Clinical trial NCT05589207: Predicting Model Based on Evidence-based Pathological Diagnose Criteria for RCC Tumor Thrombus With IVC Wall Invasion
Official title: Preoperative Imaging Diagnostic Evaluation Model Based on Evidence-based Pathological Diagnose Criteria for Renal Cell Carcinoma Tumor Thrombus With Inferior Vena Cava Wall Invasion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Renal Cell
Tumor Thrombus
Neoplasm Invasiveness
Inferior Vena Cava Interruption
Keywords: Neoplasm Grading
Diagnostic Model
Preoperative Diagnosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The groups of cohort will be selected from inhospital patients in Peking University Third Hospital.

Brief summary: The goal of this observational study is to establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations, as well as a accurate and systematic pathological grading standard of inferior vena cava (IVC) vascular wall invasion in renal cell carcinoma (RCC) with tumor thrombus invading vascular wall.The main questions it aims to answer are:

* To establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations.
* To determine what impact does different vascular wall layer invasion make on the long-term prognosis in RCC with IVC tumor thrombus;
* To determine which layer invasion according to pathological examination make sense to clinical treatment (can significantly affect prognosis); Participants 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. 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 recurrence 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 will be established.

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.

Eligibility criteria: Inclusion Criteria:

* Adults ≥18 years of age;
* Accepted abdominal ultrasonography, contrast-induced ultrasonography, enhanced CT and MRI before the surgery;
* Diagnosis of primary renal cell carcinoma with tumor thrombus before and during the surgery;
* Received radical nephrectomy and at least one kind of thrombectomy (including IVC incision only, IVC partial resection, IVC diagonal resection, and IVC segmental resection)
* Can tolerate the surgery;
* Eastern Cooperative Oncology Group Performance Status Scale (ECOG-PS) 0\~2;
* No previous history of malignant tumor;
* Willing to return for required follow-up visits

Exclusion Criteria:

* Failed to receive standard nephrectomy for any reason;
* Attached other addition operations in the surgery;
* Received neoadjuvant treatment before the surgery;
* Experience any other conditions that may affect the curative effect (e.g. active tuberculosis, autoimmune disease, or oral glucocorticoids treatment);
* Experience serious consequences or death due to anesthesia accident during operation;

Primary outcomes:
measure: Overall survival
timeFrame: From date of randomization until the date of lost follow-up or date of death from any cause, whichever came first, assessed up to 120 months
Secondary outcomes:
measure: Clinical manifestation
timeFrame: From the clinical diagnosis until the surgery, an average of 3 weeks
measure: Mayo classification
timeFrame: The time once the preoperative imaging is assessed, up to 1 weeks.
measure: Primary tumor diameter
timeFrame: The time once the preoperative imaging is assessed, up to 1 weeks.
measure: Preoperative tumor node metastasis (TNM) stage
timeFrame: The time once the preoperative imaging is assessed, up to 1 weeks.
measure: IVC residual blood flow
timeFrame: The time once the preoperative imaging is assessed, up to 1 weeks.
measure: IVC vascular wall continuity
timeFrame: The time once the preoperative imaging is assessed, up to 1 weeks.
measure: IVC complete occlusion
timeFrame: The time once the preoperative imaging is assessed, up to 1 weeks.
measure: IVC enhanced synchronization with tumor thrombus
timeFrame: The time once the preoperative imaging is assessed, up to 1 weeks.
measure: Tumor thrombus move when breathe
timeFrame: The time once the preoperative imaging is assessed, up to 1 weeks.
measure: Maximum IVC anterior-posterior (AP) diameter
timeFrame: The time once the preoperative imaging was assessed, up to 1 weeks.
measure: Maximum coronal IVC diameter
timeFrame: The time once the preoperative imaging is assessed, up to 1 weeks.
measure: Maximum IVC AP diameter at the Rvo
timeFrame: The time once the preoperative imaging is assessed, up to 1 weeks.
measure: Maximum coronal IVC diameter at the Rvo
timeFrame: The time once the preoperative imaging is assessed, up to 1 weeks.
measure: Bland thrombus
timeFrame: The time once the preoperative imaging is assessed, up to 1 weeks.
measure: growing against the direction of venous return (GADVR)
timeFrame: The time once the preoperative imaging is assessed, up to 1 weeks.
measure: Surgery approach
timeFrame: The time once the surgery finished, an average of 10 days.
measure: Surgery time
timeFrame: The time once the surgery finished, an average of 10 days.
measure: Blood loss
timeFrame: The time once the surgery finished, an average of 10 days.
measure: Histological type
timeFrame: The time once the pathological specimen is assessed, up to 1 weeks.
measure: Postoperative TNM stage
timeFrame: The time once the pathological specimen is assessed, up to 1 weeks.
measure: Invaded vascular wall layer
timeFrame: The time once the pathological specimen is assessed, up to 1 weeks.
measure: Comorbidity occurence
timeFrame: From the end of surgery until discharge, up to 3 weeks.
measure: Recurrence free survival
timeFrame: 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
measure: Tumor metastasis
timeFrame: Through study completion, an average of 3 year.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Zhuo Liu, MD
role: STUDY_DIRECTOR
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