Vascular Thrombus Involvement in Nephroblastoma

Completed

• Conditions: Nephroblastoma with Vena Cava Thrombosis

• Registration Number: NCT05195411
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Nephroblastoma (Wilms tumor) is the most common kidney tumor in children. It is a malignant embryonic tumor with a good prognosis with more than 85% long-term survival with appropriate chemotherapy, surgery (which most often consists of a total nephrectomy) and radiotherapy for locally invasive forms. Some nephroblastomas (approximately 10%) present with vascular extension with vena cava thrombus, a situation which may worsen the prognosis due to the complexity of the surgery. While the oncological treatment of nephroblastoma is highly formalized, to date there is no specific guideline on the surgical management of this rare clinical presentation of nephroblastomas.

The aim of the study is to provide recommendations for the surgical management of nephroblastomas with vena cava thrombus in a large multicenter series.

Detailed Description

Nephroblastoma (Wilms tumor) is the most common kidney tumor in children. It is a malignant embryonic tumor with a good prognosis with more than 85% long-term survival with appropriate chemotherapy, surgery (which most often consists of a total nephrectomy) and radiotherapy for locally invasive forms. Some nephroblastomas (approximately 10%) present with vascular extension with vena cava thrombus, a situation which may worsen the prognosis due to the complexity of the surgery. While the oncological treatment of nephroblastoma is highly formalized, to date there is no specific guideline on the surgical management of this rare clinical presentation of nephroblastomas.

The management of children with nephroblastomas with vena cava thrombosis is very specific because of the vital risks to diagnosis, especially pulmonary embolism but also cardiac arrest (in the event of extension in the right atrium) and Cerebrovascular accidents by embolism, rarer. Surgery of the primary tumor and its intravascular extension is complex and may require the use of extracorporeal circulation, a source of significant morbidity and even mortality. These patients who will actually have a single kidney are at high risk for renal failure due to possible contralateral kidney damage during surgery. Surgery is not clearly codified because cases are rare, including in expert centers.

The aim of the study is to provide recommendations for the surgical management of nephroblastomas with vena cava thrombus in a large multicenter series.

Study Timeline

• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-19
• Study Start: 2022-12-12
• Primary Completion: 2023-03-15
• Study Completion: 2023-03-15
• Status Verified: 2023-11
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Minors with nephroblastoma with vena cava thrombosis +/- atrial extension.
• Cared between 1999 and 2019 in the centers of the study.

Exclusion Criteria

• Other renal and non-renal tumors with vena cava thrombosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of surgical management recommendations	2 months	Study of the medical file. Determination of surgical management recommendations based on survival, the occurrence of local or metastatic recurrence and the study of medical care of the patient.
Survival	22 years	Study of the medical file.
Recurrence	22 years	Study of the medical file. Local or metastatic recurrence.

Secondary Outcome Measures

Name	Time	Method
Long-term sequelae	20 years	Study of the medical file. Sequelae linked to the toxicity of chemotherapy, radiotherapy and surgery.
Post-operative complications	30 days	Study of the medical file. Description of post-operative complications and Dindo-Clavien classification (classification that defines and grades operative complications in 10 grades).
Intraoperative complications	1 day	Study of the medical file. Description of intraoperative complications and Dindo-Clavien classification (classification that defines and grades operative complications in 10 grades).
Identify the oncological and / or surgical prognostic risk factors	2 months	Study of the medical file. Identify the oncological and / or surgical prognostic risk factors depending on the medical treatment received.

Trial Locations

Locations (2)

Hôpital Kremlin Bicêtre; 🇫🇷 Le Kremlin Bicêtre, France

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France