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Robot vs. laparoscope: which surgery is safer for early stomach cancer?

NCT ID NCT07467174

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 538 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

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

20 to 85 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Department of Gastrointestinal Surgery, Department of Surgery Severance Hospital, Yonsei University College of Medicine

    Seoul, South Korea

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