Serie de Casos Prospectiva de Gastroenteroanastomosis Guiada Por Ecoendoscopia Para la obstrucción al Vaciado gástrico en Neoplasias Avanzadas Mediante la técnica Del Drenaje Nasobiliar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 5
- 主要终点
- Early Clinical Success
研究概览
简要总结
Gastric outlet obstruction in malignant disease appears when the tumor affects the gastroduodenal area, precluding the passage of food into the small bowel. This condition severely affects the quality of life. In patients with unresectable tumors, there are various available treatments:a surgical bypass connecting the stomach to the small bowel, placing a stent through the tumor to widen the passage and creating a gastrointestinal bypass with a lumen apposing metal stent. These stents are deployed with an echoendoscope, which allows to identify a small bowel loop and to deploy the stent, connecting the small bowel and the stomach. This is called a EUS-guided gastroenterostomy (EUS-GE).
EUS-GE is a rather novel procedure. Various techniques to create EUS-GE have been proposed. In this study, the investigators will retrieve data from the procedure and during the thirty following days from consecutive patients undergoing an EUS-GE. The objectives of the study are:
- To perform a detailed step by step description of the nasobiliary drain assisted EUS-GE
- To describe the adverse events encountered
- To describe the proportion of clinical and technical success
- To assess its impact on the patients' quality of life.
- To assess the evolution of the oral intake during the first month after the procedure
详细描述
DESIGN
Prospective multicenter case series
AIMS
Primary aim To describe the proportions of technical and clinical success. To describe different variants in the nasobiliary drain assissted EUS-GE technique, offering a detailed step by step description of the procedure performance by different endoscopists
Secondary aims:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients over 18 years of age
- •unresectable malignant gastric outlet obstruction
- •Undergoing placement of nasobiliary drain assisted EUS-GE
排除标准
- •Previous gastroduodenal surgery
- •Previous endoscopic or surgical treatment for gastric outlet obstruction
- •Simultaneous biliary obstruction (malignant or benign) requiring endoscopic treatment
- •Simultaneous upper digestive tract disease requiring endoscopic treatment in the same procedure
- •Unable to understand the questionnaires
- •Distal bowel obstruction
- •Ascites grade 2 or superior
- •Uncorrectable coagulation disorders (INR>1,5) or severe thrombocytopenia (<50000 platelets/mm3).
- •Active, symptomatic SARS-CoV-2 infection
结局指标
主要结局
Early Clinical Success
时间窗: Day +7
Defined as a GOOSS \>=2.
Technical Success
时间窗: Day +1
An adequate stent placement across the GI walls, with one flange in the gastric cavity and the other in the small bowel lumen. It has to be confirmed either fluoroscopically or endoscopically.
Clinical Success
时间窗: Day +30
Defined as a GOOSS \>=2.
次要结局
- Number of Participants With Delayed Treatment-Related Adverse Events as Assessed by the ASGE classification(day+30)
- Total volume infused (ml)(Procedure)
- Baseline European Organisation for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30)(Baseline)
- Target bowel loop diameter (mm)(Procedure)
- Number of patients undergoing balloon dilation(Procedure)
- Baseline Gastric outlet obstruction score system (GOOSS)(Baseline)
- Final Gastric outlet obstruction score system (GOOSS)(day +30)
- Number of Participants With intraprocedure Treatment-Related Adverse Events as Assessed by the ASGE classification(day+1,)
- Number of Participants With Early Treatment-Related Adverse Events as Assessed by the ASGE classification(day+7)
- Early Gastric outlet obstruction score system (GOOSS)(day +7)
- Final European Organisation for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30)(Baseline, day+30)
- Recurrent GOO(Day +30)
- Type of fluid employed(Procedure)
研究者
Francisco Javier Garcia Alonso
Md PhD
Hospital del Río Hortega