NCT05205343

Brief Summary

To compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
0mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
3 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
May 2022May 2026

First Submitted

Initial submission to the registry

January 11, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 11, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

4.1 years

First QC Date

January 11, 2022

Last Update Submit

February 2, 2026

Conditions

GastrostomyGastricGastroEsophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • (MDASI-GI) MD Anderson Symptom Inventory Questionnaire

    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

Study Arms (2)

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

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

Interventions

Standard of CareOTHER

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

Standard of Care
Control GroupOTHER

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

M D Anderson Cancer Center

You may qualify if:

  • Able to speak and read English, Spanish, Japanese or Korean
  • Participants 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

ACTIVE NOT RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Keio University School of Medicine

Tokyo, 1600016, Japan

RECRUITING

Yonsei University College of Medicine

Soeul, 03722, South Korea

RECRUITING

Related Publications (2)

  • Ikoma N, Grotz T, Kawakubo H, Kim HI, Matsuda S, Okui J, Tomita K, Hirata Y, Nakao A, Williams LA, Wang XS, Wang X, Mansfield PF, Hyung WJ, Badgwell BD, Strong VE, Kitagawa Y. Transpacific multicenter collaborative study of minimally invasive proximal gastrectomy vs. minimally invasive total gastrectomy for proximal gastric and gastroesophageal junction cancers: 3-month follow-up results. Surg Endosc. 2025 Dec;39(12):8371-8384. doi: 10.1007/s00464-025-12257-4. Epub 2025 Sep 29.

    PMID: 41023216DERIVED

  • Ikoma N, Grotz T, Kawakubo H, Kim HI, Matsuda S, Hirata Y, Nakao A, Williams LA, Wang XS, Mendoza T, Wang X, Badgwell BD, Mansfield PF, Hyung WJ, Strong VE, Kitagawa Y. Trans-pacific multicenter collaborative study of minimally invasive proximal versus total gastrectomy for proximal gastric and gastroesophageal junction cancers. BMC Surg. 2023 Sep 1;23(1):262. doi: 10.1186/s12893-023-02163-8.

    PMID: 37653380DERIVED

Related Links

MeSH Terms

Interventions

Standard of CareControl Groups

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Naruhiko Ikoma, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naruhiko Ikoma, MD

CONTACT

(832) 729-2675nikoma@mdanderson.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 25, 2022

Study Start

May 11, 2022

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations

KR(1)JP(1)US(2)