Minimally Invasive Gastrectomies for Gastroesophageal Cancer
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.D. Anderson Cancer Center
Must not be taking: Narcotics
Disqualifiers: Malabsorption syndromes, Narcotic dependence, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
To compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Minimally Invasive Proximal Gastrectomy for gastroesophageal cancer?
Research suggests that Minimally Invasive Proximal Gastrectomy (MIPG) may offer benefits like preserving some stomach functions, which can help maintain appetite and reduce weight loss compared to total stomach removal. It is also associated with improved quality of life when effective antireflux techniques are used.12345
Is minimally invasive gastrectomy safe for humans?
Research indicates that minimally invasive gastrectomy, including both proximal and total gastrectomy, is generally considered safe for treating early and locally advanced gastric cancer. Studies have compared different surgical approaches and found them feasible and safe, although the long-term outcomes are still being evaluated.56789
How is the treatment Minimally Invasive Proximal Gastrectomy, Total Gastrectomy different from other treatments for gastroesophageal cancer?
Minimally Invasive Proximal Gastrectomy and Total Gastrectomy are unique because they use small incisions and specialized tools to remove part or all of the stomach, which can lead to quicker recovery and less pain compared to traditional open surgery. This approach is similar to minimally invasive techniques used for esophageal cancer, which have shown benefits in reducing complications and improving recovery times.1011121314
Research Team
NI
Naruhiko Ikoma, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with non-metastatic gastric or gastroesophageal junction cancers who are set to undergo minimally invasive surgery. Participants must speak and read English, Spanish, Korean, or Japanese depending on the study location. Pregnant individuals, those unable to follow the study procedures, with malabsorption syndromes or compromised gastrointestinal integrity, or high narcotic dependence cannot join.Inclusion Criteria
I have a confirmed diagnosis of early-stage stomach cancer and am scheduled for surgery with the intent to cure.
I am 18 years old or older.
Able to speak and read English or Spanish (for patients enrolled at MD Anderson and Mayo Clinic), English or Korean (for patients enrolled at Yonsei), and English or Japanese (for patients enrolled at Keio)
Exclusion Criteria
I take more than 5 mg of morphine or its equivalent daily due to narcotic dependence.
Patients who are pregnant (since are excluded from receiving standard-of-care MIPG or MITG)
I have a condition that affects how my body absorbs nutrients.
See 1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Preoperative Assessment
Participants complete a questionnaire about health, appetite, and quality of life within 30 days before surgery
4 weeks
1 visit (in-person)
Surgery
Participants undergo minimally-invasive proximal or total gastrectomy
1 day
1 visit (in-person)
Postoperative Follow-up
Participants complete questionnaires at 1, 3, 6, and 12 months after surgery to assess health, appetite, and quality of life
12 months
4 visits (virtual)
Treatment Details
Interventions
- Minimally Invasive Proximal Gastrectomy (Procedure)
- Total Gastrectomy (Procedure)
Trial OverviewThe study aims to compare symptoms after two types of surgeries for upper stomach cancer: Minimally Invasive Proximal Gastrectomy (MIPG) and Minimally Invasive Total Gastrectomy (MITG). Patients will be observed post-surgery to assess their recovery and symptom management.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment1 Intervention
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.
Group II: Control groupExperimental Treatment1 Intervention
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.
Minimally Invasive Proximal Gastrectomy is already approved in Japan for the following indications:
Approved in Japan as MIPG for:
- Early gastric cancer
- Proximal gastric cancer
- Gastroesophageal junction cancers
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Cancer CenterNew York, NY
Weill Cornell Medical College of Cornell UniversityNew York, NY
Mayo Clinic in RochesterRochester, MN
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Trials
3107
Patients Recruited
1,813,000+
Findings from Research
Laparoscopic proximal gastrectomy (LPG) resulted in significantly less intraoperative blood loss and lower inflammatory markers post-surgery compared to laparoscopic total gastrectomy (LTG), indicating a safer surgical profile for LPG.
Patients who underwent LPG experienced better postoperative nutritional outcomes, including less weight loss and higher levels of hemoglobin and serum albumin, suggesting that LPG may be a more effective option for preserving nutritional status after surgery for early gastric cancer.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Feasibility and Nutritional Benefits of Laparoscopic Proximal Gastrectomy for Early Gastric Cancer in the Upper Stomach.Kosuga, T., Ichikawa, D., Komatsu, S., et al.[2022]
Proximal gastrectomy, performed on 128 patients with suspected early gastric cancer, showed a high 5-year survival rate of 90.5%, indicating its effectiveness as a treatment option.
The procedure was well tolerated with a low complication rate (15.6%), and no postoperative deaths, making it a recommended standard treatment for early gastric cancer in the upper third of the stomach.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Long-term outcome after proximal gastrectomy with jejunal interposition for suspected early cancer in the upper third of the stomach.Katai, H., Morita, S., Saka, M., et al.[2022]
Laparoscopic proximal gastrectomy (LPG) is a safe surgical option for select patients with distal gastroesophageal junction or proximal stomach cancers, showing similar oncologic outcomes to total gastrectomy with low morbidity.
