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Keyhole surgery for stomach cancer: a game changer?
NCT ID NCT04710758
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study compares two types of surgery for advanced stomach cancer: keyhole (laparoscopic) and open total gastrectomy. About 1,018 patients will be randomly assigned to one of the two procedures. The main goal is to see if keyhole surgery offers similar long-term survival with faster recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- laparoscopic total gastrectomy (keyhole surgery to remove the stomach)
- What this could lead to
- If successful, this could show that keyhole surgery is as effective as open surgery for advanced stomach cancer, with faster recovery and fewer complications.
- What could go wrong
- This is a large trial, but it compares two surgical techniques—not a new drug. The results may not apply to all patients, and keyhole surgery may not be suitable for everyone.
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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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 1,018 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2021
- Expected to finish
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Dec 2028
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 75 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. Aged 18-75 years 2. Tumor located in the middle or upper third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers); 3. Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma; 4. Clinical stage T2-4aN0-3M0 (According to AJCC-8th TNM staging system); 5. Expected survival \> 6 months 6. No invasion to Z-line; 7. BMI (Body Mass Index) \< 30 kg/m2 8. No history of upper abdominal surgery (except for laparoscopic cholecystectomy); 9. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc 10. Preoperative performance status (ECOG,Eastern Cooperative Oncology Group) of 0 or 1 11. Preoperative ASA (American Society of Anesthesiologists) scoring: I-III 12. Sufficient organ functions 13. Written informed consent Exclusion Criteria: 1. Preoperative examinations indicate regional fusion of enlarged lymph nodes (max diameter ≥ 3.0cm) or enlargment of spleen hilus lymph nodes 2. Women during pregnancy or breast-feeding 3. Synchronous or metachronous (within 5 years) malignancies 4. Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated 5. Severe mental disease 6. Severe respiratory disease, FEV1 \< 50% of predicted 7. Severe hepatic and renal dysfunction 8. Unstable angina pectoris or history of myocardial infarction within 6 months 9. History of cerebral infarction or cerebral hemorrhage within 6 months 10. Continuous systemic steroid therapy within 1 month (except for topical use) 11. Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery 12. Patients are participating or have participated in another clinical trial (within 6 months)
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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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ZhongShan hospital FuDan university
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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- Electric acupoint therapy may speed digestion and ease pain after stomach cancer surgery
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