20 Participants Needed

Minimally Invasive Gastrectomies for Gastroesophageal Cancer

Recruiting at 6 trial locations
NI
Overseen ByNaruhiko Ikoma, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.678910

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.311121314

Who Is on the Research Team?

NI

Naruhiko Ikoma, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.
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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

  • Minimally Invasive Proximal Gastrectomy
  • Total Gastrectomy
Trial Overview The 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.
How Is the Trial Designed?
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, European Union, United States for the following indications:

🇯🇵
Approved in Japan as MIPG for:
  • Early gastric cancer
  • Proximal gastric cancer
  • Gastroesophageal junction cancers
🇪🇺
Approved in European Union as MIPG for:
  • Proximal gastric cancer
  • Gastroesophageal junction cancers
🇺🇸
Approved in United States as MIPG for:
  • Proximal gastric cancer
  • Gastroesophageal junction cancers

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Published Research Related to This Trial

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.
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.
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.
Laparoscopic proximal gastrectomy for gastric neoplasms.Kukar, M., Gabriel, E., Ben-David, K., et al.[2018]

Citations

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]
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