Predicting Model Based on Evidence-based Pathological Diagnose Criteria for RCC Tumor Thrombus With IVC Wall Invasion

Sponsor

Peking University Third Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05589207

Collaborator

(none)

232

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell Tumor Thrombus Neoplasm Invasiveness Inferior Vena Cava Interruption	Diagnostic Test: Vascular wall invaded

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

232 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Invaded Group Patients whose inferior vena cava vascular wall is invaded according to histopathological examination.	Diagnostic Test: Vascular wall invaded Inferior vena cava vascular wall is invaded according to pathologic examination on the postoperative tumor thrombus/ vascular wall specimen.
Non-invaded group Patients whose inferior vena cava vascular wall is not invaded according to histopathological examination.

Arm

Intervention/Treatment

Invaded Group

Patients whose inferior vena cava vascular wall is invaded according to histopathological examination.

Diagnostic Test: Vascular wall invaded

Inferior vena cava vascular wall is invaded according to pathologic examination on the postoperative tumor thrombus/ vascular wall specimen.

Non-invaded group

Patients whose inferior vena cava vascular wall is not invaded according to histopathological examination.

Outcome Measures

Primary Outcome Measures

Overall survival [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]
The duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.

Secondary Outcome Measures

Clinical manifestation [From the clinical diagnosis until the surgery, an average of 3 weeks]
Clinical manifestation related to the renal carcinoma
Mayo classification [The time once the preoperative imaging is assessed, up to 1 weeks.]
A universal grading system for renal tumor thrombus.
Primary tumor diameter [The time once the preoperative imaging is assessed, up to 1 weeks.]
Diameter of the primary tumor.
Preoperative tumor node metastasis (TNM) stage [The time once the preoperative imaging is assessed, up to 1 weeks.]
TNM stage according to the preoperative imaging.
IVC residual blood flow [The time once the preoperative imaging is assessed, up to 1 weeks.]
Inferior vena cava residual blood flow according to ultrasonography.
IVC vascular wall continuity [The time once the preoperative imaging is assessed, up to 1 weeks.]
Inferior vena cava vascular wall continuity according to ultrasonography.
IVC complete occlusion [The time once the preoperative imaging is assessed, up to 1 weeks.]
Whether the inferior vena cava is completely occluded according to ultrasonography.
IVC enhanced synchronization with tumor thrombus [The time once the preoperative imaging is assessed, up to 1 weeks.]
Whether the inferior vena cava enhanced synchronization with tumor thrombus according to ultrasonography.
Tumor thrombus move when breathe [The time once the preoperative imaging is assessed, up to 1 weeks.]
Whether the tumor thrombus move when breathe according to ultrasonography.
Maximum IVC anterior-posterior (AP) diameter [The time once the preoperative imaging was assessed, up to 1 weeks.]
Maximum inferior vena cava anterior-posterior diameter according to CT/ MRI.
Maximum coronal IVC diameter [The time once the preoperative imaging is assessed, up to 1 weeks.]
Maximun coronal inferior vena cava diameter according to CT/ MRI.
Maximum IVC AP diameter at the Rvo [The time once the preoperative imaging is assessed, up to 1 weeks.]
Maximum inferior vena cava anterior-posterior diameter at the renal vein ostium according to CT/ MRI.
Maximum coronal IVC diameter at the Rvo [The time once the preoperative imaging is assessed, up to 1 weeks.]
Maximun coronal inferior vena cava diameter at the renal vein ostium according to CT/ MRI.
Bland thrombus [The time once the preoperative imaging is assessed, up to 1 weeks.]
The presence of bland thrombus in inferior vena cava according to CT/ MRI.
growing against the direction of venous return (GADVR) [The time once the preoperative imaging is assessed, up to 1 weeks.]
The presence of tumor thrombus growing against the direction of venous return according to CT/ MRI.
Surgery approach [The time once the surgery finished, an average of 10 days.]
Radical nephrectomy and at least one kind of IVC thrombectomy (including IVC incision only, IVC partial resection, IVC diagonal resection, and IVC segmental resection)
Surgery time [The time once the surgery finished, an average of 10 days.]
Surgery time
Blood loss [The time once the surgery finished, an average of 10 days.]
Blood loss during surgery
Histological type [The time once the pathological specimen is assessed, up to 1 weeks.]
Histological type of the tumor according to pathological examination.
Postoperative TNM stage [The time once the pathological specimen is assessed, up to 1 weeks.]
TNM stage according to pathological examination.
Invaded vascular wall layer [The time once the pathological specimen is assessed, up to 1 weeks.]
The deepest Inferior vane cava vascular wall layer the tumor thrombus invaded.
Comorbidity occurence [From the end of surgery until discharge, up to 3 weeks.]
The comorbidity occurence after surgery.
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]
The duration from the date of diagnosis to death, last follow-up, or cancer recurrence.
Tumor metastasis [Through study completion, an average of 3 year.]
Location and time that the metastasis occurs.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;