NCT05644951已完成不适用
A Prospective, Multi-center, Single-arm Study for Unresectable Malignant Gastric Outlet Obstruction With EUS-guided Double-balloon-occluded Gastrojejunostomy Bypass
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 12
- 主要终点
- GOOSS 3 rate without MAE
研究概览
简要总结
A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS)
详细描述
Primary objective is to investigate the safety and effectiveness of the AXIOS™ lumen-apposing Metal Stent used in the EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS) for the management of symptoms associated with gastric outlet obstruction (GOO) secondary to malignant unresectable neoplasm.
Primary Endpoint is GOOSS 3 rate without MAE at 30 days post procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Unresectable malignant duodenal obstruction confirmed by biopsy
- •Eligible for endoscopic intervention
- •GOOSS score of 0 or 1
- •18 years of age or older
- •Willing and able to comply with the study procedures or legally authorized representative (LAR) must provide written informed consent form (ICF) to participate in the study
排除标准
- •GOO symptoms are not expected to improve after the index procedure
- •Life expectancy is about 3 months or less, which is not assumed applicable for surgical GJ
- •Prior metallic stent placement for GOO
- •Contraindicated to surgery and general anesthesia
- •Neoplasm invading the target site of puncture in gastric and/or jejunum
- •Abnormal coagulation INR > 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulation
- •Bleeding diathesis
- •Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic drainage
- •Presence of ileus caused by peritoneal carcinomatosis, or expected to present within 30 days post procedure
- •Intervening gastric varices or vessels at the target site of stent insertion
- •Ascites that may interfere the safety of the index procedure
- •Biliary tract obstruction requiring treatment at the same day of the index procedure
- •Allergic to any of the device materials
- •Contraindications to use of electrosurgical devices
- •Pregnancy, breastfeeding or intending to become pregnant during the study period
- •Subject is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the study sponsor)
- •Vulnerable subject
- •Subject has other reason not to be eligible for this study per investigators' discretion
- •Guidewire doesn't cross the area of GOO
- •EP-DB doesn't advance to the target site in jejunum
- •The distance between the gastric wall and jejunal wall when visualized on ultrasound after saline is introduced into the space between the two inflated balloons of EP-DB is deemed about 2 cm or more
研究组 & 干预措施
Hot AXIOS system
Experimental
Hot AXIOS system (20 mm diameter stent)
干预措施: Hot AXIOS system used for EPASS (Device)
结局指标
主要结局
GOOSS 3 rate without MAE
时间窗: 30 days post index-procedure
GOOSS 3 rate without MAE
次要结局
未报告次要终点
研究者
研究点 (12)
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