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Resection of the Inferior Vena Cava Due to Tumor Involvement (CAVARESECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154761
Recruitment Status : Completed
First Posted : November 6, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Diego López Guerra, Hospital Universitario Infanta Cristina

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.


Condition or disease Intervention/treatment
Neoplasms Surgery--Complications Vascular Diseases Vein Disease Procedure: Resection of inferior vena cava and reconstruction

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Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Resection of the Inferior Vena Cava Due to Tumor Involvement Allows Long-Term Survival in Different Neoplasms
Actual Study Start Date : January 31, 2019
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : October 1, 2019

Intervention Details:
  • Procedure: Resection of inferior vena cava and reconstruction
    Resection of inferior vena cava and reconstruction with primary repair, resection with autologous or prosthetic patch repair, and circumferential resection with graft replacement


Primary Outcome Measures :
  1. Complication [ Time Frame: 90 days ]
    Surgical complications rates

  2. Overall survival [ Time Frame: 5 years ]
    Patients overall survival after resection



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who, from January 2012 to December 2018, underwent surgical procedures in our unit for IVC-specific tumors or for IVC resections due to secondary infiltrative tumors.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with metastasis found during intraoperative exploration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154761


Locations
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Spain
Diego López-Guerra
Badajoz, Spain, 06006
Sponsors and Collaborators
Hospital Universitario Infanta Cristina
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Responsible Party: Diego López Guerra, Hepatobiliary Surgeon, Principal Investigator, Hospital Universitario Infanta Cristina
ClinicalTrials.gov Identifier: NCT04154761    
Other Study ID Numbers: UE-CHUB 002-2019
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diego López Guerra, Hospital Universitario Infanta Cristina:
Inferior vena cava
radical resection
Vascular reconstruction
Additional relevant MeSH terms:
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Neoplasms
Vascular Diseases
Cardiovascular Diseases