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NeoplasmsCAVARESECTNCT04154761

Resection of the Inferior Vena Cava Due to Tumor Involvement

An observational study of Neoplasms and Surgery--Complications, run by Hospital Universitario Infanta Cristina at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Resection of inferior vena cava and reconstruction
Type of treatment
Surgery or procedure
How many people
13 participants
Where
1 siteSpain
Study dates
31 Jan 2019to 1 Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Patients with metastasis found during intraoperative exploration.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Diego López-Guerra

    Badajoz, 06006

Other trials in Spain

About this study

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

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.

Read the 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).

Surgical Approach Management of IVC involvement was categorized in three groups, according to the surgical repair necessary: resection with primary repair, resection with autologous or prosthetic patch repair, and circumferential resection with graft replacement. Primary repair was defined as resection of a portion of the IVC with primary closure when <50% narrowing of the lumen would result. Patch closure was planned when a larger defect created by the resection required patch repair to avoid narrowing of the IVC. Circumferential resection of the IVC was managed with replacement using a prosthetic graft.

For surgical planning, investigators used the classification according to Kulayat, which subdivides the IVC into three segments: upper portion (level 1)-extending from the opening of the hepatic veins up to the right atrium-, middle portion (level 2)-extending from the renal veins to the hepatic veins-, and lower portion (level 3)-extending from the junction of the iliac veins to the opening of the renal veins.

Intravenous heparin was not used during the clamping time of the IVC. Heparinized saline (2units/ml of heparin sodium) was used, however, to flush out the prosthesis if being used for reconstruction. A therapeutic heparin dose is used for 30 days after surgery, and patients with prosthesis receive oral blood thinners for at least six months.

Follow-up Patient follow-up included measuring tumor markers and performing a chest-abdominal CT scan every three months for the first two years; then, twice a year; and then, annually, after five years. Local recurrence was defined as a return of a tumor within the surgical field, whereas systemic recurrence was defined as recurrent disease outside said field.

Being tested
Resection of inferior vena cava and reconstruction
Keywords
Inferior vena cava, radical resection, Vascular reconstruction
Medical subject headings
Neoplasms, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resection of inferior vena cava and reconstructionProcedure or surgery

    Resection of inferior vena cava and reconstruction with primary repair, resection with autologous or prosthetic patch repair, and circumferential resection with graft replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complication

    Surgical complications rates

    Measured: 90 days

  2. Overall survival

    Patients overall survival after resection

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2019
  2. Study start31 Jan 2019
  3. Primary completion1 Sep 2019
  4. Study completion1 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04154761
Sponsor's protocol ID
UE-CHUB 002-2019
Acronym
CAVARESECT
Status last verified
Nov 2019
First submitted
5 Nov 2019
Last updated
8 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasms and Surgery--Complications, run by Hospital Universitario Infanta Cristina at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complication (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.

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