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NCT Number: NCT05205343

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Keio University School of Medicine, Tokyo, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • 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

Exclusion:

  • 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)

Treatment and study plan

Standard of care

Other

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

Control Group

Other

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

Primary outcomes

  1. (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

Study contacts

Contact information is provided by the study sponsor or research team.

Naruhiko Ikoma, MD

CONTACT

[email protected]

(832) 729-2675

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 25, 2022
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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