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

Sponsor

University of Regensburg (Other)

Overall Status

Completed

CT.gov ID

NCT05261113

Collaborator

(none)

500

Enrollment

Location

53.9

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Neoplasms Liver/Hepatobiliary Cancer Colorectal Cancer Metastatic Metastases Surgery Ultrasound	Procedure: 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 Design

Study Type:

Observational

Actual Enrollment :

500 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Intervention cohort Patients that were operated due to liver neoplasms with use of CE-IOUS	Procedure: CE-IOUS Use of contrast-enhanced intraoperative ultrasound during liver surgery
Control cohort Patients that were operated due to liver neoplasms without use of CE-IOUS

Arm

Intervention/Treatment

Intervention cohort

Patients that were operated due to liver neoplasms with use of CE-IOUS

Procedure: CE-IOUS

Use of contrast-enhanced intraoperative ultrasound during liver surgery

Control cohort

Patients that were operated due to liver neoplasms without use of CE-IOUS

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Department of Surgery	Regensburg		Germany

Sponsors and Collaborators

University of Regensburg

Investigators

Study Chair: Hans J Schlitt, MD Prof., Head of Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Florian Bitterer, Principal Investigator, University of Regensburg

ClinicalTrials.gov Identifier:

NCT05261113

Other Study ID Numbers:

17-699-101

First Posted:

Mar 2, 2022

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Florian Bitterer, Principal Investigator, University of Regensburg

CE-IOUS

IOUS

Additional relevant MeSH terms:

Neoplasm Metastasis

Liver Neoplasms

Study Results

No Results Posted as of Mar 17, 2022