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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Renal Cell; Tumor Thrombus; Neoplasm Invasiveness; Inferior Vena Cava Interruption
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 232

Contacts and Locations

• Study Contact: Name: Jiyuan Chen, MD; Phone Number: +86 18801430995; Email: 1910301319@pku.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Zhuo Liu, Doctor; Phone Number: +086 15611908062; Email: liuzhuo1990@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The groups of cohort will be selected from inhospital patients in Peking University Third Hospital.

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Director: Zhuo Liu, MD, Peking University Third Hospital

Publications and helpful links

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Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): January 1, 2026
• Study Completion (Anticipated): January 1, 2027

Study Registration Dates

• First Submitted: October 15, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Neoplasm Grading; Diagnostic Model; Preoperative Diagnosis
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Embolism and Thrombosis; Kidney Neoplasms; Neoplastic Processes; Carcinoma, Renal Cell; Carcinoma; Thrombosis; Neoplasm Invasiveness
• Other Study ID Numbers: M2022597

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No