Preoperative Imaging Diagnostic Evaluation Model Based on Evidence-based Pathological Diagnose Criteria for Renal Cell Carcinoma Tumor Thrombus With Inferior Vena Cava Wall Invasion

Brief Summary

Detailed Description

Radical nephrectomy and thrombectomy are essential surgical treatments for renal cell carcinoma (RCC) with inferior vena cava (IVC) tumor thrombus. IVC vascular wall invasion leads to higher recurrence risk and worse long-term prognosis. The diagnosis and treatment of RCC tumor thrombus with IVC vascular wall invaded are affected by prominent difficulties: First, there is a lack of the preoperative diagnostic evaluation system consisting to the postoperative histopathological examinations, which is regarded as the gold standard of vascular wall invasion, therefore hinders the development of the neoadjuvant therapy strategy and surgery plan; Besides, the pathological diagnostic criteria of IVC vascular wall adhesion or invasion is inconsistent among different centers, an accurate and systematic criteria is needed. This study consecutively includes patients admitted in Peking University Third Hospital between January 2023 to January 2026, who were diagnosed with primary renal cell carcinoma with IVC tumor thrombus with/without vascular wall invasion, and accepted radical nephrectomy and at least one IVC thrombectomy (including IVC incision only, IVC partial resection, IVC diagonal resection, and IVC segmental resection). The patients with IVC vascular wall invasion/ non-invasion are divided into experimental group (invaded group) or control group (non-invaded group) respectively according to pathological examinations, in order to establish a prospective cohort with three-year follow-up. For the invaded group, micro invasion subgroup and tumor thrombus capsule subgroup analysis are conducted. The pathological characteristics of local recurrence and poor prognosis are summarized, and postoperative pathological diagnostic criteria of IVC vascular wall invasion and established. The local recurrence and distant recurrences outcomes are compared between experiment group and control group, in order to analyze the long-term influence of vascular wall invasion. Then the preoperative imaging diagnostic evaluation model were established: re-diagnose patients in two groups according to the established pathological diagnostic criteria, and divide them into truly-invaded group and truly-non-invaded group. Analyzing the preoperative abdominal ultrasound scan, contrast-enhanced ultrasonography, computed tomography (CT) and magnetic resonance imaging (MRI), thus explore the imaging characteristics of vascular wall invasion and establish the preoperative diagnostic model. This study aims at establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations, as well as a accurate and systematic pathological grading standard of IVC vascular wall invasion, therefore contribute to the development of a more accurate and effective preoperative treatment strategy and surgery plan.

Primary Outcomes

Secondary Outcomes

• Mayo classification(The time once the preoperative imaging is assessed, up to 1 weeks.)
• Primary tumor diameter(The time once the preoperative imaging is assessed, up to 1 weeks.)
• IVC vascular wall continuity(The time once the preoperative imaging is assessed, up to 1 weeks.)
• Maximum coronal IVC diameter(The time once the preoperative imaging is assessed, up to 1 weeks.)
• Maximum IVC anterior-posterior (AP) diameter(The time once the preoperative imaging was assessed, up to 1 weeks.)
• Surgery approach(The time once the surgery finished, an average of 10 days.)
• Surgery time(The time once the surgery finished, an average of 10 days.)
• Clinical manifestation(From the clinical diagnosis until the surgery, an average of 3 weeks)
• Preoperative tumor node metastasis (TNM) stage(The time once the preoperative imaging is assessed, up to 1 weeks.)
• IVC residual blood flow(The time once the preoperative imaging is assessed, up to 1 weeks.)
• Tumor thrombus move when breathe(The time once the preoperative imaging is assessed, up to 1 weeks.)
• growing against the direction of venous return (GADVR)(The time once the preoperative imaging is assessed, up to 1 weeks.)
• Blood loss(The time once the surgery finished, an average of 10 days.)
• Invaded vascular wall layer(The time once the pathological specimen is assessed, up to 1 weeks.)
• Comorbidity occurence(From the end of surgery until discharge, up to 3 weeks.)
• IVC complete occlusion(The time once the preoperative imaging is assessed, up to 1 weeks.)
• IVC enhanced synchronization with tumor thrombus(The time once the preoperative imaging is assessed, up to 1 weeks.)
• Maximum IVC AP diameter at the Rvo(The time once the preoperative imaging is assessed, up to 1 weeks.)
• Recurrence free survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months)
• Tumor metastasis(Through study completion, an average of 3 year.)
• Maximum coronal IVC diameter at the Rvo(The time once the preoperative imaging is assessed, up to 1 weeks.)
• Bland thrombus(The time once the preoperative imaging is assessed, up to 1 weeks.)
• Histological type(The time once the pathological specimen is assessed, up to 1 weeks.)
• Postoperative TNM stage(The time once the pathological specimen is assessed, up to 1 weeks.)