Clinical Trial of EPASS With Hot AXIOS System

Gastric Outlet Obstruction Clinical Trial

— PASSAGE  

Official title:

A Prospective, Multi-center, Single-arm Study for Unresectable Malignant Gastric Outlet Obstruction With EUS-guided Double-balloon-occluded Gastrojejunostomy Bypass

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05644951
• Other study ID #: E7127
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2024
• Source: Boston Scientific Corporation
• Contact: Ryo Konishi
• Phone: +81368537500
• Email: JapanClinicalTrials[@]bsci.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: July 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

Device:
• Hot AXIOS system used for EPASS
EUS-guided double-balloon-occluded gastrojejunostomy bypass with Hot AXIOS system

Locations

Country	Name	City	State
Japan	The University of Tokyo Hospital	Bunkyo-Ku	Tokyo
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Cancer Institute Hospital of JFCR	Koto-Ku	Tokyo
Japan	Aichi Cancer Center Hospital	Nagoya	Aichi
Japan	Teine Keijinkai Hospital	Sapporo	Hokkaido
Japan	Tokyo Medical University Hospital	Shinjuku-Ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GOOSS 3 rate without MAE	GOOSS 3 rate without MAE	30 days post index-procedure