Liver NeoplasmsNCT05261113
CE-IOUS Impact on Surgical Strategy of Liver Tumours and Liver Metastases
An observational study of Liver Neoplasms and Liver/Hepatobiliary Cancer, run by University of Regensburg at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Neoplasms, Liver/Hepatobiliary Cancer, Colorectal Cancer Metastatic
- What is being tested?
- CE-IOUS
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2017to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients that received elective liver surgery in the study centre during the study period
Who may be able to join
- 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
Who cannot join
- Intraoperative use of CE-IOUS outside the department of surgery
- Liver transplantations
- Use of CE-IOUS only for exclusion of hepatic metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate the CE-IOUS Outcome-relevant Impact on the Surgical Treatment 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.
Read the 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.
- Conditions
- Liver Neoplasms, Liver/Hepatobiliary Cancer, Colorectal Cancer Metastatic, Metastases, Surgery, Ultrasound
- Being tested
- CE-IOUS
- Keywords
- CE-IOUS, IOUS
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CE-IOUSProcedure or surgery
Use of contrast-enhanced intraoperative ultrasound during liver surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention cohort | Patients that were operated due to liver neoplasms with use of CE-IOUS Receives: Procedure: CE-IOUS | |
| Control cohort | Patients that were operated due to liver neoplasms without use of CE-IOUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on surgical strategy during CE-IOUS
Frequency of surgeries changed due to findings of CE-IOUS together with histopathological correlation.
Measured: 01.01.2017 - 31.12.2019
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.
Measured: 01.01.2017 - 30.06.2021
Secondary outcomes (1)
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.
Measured: 01.01.2017 - 31.12.2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Jan 2017
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florian Bitterer, University of Regensburg
- Investigators
- Hans J Schlitt, MD Prof., Study chair, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261113
- Sponsor's protocol ID
- 17-699-101
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the CE-IOUS Outcome-relevant Impact on the Surgical Treatment of Liver Tumours and Liver Metastases
- ClinicalTrials.gov ID
- NCT05261113
- Acronym / sponsor ID
- 17-699-101
- Conditions
- Liver Neoplasms, Liver/Hepatobiliary Cancer, Colorectal Cancer Metastatic, Metastases, Surgery, Ultrasound
- Keywords
- CE-IOUS, IOUS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention cohort | – | Procedure: CE-IOUSPatients that were operated due to liver neoplasms with use of CE-IOUS |
| Control cohort | – | –Patients that were operated due to liver neoplasms without use of CE-IOUS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that received elective liver surgery in the study centre during the study period
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Intraoperative use of CE-IOUS outside the department of surgery
- Liver transplantations
- Use of CE-IOUS only for exclusion of hepatic metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CE-IOUSUse of contrast-enhanced intraoperative ultrasound during liver surgery | Procedure or surgery | Intervention cohort |
Primary outcome
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.
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.
1 secondary outcome
Sensitivity and Specificity of CE-IOUS compared to other imaging methods
Time frame: 01.01.2017 - 31.12.2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans J Schlitt, MD Prof. study chair
Head of Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Neoplasms and Liver/Hepatobiliary Cancer, run by University of Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on surgical strategy during CE-IOUS (time frame: 01.01.2017 - 31.12.2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.