Gastric Outlet Obstruction
Conditions
Brief summary
A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS)
Detailed description
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.
Interventions
DEVICEHot AXIOS system used for EPASS
EUS-guided double-balloon-occluded gastrojejunostomy bypass with Hot AXIOS system
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GOOSS 3 rate without MAE | 30 days post index-procedure | GOOSS 3 rate without MAE |
Countries
Japan
Outcome results
None listed