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
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Proportion of patients unable to tolerate a solid diet (defined as gastric outlet obstruction scoring system)
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 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
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age ≥ 18 years
- •Presence of gastric outlet obstruction on any imaging or endoscopy from known or suspected malignancy
- •Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only).
排除标准
- •Age less than 18 years Intrauterine pregnancy Use of anticoagulants that cannot be discontinued for the procedure Unable to obtain consent for the procedure from either the patient or LAR.
结局指标
主要结局
Proportion of patients unable to tolerate a solid diet (defined as gastric outlet obstruction scoring system)
时间窗: 1. Pre index procedure | 2. Post index procedure | 3. Day of Discharge | 4. 1 month post index procedure | 5. 3 month post index procedure | 6. 6 month post index procedure
and overall rate of adverse event
时间窗: 1. Pre index procedure | 2. Post index procedure | 3. Day of Discharge | 4. 1 month post index procedure | 5. 3 month post index procedure | 6. 6 month post index procedure
次要结局
- 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).(At 1-month post-procedure)
- Rate of reintervention(During 6 months after Index procedure)
- Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 3-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).(At 3-month post-procedure)
- 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).(At 6-month post-procedure)
- Rate of technical success(24 hours)
- Procedure duration(24 hours)
- Time to diet advancement(During 1 month)
- Time to recurrence of obstructive symptoms(After achieving GOOSS ≥ 2 for at least 7 days at any time during follow-up.)
- Rate of persistence of symptoms(Up to 2 weeks after index procedure.)
- Total number of readmissions(During 6 months after Index procedure)
- Rate of adverse events due to procedures performed(From index procedure to upto 6 months)
- Rate of adverse events due to underlying disease(From index procedure to upto 6 months)
- Total length of hospital stay(From the date of the procedure to the date of discharge.)
- Length of survival(post-procedure.)
- Quality of life measurement(At baseline, discharge, 1 months and 6 months post procedure.)
- Overall treatment costs from index procedure until 6 months post-index procedure.(At 6 months post procedure)
研究者
Dr Rajesh Puri
Medanta The Medicity