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

Study Overview
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Brief Summary
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To compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.

Detailed Description
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Primary Objectives: 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 Objectives: 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.

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

Conditions
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Gastric, Gastrostomy, GastroEsophageal Cancer

Intervention / Treatment
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* Other: Standard of Care
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to speak and read English or Spanish (for patients enrolled at MD Anderson and Mayo Clinic), English or Korean (for patients enrolled at Yonsei), and English or Japanese (for patients enrolled at Keio) Patients 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 Criteria: Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract Patients with known narcotic dependence, with average daily dose > 5 mg oral morphine equivalent Subjects deemed unable to comply with study and/or follow-up procedures, at investigators' discretion Patients who are pregnant (since are excluded from receiving standard-of-care MIPG or MITG)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of Care<br>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. | Other: Standard of Care<br>* complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery<br>|
| Control group<br>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. | Other: Control Group<br>* complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (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 | 3 months after surgery |