Predictive Model to Early Diagnosis of Anastomotic Leak After Esophagectomy and Gastrectomy. PROFUGO Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- anastomotic leak
研究概览
简要总结
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.
详细描述
The methodological properties of the study are described below:
-
- Type of design
Prospective and multicenter study 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 and/or major complications through the analysis of different clinical and analytical variables collected during the postoperative period. of patients undergoing esophagectomy or gastrectomy. 2. - Study population
Patients diagnosed with neoplasia of the esophagus or stomach with an indication for oncological surgery with curative intent in any of the centers participating in the study. 3. - Inclusion and exclusion criteria
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
anastomotic leak
时间窗: 90 postoperative days
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
次要结局
- chylothorax(90 postoperative days)
- recurrent nerve plasy(90 postoperative days)
- major complication(90 postoperative days)
- plasty necrosis(90 postoperative days)
- infection(90 postoperative days)
研究者
Marcos Bruna
Surgeon. Esophagogastric Unit. Universitary Hospital La Fe. Valencia
Hospital Universitario La Fe