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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05261113
Enrollment
500
Registered
2022-03-02
Start date
2017-01-01
Completion date
2021-06-30
Last updated
2022-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

CE-IOUS, IOUS

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.

Interventions

PROCEDURECE-IOUS

Use of contrast-enhanced intraoperative ultrasound during liver surgery

Sponsors

University of Regensburg
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Impact on surgical strategy during CE-IOUS01.01.2017 - 31.12.2019Frequency of surgeries changed due to findings of CE-IOUS together with histopathological correlation.
Outcome relevance of CE-IOUS01.01.2017 - 30.06.2021Comparison of recurrence-free interval, overall survival rate of the intervention cohort and control cohort as well as the groups themselves.

Secondary

MeasureTime frameDescription
Sensitivity and Specificity of CE-IOUS compared to other imaging methods01.01.2017 - 31.12.2019Accuracy of CE-IOUS in comparison to CT and MRI measured right localisation as well as classification of tumour dignity.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026