Clinical trial NCT05205343: Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
Official title: Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastrostomy
Gastric
GastroEsophageal Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 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.

Eligibility 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)

Primary outcomes:
measure: (MDASI-GI) MD Anderson Symptom Inventory Questionnaire
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Tokyo
country: Japan
facility: Keio University School of Medicine
city: Soeul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Naruhiko Ikoma, MD
role: PRINCIPAL_INVESTIGATOR
References: