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
- 2/3 期
- 状态
- 进行中（未招募）
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- AXIOS stent related or AXIOS endoscopic and/or study procedure related Serios Adverse Events through 30 days post stent placement
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. Gastric outlet obstruction is the mechanical impediment to gastric emptying, a complication seen frequently in patients with benign or malignant pancreatic or upper gastrointestinal tumors. The most common occurrence of GOO in malignant etiologies is seen in pancreatic malignancies, reported up to 15 to 20 percent, and is associated with significant morbidity and poor survival rates. Patients are often presented with nausea, vomiting, malnutrition, weight loss, and reduced quality of life. When the normal emptying of the stomach becomes mechanically impeded, palliation by the management of oral intake is most commonly treated through two treatment modalities the traditional gold standard of surgical bypass or the endoscopic placement of a duodenal Self-Expanding Metallic Stent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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 cm.
排除标准
- •Patients with baseline ECOG greater than 2 and or Karnofsky Performance score less than 30 Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent Abnormal coagulation INR greater than 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 drainage 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 cm at the proposed site of AXIOSTM stent insertion Gastric varices located within a 2 cm radius of the device insertion location on the gastric wall Ascites Grade greater than or equal to 2 confirmed by cross-sectional imaging Vessels located within a 2 cm 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 Pregnancy Prisoners and other vulnerable populations.
结局指标
主要结局
AXIOS stent related or AXIOS endoscopic and/or study procedure related Serios Adverse Events through 30 days post stent placement
时间窗: At the time of the stent placement through study completion, an average of 1-year.
次要结局
- 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(During the Procedure)
- Improvement of GOOS by 1 point from baseline to any point during 14 days after AXIOS stent placement & 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.(Through 14 days after procedure)
- Clinical success over time defined as improvement of GOOS by 1 point from baseline at any time during 14 days after AXIOS stent placement & GOOS remaining at 1 or more. This endpoint will be evaluated at 3 months, 6 months, & 12 months(A patient undergoing reintervention for GOO is considered a failure of clinical success)
- Time to resumption of oral intake after stent placement.(Immediately after the procedure)
- Time to start or resume chemotherapy after AXIOSTM stent placement (where applicable)(Immediately after the procedure)
- Change in Quality-of-Life score (SF-12 questionnaire) from baseline to 30 days, 3 months, 6 months, & 12 months(through study completion, an average of 1 year)
- Incidence of Device Deficiencies. Including but not limited to stent migration & misplacement, stent occlusion, leakage at site of stent placement(Immediately after the procedure)
- Incidence of Reintervention for GOO. Need for repeat treatment for persistent or recurrent GOO symptoms(Immediately after the procedure)
研究者
Sundeep Lakhtakia
Asian Institute of Gastroenterology