Vascular Thrombus Involvement in Nephroblastoma

NCT ID: NCT05195411

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-12
• Study Completion Date: 2023-03-15

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.

Conditions

Nephroblastoma With Vena Cava Thrombosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Nephroblastoma with vena cava thrombosis

Children with nephroblastoma with vena cava thrombosis +/- atrial extension, cared between 1999 and 2019 in Parisian hospitals: Necker and Bicêtre.

No interventions assigned to this group

Eligibility Criteria

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.

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabine Sarnacki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Luca Pio, MD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Kremlin Bicêtre

Le Kremlin-Bicêtre, , France

Hôpital Necker-Enfants Malades

Paris, , France

Countries

France

References

Pio L, Abib S, Guerin F, Chardot C, Blanc T, Sarrai N, Martelli H, De Souza FKM, Fanelli MCA, Tamisier D, Guilhen JCS, Le Bret E, Belli E, Fadel E, Cypriano MDS, Minard V, Pasqualini C, Schleiermacher G, Lemelle L, Rod J, Irtan S, Pistorio A, Gauthier F, Branchereau S, Sarnacki S. Surgical Management of Wilms Tumors with Intravenous Extension: A Multicenter Analysis of Clinical Management with Technical Insights. Ann Surg Oncol. 2024 Jul;31(7):4713-4723. doi: 10.1245/s10434-024-15232-w. Epub 2024 Apr 5.

Reference Type: BACKGROUND

PMID: 38578552 (View on PubMed)

Other Identifiers

APHP201331

Identifier Type: -

Identifier Source: org_study_id