Comparing minimally invasive surgeries for stomach cancer
Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
M.D. Anderson Cancer Center · NCT05205343
This study is testing whether a less invasive stomach surgery helps people with stomach cancer feel better and maintain their appetite compared to a more extensive surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Locations | 4 sites (Rochester, Minnesota and 3 other locations) |
| Trial ID | NCT05205343 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the short-term appetite and nutritional outcomes of patients undergoing minimally invasive proximal gastrectomy (MIPG) versus those undergoing total gastrectomy (MITG) for non-metastatic gastric and gastroesophageal junction adenocarcinoma. The primary objective is to determine if MIPG leads to better postoperative appetite levels, which may improve nutritional status and body weight maintenance. Patient-reported outcomes will be assessed using the MD Anderson Symptom Inventory Gastrointestinal Cancer Module and additional questionnaires to evaluate quality of life and correlate appetite levels with fasting ghrelin levels. The study will also investigate safety and oncological outcomes associated with both surgical approaches.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a biopsy-confirmed diagnosis of non-metastatic gastric or gastroesophageal junction adenocarcinoma scheduled for curative surgery.
Not a fit: Patients with known malabsorption syndromes, narcotic dependence, or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative appetite and nutritional outcomes for patients undergoing surgery for gastric cancer.
How similar studies have performed: Other studies have shown promising results with minimally invasive surgical approaches, suggesting potential benefits in postoperative recovery and quality of life.
Eligibility criteria
Show full inclusion / 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)
Where this trial is running
Rochester, Minnesota and 3 other locations
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (ACTIVE_NOT_RECRUITING)
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- Keio University School of Medicine — Tokyo, Japan (RECRUITING)
- Yonsei University College of Medicine — Soeul, South Korea (RECRUITING)
Study contacts
- Principal investigator: Naruhiko Ikoma, MD — M.D. Anderson Cancer Center
- Study coordinator: Naruhiko Ikoma, MD
- Email: nikoma@mdanderson.org
- Phone: (832) 729-2675
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastrostomy, Gastric, GastroEsophageal Cancer