder, marketed under the name Hemospray. The patients will be submitted to endoscopy exam in 12 to 24 hours after the therapeutic procedure to confirm the success of the therapy and measure if there the presence of rebleeding.
干预措施: Endoscopy Exam (Procedure)
Group 2
Patients with a clinical diagnosis of upper gastrointestinal bleeding and that during endoscopy revealed to non-varicose bleeding lesions in the endoscopic treatment being necessary. The group will be submitted to injection of adrenaline at a proportion of 1: 10,000 in the four quadrants of the lesion associated with application adsorption powder, marketed under the name Hemospray. The patients will be submitted to endoscopy exam in 12 to 24 hours after the therapeutic procedure to confirm the success of the therapy and measure if there the presence of rebleeding.
干预措施: Adrenaline (Drug)
结局指标
主要结局
Initail hemostasis after endoscopic hemostatic procedure
时间窗: up to 24 hours after endoscopic hemostatic procedure
次要结局
- Rebleeding rate after endoscopic hemostatic procedure(participants will be followed for the duration of hospital stay, an expected avarage of 1 week)