Gastric CancerNCT05715775
Learning Curve and Optimization of Robotic Gastrectomy
An observational study of Gastric Cancer, run by Fujian Medical University at 1 site in China.
Trial summary
we explore the learning curve and the impact of technique optimization on surgical outcomes and the first to construct a referenceable learning phase for performing robotic gastric cancer surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer
- How many people
- 527 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2016to 1 Dec 2022
- 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: 527 patients who underwent RG between August 2016 and June 2021.
Who may be able to join
- Case inclusion criteria: (1) patients with pathologically confirmed gastric adenocarcinoma; (2) no distant metastases; and (3) R0 resection was performed.
Who cannot join
- Case exclusion criteria: (1) the presence of distant metastases was found ; (2) preoperative neoadjuvant chemotherapy was administered; and (3) clinical information was incomplete.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enlightenment of Robotic Gastrectomy From 527 Patients With Gastric Cancer in the Minimally Invasive Era: 5 Years of Optimizing Surgical Performance in a High-volume Center
we explore the learning curve and the impact of technique optimization on surgical outcomes and the first to construct a referenceable learning phase for performing robotic gastric cancer surgery.
- Conditions
- Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The LN dissection rate
The LN dissection rate was defined as the number of the LN station was examined divided by the total number of retrieval LN station.
Measured: 36 months
Secondary outcomes (1)
LN noncompliance
LN noncompliance was defined as the absence of LNs from more than 1 LN station.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Aug 2016
- Primary completion1 Jun 2021
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- 527 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715775
- Sponsor's protocol ID
- RGLC-01
- Status last verified
- Feb 2023
- First submitted
- 28 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xue Z, Lu J, Lin J, Xu KX, Xu BB, Wu D, Zheng HL, Xie JW, Wang JB, Lin JX, Chen QY, Li P, Huang CM, Zheng CH. Enlightenment of robotic gastrectomy from 527 patients with gastric cancer in the minimally invasive era: 5 years of optimizing surgical performance in a high-volume center - a retrospective cohort study. Int J Surg. 2024 Sep 1;110(9):5605-5614. doi: 10.1097/JS9.0000000000001652.
PubMed 38775618
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enlightenment of Robotic Gastrectomy From 527 Patients With Gastric Cancer in the Minimally Invasive Era: 5 Years of Optimizing Surgical Performance in a High-volume Center
- ClinicalTrials.gov ID
- NCT05715775
- Acronym / sponsor ID
- RGLC-01
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 8 Feb 2023 (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.
we explore the learning curve and the impact of technique optimization on surgical outcomes and the first to construct a referenceable learning phase for performing robotic gastric cancer surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 527 patients who underwent RG between August 2016 and June 2021.
Key inclusion criteria (1 listed)
- Case inclusion criteria: (1) patients with pathologically confirmed gastric adenocarcinoma; (2) no distant metastases; and (3) R0 resection was performed.
Key exclusion criteria (1 listed)
- Case exclusion criteria: (1) the presence of distant metastases was found ; (2) preoperative neoadjuvant chemotherapy was administered; and (3) clinical information was incomplete.
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
The LN dissection rate
Time frame: 36 months
The LN dissection rate was defined as the number of the LN station was examined divided by the total number of retrieval LN station.
1 secondary outcome
LN noncompliance
Time frame: 30 days
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 21 Feb 2023.
- Derived from this study: PubMed 38775618Xue Z, Lu J, Lin J, Xu KX, Xu BB, Wu D, Zheng HL, Xie JW, Wang JB, Lin JX, Chen QY, Li P, Huang CM, Zheng CH. Enlightenment of robotic gastrectomy from 527 patients with gastric cancer in the minimally invasive era: 5 years of optimizing surgical performance in a high-volume center - a retrospective cohort study. Int J Surg. 2024 Sep 1;110(9):5605-5614. doi: 10.1097/JS9.0000000000001652.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gastric Cancer, 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 1 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 21 Feb 2023. 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?
The LN dissection rate (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05715775, which also lists 1 linked publication.
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 21 Feb 2023.