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

February 2, 2026 updated by: M.D. Anderson Cancer Center
To compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objective:

Delineate the short-term appetite of patients who undergo minimally-invasive proximal gastrectomy (MIPG) and compare them with those of patients with gastric and gastroesophageal adenocarcinoma who undergo total gastrectomy (MITG). We hypothesize that MIPG is associated with better postoperative appetite levels compared to MITG, which would result in improved nutritional status and maintained body weight after surgery.

Secondary Objective:

- Assess patient-reported outcomes (PROs) and nutrition measures. We will use the MD Anderson Symptom Inventory Gastrointestinal Cancer Module (MDASI-GI) questionnaire with additional three experimental question items ("PRO questionnaire") to collect preoperative and postoperative patient-reported outcomes (PROs) of QoL and check fasting ghrelin levels to correlate them with reported appetite levels. We will also retrospectively investigate factors associated with improved QoL after surgery, safety of MIPG and MITG, and oncological outcomes after MIPG and MITG.

Study Type

Observational

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Tokyo, Japan, 1600016
        • Recruiting
        • Keio University School of Medicine
        • Contact:
        • Principal Investigator:
          • Satoru Matsuda, MD, PhD
  • South Korea
      • Soeul, South Korea, 03722
        • Recruiting
        • Yonsei University College of Medicine
        • Contact:
          • Hyoung-II Kim, MD, PhD
          • Phone Number: +82-1599-1004
          • Email: cairus@yuhs.ac
        • Principal Investigator:
          • Hyoung-II Kim, MD, PhD
  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Active, not recruiting
        • Mayo Clinic in Rochester
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Naruhiko Ikoma, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

M D Anderson Cancer Center

Description

Inclusion:

  1. Able to speak and read English, Spanish, Japanese or Korean
  2. Participants with a biopsy-confirmed diagnosis of non-metastatic gastric or GEJ adenocarcinoma, who are scheduled to undergo MIPG or MITG for curative-intention
  3. Age ≥ 18

Exclusion:

  1. Participants with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract
  2. Participants with known narcotic dependence, with average daily dose > 5 mg oral morphine equivalent
  3. Participants deemed unable to comply with study and/or follow-up procedures, at investigators' discretion
  4. Participants 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
Standard of Care

questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery.

The questionnaire will ask about your health, appetite, and quality of life. It should take about 3-5 minutes to complete.
Other: Standard of Care
complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery
Control group

questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery.

The questionnaire will ask about your health, appetite, and quality of life. It should take about 3-5 minutes to complete.
Other: Control Group
complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(MDASI-GI) MD Anderson Symptom Inventory Questionnaire
Time Frame: 3 months after surgery
Appetite level (reported on a 0-10 scale, in Q8 of MDASI-GI) scale 0-not present-10 as bad as you can image
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Naruhiko Ikoma, MD, M.D. Anderson 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.

General Publications

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)

May 11, 2022

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

January 11, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0914
  • NCI-2022-00267 (Other Identifier: NCI-CTRP Clinical Trial Registry)

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.

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