Randomized Trial Comparing Endoscopic Ultrasound-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Composite end point of inability to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring additional interventions or supplemental nutrition or procedure-related adverse events.
研究概览
简要总结
Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.
详细描述
Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The consequences of GOO are abdominal pain, nausea, vomiting, anorexia, inability to maintain an oral diet and weight loss, with associated poor quality of life and inability to continue with cancer therapy. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.
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 (Outcomes Assessor)
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
- •Presence of gastric outlet or duodenal obstruction on any imaging or endoscopy from known or suspected inoperable malignancy
- •Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only)
- •Amenable to treatment by both EUS-guided and surgical gastrojejunostomy
排除标准
- •Age < 18 years
- •Intrauterine pregnancy
- •Use of anticoagulants that cannot be discontinued for the procedure or irreversible coagulopathy
- •Unable to obtain consent for the procedure from either the patient or LAR
- •Altered anatomy due to prior gastroduodenal surgery
- •Presence of other adhesions or synchronous obstructive lesions in the small bowel
- •Prior treatment for gastric outlet obstruction
- •Presence of large volume malignant ascites
结局指标
主要结局
Composite end point of inability to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring additional interventions or supplemental nutrition or procedure-related adverse events.
时间窗: 6 months
Proportion of patients unable to tolerate a solid diet at time of hospital discharge (defined as gastric outlet obstruction scoring system score \<2) or requiring additional interventions or supplemental nutrition or procedure-related adverse events.
次要结局
- Rate of persistence of symptoms(6 months)
- Rate of reintervention(6 months)
- Time to recurrence of obstructive symptoms(6 months)
- Total number of readmissions(6 months)
- Rate of adverse events due to procedures performed(6 months)
- Rate of adverse events due to underlying disease(6 months)
- Total length of hospital stay(6 months)
- Length of survival(6 months)
- Time to initiation of chemotherapy post-procedure(6 months)
- Quality of life measurement(6 months)
- Treatment costs(6 months)
- Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).(6 months)
- Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).(6 months)
- Rate of technical success(24 hours)
- Procedure duration(24 hours)
- Time to diet advancement(1 month)