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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Liver Neoplasms, Liver/Hepatobiliary Cancer, Colorectal Cancer Metastatic, Metastases, Surgery, Ultrasound

Intervention / Treatment
-----------------
* Procedure: CE-IOUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operations during study period from 01/2017 until 12/2019 Elective liver surgery in the department of surgery at the University Hospital Regensburg Liver resections due to primary hepatic tumours (benign, malignant) or hepatic metastases Liver surgery with intraoperative use of CE-IOUS Exclusion Criteria: Intraoperative use of CE-IOUS outside the department of surgery Liver transplantations Use of CE-IOUS only for exclusion of hepatic metastasis
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention cohort<br>Patients that were operated due to liver neoplasms with use of CE-IOUS | Procedure: CE-IOUS<br>* Use of contrast-enhanced intraoperative ultrasound during liver surgery<br>|
| Control cohort<br>Patients that were operated due to liver neoplasms without use of CE-IOUS | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on surgical strategy during CE-IOUS | Frequency of surgeries changed due to findings of CE-IOUS together with histopathological correlation. | 01.01.2017 - 31.12.2019 | 
| Outcome relevance of CE-IOUS | Comparison of recurrence-free interval, overall survival rate of the intervention cohort and control cohort as well as the groups themselves. | 01.01.2017 - 30.06.2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of CE-IOUS compared to other imaging methods | Accuracy of CE-IOUS in comparison to CT and MRI measured right localisation as well as classification of tumour dignity. | 01.01.2017 - 31.12.2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CE-IOUS, IOUS