Clinical Trial of EPASS With Hot AXIOS System

A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS)

Inclusion Criteria:Unresectable malignant duodenal obstruction confirmed by biopsyEligible for endoscopic interventionGOOSS score of 0 or 118 years of age or olderWilling and able to comply with the study procedures or legally authorized representative (LAR) must provide written informed consent form (ICF) to participate in the studyExclusion Criteria:GOO symptoms are not expected to improve after the index procedureLife expectancy is about 3 months or less, which is not assumed applicable for surgical GJPrior metallic stent placement for GOOContraindicated to surgery and general anesthesiaNeoplasm invading the target site of puncture in gastric and/or jejunumAbnormal coagulation INR > 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulationBleeding diathesisAltered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic drainagePresence of ileus caused by peritoneal carcinomatosis, or expected to present within 30 days post procedureIntervening gastric varices or vessels at the target site of stent insertionAscites that may interfere the safety of the index procedureBiliary tract obstruction requiring treatment at the same day of the index procedureAllergic to any of the device materialsContraindications to use of electrosurgical devicesPregnancy, breastfeeding or intending to become pregnant during the study periodSubject 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 subjectSubject has other reason not to be eligible for this study per investigators' discretionGuidewire doesn't cross the area of GOOEP-DB doesn't advance to the target site in jejunumThe 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