Using AXIOS stent to treat gastric outlet obstruction
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
NA · Boston Scientific Corporation · NCT06174805
This study is testing if a new type of stent can help people with blocked stomachs due to cancer feel better and improve their health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 67 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Scientific Corporation (industry) |
| Locations | 10 sites (Boston, Massachusetts and 9 other locations) |
| Trial ID | NCT06174805 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of EUS-guided gastroenterostomy using the AXIOS lumen-apposing metal stent for patients suffering from gastric outlet obstruction due to unresectable malignant tumors. It is a prospective, multi-center, single-arm study involving up to 67 participants across 10 clinical centers. Eligible patients will receive the AXIOS stent and will be monitored for up to 12 months to assess outcomes related to their symptoms and overall health.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with gastric outlet obstruction caused by unresectable malignant neoplasms who are eligible for endoscopic intervention.
Not a fit: Patients with severe baseline performance status, certain types of gastric cancer, or significant coagulation issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with gastric outlet obstruction by alleviating symptoms and restoring oral intake.
How similar studies have performed: Other studies using similar endoscopic techniques have shown promise, suggesting that this approach may be effective, although the specific use of the AXIOS stent in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Gastric outlet obstruction from unresectable malignant neoplasm 2. Eligible for endoscopic intervention 3. GOOS of 0 or 1 0 - no oral intake 1 - liquids only 2 - soft solids only 3 - low-residue or full diet 4. 18 years of age or older 5. 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 6. The distance between the gastric lumen and jejunal lumen must be no more than 1.0 cm Exclusion Criteria: 1. Patients with baseline ECOG \> 2 and/or Karnofsky Performance score \< 30 2. Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent 3. 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 4. Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic gastroenterostomy 5. 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 6. 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 7. Gastric varices located within a two-centimeter radius of the device insertion location on the gastric wall 8. Ascites Grade ≥ 2 confirmed by cross-sectional imaging 9. Vessels located within a two-centimeter radius of the device insertion location 10. History of multiple abdominal surgeries and/or evidence of small bowel adhesions 11. Allergic to any of the device materials 12. Contraindications to use of electrical devices 13. Pregnancy 14. Prisoners and other vulnerable populations
Where this trial is running
Boston, Massachusetts and 9 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
- New York Presbyterian/ Weill Cornell Medical Center — New York, New York, United States (RECRUITING)
- University of Pittsburg Medical Center — Pittsburgh, Pennsylvania, United States (RECRUITING)
- Virginia Mason Medical Center — Seattle, Washington, United States (RECRUITING)
- UZ Leuven — Leuven, Belgium (RECRUITING)
- Instituto do Cancer do Estado de Sao Paulo — São Paulo, Brazil (NOT_YET_RECRUITING)
- McGill University Health Care — Montréal, Canada (NOT_YET_RECRUITING)
- Shanghai Changhai Hospital — Shanghai, Shanghai, China (RECRUITING)
- Asian Institute of Gastroenterology — Hyderabad, India (RECRUITING)
Study contacts
- Principal investigator: Shayan Irani, MBBS, MD — Virginia Mason Medical Center
- Study coordinator: Evelyne Ho, MPH, MBA
- Email: Evelyne.Ho@bsci.com
- Phone: (978) 483-8856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastric Outlet Obstruction, GOO, AXIOS, Gastroenterostomy