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

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

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

Study Overview

• Status: Completed
• Conditions: Renal Cell Carcinoma Stage III
• Intervention / Treatment: Procedure: Radical nephrectomy with inferior vena cava thrombectomy without thoracotomy

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• Greece
  • Chaidari, Greece, 12462
    • Attikon University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Among all patients with renal cell carcinoma operated in Attikon University Hospital, the ones with level IV tumor thrombus were included in the study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Transabdominal inferior vena cava thrombectomy; Patients undergoing radical nephrectomy and inferior vena cava thrombectomy transabdominal without thoracotomy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short term mortality rate	Percentage of patients' postoperative deaths	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short term major complications' rate	Incidence of Clavien/Dindo grade 3 or more postoperative complications	30 days
Recurrence rate	Rate of local or systemic recurrence	27 months

Collaborators and Investigators

• Sponsor: Attikon Hospital
• Investigators: Study Director: Nikolaos Arkadopoulos, MD, PhD, Attikon Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Renal cell carcinoma; Inferior vena cava; Tumor thrombus; level IV
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Embolism and Thrombosis; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Thrombosis
• Other Study ID Numbers: Not appicable

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No