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Clinical Trials/NCT04154761
NCT04154761CompletedNot Applicable

Resection of the Inferior Vena Cava Due to Tumor Involvement Allows Long-Term Survival in Different Neoplasms

Hospital Universitario Infanta Cristina1 site in 1 country13 target enrollmentStarted: January 31, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
13
Locations
1
Primary Endpoint
Complication

Study Overview

Brief Summary

The involvement of the inferior vena cava (IVC) in advanced abdominal tumors is a surgical challenge, given the high postoperative morbidity and poor long-term prognosis. The goal was to analyze the experience, perioperative management, and results.

Investigators have evaluated short and long-term results of surgical resections of tumors with associated inferior vena cava resection performed between 2012 and 2018.

Detailed Description

Data Collection:

Investigators retrospectively looked at patients who, from January 2012 to December 2018, underwent surgical procedures in the unit for IVC-specific tumors or for IVC resections due to secondary infiltrative tumors. In some cases, the IVC involvement was an intraoperative finding.

Patients with primary or secondary IVC involvement who underwent surgery were included in the study. Patients with metastasis found during intraoperative exploration were excluded from the study.

Diagnostic management included establishment of a medical history, performance of clinical examination and imaging tests, including an abdominal ultrasound and computerized tomography (CT) scan, to confirm the tumor origin and growth, as well as infiltration, if any, of adjacent structures. These also allowed to rule out distant metastases, and to assess resectability and the option for vascular reconstruction. In some cases, the decision to resect the IVC was made during surgery, because IVC involvement was an intraoperative finding which remained unknown up to that point.

The variables taken into account were age, sex, BMI, the American Society of Anesthesiologists (ASA) classification, tumor type, preoperative chemotherapy and/or radiation therapy. In addition, another variable considered was whether the finding was intraoperative or preoperative. Perioperative clinical results, surgical approach, type of IVC resection and reconstruction, and intraoperative complications were recorded. Details of the postoperative course were collected. Some of the key short-term data recorded included length of hospital stay, complications' ranking (according to the Clavien-Dindo score; 'severe complication' is defined as greater or equal to IIIa), re-operation, re-admission and operative mortality (< 90 days after operation). Some of the key long-term data recorded were patency of IVC or prosthesis (as determined by a CT scan), neoadjuvant and adjuvant chemotherapy, specific disease-free survival and overall survival (OS).

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with primary or secondary IVC involvement who underwent surgery.

Exclusion Criteria

  • Patients with metastasis found during intraoperative exploration.

Outcomes

Primary Outcomes

Complication

Time Frame: 90 days

Surgical complications rates

Overall survival

Time Frame: 5 years

Patients overall survival after resection

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Diego López Guerra

Hepatobiliary Surgeon, Principal Investigator

Hospital Universitario Infanta Cristina

Study Sites (1)

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