An observational study in Liver Neoplasms, Liver/Hepatobiliary Cancer and Colorectal Cancer Metastatic, sponsored by University of Regensburg. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2022-03-17.
Sponsored by University of Regensburg · Observational
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 500 is above the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →University of Regensburg is the lead sponsor of 67 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients that received elective liver surgery in the study centre during the study period
Exclusion Criteria:
Patients that were operated due to liver neoplasms with use of CE-IOUS
Procedure: CE-IOUS
Patients that were operated due to liver neoplasms without use of CE-IOUS
Use of contrast-enhanced intraoperative ultrasound during liver surgery
Impact on surgical strategy during CE-IOUS
Frequency of surgeries changed due to findings of CE-IOUS together with histopathological correlation.
Time frame: 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.
Time frame: 01.01.2017 - 30.06.2021
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.
Time frame: 01.01.2017 - 31.12.2019
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Regensburg