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Clinical Trials/NCT06243757
NCT06243757Active, not recruitingNot Applicable

Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers

Memorial Sloan Kettering Cancer Center16 sites in 1 country4 target enrollmentStarted: January 8, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
4
Locations
16
Primary Endpoint
Appetite level score according to the MDASI-GI
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Participants will a diagnosis of gastroesophageal junction (GEJ) adenocarcinoma and will have either a minimally invasive proximal gastrectomy (MIPG) or a minimally invasive total gastrectomy (MITG) as part of their routine care. Participants with complete a questionnaire 1 month before the surgical procedure and then 1, 3, 6 and 12 months after the surgical procedure.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Able to speak and read English, Spanish, Japanese or Korean
  • •Patients with a biopsy-confirmed diagnosis of non-metastatic gastric or GEJ adenocarcinoma, who are scheduled to undergo MIPG or MITG for curative-intention

Exclusion Criteria

  • •Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract
  • •Patients with known narcotic dependence, with average daily dose > 5 mg oral morphine equivalent
  • •Subjects deemed unable to comply with study and/or follow-up procedures, at investigators' discretion
  • •Patients who are pregnant (since are excluded from receiving standard-of-care MIPG or MITG)

Outcomes

Primary Outcomes

Appetite level score according to the MDASI-GI

Time Frame: 3 months after surgery

The primary outcome is the appetite level score (with 0 being the best and 10 being the worst) according to the MDASi-GI at 3 months after surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (16)

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