The Use of Over-the-scope-clips in Large Bleeding Gastro-duodenal Ulcers; a Randomized Comparison to Standard Endoscopic Hemostatic Methods
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 136
- 主要终点
- bleeding free probability in 30 days after randomization
研究概览
简要总结
In managing bleeding gastroduodenal ulcers, endoscopic control of bleeding is the first line treatment-further bleeding after endoscopic hemostasis is associated with a 3-fold increase in mortality. Large ulcer size (> 20 mm) predicts further bleeding. These ulcers erode into arteries of significant size (>2 mm) from either the gastro-duodenal or left gastric arterial complexes. An over-the-scope clip is an endoscopic clamp device with a high tensile strength. It can compress sizeable arteries, and firmly anchor onto the ulcer base avoiding recurrent bleeding from clip dislodgement. It therefore offers secure and durable hemostasis.
In the proposed randomized controlled trial, the investigators hypothesize that after initial endoscopic control of bleeding from large gastro-duodenal ulcers (20 mm in size or more), adding an OTSC can prevent recurrent bleeding and improve patients' outcomes. Investigators enroll patients with bleeding from large ulcers as defined. After initial endoscopic control of bleeding using injection with diluted epinephrine, these patients are randomized, during endoscopy, to receive standard treatment (thermo-coagulation or hemo-clips) or an added OTSC. The primary endpoint is recurrent bleeding over 30 days confirmed on endoscopy. Secondary endpoints include the need for rescue treatment; endoscopic, angiographic embolization or surgery, red blood cell (RBC) transfusion, hospitalization, and bleeding related and all-cause mortality.
详细描述
Endoscopic hemostatic treatment is the cornerstone of the management of patients with acute nonvariceal upper gastrointestinal bleeding. The current standard in endoscopic hemostasis includes the use of hemo-clips or contact thermal devices with or without pre-injection with diluted epinephrine. However, the failure rate with either method approaches 10%. Further bleeding after endoscopic treatment is associated with a 3-fold increase in mortality. The United Kingdom audit reported a 30% mortality in those who required surgery after failed endoscopic treatment.
Over-the-scope clips (OTSCs) are memory-shaped nitinol clips that are cap-mounted onto the end of an endoscope. They were designed for endoscopic closure of full-thickness mucosal defects. They are being increasingly used for the purpose of hemostasis. When deployed, the OTSC provides firm compression on bleeding vessels of significant sizes (>2mm). The retention rate with OTSCs is high avoiding recurrent bleeding from clip dislodgement.
The OTSCs were first evaluated as a rescue treatment in the German Multicenter Trial (Stop the Bleeding or STING 1 trial). The trial enrolled patients with bleeding from their ulcers refractory to standard endoscopic treatment and randomized them to receive either OTSC or further treatment with standard methods. Further bleeding within 30 days after either treatment was 15.2% and 57.6% respectively.
The primary use of OTSC i.e. as the first hemostatic device has been studied in several trials. (see Table 1).
Table 1: Further bleeding in 30 days Author, Year OTSC Standard Treatment
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
- 18 Years 至 111 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients admitted with acute upper gastrointestinal bleeding (melena, hematemesis, or decrease in hemoglobin level with or without hypotension).
- •large gastro-duodenal ulcers (20 mm in size or more)
- •active bleeding (pulsatile or Forrest Ia bleeding, oozing from a visible vessel, or Forrest Ib bleeding) or a nonbleeding visible vessel (Forrest IIa lesion). Clots overlying bleeding lesions are injected with diluted epinephrine and then irrigated or elevated using a cheese-wiring technique. If a vessel is then unveiled, we can proceed with randomization.
排除标准
- •patients with esophagogastric varices
- •pregnant or lactating women
- •patients who cannot provide written consent
- •moribund from their co-morbid illnesses and are not considered for active treatment.
结局指标
主要结局
bleeding free probability in 30 days after randomization
时间窗: 30 days
further bleeding defined by the composite of failure to control bleeding after assigned endoscopic treatment and recurrent bleeding.
次要结局
- number of participants using surgical treatment(30 days)
- second endoscopic attempts at hemostasis(30 days)
- failure to control bleeding with assigned endoscopic treatment and recurrent bleeding after initial hemostasis(30 days)
- number of participants using angiographic treatment(30 days)
研究者
James Yun-wong Lau, MD
PROFESSOR
Chinese University of Hong Kong