In a study of 6 patients, LPG resulted in negative margins and adequate lymph node dissection, with a median postoperative stay of 7 days, indicating effective surgical management despite some complications like anastomotic strictures.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Laparoscopic proximal gastrectomy for gastric neoplasms.Kukar, M., Gabriel, E., Ben-David, K., et al.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Trans-pacific multicenter collaborative study of minimally invasive proximal versus total gastrectomy for proximal gastric and gastroesophageal junction cancers.Ikoma, N., Grotz, T., Kawakubo, H., et al.[2023]
Laparoscopic proximal gastrectomy (LPG) may offer better postoperative nutritional outcomes compared to laparoscopic total gastrectomy (LTG), as patients who underwent LPG maintained higher body weight and hemoglobin levels one year after surgery.
While LPG showed trends towards shorter operative times and less blood loss, these differences were not statistically significant, indicating that both surgical methods have similar short-term surgical outcomes.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Surgical and nutritional outcomes of laparoscopic proximal gastrectomy versus total gastrectomy: a meta-analysis.Tanioka, T., Waratchanont, R., Fukuyo, R., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Feasibility and safety of pure single-incision laparoscopic total and proximal gastrectomy for early gastric cancer: propensity score-matched comparison to multiport totally laparoscopic approach.Lee, S., Suh, YS., Berlth, F., et al.[2023]
In a study of 329 patients with proximal advanced gastric cancer, proximal gastrectomy (PG) showed a 5-year overall survival rate of 74.9%, comparable to 64.3% for total gastrectomy (TG), indicating that PG can be a safe surgical option for selected patients.
PG is particularly recommended for patients with tumors that are 4 cm or smaller, classified as Borrmann type I/II, and with pathological T2/3, as these patients showed no metastasis in critical lymph node stations.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Proximal gastrectomy may be a reasonable choice for patients with selected proximal advanced gastric cancer: A propensity score-matched analysis.Peng, R., Yue, C., Wei, W., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Laparoscopy-assisted proximal gastrectomy with sentinel node mapping for early gastric cancer.Takeuchi, H., Oyama, T., Kamiya, S., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Clinical outcomes of proximal gastrectomy versus total gastrectomy for locally advanced proximal gastric cancer: a propensity score matching analysis.Zhao, L., Ling, R., Ma, F., et al.[2022]
Minimally invasive esophagectomy performed in a prone position (MIE-PP) shows a low conversion rate to open surgery and results in lower blood loss compared to open transthoracic esophagectomy (OE), although it has a longer operative time.
A multicenter randomized controlled trial indicated that MIE-PP may reduce the risk of pulmonary infections and recurrent laryngeal nerve palsy compared to OE, suggesting potential safety benefits, but further studies are needed to confirm its advantages over other minimally invasive techniques.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Minimally invasive esophagectomy performed with the patient in a prone position: a systematic review.Koyanagi, K., Ozawa, S., Tachimori, Y.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Current status of minimally invasive esophagectomy.Nguyen, NT., Gelfand, D., Stevens, CM., et al.[2014]
Minimally invasive esophagectomies (MIEs) show comparable short-term and long-term outcomes to conventional open esophagectomies (OEs) for patients with resectable esophageal cancer, with no significant differences in mortality, hospital stays, or major complications over a 10-year period involving multiple patient groups.
Although MIEs had a longer operative time, they demonstrated a low incidence of long-term complications, and overall surgical outcomes improved over time, indicating that experience with MIEs may enhance their effectiveness and safety.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Morbidity analysis in minimally invasive esophagectomy for oesophageal cancer versus conventional over the last 10 years, a single institution experience.Khan, M., Ashraf, MI., Syed, AA., et al.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Minimally invasive oesophagectomy: The first case report of a thoracolaparoscopic oesophagectomy done in the Caribbean.Singh, Y., Hosein, A., Mohammed, S., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Minimally invasive esophagectomy in the lateral-prone position: Experience of 124 cases in a single center.Ma, S., Yan, T., Liu, D., et al.[2018]
References
Feasibility and Nutritional Benefits of Laparoscopic Proximal Gastrectomy for Early Gastric Cancer in the Upper Stomach. [2022]
Long-term outcome after proximal gastrectomy with jejunal interposition for suspected early cancer in the upper third of the stomach. [2022]
Laparoscopic proximal gastrectomy for gastric neoplasms. [2018]
Trans-pacific multicenter collaborative study of minimally invasive proximal versus total gastrectomy for proximal gastric and gastroesophageal junction cancers. [2023]
Surgical and nutritional outcomes of laparoscopic proximal gastrectomy versus total gastrectomy: a meta-analysis. [2021]
Feasibility and safety of pure single-incision laparoscopic total and proximal gastrectomy for early gastric cancer: propensity score-matched comparison to multiport totally laparoscopic approach. [2023]
Proximal gastrectomy may be a reasonable choice for patients with selected proximal advanced gastric cancer: A propensity score-matched analysis. [2022]
Laparoscopy-assisted proximal gastrectomy with sentinel node mapping for early gastric cancer. [2021]
Clinical outcomes of proximal gastrectomy versus total gastrectomy for locally advanced proximal gastric cancer: a propensity score matching analysis. [2022]
Minimally invasive esophagectomy performed with the patient in a prone position: a systematic review. [2018]
Current status of minimally invasive esophagectomy. [2014]
Morbidity analysis in minimally invasive esophagectomy for oesophageal cancer versus conventional over the last 10 years, a single institution experience. [2020]
Minimally invasive oesophagectomy: The first case report of a thoracolaparoscopic oesophagectomy done in the Caribbean. [2021]
Minimally invasive esophagectomy in the lateral-prone position: Experience of 124 cases in a single center. [2018]