Gastrectomy for Gastric CancerNCT06752538
Assessment of Robotic Versus Laparoscopic Gastrectomy for GC Patients With Intraoperative Technical Complexity
An observational study of Gastrectomy for Gastric Cancer and Robotic Surgical Procedures, run by Fujian Medical University at 1 site in China.
Trial summary
While robotic gastrectomy (RG) is increasingly used in gastric cancer surgery, its potential advantages over laparoscopic gastrectomy (LG) in Intraoperative technical complexity (ITC) cases remain debated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrectomy for Gastric Cancer, Robotic Surgical Procedures, Laparoscopic Surgical Procedures
- How many people
- 3,534 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pathologically confirmed T1-4aN0-3bM0 gastric adenocarcinoma who underwent radical RG or LG between August 2016 and June 2019 at eight high-volume tertiary teaching hospitals in China
Who may be able to join
- Patients with postoperatively histologically confirmed T1-4aN0-3bM0 gastric adenocarcinoma who underwent RG or LG
Who cannot join
- Remnant gastric cancer
- Previous malignant
- ASA class >3
- Use of indocyanine green
- Neoadjuvant chemotherapy
- Loss to follow-up
- Combined resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Robotic Versus Laparoscopic Gastrectomy for Gastric Cancer Patients With Intraoperative Technical Complexity: A Multicenter Retrospective Study
While robotic gastrectomy (RG) is increasingly used in gastric cancer surgery, its potential advantages over laparoscopic gastrectomy (LG) in Intraoperative technical complexity (ITC) cases remain debated.
Read the detailed description
This retrospective cohort study included 3,534 patients with gastric cancer who underwent radical gastrectomy at eight high-volume hospitals. ITC was defined by any of the following criteria: operative time exceeding the third quartile, intraoperative estimated blood loss ≥ 400 mL, or conversion to open surgery. Propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were conducted to compare short- and long-term outcomes.
- Conditions
- Gastrectomy for Gastric Cancer, Robotic Surgical Procedures, Laparoscopic Surgical Procedures
- Keywords
- Surgical difficulty, Gastrectomy, Robotic, Laparoscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RG group | Patients undergoing robotic gastrectomy | |
| LG group | Patients undergoing laparoscopic gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Telephone follow-up
Measured: Within 3 years after surgery
Secondary outcomes (2)
recurrence
Telephone follow-up
Measured: 36 months
Postoperative complications
Postoperative complications were evaluated according to the Clavien-Dindo classification and categorized as surgical or medical
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study startAug 2016
- Primary completionJun 2019
- Study completionJul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrectomy for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
- Investigators
- Chang-Ming Huang, PhD, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752538
- Sponsor's protocol ID
- 2024KY216
- Other IDs
- 2024KY216
- Status last verified
- Jun 2025
- First submitted
- 22 Dec 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Robotic Versus Laparoscopic Gastrectomy for Gastric Cancer Patients With Intraoperative Technical Complexity: A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT06752538
- Acronym / sponsor ID
- 2024KY216
- Conditions
- Gastrectomy for Gastric Cancer, Robotic Surgical Procedures, Laparoscopic Surgical Procedures
- Keywords
- Surgical difficulty, Gastrectomy, Robotic, Laparoscopic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,534 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jul 2024 (actual)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While robotic gastrectomy (RG) is increasingly used in gastric cancer surgery, its potential advantages over laparoscopic gastrectomy (LG) in Intraoperative technical complexity (ITC) cases remain debated.
Detailed description
This retrospective cohort study included 3,534 patients with gastric cancer who underwent radical gastrectomy at eight high-volume hospitals. ITC was defined by any of the following criteria: operative time exceeding the third quartile, intraoperative estimated blood loss ≥ 400 mL, or conversion to open surgery. Propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were conducted to compare short- and long-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RG group | – | –Patients undergoing robotic gastrectomy |
| LG group | – | –Patients undergoing laparoscopic gastrectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pathologically confirmed T1-4aN0-3bM0 gastric adenocarcinoma who underwent radical RG or LG between August 2016 and June 2019 at eight high-volume tertiary teaching hospitals in China
Key inclusion criteria (1 listed)
- Patients with postoperatively histologically confirmed T1-4aN0-3bM0 gastric adenocarcinoma who underwent RG or LG
Key exclusion criteria (7 listed)
- Remnant gastric cancer
- Previous malignant
- ASA class >3
- Use of indocyanine green
- Neoadjuvant chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: Within 3 years after surgery
Telephone follow-up
2 secondary outcomes
recurrence
Time frame: 36 months
Postoperative complications
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang-Ming Huang, PhD principal investigator
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrectomy for Gastric Cancer and Robotic Surgical Procedures, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Within 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.