Safety and Efficacy of Endoscopic Ultrasound-Guided Gastroenterostomy for the Treatment of Malignant Gastric Outlet Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Incidence of immediate adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
研究概览
简要总结
Malignant gastric outlet obstruction is a very disabling complication of patients with gastric, duodenal, ampullary, pancreatic, or bile duct cancer and worsens their prognosis. Current treatments have reported a similar complication rate and higher mortality in surgically treated patients. Recently, the creation of endoscopic ultrasound-guided gastroenterostomy (EUS) has shown promising results in these patients. The aim of this research is to determine the safety and efficacy of EUS-guided gastro-enterostomy in the treatment of patients with malignant gastric outlet obstruction.
详细描述
Malignant gastric outlet obstruction is a very disabling complication that occurs in 15% to 25% of patients with gastric, duodenal, ampullary, pancreatic, or bile duct cancer and worsens their prognosis. Roux-en-Y gastrojejunostomy is considered the gold standard treatment with technical success of 98.6% (97-3% -99.9%) and clinical success of 80.1% with patency of 169.2 (136.8-201.7) days. On the other hand, the technical success reported for self-expanding metal stents is 96.2% (94.1% vs. 98.4%), technical success is 79.4%, and patency at 6 months was only 57%. However, complications occur in a similar way in both forms of treatment (major complications in 6% and late complications in 17% in both, but mortality is higher in the group treated with Roux-en-Y gastrojejunostomy (29% vs. 17%). , p <0.001) Recently, the creation of endoscopic ultrasound-guided gastroenterostomy has shown success rates of over 90% in case series, but prospective studies evaluating the safety and efficacy of the procedure are lacking. The aim of this research to determine the safety and efficacy of EUS-guided gastro-enterostomy in the treatment of patients with malignant gastric outlet obstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders over 18 years of age with gastric outlet obstruction syndrome secondary to stage III or more at gastric, duodenal or pancreatic cancer who are candidates for palliative treatment, who do not want surgical treatment.
- •Diagnosis confirmed as follows:
- •Histopathological report of cancer.
- •Simple and contrasted thoracoabdominal tomography.
- •Tolerance to oral feeding based on liquids only or null.
排除标准
- •Patients who do not accept the signing of the informed consent.
- •Postoperative patients with Roux-en-Y gastrojejunostomy.
- •Patients with large volume ascites.
- •Patients with malignant obstruction distal to the jejunal puncture.
- •Pregnant women.
- •Patients with a Karnofsky index less than 50 or an E.C.O.G. greater than or equal to 4 points.
- •Patients in whom any endoscopic procedure has been contraindicated for any reason.
- •Patients who want to undergo surgical treatment as an initial option.
- •Patients with malignant biliary obstruction without endoscopic treatment at the time of gastric outflow tract obstruction presentation.
- •Elimination Criteria:
- •Patients who undergo the endoscopic procedure but cannot be completed due to transmural invasion of malignancy, hemorrhage or inability to puncture the intestinal loop with any method described, puncture site> 2cm away from the gastric wall or inability to pass the guidewire through obstruction (unless direct technique is performed).
- •Patients who do not attend follow-up.
结局指标
主要结局
Incidence of immediate adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
时间窗: Adverse events will be recorded during the first 24 hours of the procedure
To evaluate the proportion of patients that presents with bleeding , prostheses misplacement or perforation.
Incidence of early-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
时间窗: Adverse events will be recorded after the first day up to 30 days of the procedure
we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.
Incidence of mid-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
时间窗: Adverse events will be recorded from the first month up to the third month after procedure
we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.
Incidence of long-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
时间窗: Adverse events will be recorded after the third month of the stent placement up to study completion, an average of 6 months
we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.
Incidence of the correct stent placement for endoscopic ultrasound gastro-enterostomy anastomosis creation at the desired loop
时间窗: During each procedure correct stent placement will be assessed
Technical success: We will determine the ability to place the stents in the desired loop and in a correct position.
次要结局
- Changes in quality of life assessed by the self-report health-related quality of life questionnaire in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.(Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.)
- Changes in functional status with Eastern Cooperative Oncology Group (ECOG) performance scale in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.(Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.)
- Improvement in tolerance to oral feeding assessed by the gastric outlet obstruction scoring system (GOOSS) in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy(Immediately after the intervention/procedure/surgery and every month through study completion, an average of 6 months)
- Changes of functional impairment assessed by Karnofsky Performance Scale Index in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.(Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.)