Gastric CancerNCT05253430
D1 vs D2 Lymphadenectomy in Gastric Cancer
An observational study of Gastric Cancer, run by Fundación para la Investigación del Hospital Clínico de Valencia.
Trial summary
This study is a retrospective study with a propensity score-matched analysis in order to balance differences between patients with D1 and D2 lymphadenectomy for gastric cancer.The main aim is to analyse differences in the postoperative and oncological outcomes of patients with gastric cancer (GC) who underwent D1 and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Lymphadenectomy type
- Type of treatment
- Surgery or procedure
- How many people
- 357 participants
- Where
- No sites listed yet
- Study dates
- Apr 1990to Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A retrospective study was carried out in all consecutive patients diagnosed with GC who underwent curative-intent surgery between April 1999 and October 2019
Who may be able to join
- patients diagnosed with GC stage I-III who underwent a curative gastrectomy +/- perioperative chemotherapy
Who cannot join
- patients with adenocarcinoma Siewert type I/II, palliative surgery, R1/R2 resections and pathological stage (pStage) IV.
About this study
Official title: Prognostic Implications of D1 vs D2 Lymphadenectomy in Gastric Cancer: a Propensity Score Matched Analysis
This study is a retrospective study with a propensity score-matched analysis in order to balance differences between patients with D1 and D2 lymphadenectomy for gastric cancer.The main aim is to analyse differences in the postoperative and oncological outcomes of patients with gastric cancer (GC) who underwent D1 and D2 gastrectomy.
Read the detailed description
In this propensity score-matched analysis of 128 patients, D2 lymphadenectomy improved long-term outcomes compared with D1 in patients with curative intent surgery for gastric cancer except for the group of patients older than 75 years and with early tumors.
- Conditions
- Gastric Cancer
- Being tested
- Lymphadenectomy type
- Keywords
- gastric cancer, lymphadenectomy, outcomes
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphadenectomy typeProcedure or surgery
D1 vs D2 lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| D1 lymph node dissection (LND) | Patients with gastric cancer that underwent curative surgery with gastrectomy and D1 lymph node dissection | |
| D2 lymph node dissection (LND) | Patients with gastric cancer that underwent curative surgery with gastrectomy and D2 lymph node dissection Receives: Procedure: Lymphadenectomy type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Disease-free survival (DFS) was defined as the time from gastric surgery to the date of recurrence (locoregional, peritoneal recurrence and/or distant metastases).
Measured: percentage of patients without disease recurrence alive at 3 and 5 years after surgery
Secondary outcomes (3)
Overall survival
Overall survival (OS) was defined as the time from the date of surgery to the date of death from any cause
Measured: percentage of patients alive at 3 and 5 years after surgery
Postoperative morbidity
Surgical complications were defined as any deviation from the normal postoperative course within 90 days after surgery, both during the hospital stay or after discharge.
Measured: from the surgery up to 90 days after the surgery
Postoperative mortality
Mortality through post-operative follow-up
Measured: from the surgery up to 90 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study startApr 1990
- Primary completionOct 2019
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253430
- Sponsor's protocol ID
- 2021/115
- Status last verified
- Dec 2021
- First submitted
- 13 Jan 2022
- Last updated
- 23 Feb 2022
- 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 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Implications of D1 vs D2 Lymphadenectomy in Gastric Cancer: a Propensity Score Matched Analysis
- ClinicalTrials.gov ID
- NCT05253430
- Acronym / sponsor ID
- 2021/115
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, lymphadenectomy, outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- Apr 1990 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 23 Feb 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.
This study is a retrospective study with a propensity score-matched analysis in order to balance differences between patients with D1 and D2 lymphadenectomy for gastric cancer.The main aim is to analyse differences in the postoperative and oncological outcomes of patients with gastric cancer (GC) who underwent D1 and D2 gastrectomy.
Detailed description
In this propensity score-matched analysis of 128 patients, D2 lymphadenectomy improved long-term outcomes compared with D1 in patients with curative intent surgery for gastric cancer except for the group of patients older than 75 years and with early tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D1 lymph node dissection (LND) | – | –Patients with gastric cancer that underwent curative surgery with gastrectomy and D1 lymph node dissection |
| D2 lymph node dissection (LND) | – | Procedure: Lymphadenectomy typePatients with gastric cancer that underwent curative surgery with gastrectomy and D2 lymph node dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective study was carried out in all consecutive patients diagnosed with GC who underwent curative-intent surgery between April 1999 and October 2019
Key inclusion criteria (1 listed)
- patients diagnosed with GC stage I-III who underwent a curative gastrectomy +/- perioperative chemotherapy
Key exclusion criteria (1 listed)
- patients with adenocarcinoma Siewert type I/II, palliative surgery, R1/R2 resections and pathological stage (pStage) IV.
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 |
|---|---|---|
| Lymphadenectomy typeD1 vs D2 lymph node dissection | Procedure or surgery | D2 lymph node dissection (LND) |
Primary outcome
Disease-free survival
Time frame: percentage of patients without disease recurrence alive at 3 and 5 years after surgery
Disease-free survival (DFS) was defined as the time from gastric surgery to the date of recurrence (locoregional, peritoneal recurrence and/or distant metastases).
3 secondary outcomes
Overall survival
Time frame: percentage of patients alive at 3 and 5 years after surgery
Postoperative morbidity
Time frame: from the surgery up to 90 days after the surgery
Postoperative mortality
Time frame: from the surgery up to 90 days after the 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 23 Feb 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Fundación para la Investigación del Hospital Clínico de Valencia.
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 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Disease-free survival (time frame: percentage of patients without disease recurrence alive at 3 and 5 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 23 Feb 2022; AzTrials last refreshed its copy on 6 Nov 2026.