Robot vs. laparoscope: which surgery is safer for early stomach cancer?
NCT ID NCT07467174
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two types of minimally invasive surgery for early-stage stomach cancer: a newer robotic method using fewer incisions (reduced-port) and the standard laparoscopic method. About 538 patients will be randomly assigned to one of the two surgeries. The main goal is to see if the robotic approach is as safe as the standard one, looking at complications within 30 days after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- surgery (reduced-port robotic subtotal gastrectomy vs. conventional laparoscopic subtotal gastrectomy)
- What this could lead to
- If successful, this could show that a less invasive robotic surgery is as safe as standard laparoscopic surgery for early gastric cancer, potentially leading to faster recovery and less pain.
- What could go wrong
- This is an early-stage comparison trial, not a test of a new drug or cure. The results may not apply to all patients or cancer stages, and the robotic approach may not prove superior.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 538 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients aged between 20 and 80 years diagnosed with early gastric cancer (cT1N0) 2. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 3. Patients with an American Society of Anesthesiologists (ASA) physical status classification of Class I to III 4. Patients with a histologically confirmed diagnosis of gastric adenocarcinoma by endoscopic biopsy prior to surgery 5. Patients with early gastric cancer suspected to have submucosal invasion limited to less than the muscularis propria based on preoperative examinations 6. Patients deemed eligible for distal subtotal gastrectomy based on preoperative assessment 7. Patients who have received a full explanation of the study purpose and procedures, and who voluntarily sign the written informed consent approved by the Institutional Review Board (IRB) exclusion Criteria: 1. Patients determined to have advanced gastric cancer rather than early gastric cancer based on preoperative endoscopy or computed tomography 2. Patients with confirmed distant metastasis on preoperative examinations 3. Patients with a history of previous gastrectomy 4. Patients with complications from gastric cancer, such as significant obstruction or perforation 5. Patients who have received chemotherapy or radiotherapy for the current gastric cancer diagnosis prior to surgery 6. Patients who have undergone surgery or received chemotherapy or radiotherapy for another primary malignancy within the past 5 years (with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix) 7. Vulnerable subjects, including individuals lacking decision-making capacity, pregnant women, or those planning pregnancy 8. Patients who have participated in another clinical trial within the past 6 months or who are currently enrolled in another clinical trial 9. Patients with active synchronous multiple primary malignancies Exclusion Criteria: 1. Patients determined to have advanced gastric cancer rather than early gastric cancer based on preoperative endoscopy or computed tomography 2. Patients with confirmed distant metastasis on preoperative examinations 3. Patients with a history of previous gastrectomy 4. Patients with complications from gastric cancer, such as significant obstruction or perforation 5. Patients who have received chemotherapy or radiotherapy for the current gastric cancer diagnosis prior to surgery 6. Patients who have undergone surgery or received chemotherapy or radiotherapy for another primary malignancy within the past 5 years (with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix) 7. Vulnerable subjects, including individuals lacking decision-making capacity, pregnant women, or those planning pregnancy 8. Patients who have participated in another clinical trial within the past 6 months or who are currently enrolled in another clinical trial 9. Patients with active synchronous multiple primary malignancies
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Gastrointestinal Surgery, Department of Surgery Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
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