A Study of Minimally Invasive Proximal Gastrectomy Versus Minimally Invasive Total Gastrectomy for Gastric and Gastroesophageal Junction Cancers

Recruiting

• Conditions: Gastric Cancer; GastroEsophageal Cancer; Gastroesophageal Junction Adenocarcinoma
• Interventions: Other: MDASI-GI

• Registration Number: NCT06243757
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

Participants will a diagnosis of gastroesophageal junction (GEJ) adenocarcinoma and will have either a minimally invasive proximal gastrectomy (MIPG) or a minimally invasive total gastrectomy (MITG) as part of their routine care. Participants with complete a questionnaire 1 month before the surgical procedure and then 1, 3, 6 and 12 months after the surgical procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-08
• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2036-01-08
• Study Completion: 2036-01-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Able to speak and read English, Spanish, Japanese or Korean
• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Minimally Invasive Proximal Gastrectomy/MIPG	MDASI-GI	Participants will undergo MIPG (Trial Procedure)
Minimally Invasive Total Gastrectomy/MITG	MDASI-GI	Participants will undergo MITG (Standard of Care/Control Group)

Primary Outcome Measures

Name	Time	Method
Appetite level score according to the MDASI-GI	3 months after surgery	The primary outcome is the appetite level score (with 0 being the best and 10 being the worst) according to the MDASi-GI at 3 months after surgery

Trial Locations

Locations (8)

Memorial Sloan Kettering Westchester (All Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Basking Ridge (All Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Commack (All Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Bergen (All protocol activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

MD Anderson Cancer Center (Data Analysis Only); 🇺🇸 Houston, Texas, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites); 🇺🇸 Rockville Centre, New York, United States