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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-08

Study Completion Date

2036-01-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastric Cancer GastroEsophageal Cancer Gastroesophageal Junction Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Minimally Invasive Proximal Gastrectomy/MIPG

Participants will undergo MIPG (Trial Procedure)

MDASI-GI

Intervention Type OTHER

The MDASI-GI assesses 5 symptoms specific to gastrointestinal cancer:

constipation diarrhea or watery stools difficulty swallowing change in taste feeling bloated

Using this questionnaire, participants score the severity of their symptoms over the previous 24 hours on a scale of 0 (not present) to 10 (as bad as you can imagine).

Minimally Invasive Total Gastrectomy/MITG

Participants will undergo MITG (Standard of Care/Control Group)

MDASI-GI

Intervention Type OTHER

The MDASI-GI assesses 5 symptoms specific to gastrointestinal cancer:

constipation diarrhea or watery stools difficulty swallowing change in taste feeling bloated

Using this questionnaire, participants score the severity of their symptoms over the previous 24 hours on a scale of 0 (not present) to 10 (as bad as you can imagine).

Interventions

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MDASI-GI

The MDASI-GI assesses 5 symptoms specific to gastrointestinal cancer:

constipation diarrhea or watery stools difficulty swallowing change in taste feeling bloated

Using this questionnaire, participants score the severity of their symptoms over the previous 24 hours on a scale of 0 (not present) to 10 (as bad as you can imagine).

Intervention Type OTHER

Other Intervention Names

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MD Anderson Symptom Inventory for gastrointestinal cancer

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No