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

Completed

• Conditions: Liver/Hepatobiliary Cancer; Surgery; Liver Neoplasms; Colorectal Cancer Metastatic; Metastases; Ultrasound
• Interventions: Procedure: CE-IOUS

• Registration Number: NCT05261113
• Lead Sponsor: University of Regensburg

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Study First Submitted: 2022-02-19
• Study First Submitted QC: 2022-02-19
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Study First Posted: 2022-03-02
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

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Exclusion Criteria

• Intraoperative use of CE-IOUS outside the department of surgery
• Liver transplantations
• Use of CE-IOUS only for exclusion of hepatic metastasis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention cohort	CE-IOUS	Patients that were operated due to liver neoplasms with use of CE-IOUS

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Department of Surgery; 🇩🇪 Regensburg, Germany