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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05261113
• Other study ID #: 17-699-101
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Liver Neoplasms
• Metastases
• Neoplasm Metastasis
• Surgery
• Ultrasound

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