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

NCT05390684 | Unknown

• 1 other identifier: AEC-PROFUGO
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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 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

Esophagus Cancer; Gastric Cancer; Leak, Anastomotic; Complication

Keywords

esophagectomy; gastrectomy; leak

Outcome Measures

Primary Outcomes (1)

• anastomotic leak

  a categorical variable divided into the following categories, according to the consensus definitions of the Consensus Group on Complications of Esophagectomy (ECCG) (27), which in this study will be applicable both to fistulas occurred after esophagectomy and after gastrectomy: * NO: If this complication did not occur. * I: Defect that does not require specific treatment or that can be treated medically or with diet modification * II: Defect that requires some intervention, but not surgical, such as: drainage by interventional radiology, prosthesis placement, opening of the wound at the bedside, compression or wound healing. * III: Defect requiring surgical intervention

  90 postoperative days

Secondary Outcomes (5)

• major complication

  90 postoperative days

• chylothorax

  90 postoperative days

• plasty necrosis

  90 postoperative days

• recurrent nerve plasy

  90 postoperative days

• infection

  90 postoperative days

Interventions

audit of complications, prospective data collection OTHER

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with neoplasia of the esophagus or stomach with an indication for oncological surgery with curative intention in any of the centers participating in the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario La Fe: lead

Study Sites (1)

Marcos Bruna

Valencia, 46003, Spain

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcos Bruna

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon. Esophagogastric Unit. Universitary Hospital La Fe. Valencia

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 25, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)