PASSAGE Clinical Trial

JRCT ID: jRCT2032220496

Registered date:08/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable malignant gastric outlet obstruction
• Date of first enrollment: 23/12/2022
• Target sample size: 51
• Study type: Interventional
• Intervention(s): Investigational device (BSJ018A) will be implanted in the EUS-guided gastrojejunostomy

Outcome(s)

• Primary Outcome: GOOSS 3 rate without MAE at 30 days post procedure

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

Exclusion Criteria at informed consent
Prior metallic stent placement for GOO
Contraindicated to surgery and general anesthesia
Neoplasm invading the target site of puncture in gastric and/or jejunum
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
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 Boston Scientific study team)
Vulnerable subject

Exclusion Criteria at the index procedure
Guidewire does not cross the area of GOO
EP-DB does not 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 Information

• Primary Sponsor: Kawahara Kazuo
• Secondary ID(s): NCT05644951