臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 08, 2022
Last modified on	May. 19, 2025
Trial ID	jRCT2032220496

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

Contact for Scientific Queries	Name	Kawahara Kazuo
	Affiliation	Boston Scientific Japan K.K.
	Address	4-10-2 Nakano, Nakano-ku, Tokyo
	Telephone	+81-3-6853-7500
	E-mail	JapanClinicalTrials@bsci.com
Contact for Public Queries	Name	Konishi Ryo
	Affiliation	Boston Scientific Japan K.K.
	Address	4-10-2 Nakano, Nakano-ku, Tokyo
	Telephone	+81-3-6853-7500
	E-mail	JapanClinicalTrials@bsci.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 19, 2022
Actual date of first enrollment		Dec. 23, 2022
Target sample size		51
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	supportive care
Key inclusion & exclusion 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	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
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Unresectable malignant gastric outlet obstruction
Intervention(s)		Investigational device (BSJ018A) will be implanted in the EUS-guided gastrojejunostomy
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		GOOSS 3 rate without MAE at 30 days post procedure
Secondary Outcome(s)

Primary Sponsor	Boston Scientific Japan K.K.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Saitama Medical University International Medical Center Institutional Review Board
Address	1397-1 Yamane, Hidaka-city , Saitama
Telephone	+81-42-984-4183
E-Mail	chikenme@saitama-med.ac.jp
Approval Status	Approval
Date of approval	Dec. 06, 2022

Plan to share IPD	No
Plan description	Although it was selected to "No", currently preparing to support.

Secondary ID(s)	NCT05644951
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
7	May. 19, 2025	(this page)	Changes
6	Nov. 21, 2024	Detail	Changes
5	Oct. 24, 2024	Detail	Changes
4	Feb. 14, 2024	Detail	Changes
3	June. 07, 2023	Detail	Changes
2	Jan. 22, 2023	Detail	Changes
1	Dec. 08, 2022	Detail

List of change history