Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of Care, Control Group.
- Who it may be relevant to
- Registry conditions: Gastrostomy, Gastric, GastroEsophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Japan, South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Standard of Care
complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery - Other Control Group
complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery
Primary outcome measures
- (MDASI-GI) MD Anderson Symptom Inventory Questionnaire [Time frame: 3 months after surgery]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Mayo Clinic in Rochester — Rochester
- M D Anderson Cancer Center — Houston
Japan · 1 center
- Keio University School of Medicine — Tokyo
South Korea · 1 center
- Yonsei University College of Medicine — Soeul
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 End PMID 41023216
- 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 37653380
Identifiers
NCT: NCT05205343 · 2021-0914 · NCI-2022-00267