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

NCT04350047 | Completed

• 1 other identifier: Not appicable
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Cell Carcinoma Stage III

Keywords

Renal cell carcinoma; Tumor thrombus; Inferior vena cava; level IV

Outcome Measures

Primary Outcomes (1)

• Short term mortality rate

  Percentage of patients' postoperative deaths

  30 days

Secondary Outcomes (2)

• Short term major complications' rate

  30 days

• Recurrence rate

  27 months

Study Arms (1)

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

Interventions

Radical nephrectomy with inferior vena cava thrombectomy without thoracotomy PROCEDURE

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.

Transabdominal inferior vena cava thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

Attikon University Hospital

Chaïdári, 12462, Greece

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Thoracotomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thoracic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Nikolaos Arkadopoulos, MD, PhD

  Attikon Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: January 1, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)