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临床试验/NCT04154761
NCT04154761已完成不适用

Resection of the Inferior Vena Cava Due to Tumor Involvement Allows Long-Term Survival in Different Neoplasms

Hospital Universitario Infanta Cristina1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2019年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
1
主要终点
Complication

研究概览

简要总结

The involvement of the inferior vena cava (IVC) in advanced abdominal tumors is a surgical challenge, given the high postoperative morbidity and poor long-term prognosis. The goal was to analyze the experience, perioperative management, and results.

Investigators have evaluated short and long-term results of surgical resections of tumors with associated inferior vena cava resection performed between 2012 and 2018.

详细描述

Data Collection:

Investigators retrospectively looked at patients who, from January 2012 to December 2018, underwent surgical procedures in the unit for IVC-specific tumors or for IVC resections due to secondary infiltrative tumors. In some cases, the IVC involvement was an intraoperative finding.

Patients with primary or secondary IVC involvement who underwent surgery were included in the study. Patients with metastasis found during intraoperative exploration were excluded from the study.

Diagnostic management included establishment of a medical history, performance of clinical examination and imaging tests, including an abdominal ultrasound and computerized tomography (CT) scan, to confirm the tumor origin and growth, as well as infiltration, if any, of adjacent structures. These also allowed to rule out distant metastases, and to assess resectability and the option for vascular reconstruction. In some cases, the decision to resect the IVC was made during surgery, because IVC involvement was an intraoperative finding which remained unknown up to that point.

The variables taken into account were age, sex, BMI, the American Society of Anesthesiologists (ASA) classification, tumor type, preoperative chemotherapy and/or radiation therapy. In addition, another variable considered was whether the finding was intraoperative or preoperative. Perioperative clinical results, surgical approach, type of IVC resection and reconstruction, and intraoperative complications were recorded. Details of the postoperative course were collected. Some of the key short-term data recorded included length of hospital stay, complications' ranking (according to the Clavien-Dindo score; 'severe complication' is defined as greater or equal to IIIa), re-operation, re-admission and operative mortality (< 90 days after operation). Some of the key long-term data recorded were patency of IVC or prosthesis (as determined by a CT scan), neoadjuvant and adjuvant chemotherapy, specific disease-free survival and overall survival (OS).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with primary or secondary IVC involvement who underwent surgery.

排除标准

  • Patients with metastasis found during intraoperative exploration.

结局指标

主要结局

Complication

时间窗: 90 days

Surgical complications rates

Overall survival

时间窗: 5 years

Patients overall survival after resection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diego López Guerra

Hepatobiliary Surgeon, Principal Investigator

Hospital Universitario Infanta Cristina

研究点 (1)

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