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.
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
- Conditions the study is for
- Neoplasms, Surgery--Complications, Vascular Diseases
- 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.
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.
- Conditions
- Neoplasms, Surgery--Complications, Vascular Diseases, Vein Disease
- 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.
Complication
Surgical complications rates
Measured: 90 days
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.
- First posted6 Nov 2019
- Study start31 Jan 2019
- Primary completion1 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Infanta Cristina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego López Guerra, Hospital Universitario Infanta Cristina
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resection of the Inferior Vena Cava Due to Tumor Involvement Allows Long-Term Survival in Different Neoplasms
- ClinicalTrials.gov ID
- NCT04154761
- Acronym / sponsor ID
- CAVARESECT / UE-CHUB 002-2019
- Conditions
- Neoplasms, Surgery--Complications, Vascular Diseases, Vein Disease
- Keywords
- Inferior vena cava, radical resection, Vascular reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospital Universitario Infanta CristinaUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Patients with primary or secondary IVC involvement who underwent surgery.
Key exclusion criteria (1 listed)
- Patients with metastasis found during intraoperative exploration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resection of inferior vena cava and reconstructionResection of inferior vena cava and reconstruction with primary repair, resection with autologous or prosthetic patch repair, and circumferential resection with graft replacement | Procedure or surgery | – |
Primary outcome
Complication
Time frame: 90 days
Surgical complications rates
Overall survival
Time frame: 5 years
Patients overall survival after resection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.