Surgery-ComplicationsNCT05585073
Factors Affecting the Difficulty of Laparoscopic D2 Lymph Node Dissection for Gastric Cancer
An observational study of Surgery-Complications, run by Fujian Medical University at 1 site in China.
Trial summary
Laparoscopic D2 lymph node dissection (LND) for gastric cancer has a wide range of operations and a high degree of difficulty.The purpose of this study was to evaluate the relationship between clinicopathological factors and the difficulty of laparoscopic D2 LND. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery-Complications
- What is being tested?
- Whether lymph node dissection is qualified or not
- How many people
- 187 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 20 Jun 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: The CLASS-01 trial is a prospective multicenter randomized controlled study (ClinicalTrials.gov.number:NCT01609309) to compare the oncological efficacy of laparoscopy and laparotomy in the treatment of locally advanced distal gastric cancer. In this study, 119 patients who underwent laparoscopic surgery at our center who participated in CLASS-01 were selected. All the patients were operated with 2D laparoscopic system.The 2D/3D trial is a prospective clinical trial (ClinicalTrials.gov.number:NCT02327481) that compares the curative effect of 2D and 3D laparoscopic radical gastrectomy in our center. Seventy cases of 2D laparoscopic distal gastrectomy (LDG) were selected
Who may be able to join
- all patients undergoing laparoscopic surgery
- Laparoscopic system is 2D and has complete D2 lymph node dissection.
Who cannot join
- patients undergoing laparotomy
- incomplete video or clinicopathological information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Affecting the Difficulty of Laparoscopic D2 Lymph Node Dissection for Gastric Cancer:a Retrospective Cohort Study
Laparoscopic D2 lymph node dissection (LND) for gastric cancer has a wide range of operations and a high degree of difficulty.The purpose of this study was to evaluate the relationship between clinicopathological factors and the difficulty of laparoscopic D2 LND.
- Conditions
- Surgery-Complications
- Being tested
- Whether lymph node dissection is qualified or not
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whether lymph node dissection is qualified or notOther
Klass-02-QC LND scale and general error score tool were used to quantitatively evaluate the intraoperative performance of D2 LND
| Study group | Role | What they receive |
|---|---|---|
| qualified of D2 Lymph node dissection group | Not described Receives: Other: Whether lymph node dissection is qualified or not | |
| not-qualified D2 Lymph node dissection group | Not described Receives: Other: Whether lymph node dissection is qualified or not |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgery complicated
Incidence of operative complications between qualified group and unqualified group
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Jan 2022
- Primary completion10 May 2022
- Study completion20 Jun 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 Surgery-ComplicationsStudies 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
- 187 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
- NCT05585073
- Sponsor's protocol ID
- SD-GC
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lu J, Huang JB, Wu D, Xie JW, Wang JB, Lin JX, Zheng CH, Huang CM, Li P. Factors affecting the quality of laparoscopic D2 lymph node dissection for gastric cancer: a cohort study from two randomized controlled trials. Int J Surg. 2023 May 1;109(5):1249-1256. doi: 10.1097/JS9.0000000000000290.
PubMed 37026819
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting the Difficulty of Laparoscopic D2 Lymph Node Dissection for Gastric Cancer:a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05585073
- Acronym / sponsor ID
- SD-GC
- Conditions
- Surgery-Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 18 Oct 2022 (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.
Laparoscopic D2 lymph node dissection (LND) for gastric cancer has a wide range of operations and a high degree of difficulty.The purpose of this study was to evaluate the relationship between clinicopathological factors and the difficulty of laparoscopic D2 LND.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| qualified of D2 Lymph node dissection group | – | Other: Whether lymph node dissection is qualified or not |
| not-qualified D2 Lymph node dissection group | – | Other: Whether lymph node dissection is qualified or not |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The CLASS-01 trial is a prospective multicenter randomized controlled study (ClinicalTrials.gov.number:NCT01609309) to compare the oncological efficacy of laparoscopy and laparotomy in the treatment of locally advanced distal gastric cancer. In this study, 119 patients who underwent laparoscopic surgery at our center who participated in CLASS-01 were selected. All the patients were operated with 2D laparoscopic system.The 2D/3D trial is a prospective clinical trial (ClinicalTrials.gov.number:NCT02327481) that compares the curative effect of 2D and 3D laparoscopic radical gastrectomy in our center. Seventy cases of 2D laparoscopic distal gastrectomy (LDG) were selected
Key inclusion criteria (2 listed)
- all patients undergoing laparoscopic surgery
- Laparoscopic system is 2D and has complete D2 lymph node dissection.
Key exclusion criteria (2 listed)
- patients undergoing laparotomy
- incomplete video or clinicopathological information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whether lymph node dissection is qualified or notKlass-02-QC LND scale and general error score tool were used to quantitatively evaluate the intraoperative performance of D2 LND | Other | not-qualified D2 Lymph node dissection group, qualified of D2 Lymph node dissection group |
Primary outcome
surgery complicated
Time frame: 30 days after operation
Incidence of operative complications between qualified group and unqualified group
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 18 Oct 2022.
- Derived from this study: PubMed 37026819Lu J, Huang JB, Wu D, Xie JW, Wang JB, Lin JX, Zheng CH, Huang CM, Li P. Factors affecting the quality of laparoscopic D2 lymph node dissection for gastric cancer: a cohort study from two randomized controlled trials. Int J Surg. 2023 May 1;109(5):1249-1256. doi: 10.1097/JS9.0000000000000290.
- Individual participant dataSharing planned: Yes
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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 Surgery-Complications, 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 2 inclusion and 2 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 18 Oct 2022. 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?
surgery complicated (time frame: 30 days after operation). 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 NCT05585073, 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 18 Oct 2022.