The Use of Over-the-scope-clip (OTSC) Versus Standard Therapy for the Prevention of Rebleeding in High Risk Peptic Ulcers: a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The number of cases that develop clinical rebleeding
研究概览
简要总结
Non-variceal acute gastrointestinal bleeding is a common and potentially life-threatening problem. The conventional treatment of this condition is for esophagogastroduodenoscopy (OGD) for haemostasis. Treatment methods include heater probe, clipping and injection of adrenaline. Recently, a new device called the Over-the-scope clip (OTSC) has been device to treat perforations and bleeding in the gastrointestinal tract. Therefore, the aim of the study is to compare between the treatment outcomes between OTSC and conventional endoscopic haemostatic methods in ulcers that are of high risk for rebleeding.
详细描述
Acute upper gastrointestinal bleeding is a common and potentially life-threatening condition. Non-variceal bleeding accounts for more than 80-90% of the cause with gastroduodenal peptic ulcer being the major cause. Endoscopic haemostasis has significantly improved the outcome of these patients. Recurrent bleeding remains one of the most important predictors of mortality. Previous studies have identified ulcers that are high risk for rebleeding.
Conventionally, endoscopic haemostasis is achieved by injection therapy, thermocoagulation or mechanical therapy such as haemostatic clips. However, there are limitations to thermo-coagulation and conventional haemostatic clips. Over the past few years, a novel endoscopic clipping device, the Over-The-Scope Clip (OTSC; Oversco Endoscopy AG, Tübingen, Germany) has become available. The device provides a robust and strong tissue apposition. The system was developed to close perforations and treat bleeding in the gastrointestinal tract. In chronic ulcers, an anchor device can be used to pull the ulcer base toward the aspiration cap to facilitate accurate clip application. With a larger jaw width and greater strength, the OTSC is expected to have superior haemostatic properties when compared to hemo-clips. Case series have been published on the clinical experience of OTSC on gastrointestinal bleeding with promising results.
Therefore, in this randomised controlled trial, we aim to compare the efficacy of the OTSC to standard endoscopic therapy in primary treatment of patients with peptic ulcer bleeding that are of high-risk for rebleeding. The hypothesis is that the use OTSC can significantly decrease the rebleeding rate in this group of patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participant, the investigator and the outcome assessor would 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
- •Actively bleeding peptic ulcers (Forrest Ia, Ib), ulcers with non-bleeding visible vessel or Forrest IIa ulcer (defined as protuberant discoloration, or ulcers with an initial clot and upon irrigation shows a vessel) AND
- •Ulcer size ≥ 1.5 cm as determined by an opened biopsy forceps;
排除标准
- •Patients aged below 18
- •Peptic ulcer with concomitant perforation
- •Tumor bleeding
- •Variceal bleeding
- •Patients who are pregnant or lactating
- •Moribund patients or patients with terminal malignancy or end-stage non-malignant conditions, in whom life expectancy is less than 30 days
结局指标
主要结局
The number of cases that develop clinical rebleeding
时间窗: Within 30 days of therapy
Clinical rebleeding is defined as fresh hematemesis, fresh melena or hematochezia and signs of hypovolemic shock (systolic blood pressure of \<90mmHg and pulse rate \>110 per minute) and/or a drop in hemoglobin of \> 2 g/dl per 24 hours despite adequate transfusion. Rebleeding would be confirmed by an immediate endoscopy showing fresh blood in stomach or active bleeding from a previously seen ulcer. A clinical rebleeding will be independently reviewed by an adjudication panel.
次要结局
- Hospital stay(up to one year)
- Number of units of blood transfusion required in each patient(within 30 days of therapy)
- Number of cases with failure of achieving primary haemostasis(Within 30 days of therapy)
- Hospital costs(Up to one year)
- Number of cases that died(within 30 days of therapy)
- The number of cases requiring further interventions such as repeat endoscopy, surgery or transarterial embolization(Within 30 days of therapy)
研究者
CHAN SHANNON MELISSA
Resident Specialist
Chinese University of Hong Kong