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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Gastrostomy; Gastric; GastroEsophageal Cancer

Treatments: Other: Control Group; Other: Standard of Care

Study type: Observational

Funder types: Other

Identifiers

NCT05205343

2021-0914

NCI-2022-00267 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

1. Able to speak and read English, Spanish, Japanese or Korean
2. Participants 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

Exclusion:

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

Trial design

20 participants in 2 patient groups

Standard of Care

Description:

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.

Treatment:

Other: Standard of Care

Control group

Description:

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.

Treatment:

Other: Control Group