Gastric, GastroEsophageal Cancer, Gastrostomy
Conditions
Brief summary
To compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.
Detailed 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.
Interventions
OTHERStandard of Care
complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery
OTHERControl Group
complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (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 |
Countries
Japan, South Korea, United States
Contacts
CONTACTNaruhiko Ikoma, MD
PRINCIPAL_INVESTIGATORNaruhiko Ikoma, MD
M.D. Anderson Cancer Center
Outcome results
None listed