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

Overview

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.

Interventions

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

Primary outcome measures

• Overall survival [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 outcome measures (12)

• Clinical manifestation [Time frame: From the clinical diagnosis until the surgery, an average of 3 weeks]
• Mayo classification [Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.]
• Primary tumor diameter [Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.]
• Preoperative tumor node metastasis (TNM) stage [Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.]
• IVC residual blood flow [Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.]
• IVC vascular wall continuity [Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.]
• IVC complete occlusion [Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.]
• IVC enhanced synchronization with tumor thrombus [Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.]
• Tumor thrombus move when breathe [Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.]
• Maximum IVC anterior-posterior (AP) diameter [Time frame: The time once the preoperative imaging was assessed, up to 1 weeks.]
• Maximum coronal IVC diameter [Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.]
• Maximum IVC AP diameter at the Rvo [Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Peking University Third Hospital — Beijing

Publications

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
• Adams LC, Ralla B, Bender YY, Bressem K, Hamm B, Busch J, Fuller F, Makowski MR. Renal cell carcinoma with venous extension: prediction of inferior vena cava wall invasion by MRI. Cancer Imaging. 2018 May 3;18(1):17. doi: 10.1186/s40644-018-0150-z. PMID 29724245
• Ingels A, Campi R, Capitanio U, Amparore D, Bertolo R, Carbonara U, Erdem S, Kara O, Klatte T, Kriegmair MC, Marchioni M, Mir MC, Ouzaid I, Pavan N, Pecoraro A, Roussel E, de la Taille A. Complementary roles of surgery and systemic treatment in clear cell renal cell carcinoma. Nat Rev Urol. 2022 Jul;19(7):391-418. doi: 10.1038/s41585-022-00592-3. Epub 2022 May 11. PMID 35546184
• Labbate C, Hatogai K, Werntz R, Stadler WM, Steinberg GD, Eggener S, Sweis RF. Complete response of renal cell carcinoma vena cava tumor thrombus to neoadjuvant immunotherapy. J Immunother Cancer. 2019 Mar 11;7(1):66. doi: 10.1186/s40425-019-0546-8. PMID 30857555
• Shi T, Huang Q, Liu K, Du S, Fan Y, Yang L, Peng C, Shen D, Wang Z, Gao Y, Gu L, Niu S, Ai Q, Li H, Liu F, Li Q, Wang H, Guo A, Fu B, Yang X, Zhang X, Wang D, Wang D, Guo H, Li H, Olivero A, Fam XI, Ma X, Wang B, Zhang X. Robot-assisted Cavectomy Versus Thrombectomy for Level II Inferior Vena Cava Thrombus: Decision-making Scheme and Multi-institutional Analysis. Eur Urol. 2020 Oct;78(4):592-602. PMID 32305170
• Liu Z, Zhao X, Zhang HX, Li LW, Tang SY, Wang GL, Zhang SD, Wang SM, Ma LL, Tian XJ. Surgical complexity and prognostic outcome of small volume renal cell carcinoma with high-level venous tumor thrombus and large volume renal cell carcinoma with low-level thrombus. Chin Med J (Engl). 2019 Aug 5;132(15):1780-1787. doi: 10.1097/CM9.0000000000000352. PMID 31306232
• Rodriguez Faba O, Linares E, Tilki D, Capitanio U, Evans CP, Montorsi F, Martinez-Salamanca JI, Libertino J, Gontero P, Palou J. Impact of Microscopic Wall Invasion of the Renal Vein or Inferior Vena Cava on Cancer-specific Survival in Patients with Renal Cell Carcinoma and Tumor Thrombus: A Multi-institutional Analysis from the International Renal Cell Carcinoma-Venous Thrombus Consortium. Eur Ur PMID 28753848
• Lardas M, Stewart F, Scrimgeour D, Hofmann F, Marconi L, Dabestani S, Bex A, Volpe A, Canfield SE, Staehler M, Hora M, Powles T, Merseburger AS, Kuczyk MA, Bensalah K, Mulders PF, Ljungberg B, Lam TB. Systematic Review of Surgical Management of Nonmetastatic Renal Cell Carcinoma with Vena Caval Thrombus. Eur Urol. 2016 Aug;70(2):265-80. doi: 10.1016/j.eururo.2015.11.034. Epub 2015 Dec 23. PMID 26707869

Identifiers

NCT: NCT05589207 · M2022597

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