Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Re-intervention rate
研究概览
简要总结
To compare the efficacy of a novel partially covered (PC) versus uncovered (UC) pyloro-duodenal stents (DS) in unresectable malignant gastric outlet obstruction. We hypothesize that the use of PCDS could reduce the re-intervention rates when compared to UCDS.
详细描述
This would be a prospective multi-centred double-blinded randomised controlled study including all patients suffering from malignant gastric outlet obstruction due unresectable primary gastro-duodenal or pancreatico-biliary malignancies. Five international institutions in Hong Kong, Singapore and India would participate in the study.
The procedure would be performed under conscious sedation or monitored anaesthesia. The patients would be randomised PCDS or UCDS after cannulation of the obstruction site is achieved with the guide-wire. The patients or assessors would be blinded to the type of stent that is inserted.
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
- Single (Participant)
盲法说明
Recruited patients would not be informed of the type of stent that was inserted
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
- •Consecutive patients ≥ 18 years old
- •Confirmed unresectable gastro-duodenal or pancreatico-biliary malignancies
- •Suffering from gastric outlet obstruction with a gastric outlet obstruction score of ≤ 1 (appendix 1) 19
- •Performance status ECOG ≤3 (appendix 2)
排除标准
- •Prior metallic stent placement
- •Severe comorbidities precluding the endoscopic procedure (such as cardiopulmonary disease, sepsis, or a bleeding disorder)
- •Life expectancy of less than 1 month
- •History of gastric surgery
- •Linitus plastica
- •Coagulation disorders
- •Pregnancy
- •Unable to give informed consent
研究组 & 干预措施
Partially covered duodenal stent (PCDS)
The PCDS used in the current study is a partially covered metallic pyloro-duodenal stent. It consists of two portions. The stent is 2cm in diameter and the proximal 2cm of the stent is uncovered and flared. The remaining of the stent is covered, where a polytetrafluoroethylene (PTFE) membrane is held between two nitinol mesh.
干预措施: Partially covered pyloro-duodenal stent (Other)
Uncovered duodenal stent (UDS)
The UCDS used in the current study is an uncovered stent made of nitinol wire, with a diameter of 20mm. This stent is an unfixed-cell braided stent with low axial force, high flexibility and good conformability.
干预措施: Uncovered pyloro-duodenal stents (Other)
结局指标
主要结局
Re-intervention rate
时间窗: 1 year
Percentage of patients requiring additional endoscopic intervention due to stent dysfunction
次要结局
- Mortality(30 days)
- Duration of stent patency(1 year)
- Clinical success(3 days)
- Adverse events rate(1 year)
- Gastric outlet obstruction scores (GOOS)(1 year)
- Stent dysfunction(1 year)
- Technical success(1 day)
- Quality of life assessment scores(1 year)
研究者
Anthony Teoh
Honorary Associate Professor
Chinese University of Hong Kong