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NCT Number: NCT05261113

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

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.

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Key information

Conditions

Liver Neoplasms Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Colorectal Cancer Metastatic Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver/Hepatobiliary Cancer Metastases Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Surgery Ultrasound

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Department of Surgery

Regensburg, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CE-IOUS

Procedure

Use of contrast-enhanced intraoperative ultrasound during liver surgery

Primary outcomes

  1. Impact on surgical strategy during CE-IOUS

    Time frame: 01.01.2017 - 31.12.2019

    Frequency of surgeries changed due to findings of CE-IOUS together with histopathological correlation.

  2. Outcome relevance of CE-IOUS

    Time frame: 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 outcomes

  1. Sensitivity and Specificity of CE-IOUS compared to other imaging methods

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 2, 2022
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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