D1 vs D2 Lymphadenectomy in Gastric Cancer

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT05253430
• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

Brief 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 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 Timeline

• Study Start: 1990-04
• Primary Completion: 2019-10
• Study Completion: 2021-02
• Status Verified: 2021-12
• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-02-22
• Last Update Submitted: 2022-02-22
• Study First Posted: 2022-02-23
• Last Update Posted: 2022-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 357

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival	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).

Secondary Outcome Measures

Name	Time	Method
Postoperative mortality	from the surgery up to 90 days after the surgery	Mortality through post-operative follow-up
Overall survival	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
Postoperative morbidity	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.