NCT04154761

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

7 months

First QC Date

November 5, 2019

Last Update Submit

November 6, 2019

Conditions

NeoplasmsSurgery--ComplicationsVascular DiseasesVein Disease

Keywords

Inferior vena cavaradical resectionVascular reconstruction

Outcome Measures

Primary Outcomes (2)

  • Complication

    Surgical complications rates

    90 days

  • Overall survival

    Patients overall survival after resection

    5 years

Interventions

Resection of inferior vena cava and reconstructionPROCEDURE

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patients with metastasis found during intraoperative exploration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diego López-Guerra

Badajoz, 06006, Spain

Location

MeSH Terms

Conditions

NeoplasmsVascular Diseases

Interventions

Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hepatobiliary Surgeon, Principal Investigator

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 6, 2019

Study Start

January 31, 2019

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

November 8, 2019

Record last verified: 2019-11

Locations

ES(1)