Minimally Invasive Surgery for Stomach Cancer

Not currently recruiting at 7 trial locations
VS
DC
Overseen ByDaniel Coit, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Memorial Sloan Kettering 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?

This trial explores two surgical approaches for treating gastric and gastroesophageal junction (GEJ) cancers. Researchers compare minimally invasive partial stomach removal (MIPG) with complete stomach removal (MITG) to determine which leads to better patient outcomes. Participants will complete questionnaires before and after surgery to provide insights into recovery and quality of life. Individuals with a confirmed diagnosis of non-spreading gastric or GEJ cancer scheduled for one of these surgeries may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

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 prior data suggests that these surgical techniques are safe for patients with GEJ adenocarcinoma?

Research has shown that minimally invasive proximal gastrectomy (MIPG) is generally safe for individuals with advanced stomach cancer. Studies have found that this surgery, often performed after chemotherapy, is feasible and well-tolerated. Patients undergoing this procedure reported fewer complications compared to more invasive methods. Although the surgery might take slightly longer, it typically results in less blood loss and a shorter hospital stay. Overall, evidence suggests that MIPG is a reliable option for treating stomach and gastroesophageal junction cancers.12345

Why are researchers excited about this trial?

Researchers are excited about the trial comparing minimally invasive proximal gastrectomy (MIPG) to minimally invasive total gastrectomy (MITG) for gastric and gastroesophageal junction cancers because it explores a potentially less extensive surgical option. Unlike the standard total gastrectomy, which removes the entire stomach, MIPG only involves removing the upper part. This might lead to better preservation of stomach function, potentially improving the patient's quality of life. Additionally, because MIPG is minimally invasive, it may result in quicker recovery times and fewer complications, making it a promising alternative to the more extensive surgery.

What evidence suggests that this trial's procedures could be effective for GEJ adenocarcinoma?

Research has shown that minimally invasive proximal gastrectomy (MIPG), which participants in this trial may undergo, can be as effective as open surgery for treating stomach cancer. Studies have found that laparoscopic surgery, using small incisions, offers survival rates similar to traditional open surgery. This method often results in a shorter hospital stay, averaging 7 days, and a lower complication rate of about 12.2%. Although the number of lymph nodes removed, crucial for determining cancer stage, might be lower, survival outcomes remain similar. These findings suggest that MIPG could be a promising option for patients with gastroesophageal junction (GEJ) adenocarcinoma. Meanwhile, another group in this trial will undergo minimally invasive total gastrectomy (MITG), serving as the standard of care/control group.45678

Who Is on the Research Team?

VS

Vivian Strong, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I can speak and read English, Spanish, Japanese, or Korean.
I am diagnosed with early-stage stomach cancer and will have minimally invasive surgery.
I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Assessment

Participants complete a questionnaire 1 month before the surgical procedure

1 month
1 visit (in-person)

Surgery

Participants undergo either minimally invasive proximal gastrectomy (MIPG) or minimally invasive total gastrectomy (MITG)

1 day
1 visit (in-person)

Follow-up

Participants complete questionnaires and are monitored for safety and effectiveness at 1, 3, 6, and 12 months after surgery

12 months
4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Minimally Invasive Proximal Gastrectomy
  • Minimally Invasive Total Gastrectomy

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Minimally Invasive Total Gastrectomy/MITGExperimental Treatment1 Intervention
Group II: Minimally Invasive Proximal Gastrectomy/MIPGExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Citations

Minimally Invasive and Open Gastrectomy for Gastric Cancer

Overall, 31.8% of included studies reported outcomes for analysis in relation to OS (7/22). The mean follow-up was 56.4 months (range 22.1–99.8 ...

Long-term oncological outcomes of minimally invasive ...

Laparoscopic gastrectomy, while associated with a lower lymph node yield, provides similar overall survival rates compared to open surgery.

A Study of Minimally Invasive Proximal Gastrectomy Versus ...

A Study of Minimally Invasive Proximal Gastrectomy Versus Minimally Invasive Total Gastrectomy for Gastric and Gastroesophageal Junction Cancers.

Surgical considerations and outcomes of minimally invasive ...

Laparoscopic gastrectomy (LG) showed early promise with short-term outcomes, and the 2014 Japanese national guidelines recommended the ...

Minimally invasive surgery for gastric cancer in USA

In terms of postoperative outcomes, the average length of hospital stay was 7 days, postoperatively morbidity was 12.2%, and postoperative mortality was 4.1%.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38360577/

Safety and feasibility of minimally invasive gastrectomy ...

Minimally invasive gastrectomy following preoperative chemotherapy was feasible and safe for patients with highly advanced gastric cancer.

Safety and feasibility of minimally invasive gastrectomy ...

Minimally invasive gastrectomy following preoperative chemotherapy was feasible and safe for patients with highly advanced gastric cancer.

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41023216/

Transpacific multicenter collaborative study of minimally ...

Results: Among 71 patients with P/GEJ cancers enrolled from 2022 through 2024, 64 underwent either MITG (n = 26, 41%) or MIPG (n = 38, 59%). ...