Randomized Controlled Trial (RCT) of Standard Endoscopic Hemostasis Compared to OVESCO for Severe Non-variceal UGI Hemorrhage
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- The rebleeding rate of non-variceal focal UGI lesions
研究概览
简要总结
The primary specific aim is to perform a randomized controlled trial (RCT) to compare 30 day rebleed rates and other clinical outcomes of patients with severe, non-variceal upper GI hemorrhage (NVUGIH) - ulcers and Dieulafoy's lesions who are randomized as initial treatment with the new large over-the-scope-clip device for endoscopic hemostasis versus standard endoscopic hemostasis.
详细描述
Upper GI Hemorrhage (UGIH) causes significant morbidity and mortality, although endoscopic hemostasis has revolutionized management of these patients. Despite standard endoscopic treatment and high dose proton pump infusions, 25% - 30% of high risk patients with UGIB from ulcers or other non-variceal UGI lesions (NVUGI) had recurrent bleeding in a recent RCT and cohort studies by our group. Potential risk factors for NVUGI rebleeding were large ulcers (≥ 15 mm), fibrotic bases, Dieulafoy's lesions, anastomotic ulcers, coagulopathies, cirrhosis, other severe co-morbidities and residual arterial blood flow under stigmata of recent hemorrhage (SRH) after endoscopic treatment. Such patients with rebleeding after standard endoscopic hemostasis usually required angiography (by interventional radiologists-IR) or surgery for definitive hemostasis. A new, large, FDA approved, over-the-scope hemoclipping device (OTSC® System OVESCO Endoscopy, Tübingen, Germany) can capture larger amounts of tissue and underlying arteries than standard hemoclips and potentially can improve endoscopic hemostasis of such bleeding lesions.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent from the patient or a surrogate.
- •Clinical evidence of severe UGIB.
- •Presence of a benign appearing peptic ulcer, anastomotic ulcer, or Dieulafoy's lesion, with some SRH on endoscopy.
- •Severe upper GI bleeding.
- •Life expectancy of at least 30 days based on lack of severe or terminal comorbidity as judged by the generalist or subspecialist caring for the patient.
排除标准
- •Patients who are do-not-resuscitate (DNR) that is not reversible, uncooperative, refuse to participate, or are unable to give consent personally or through a legal surrogate.
- •Active GI malignancy, under treatment but not in remission.
- •Acute hypovolemic shock that is unresponsive to transfusion of 5 or more units of red blood cells (RBC's) or requires continuous intravenous vasopressor infusion for blood pressure support.
- •ASA (American Society of Anesthesiology) class V or higher, moribund, or with a very poor prognosis and expected survival <30 days.
- •Severe coagulopathy or thrombocytopenia despite attempted reversal with transfusion of blood products (e.g persistent International Normalized Ratio [INR] >2.0, platelet count <20,000, a Partial Thromboplastin Time [PTT] greater than 2x upper limit of normal).
- •Absolute contraindication to urgent endoscopy (such as suspected perforated viscus, or peritonitis).
- •Stricture of the esophagus or pylorus that can not be dilated or precludes passage of a diagnostic sized endoscope and/or the GI endoscope with an 11, 3a OTSC device attached.
结局指标
主要结局
The rebleeding rate of non-variceal focal UGI lesions
时间窗: Outcome measure will be assessed at 30 days after participants are enrolled
The investigators will compare the rebleeding rate at 30 days follow up in the two treatment groups for all patients, ulcer patients only, and also patients with major stigmata of hemorrhage vs. lesser stigmata (oozing or flat spots).
次要结局
- Obliteration rates of underlying arterial blood flow (detected by Doppler endoscopic probe)(Outcome measure will be assessed at 30 days after the endoscopy treatment is completed)
- Rates of surgery or IR, complications, and death(Outcome measure will be assessed at 30 days after participants are enrolled)