Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
NCT ID: NCT05205343
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2022-05-11
2026-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Control Group
complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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)
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Naruhiko Ikoma, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
M D Anderson Cancer Center
Houston, Texas, United States
Keio University School of Medicine
Tokyo, , Japan
Yonsei University College of Medicine
Soeul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2022-00267
Identifier Type: OTHER
Identifier Source: secondary_id
2021-0914
Identifier Type: -
Identifier Source: org_study_id
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