Recruiting

Gastrectomy Comparison

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05205343

Conditions

Gastrostomy

Gastric

GastroEsophageal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of Care

Control Group

Study Details

Brief summary:

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

Conditions

Gastrostomy

Gastric

GastroEsophageal Cancer

Study ID

NCT05205343

Start date

May 11, 2022

Status verified date

Aug, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

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

Primary outcome measure

  • (MDASI-GI) MD Anderson Symptom Inventory Questionnaire [ Time Frame: 3 months after surgery ]

Central Contacts and Locations

Central contacts

Naruhiko Ikoma, MD

(832) 729-2675nikoma@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Naruhiko Ikoma, MD

832-729-2675nikoma@mdanderson.org

Principal Investigator:

Naruhiko Ikoma, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-21.