Clinical Trial of EPASS With Hot AXIOS System
- Conditions
- Gastric Outlet Obstruction
- Interventions
- Device: Hot AXIOS system used for EPASS
- Registration Number
- NCT05644951
- Lead Sponsor
- Boston Scientific Corporation
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 51
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hot AXIOS system Hot AXIOS system used for EPASS Hot AXIOS system (20 mm diameter stent)
- Primary Outcome Measures
Name Time Method GOOSS 3 rate without MAE 30 days post index-procedure GOOSS 3 rate without MAE
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Aichi Cancer Center Hospital
🇯🇵Nagoya, Aichi, Japan
Teine Keijinkai Hospital
🇯🇵Sapporo, Hokkaido, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka, Saitama, Japan
The University of Tokyo Hospital
🇯🇵Bunkyō-Ku, Tokyo, Japan
Cancer Institute Hospital of JFCR
🇯🇵Koto-Ku, Tokyo, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan