Clinical Trial of EPASS With Hot AXIOS System (PASSAGE)

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

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

Study Overview

• Status: Completed
• Conditions: Gastric Outlet Obstruction
• Intervention / Treatment: Device: Hot AXIOS system used for 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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 4648681
      • Aichi Cancer Center Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 0060829
      • Teine Keijinkai Hospital
  • Saitama
    • Hidaka, Saitama, Japan, 3501241
      • Saitama Medical University International Medical Center
  • Tokyo
    • Bunkyō-Ku, Tokyo, Japan, 1130033
      • The University of Tokyo Hospital
    • Koto-Ku, Tokyo, Japan, 1350063
      • Cancer Institute Hospital of Jfcr
    • Shinjuku-Ku, Tokyo, Japan, 1600023
      • Tokyo Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hot AXIOS system; Hot AXIOS system (20 mm diameter stent)	Device: Hot AXIOS system used for EPASS; EUS-guided double-balloon-occluded gastrojejunostomy bypass with Hot AXIOS system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GOOSS 3 rate without MAE	GOOSS 3 rate without MAE	30 days post index-procedure

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Takao Itoi, MD, Tokyo Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2022
• Primary Completion (Actual): December 5, 2024
• Study Completion (Actual): August 29, 2025

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastric Outlet Obstruction
• Other Study ID Numbers: E7127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The anonymized data and study protocol for this clinical trial may be made available to other researchers in accordance with Boston Scientific Data Sharing Policy: (http://www.bostonscientific.com/en-US/data-sharing-requests.html)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No