Over-the-scope Clip Versus Through-the-scope Clip for Endoscopic Hemostasis of High Risk Bleeding Peptic Ulcers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- successful haemostasis rate
研究概览
简要总结
To compare in a multicenter, prospective, randomized, controlled trial the efficacy and safety of OTSC versus TTS clip for first-line hemostasis of high risk bleeding peptic ulcers
详细描述
Despite major advances in the management of non-variceal upper gastrointestinal bleeding (NVUGIB) over the past decade including prevention of peptic ulcer bleeding, optimal use of endoscopic therapy and high-dose proton pump inhibition, this still carries considerable morbidity, mortality and health economic burden Of particular note are the re-bleeding rates, one of the most crucial predictive factors of morbidity and mortality that has not significantly improved as evident from longitudinal data in the past 15 years Although huge advances have been made in terms of therapeutic endoscopic devices available today, complete haemostasis of complicated lesions (i.e. severe bleeding from large vessels or fibrotic ulcer) still remains a challenge and can be difficult to achieve. In particular, traditional clipping devices often appear technically difficult to place and insufficient to provide adequate tissue compression to obliterate large bleeding vessels.
The over-the-scope clip (OTSC) (Ovesco Endoscopy AG, Tubingen, Germany) system is a recently developed endoscopic device. In a preliminary experience, it has been successfully used in patients with severe bleeding or deep wall lesions, or perforations of the GI tract.
Recent retrospectives studies have demonstrated the efficacy and safety of OTSC in patients undergoing emergency endoscopy for severe acute NVUGIB after failure of conventional techniques and as first-line To the best of the investigator's knowledge, no randomized clinical trial have been performed investigating the use of OTSC as first-line endoscopic treatment in patients with high-risk NVUGIB.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with suspected NVUGIB and subsequent endoscopic finding of peptic ulcer (Ia-IIb according to Forrest classification)
- •age ≥ 18 years
排除标准
- •patients who refused to participate at the trial
- •pregnancy
结局指标
主要结局
successful haemostasis rate
时间窗: during the EGDS
defined as the absence of bleeding upon at least one minute observation after the assigned endoscopic therapy
30-day rebleeding
时间窗: up to 30 days
re-bleeding episodes (per patient), after the primary endoscopic hemostatic treatment, defined as one or more of the following signs: * hematemesis * presence of fresh blood in the nasogastric tube * hemodynamic instability (pulse and blood pressure) * reduction of Hb by more than 2 g/dL over a 24 h period (early recurrence) or over a 7 days period (late recurrence) after initial stabilization
overall clinical success
时间窗: up to 30 days
defined as successful homeostasis rate without evidence of 30-day rebleeding
次要结局
- lenght of hospital stay(up to 30 days)
- transfusion requirements(up to 30 days)
- mortality(up to 30 days)
- need for radiology(up to 30 days)
- need for surgery(up to 30 days)
研究者
Dr. Mauro Manno
Director, Head of Digestive Endoscopy Unit, Principal Investigator
Azienda USL Modena