Renal Cell Carcinoma and Stage IV Inferior Vena Cava Thrombus: Resection Without Thoracotomy

Renal Cell Carcinoma Stage III Clinical Trial

Official title:

Resection of Renal Cell Carcinoma and Stage IV Inferior Vena Cava Thrombus Without Thoracotomy: A Case Series and Literature Review.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04350047
• Other study ID #: Not appicable
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2020
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assessment of short-term outcomes of radical nephrectomy combined with IVC thrombectomy with a novel technique without thoracotomy: single center case series.

Description:

Assessment of the 30-day mortality and major complications as well as long-term oncological outcomes of three patients undergoing radical nephrectomy combined with inferior vena cava (IVC) thrombectomy with a novel technique without thoracotomy for renal cell carcinoma with IVC level IV thrombus. This is a retrospective case series carried out at Attikon University Hospital between January 2018 to March 2020.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients

• Documented radiological and/or pathological diagnosis of renal cell carcinoma with level IV tumor thrombus

Exclusion Criteria:

• American Anesthesia Association (ASA) Class V and/or any contraindications to general anesthesia

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma Stage III
• Thrombosis

Intervention

Procedure:
• Radical nephrectomy with inferior vena cava thrombectomy without thoracotomy
The abdomen was accessed through a Makuuchi incision. After mobilization of the liver and assessment of the inferior vena cava infiltration (IVC), IVC was clamped below the level of the renal veins. In order to get access to the intrapericardial IVC, an incision was made through the tendon of the diaphragm and a clamp was placed first in the hepatoduodenal ligament (Pringle maneuver) and then in the endopericardial portion of the IVC, in that order. A longitudinal 3-4 cm incision was made incorporating the junction of IVC and right renal vein. After tumor removal thrombus was removed and a fine clamp was placed at the IVC just below the hepatocaval junction and immediate release of the clamping of the hepatoduodenal ligament. Total endopericardial clamp time was 4 minutes. Patients then underwent radical nephrectomy in a standard fashion with en bloc resection of the IVC thrombus.

Locations

Country	Name	City	State
Greece	Attikon University Hospital	Chaidari

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short term mortality rate	Percentage of patients` postoperative deaths	30 days
Secondary	Short term major complications` rate	Incidence of Clavien/Dindo grade 3 or more postoperative complications	30 days
Secondary	Recurrence rate	Rate of local or systemic recurrence	27 months