A Study of Minimally Invasive Proximal Gastrectomy Versus Minimally Invasive Total Gastrectomy for Gastric and Gastroesophageal Junction Cancers
July 21, 2026 updated by: Memorial Sloan Kettering Cancer Center
Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
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 Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth (All Protocol Activities)
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Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen (All Protocol Activities)
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Commack (All Protocol Activities)
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester (All Protocol Activities)
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Rockville Centre, New York, United States, 11553
- Memorial Sloan Kettering Nassau (Limited Protocol Activites)
-
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center (Data Analysis Only)
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The initial contact with the potential participants will be conducted either by the treatment team, investigator or the research staff working in consultation with the treatment team.
Participants will be screened in gastric and mixed tumor surgery clinics on the 5th floor of the MSKCC 53rd Street outpatient clinic building.
The investigator/research staff will review portions of the medical record to determine if they are eligible.
Participants who are eligible will be approached by study personnel in clinic.
The study will be explained to participants by the study personnel and interested participants will be given the consent form to review.
Description
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
- Age ≥ 18
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Minimally Invasive Proximal Gastrectomy/MIPG
Participants will undergo MIPG (Trial Procedure)
|
The MDASI-GI assesses 5 symptoms specific to gastrointestinal cancer: constipation diarrhea or watery stools difficulty swallowing change in taste feeling bloated Using this questionnaire, participants score the severity of their symptoms over the previous 24 hours on a scale of 0 (not present) to 10 (as bad as you can imagine).
Other Names:
|
|
Minimally Invasive Total Gastrectomy/MITG
Participants will undergo MITG (Standard of Care/Control Group)
|
The MDASI-GI assesses 5 symptoms specific to gastrointestinal cancer: constipation diarrhea or watery stools difficulty swallowing change in taste feeling bloated Using this questionnaire, participants score the severity of their symptoms over the previous 24 hours on a scale of 0 (not present) to 10 (as bad as you can imagine).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Vivian Strong, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2024
Primary Completion (Estimated)
January 8, 2036
Study Completion (Estimated)
January 8, 2036
Study Registration Dates
First Submitted
January 29, 2024
First Submitted That Met QC Criteria
January 29, 2024
First Posted (Actual)
February 6, 2024
Study Record Updates
Last Update Posted (Actual)
July 22, 2026
Last Update Submitted That Met QC Criteria
July 21, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-324
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials.
The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov
when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required.
Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.
Requests may be made to: crdatashare@mskcc.org.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.