VIN: Vascular Thrombus Involvement in Nephroblastoma

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05195411

Collaborator

(none)

Enrollment

Locations

1.9

Anticipated Duration (Months)

Patients Per Site

18.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nephroblastoma With Vena Cava Thrombosis

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Nephroblastoma With Vena Cava Thrombosis : Multicenter Study Over 20 Years - Analysis of Key Elements of Surgical Management

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Survival [22 years]
Study of the medical file.
Recurrence [22 years]
Study of the medical file. Local or metastatic recurrence.
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.

Secondary Outcome Measures

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).
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).
Long-term sequelae [20 years]
Study of the medical file. Sequelae linked to the toxicity of chemotherapy, radiotherapy and surgery.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Kremlin Bicêtre	Le Kremlin Bicêtre		France	94270
2	Hôpital Necker-Enfants Malades	Paris		France	75015

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Sabine Sarnacki, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study Director: Luca Pio, MD, Assistance Publique - Hôpitaux de Paris