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Clinical Trials/JPRN-jRCT2032220496
JPRN-jRCT2032220496
Recruiting
未知

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

Kawahara Kazuo0 sites51 target enrollmentDecember 8, 2022
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Kawahara Kazuo
Enrollment
51
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 8, 2022
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Kawahara Kazuo

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

  • •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

Outcomes

Primary Outcomes

Not specified

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