Clinical Trials Directory

Trials / Completed

CompletedNCT05261113

CE-IOUS Impact on Surgical Strategy of Liver Tumours and Liver Metastases

Clinical Study to Evaluate the CE-IOUS Outcome-relevant Impact on the Surgical Treatment of Liver Tumours and Liver Metastases

Status
Completed
Phase
—
Study type
Observational
Enrollment
500 (actual)
Sponsor
University of Regensburg · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

Summary

Contrast-enhanced intraoperative ultrasound (CE-IOUS) plays an increasingly important role in the surgical therapy planning of primary liver lesions as well as liver metastases. The present study was designed to evaluate the significance of CE-IOUS by specificity and sensitivity and particularly the impact it exerts on the surgical strategy. A secondary aim was assessing the outcome relevance of surgeries influenced by CE-IOUS.

Detailed description

CE-IOUS has been used during hepatobiliary surgery for almost 25 years. During this time, it has proven to be an excellent diagnostic tool for detecting and characterising previously unknown lesions. It is still unclear to what extent the findings of this imaging modality impacts the strategy of such operations. The currently planned study is intended to evaluate the impact of contrast-enhanced intraoperative ultrasound on the surgical procedure in hepatic surgery. For this purpose, patient data of the time period between 2017 and 2019 was prospectively analysed. Another aim of the study was to measure the outcome relevance of CE-IOUS. This assessment was carried out by comparing an intervention cohort with a control cohort. The control cohort consisted of patients that were operated due similar liver lesions as the intervention cohort however did not receive CE-IOUS during the operation. Aspects like the recurrence free time and overall survival rate of the two cohorts were compared together with the patients' characteristics of the groups themselves.

Conditions

Interventions

TypeNameDescription
PROCEDURECE-IOUSUse of contrast-enhanced intraoperative ultrasound during liver surgery

Timeline

Start date
2017-01-01
Primary completion
2021-06-30
Completion
2021-06-30
First posted
2022-03-02
Last updated
2022-03-17

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT05261113. Inclusion in this directory is not an endorsement.