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

Recruiting

• Conditions: Gastric; Gastrostomy; GastroEsophageal Cancer
• Interventions: Other: Standard of Care; Other: Control Group

• Registration Number: NCT05205343
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-25
• Study Start: 2022-05-11
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. 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)
2. Patients 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

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Exclusion Criteria

1. Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract
2. Patients with known narcotic dependence, with average daily dose > 5 mg oral morphine equivalent
3. Subjects deemed unable to comply with study and/or follow-up procedures, at investigators' discretion
4. Patients who are pregnant (since are excluded from receiving standard-of-care MIPG or MITG)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard of Care	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.
Control group	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.

Primary Outcome Measures

Name	Time	Method
(MDASI-GI) MD Anderson Symptom Inventory Questionnaire	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

Trial Locations

Locations (4)

Yonsei University College of Medicine; 🇰🇷 Soeul, Korea, Republic of

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Keio University School of Medicine; 🇯🇵 Tokyo, Japan

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States