Minimally Invasive Gastrectomies for Gastroesophageal Cancer

Recruiting at 7 trial locations

Overseen By Naruhiko Ikoma, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Narcotics

Disqualifiers: Malabsorption syndromes, Narcotic dependence, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of surgeries for treating gastroesophageal cancer, which affects the stomach and the area where the esophagus meets the stomach. Researchers aim to compare patient outcomes after a Minimally Invasive Proximal Gastrectomy (MIPG) versus a Total Gastrectomy. Both procedures seek to remove cancer while minimizing side effects during recovery. Participants must have a diagnosis of non-spreading gastric or gastroesophageal junction cancer and be scheduled for one of these surgeries. 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.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both minimally invasive proximal gastrectomy (MIPG) and total gastrectomy are generally safe, but each has its own considerations.

For MIPG, studies have found that patients tolerate this method well. It usually leads to fewer complications compared to more invasive surgeries. Research also indicates that laparoscopic gastrectomy, which uses small cuts, offers survival rates similar to those of more invasive open surgery. Thus, MIPG is considered safe and offers benefits like quicker recovery times.

Conversely, total gastrectomy, while effective, can have more serious effects. One study found that about 9.1% of patients faced serious risks within 90 days after this surgery. However, many patients still recover well and learn to live without a stomach over time. It's important to consider these risks when evaluating this treatment.

Both procedures have been thoroughly studied and can be safe options for treating gastric and gastroesophageal cancer when performed by experienced surgeons. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about minimally invasive gastrectomies for gastroesophageal cancer because these techniques promise quicker recovery and less postoperative pain compared to traditional open surgeries. Unlike standard treatments that often involve large incisions, minimally invasive procedures use small incisions and advanced tools, potentially leading to fewer complications and shorter hospital stays. This approach may improve quality of life for patients by reducing the physical stress of surgery.

What evidence suggests that this trial's treatments could be effective for gastroesophageal cancer?

This trial will compare two surgical options for gastroesophageal cancer: minimally invasive proximal gastrectomy (MIPG) and total gastrectomy. Research has shown that MIPG can improve quality of life without compromising cancer treatment outcomes. Studies indicate it is a safe choice for treating gastroesophageal cancer, offering survival rates similar to traditional open surgery. MIPG involves smaller incisions, which can lead to faster recovery and less pain after surgery.

For total gastrectomy, research has found it can extend the lives of patients with advanced stomach cancer. It is one of the most effective treatments for this type of cancer, especially in later stages. Long-term results show that many patients can return to their daily activities after surgery. Both surgical options in this trial aim to treat cancer while also considering the patient's overall well-being. ^{2 4 5 6 7}

Who Is on the Research Team?

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.

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?

Group I: Standard of Care Experimental Treatment 1 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 group Experimental Treatment 1 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

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.

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]

Minimally invasive esophagectomy performed in the lateral-prone position was successful in all 124 patients studied, with no mortality within 30 days post-surgery, indicating a high safety profile for this technique.

The procedure resulted in an average blood loss of 156 mL and a mean operation duration of 376 minutes, with a significant learning curve suggesting improved outcomes over time, including reduced blood loss and shorter operation times.

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]

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]

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]

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]

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]

A patient in Trinidad and Tobago successfully underwent a minimally invasive McKeown oesophagectomy for oesophageal cancer after receiving neoadjuvant chemotherapy, showcasing advanced surgical techniques in the Caribbean.

The patient experienced an uneventful recovery and remained tumor-free with an excellent quality of life four years post-surgery, indicating the efficacy and safety of this surgical approach.

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]

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]

This study aims to evaluate the short-term quality of life (QoL) benefits of minimally invasive proximal gastrectomy (MIPG) compared to minimally invasive total gastrectomy (MITG) in patients with proximal gastric and gastroesophageal junction cancers, focusing on appetite improvement and safety.

With 60 patients expected to be enrolled, the study will assess appetite levels and other QoL metrics at 3 months post-surgery, providing insights into whether MIPG can reduce postoperative complications like impaired appetite and reflux compared to MITG.

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]

Minimally invasive esophagectomy is becoming a preferred method for treating both benign and malignant esophageal diseases, replacing traditional open surgery techniques with less invasive laparoscopic and thoracoscopic approaches.

The article reviews various surgical techniques and their outcomes, highlighting the potential benefits of minimally invasive procedures, such as reduced recovery time and lower complication rates compared to conventional surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of minimally invasive esophagectomy. Nguyen, NT., Gelfand, D., Stevens, CM., et al.[2014]

The study analyzed 21 patients undergoing single-incision laparoscopic total gastrectomy (SITG) and 15 patients undergoing proximal gastrectomy (SIPG) for early gastric cancer, finding that these procedures are feasible and safe with no conversions to open surgery.

SITG/SIPG showed similar operation times and complication rates compared to multiport laparoscopic approaches, indicating that single-incision techniques can be a viable alternative without compromising safety or effectiveness.

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]

The newly developed laparoscopic-assisted proximal gastrectomy (LAPG) procedure was successfully completed in 36 out of 37 patients with early-stage proximal gastric cancer, demonstrating its feasibility and effectiveness as a minimally invasive surgical option.

There were no severe postoperative complications, and only one patient experienced mild reflux symptoms, which were effectively managed, indicating that LAPG has a favorable safety profile and maintains quality of life post-surgery.

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]

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]

In a study of 2,918 patients with locally advanced proximal gastric cancer, proximal gastrectomy (PG) was associated with shorter operative times and less need for blood transfusions compared to total gastrectomy (TG).

Although PG showed slightly better 3- and 5-year overall survival rates than TG, there was no significant difference in long-term survival outcomes between the two surgical approaches, suggesting that the extent of resection does not impact survival for these patients.

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]

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