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Clinical Study to Evaluate the CE-IOUS Outcome-relevant Impact on the Surgical Treatment of Liver Tumours and Liver Metastases
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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
University Hospital Department of Surgery
Regensburg, Germany
Start Date
January 1, 2017
Primary Completion Date
June 30, 2021
Completion Date
June 30, 2021
Last Updated
March 17, 2022
500
ACTUAL participants
CE-IOUS
PROCEDURE
Lead Sponsor
University of Regensburg
NCT05759728
NCT07328087
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07225114