EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 9
- 主要终点
- Rate of gastric outlet obstruction recurrence
研究概览
简要总结
Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is associated with substantial morbidity. Palliation of GOO has traditionally been through the surgical bypass of the obstructed lumen by creating an opening between the stomach and small intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this study, the investigators are going to compare the safety and efficacy of the two different endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) and enteral stenting (ES).
详细描述
In recent years, Enteral Stenting (ES) has commonly been used as the first line management of unresectable malignant gastric outlet obstruction. On the other hand, Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is the most recently described technique for palliation of malignant GOO, which has the theoretical potential to minimize the risk for stent occlusion while maintaining the less invasive endoscopic approach. This novel endoscopic treatment entails creating a gastroenterostomy under EUS-guidance thereby bypassing the occluded lumen. This endoscopic technique has been performed to treat patients with GOO since 2014, and recent retrospective studies have shown that EUS-GE was comparable to ES in terms of efficacy and safety; however, EUS-GE was associated with a significantly decreased risk of recurrent GOO and reinterventions.
Based on the investigator's clinical experience for the last three years and the above-mentioned study results, the goal of this study is to prospectively compare EUS-GE with ES in the management of unresectable malignant gastric outlet obstruction. The investigators hypothesize that EUS-GE is associated with comparable technical and clinical success and safety profile while requiring fewer re-interventions.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with malignant, symptomatic gastric outlet obstruction due to an unresectable malignant lesion
- •Gastric outlet obstruction scoring system (GOOSS) score of 0 (no oral intake) or 1 (liquids only)
- •Age 18-80 years
排除标准
- •Evidence of other strictures in the gastrointestinal (GI) tract
- •Previous gastric, periampullary or duodenal surgery
- •World Health Organization (WHO) performance score of 4 (patient is 100% of time in bed)
- •Unable to fill out quality of life questionnaire
- •Unable to sign the informed consent
- •Life expectancy of less than 3 months based on the endoscopist's opinion
- •Cancer extending into the body of the stomach, 4th portion of the duodenum or proximal jejunum around the ligament of Treitz
- •Large volume ascites
- •Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other severe comorbidities
- •Pregnant or breastfeeding women
- •Uncorrectable coagulopathy defined by INR > 1.5 or platelet < 50000/µl
- •Complete GOO evidenced by inability to either pass a wire across the stricture and/or inability to opacify small bowel distal to the malignant stricture
- •Resectable or borderline resectable tumors
- •One of the two techniques (EUS-GE and ES) cannot be performed (at the discretion of the endoscopist)
研究组 & 干预措施
EUS-guided gastroenterostomy (EUS-GE)
In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.
干预措施: Lumen-apposing metal stent (Device)
Enteral Stenting (ES)
In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.
干预措施: Self-expandable metal stent (Device)
结局指标
主要结局
Rate of gastric outlet obstruction recurrence
时间窗: 3 months
Recurrence of nausea, vomiting, and inability to tolerate PO intake up to 3 months after the procedure confirmed either endoscopically and/or radiographically.
Percentage of Participants With Gastric Outlet Obstruction Recurrence
时间窗: 12 months
Defined as percentage of participants with recurrence of nausea, vomiting, and inability to tolerate PO intake up to 12 months after the procedure confirmed either endoscopically and/or radiographically.
次要结局
- Reintervention rate for recurrent gastric outlet obstruction(3 months)
- Gastric Outlet Obstruction Scoring system (GOOSS)(1 year)
- Technical success rate(Day of procedure)
- Clinical success rate(1 week)
- Time to recurrent gastric outlet obstruction(3 months)
- Length of procedure(Day of procedure)
- Adverse events rate(1 week)
- Post-procedure length of hospital stay(1 week)
- Quality of Life SF-36 questionnaire scoring(3 months)
- Duration of stent patency(3 months)
- Overall survival rate(1 year)
- Stent Dysfunction Rate(3 months)
- Technical Success Rate(Day of procedure)
- Participants With Improved Clinical Success Rate(1 week)
- Length of Procedure(Day of procedure)
- Participants With Adverse Events(12 months)
- Post-procedure Length of Hospital Stay(1 week)
- Reintervention Rate for Recurrent Gastric Outlet Obstruction(12 months)
- Quality of Life SF-36 Questionnaire Scoring(3 months)
- Overall Survival Rate(1 year)
- Time in Days to Recurrent Gastric Outlet Obstruction(12 months)