Clinical trial NCT05644951: Clinical Trial of EPASS With Hot AXIOS System
Official title: A Prospective, Multi-center, Single-arm Study for Unresectable Malignant Gastric Outlet Obstruction With EUS-guided Double-balloon-occluded Gastrojejunostomy Bypass
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gastric Outlet Obstruction
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: GOOSS 3 rate without MAE
timeFrame: 30 days post index-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Sapporo
country: Japan
facility: Teine Keijinkai Hospital
state: Hokkaido
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Bunkyō-Ku
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Koto-Ku
country: Japan
facility: Cancer Institute Hospital of JFCR
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
Study officials:
affiliation: Tokyo Medical University Hospital
name: Takao Itoi, MD
role: PRINCIPAL_INVESTIGATOR
References: