One small incision vs several: robotic stomach cancer surgery put to the test
NCT ID NCT07828899
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are comparing two ways of performing robotic surgery to remove stomach cancer: a single-port approach and a standard multi-port approach. The trial enrolls 212 adults with stomach cancer that can be removed with distal gastrectomy. The main question is whether the single-port operation succeeds as reliably as the multi-port operation, and a substudy tracks early pain, abdominal wall trauma, and recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Robotic-assisted radical distal gastrectomy, performed either through a single surgical port or multiple ports
- What this could lead to
- If single-port robotic surgery matches the multi-port approach, patients could have a stomach cancer operation with less abdominal wall trauma and less early pain.
- What could go wrong
- The single-port approach may prove harder to perform or less reliable than the standard multi-port method, and any differences in pain or recovery may turn out to be small.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 212 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
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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18 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: * Age 18-85 years, irrespective of sex. * Histologically confirmed primary gastric adenocarcinoma based on endoscopic biopsy. * The primary tumor is located in the middle or distal third of the stomach, or at another site considered amenable to radical distal gastrectomy. Preoperative evaluation indicates that robot-assisted radical distal gastrectomy is technically feasible and that an R0 resection is anticipated. Patients who have received standard neoadjuvant therapy may also be eligible if reassessment confirms fulfillment of the above surgical criteria. * Clinical stage cT1-3N0-1M0 according to the 8th edition of the AJCC TNM staging system for gastric cancer, as assessed by gastroscopy and contrast-enhanced computed tomography of the chest, abdomen, and pelvis, with endoscopic ultrasonography, abdominal magnetic resonance imaging, or diagnostic laparoscopy performed when clinically indicated. Preoperative assessment should indicate that R0 resection can be achieved by distal gastrectomy, with no evidence of adjacent organ invasion or distant metastasis. * No history of other malignancies within the preceding 5 years, except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies with a similarly negligible risk of recurrence. * American Society of Anesthesiologists (ASA) physical status class I-III. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1. * Adequate major organ function, with preoperative assessment confirming fitness for general anesthesia and robot-assisted radical distal gastrectomy. * Subjects voluntarily participate in the study, fully understand the trial protocol and provide written informed consent. Exclusion Criteria: * Body mass index (BMI) \>35 kg/m². * Previous gastrectomy, or a history of major upper abdominal surgery considered likely to substantially compromise the feasibility or safety of robot-assisted distal gastrectomy, such as complex hepatobiliary-pancreatic surgery or surgery involving the esophagogastric junction. Previous uncomplicated laparoscopic cholecystectomy, appendectomy, or similar procedures are not, in principle, considered exclusionary. * Tumor-related acute obstruction, active major hemorrhage, or perforation requiring emergency surgery. * Preoperative confirmation of synchronous multiple gastric cancers or remnant gastric cancer, or the presence or history within the preceding 5 years of another active malignancy that may interfere with study treatment or assessment of study endpoints. * Preoperative assessment indicating that radical distal gastrectomy is oncologically or technically inappropriate, including anticipated requirement for total gastrectomy, proximal gastrectomy, combined esophagectomy, or any other procedure other than distal gastrectomy. * Preoperative evaluation or diagnostic laparoscopy demonstrating definite invasion of adjacent organs requiring en bloc multivisceral resection; distant metastasis, including peritoneal, hepatic, pulmonary, osseous, or distant lymph-node metastasis; or positive peritoneal lavage cytology. * Standard preoperative evaluation indicating that the patient is not currently an appropriate candidate for upfront radical distal gastrectomy and requires initiation or continuation of neoadjuvant therapy or other antineoplastic treatment. * Concomitant disease requiring an additional surgical procedure at the time of radical gastrectomy that may substantially affect operative duration, perioperative safety, postoperative recovery, or assessment of the primary endpoint. * Pregnancy or lactation, or planned pregnancy during the study period. * Severe cardiac, pulmonary, hepatic, or renal dysfunction; severe coagulation abnormalities; uncontrolled infection; or any other medical condition considered to preclude safe administration of general anesthesia or surgical treatment. * Inability to provide valid informed consent because of cognitive impairment, psychiatric or mental status abnormalities, or other reasons, or inability to comply with protocol-specified treatment and follow-up procedures. * Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation in the study.
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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
5 sites. 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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Beijing Tsinghua Changgung Hospital
Beijing, China
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PLA Army Characteristic Medical Center
Chongqing, China
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Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
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The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
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The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
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