A Prospective Multi-Center, Single-Arm Study of Endoscopic Ultrasound-Guided Gastroenterostomy With Lumen-Apposing Metal Stent for Gastric Outlet Obstruction From Malignant Unresectable Disease
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 67
- 试验地点
- 10
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
To investigate the safety and technical success of EUS-guided gastroenterostomy (EUS-GE) using the AXIOSTM lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm.
详细描述
The study is a prospective multi-center, single -arm study with treatment of up to 67 subjects at up to 10 clinical centers. Subjects who meet all eligibility criteria will receive the AXIOS stent and up to 12 months follow-up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric outlet obstruction from unresectable malignant neoplasm
- •Eligible for endoscopic intervention
- •GOOS of 0 or 1 0 - no oral intake 1 - liquids only 2 - soft solids only 3 - low-residue or full diet
- •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
- •The distance between the gastric lumen and jejunal lumen must be no more than 1.0 cm
排除标准
- •Patients with baseline ECOG > 2 and/or Karnofsky Performance score < 30
- •Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent
- •Abnormal coagulation INR > 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulation, and/or any underlying condition associated with high risk of bleeding
- •Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic gastroenterostomy
- •Multiple-level bowel obstruction downstream from the intended location of the EUS-guided bypass confirmed by radiography such as small bowel series or computed tomography
- •Presence of intraperitoneal fat between the gastric lumen and jejunal lumen estimated to be larger than 1.0 cm at the proposed site of AXIOSTM stent insertion
- •Gastric varices located within a two-centimeter radius of the device insertion location on the gastric wall
- •Ascites Grade ≥ 2 confirmed by cross-sectional imaging
- •Vessels located within a two-centimeter radius of the device insertion location
- •History of multiple abdominal surgeries and/or evidence of small bowel adhesions
- •Allergic to any of the device materials
- •Contraindications to use of electrical devices
- •Prisoners and other vulnerable populations
研究组 & 干预措施
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
Patients who meet all the inclusion criteria and none of the exclusion criteria will have a EUS-guided gastroenterostomy (EUS-GE) using the AXIOS(TM) lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm
干预措施: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System (Device)
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: through 14 days after procedure
Clinical Success defined as improvement of Gastric Outlet Obstruction Score (GOOS)by 1 point from baseline to any point during 14 days after AXIOS stent placement and GOOS remaining at 1 or more without the need for reintervention due to loss of stent function at 30 days post-index procedure or death, whichever comes first.
Primary Safety Endpoint
时间窗: Through study completion, an average of 1 year
AXIOS stent related or AXIOS endoscopic and/or study procedure related serious adverse events through 30 days post stent placement.
Primary Technical Success Endpoint
时间窗: During the procedure
Successful stent placement, defined as transmural placement of the AXIOS stent with confirmed stent patency by visualization of the contralateral wall of the small bowel through the AXIOS stent lumen. Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placement. Note: Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placement.
Serious Adverse Events
时间窗: Through study completion, an average of 1 year
The proportion of subjects with one or more AXIOS stent related or AXIOS endoscopic and/or study procedure related serious adverse events through 30 days post stent placement.
Technical Success
时间窗: During the procedure
The proportion of subjects that demonstrate technical Successful stent placement, defined as transmural placement of the AXIOS stent with confirmed stent patency by visualization of the contralateral wall of the small bowel through the AXIOS stent lumen. Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placement. Note: Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placement.
次要结局
未报告次要终点