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

NCT04439812 | Completed DMC

• 1 other identifier: 186/20
• Study Type: observational
• Target: 267
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stomach Neoplasms

Keywords

Gastric cancer; gastrectomy; R1; positive margins; recurrence; overall survival; prognosis

Outcome Measures

Primary Outcomes (1)

• evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC

  8 years

Secondary Outcomes (1)

• The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy.

  8 years

Study Arms (2)

R=0

Patients without positive margins after gastrectomy for gastric cancer

Other: Observation

R=1

Patients with positive margins after gastrectomy for gastric cancer

Other: Observation

Interventions

Observation OTHER

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.

R=0; R=1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal: lead

MeSH Terms

Conditions

Stomach Neoplasms; Margins of Excision; Recurrence

Interventions

Observation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Pablo Priego, MD, PhD

  Hospital Universitario Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant surgeon MD, PhD. Associate Profesor of Surgery

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: January 1, 2010
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: June 19, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share