GastrostomyNCT05205343
Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
An observational study of Gastrostomy and Gastric, run by M.D. Anderson Cancer Center at 4 sites in 3 countries.
Trial summary
To compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrostomy, Gastric, GastroEsophageal Cancer
- How many people
- 20 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 11 May 2022to 31 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: M D Anderson Cancer Center
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
United States2 sites, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Naruhiko Ikoma, MD, 832-729-2675, nikoma@mdanderson.org
Naruhiko Ikoma, MD
- Active, not recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Japan1 site, 1 recruiting
- Recruiting
Keio University School of Medicine
Tokyo, 1600016
Satoru Matsuda, MD, PhD, +81 3-3353-1211, s.matsuda.a8@keio.jp
Satoru Matsuda, MD, PhD
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University College of Medicine
Soeul, 03722
Hyoung-II Kim, MD, PhD, +82-1599-1004, cairus@yuhs.ac
Hyoung-II Kim, MD, PhD
About this study
To compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.
Read the 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.
- Conditions
- Gastrostomy, Gastric, GastroEsophageal Cancer
- Being tested
- Standard of Care, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery
Control GroupOther
complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start11 May 2022
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GastrostomyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naruhiko Ikoma, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205343
- Sponsor's protocol ID
- 2021-0914
- Other IDs
- NCI-2022-00267
- Status last verified
- Aug 2026
- First submitted
- 11 Jan 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41023216Ikoma 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.
PubMed 37653380
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
- ClinicalTrials.gov ID
- NCT05205343
- Acronym / sponsor ID
- 2021-0914
- Conditions
- Gastrostomy, Gastric, GastroEsophageal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | – | Other: Standard of Carequestionnaire 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 | – | Other: Control Groupquestionnaire 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- M D Anderson Cancer Center
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Carecomplete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery | Other | Standard of Care |
| Control Groupcomplete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery | Other | Control group |
Primary outcome
(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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Derived from this study: PubMed 41023216Ikoma 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.
- Derived from this study: PubMed 37653380Ikoma 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.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Naruhiko Ikoma, MD principal investigator
M.D. Anderson Cancer Center
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrostomy and Gastric, run by M.D. Anderson Cancer Center at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naruhiko Ikoma, MD ((832) 729-2675, nikoma@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(MDASI-GI) MD Anderson Symptom Inventory Questionnaire (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05205343, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.