Randomized Controlled Multi-Center Non-Inferiority Trial of UI-EWD (Nexpowder™) vs. Conventional Treatment as First-Line Endoscopic Therapy for Patients With High-Risk Nonvariceal Upper Gastrointestinal Bleeding (TREET)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 278
- 试验地点
- 25
- 主要终点
- No further bleeding during the 7-day period after hemostatic treatment
研究概览
简要总结
A prospective, multi-center, noninferiority randomized controlled trial designed to compare the efficacy of UI-EWD (Nexpowder™) hemostatic powder versus conventional endoscopic hemostatic therapy in patients presenting with acute overt gastrointestinal bleeding which is found at endoscopy to be due to one of the following sources: a gastric or duodenal ulcer with active bleeding (spurting or oozing) or a non-bleeding visible vessel; an esophageal, gastric or duodenal tumor with active bleeding or a non-bleeding visible vessel; a gastric or duodenal Dieulafoy lesion with active bleeding or a non-bleeding visible vessel; or an actively bleeding Mallory-Weiss tear.
详细描述
Endoscopic hemostatic therapy is recommended as the first line therapy for patients with upper gastrointestinal bleeding (UGIB) due to ulcers with active bleeding or a non-bleeding visible vessel identified at endoscopy. A variety of endoscopic modalities are used in the treatment of UGIB, including thermal therapies (e.g., bipolar electrocoagulation), injection therapy (e.g., epinephrine), clips, and hemostatic powder spray. Topical therapies, such as hemostatic powder spray, have been the most recent addition to the armamentarium of endoscopic therapies for UGIB.
UI-EWD hemostatic powder (Nexpowder™), which is manufactured by NextBiomedical and distributed by Medtronic, is approved for treatment of nonvariceal GI bleeding in the U.S., Canada, European Union and other countries.
A retrospective study of UI-EWD hemostatic powder in 56 patients with active bleeding found immediate hemostasis in 54 (96.4%), with rebleeding within 7 days in only 2 patients (3.7%)[1]. A large multi-center randomized trial in 340 patients with nonvariceal UGIB and either active bleeding or a non-bleeding visible vessel compared conventional endoscopic hemostatic therapy alone to conventional therapy plus UI-EWD. Rebleeding was significantly lower in the UI-EWD group at 3 days (3 vs. 11%) and at 30 days (19% vs. 7%) [2].
The primary aim of this trial is to demonstrate that UI-EWD when used as initial hemostatic therapy is non-inferior to older conventional endoscopic hemostatic therapy for the treatment of patients with high-risk nonvariceal upper GI bleeding.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 22 years or older
- •Presentation with acute overt gastrointestinal bleeding (hematemesis, melena, and/or hematochezia)
- •Subject voluntarily agrees to participate in the clinical investigation, provides written informed consent, and will be able to comply with the investigational protocol in the opinion of the site investigator
- •Cause of bleeding as determined at upper endoscopy is one of the following sources: a gastric or duodenal ulcer with active bleeding (spurting or oozing) or a non-bleeding visible vessel; an esophageal, gastric or duodenal tumor with active bleeding or a non-bleeding visible vessel; a gastric or duodenal Dieulafoy lesion with active bleeding or a non-bleeding visible vessel; or an actively bleeding Mallory-Weiss tear. The definition of "active oozing" will require bleeding to persist for ≥ 3 minutes of endoscopic observation.
排除标准
- •Incarceration
- •Subjects that are not able to provide written informed consent
- •Pregnancy or nursing mothers
- •Endoscopic hemostatic treatment in the past 30 days
- •Use of triple antithrombotic therapy at the time of presentation
- •Subjects who underwent gastric or duodenal endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) procedures within the past 2 months
- •Post-polypectomy bleeding
- •Subjects with erosive esophagitis, erosive gastritis, esophageal ulcer, or vascular ectasia including gastric antral vascular ectasia
- •Platelet count < 50 x 10^9/L
- •INR > 3.5 (or prothrombin time >35 seconds in patient not on warfarin and only prothrombin time is provided by local lab), at time of procedure or closest to procedure time
- •Subjects who have documented galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Subjects with documented hypersensitivity to Brilliant Blue FCF
- •Subjects with suspected bowel obstruction or gastrointestinal fistulas, and those suspected or are at high risk of having gastrointestinal perforation.
- •Endoscopy not performed within 36 hours of presentation to hospital/emergency department
研究组 & 干预措施
Test Group
UI-EWD
干预措施: UI-EWD (Device)
Control Group
Conventional endoscopic therapy
干预措施: Conventional therapy (Device)
结局指标
主要结局
No further bleeding during the 7-day period after hemostatic treatment
时间窗: 7 days
Further bleeding includes patients with persistent bleeding despite study-assigned endoscopic therapy or patients with recurrent bleeding
次要结局
- Composite 30-day outcome of further bleeding(30 days)
- Initial hemostasis for patients with active bleeding at randomization(During index endoscopy procedure)
- Number of participants with recurrent bleeding over the 7-day period after randomization(7 days)
- Mortality(30 days)
- Initial hemostasis for patients with active bleeding at randomization(During index endoscopy procedure)
- Number of participants with recurrent bleeding over the 7-day period after randomization(7 days)
- Mortality(30 days)
- Composite 30-day outcome of further bleeding(30 days)