D1 vs D2 Lymphadenectomy in Gastric Cancer

February 22, 2022 updated by: Fundación para la Investigación del Hospital Clínico de Valencia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

357

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • patients diagnosed with GC stage I-III who underwent a curative gastrectomy +/- perioperative chemotherapy

Exclusion Criteria:

  • patients with adenocarcinoma Siewert type I/II, palliative surgery, R1/R2 resections and pathological stage (pStage) IV.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Procedure: Lymphadenectomy type
D1 vs D2 lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
percentage of patients without disease recurrence alive at 3 and 5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: percentage of patients alive at 3 and 5 years after surgery
Overall survival (OS) was defined as the time from the date of surgery to the date of death from any cause
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
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.
from the surgery up to 90 days after the surgery
Postoperative mortality
Time Frame: from the surgery up to 90 days after the surgery
Mortality through post-operative follow-up
from the surgery up to 90 days after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 1990

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

February 22, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Actual)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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