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NCT04439812 Clinical Trial

Influence of Positive Margins on Tumour Recurrence and Overall Survival After Gastrectomy for Gastric Cancer

Stomach Neoplasms Clinical Trial

Official title:
Influence of Positive Margins on Tumour Recurrence and Overall Survival After Gastrectomy for Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04439812
Other study ID # 186/20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date December 31, 2018

Study information
Verified date June 2020
Source Hospital Universitario Ramon y Cajal
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Incidence of positive surgical margins after curative gastrectomy ranges from 1% to 20%. It has been suggested that positive surgical margins is an adverse prognosis factor, with a higher local recurrence and worse overall survival (OS). However, the management of these patients remains unclear.

Recruitment information / eligibility
Status Completed
Enrollment 267
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- all consecutive patients who underwent an oncological gastrectomy due to gastric cancer, between January 2010 and December 2018 at Ramon y Cajal University Hospital.

Exclusion Criteria:

- distant disease (including patients with positive cytology), early postoperative mortality (within 30 days after surgery) and follow-up data not available. Resections in patients with palliative intent were also excluded.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Observation
The primary aim of this study was to evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC. The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario Ramon y Cajal

Outcome
Type Measure Description Time frame Safety issue
Primary evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC 8 years
Secondary The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy. 8 years
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