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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05261113
Other study ID # 17-699-101
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date June 30, 2021

Study information

Verified date March 2022
Source University of Regensburg
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Intervention

Procedure:
CE-IOUS
Use of contrast-enhanced intraoperative ultrasound during liver surgery

Locations

Country Name City State
Germany University Hospital Department of Surgery Regensburg

Sponsors (1)

Lead Sponsor Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
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