D1 vs D2 Lymphadenectomy in Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Prognostic Implications of D1 vs D2 Lymphadenectomy in Gastric Cancer: a Propensity Score Matched Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05253430
• Other study ID #: 2021/115
• Status: Completed
• Start date: April 1990
• Est. completion date: February 2021

Study information

• Verified date: December 2021
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 D2 gastrectomy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: February 2021
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Lymphadenectomy type
D1 vs D2 lymph node dissection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	percentage of patients without disease recurrence alive at 3 and 5 years after surgery
Secondary	Overall survival	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
Secondary	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.	from the surgery up to 90 days after the surgery
Secondary	Postoperative mortality	Mortality through post-operative follow-up	from the surgery up to 90 days after the surgery