Status:

UNKNOWN

Predictive Model to Early Diagnosis of Anastomotic Leak After Esophagectomy and Gastrectomy.

Lead Sponsor:

Hospital Universitario La Fe

Conditions:

Esophagus Cancer

Gastric Cancer

Eligibility:

All Genders

18-85 years

Brief Summary

The PROFUGO study (PRedictive Model for the early diagnosis of anastomotic leak after esophagectomy and gastrectomy) is proposed as a prospective and multicenter study at spanish national level that a...

Detailed Description

The methodological properties of the study are described below: 1. \- Type of design Prospective and multicenter study that aims to develop, with the help of artificial intelligence methods, a to...

Eligibility Criteria

Inclusion

  • \- Patients with a surgical indication and curative intent due to esophagogastric neoplasia who do not meet exclusion criteria and recruited by hospitals nationwide that decide to participate in the study will be included.

Exclusion

  • Patients under 18 or over 85 years
  • Patients with chronic infections
  • Patients with synchronous tumors in other locations
  • Patients with autoimmune disease
  • Patients who die in the operating room
  • Patients who do not sign the informed consent to participate in the study
  • Patients in clinical stage IVB
  • Surgical resection R2 (there are macroscopic remains of the tumor in the surgical field after performing the resection of the surgical piece)
  • Combined intraoperative resection of other organs
  • Surgeries without anastomosis

Key Trial Info

Start Date :

May 1 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2023

Estimated Enrollment :

800 Patients enrolled

Trial Details

Trial ID

NCT05390684

Start Date

May 1 2022

End Date

December 31 2023

Last Update

May 25 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Marcos Bruna

Valencia, Spain, 46003