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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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);

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Vascular wall invaded

    Diagnostic test

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

Treatment groups

232 Participants
are divided into 2 treatment groups
Group A: Invaded Group1 intervention
Group B: Non-invaded group0 interventions

Trial outcomes

Primary outcomes

1

Overall survival

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

Time frame
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

1

Clinical manifestation

Clinical manifestation related to the renal carcinoma

Time frame
From the clinical diagnosis until the surgery, an average of 3 weeks
2

Mayo classification

A universal grading system for renal tumor thrombus.

Time frame
The time once the preoperative imaging is assessed, up to 1 weeks.
3

Primary tumor diameter

Diameter of the primary tumor.

Time frame
The time once the preoperative imaging is assessed, up to 1 weeks.
4

Preoperative tumor node metastasis (TNM) stage

TNM stage according to the preoperative imaging.

Time frame
The time once the preoperative imaging is assessed, up to 1 weeks.

Other outcomes

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