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

NCT05390684 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2022-05-25

No results posted yet for this study

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 aims to develop, with the help of artificial intelligence methods, a tool and predictive model that allows identifying cases with a high risk of anastomotic leak (AF) and/or major complications through the analysis of different clinical and analytical variables collected during the perioperative period of patients undergoing esophagectomy or gastrectomy.

2.-HYPOTHESIS

Early identification of patients at high risk of developing AF and/or major complications after esophagogastric surgery can be carried out through the perioperative study of objective clinical variables and analytical markers.

3.-OBJECTIVE

The main objective of the study is to design a predictive model based on clinical and analytical variables that allow the identification of patients with a high risk of anastomotic leak (main variable) and/or major complication during the postoperative period of esophagogastric surgery.

4.-MATERIAL AND METHODS

* DESIGN: Prospective and multicenter study of 1 year duration.
* STUDY POPULATION: Patients diagnosed with neoplasia of the esophagus or stomach with an indication for oncological surgery with curative intent.
* INCLUSION CRITERIA: patients with surgical indication and curative intention due to esophagogastric neoplasm who do not meet exclusion criteria and recruited by hospitals nationwide that decide to participate in the study.
* EXCLUSION CRITERIA
* 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
* MONITORING: The patient will be monitored during the first 90 postoperative days.

5.-DURATION OF THE STUDY The time for the inclusion of patients in the study will be 1 year in each center from the incorporation of the first of their patients.

Conditions

Interventions

OTHER

audit of complications, prospective data collection

Prospective colecction of data will be performed to create a predictive model of leak and major complication

Sponsors & Collaborators

  • Hospital Universitario La Fe

    lead OTHER

Principal Investigators

  • Marcos Bruna · Hospital Universitario La Fe

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-12-01
Completion
2023-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05390684 on ClinicalTrials.gov