Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy for Treatment of Malignant Gastric Outlet Obstruction: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Compare post procedure length of hospital stay
研究概览
简要总结
Recent comparative data suggest that EUS gastroenterostomy offers more durable patency than enteral stents for treatment of malignant GOO, leading some endoscopists to suggest that EUS gastroenterostomy should be the preferred endoscopic treatment approach.
EUS gastroenterostomy and surgical gastrojejunostomy have been compared in retrospective cohort analysis, suggesting a high technical success rate a shorter hospital length of stay for the endoscopic approach [4]. Comparison of these techniques has not been reported in controlled prospective fashion. A prospective trial is necessary in order to define the optimal interventional management option for treatment of malignant GOO in the context of the contemporary and rapidly evolved range of available endoscopic and surgical treatment options.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Due to the nature and means of access of the two interventions (one via peroral approach and one via abdominal incision) blinding of the subjects, study investigators, and treating clinicians will not be practicable short of subjecting patients to sham endoscopy and/or surgery, which we feel would be unethical.
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
- •Age 18 years or older
- •Able to provide informed consent
- •Biopsy-proven cancer
- •Cancer without surgical resection as a curative treatment option
- •Clinical and radiographic presentation consistent with primary or metastatic tumor causing foregut obstruction at the level of the pylorus and/or duodenum
排除标准
- •Age <18 years
- •Pregnancy
- •Unable to provide informed consent
- •White Blood Count < 3,000
- •Absolute Neutrophil Count < 1,500
- •International normalized ratio > 1.6
- •Platelet count < 100,000
- •Cancer with surgical resection as a curative treatment option
- •Surgically altered foregut anatomy
- •Multifocal intestinal obstruction
- •Abdominal ascites prohibitive of surgical candidacy
- •Abdominal wall mesh prohibitive of surgical candidacy
- •Child's Class B or C cirrhosis
- •Gastroesophageal varices or known portal hypertension
- •Body mass index >40
结局指标
主要结局
Compare post procedure length of hospital stay
时间窗: 14 days post-operative
This outcome will be measured as the length of hospital stay (in days) from study intervention to discharge. Any accrued hospital stay from admission prior to study intervention will not be included in this assessment.
Compare of restoration of oral intake following EUS versus surgical gastrojejunostomy
时间窗: 1 day post-operative
A GOOSS score of 0 will be defined as intolerant of oral intake, while any GOOSS score greater than 0 will be defined as tolerant of oral intake. 0: no oral intake 1. oral liquids only 2. soft solids 3. low residue or full diet This will be given to subjects
次要结局
未报告次要终点
研究者
Patrick Yachimski
Professor of Medicine
Vanderbilt University Medical Center