Gastric Outlet Obstruction
Conditions
Keywords
GOO, Gastric Outlet Obstruction, AXIOS, Gastroenterostomy
Brief summary
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.
Detailed description
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.
Interventions
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
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | 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 | 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. |
| Primary Effectiveness Endpoint | 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. |
Countries
Belgium, Brazil, Canada, China, India, United States
Contacts
PRINCIPAL_INVESTIGATORShayan Irani, MBBS, MD
Virginia Mason Medical Center
Outcome results
None listed