Liver NeoplasmNCT04187937
Feasibility of Ultrasound-based Navigation for Non-anatomical Liver Resections
A study testing Stereotactic image-guided resection in people with Liver Neoplasm, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
In a non-anatomical resection of a liver tumor, only the part of the liver with the tumor and a safety margin of 5 - 10 mm are resected. This is done to ensure a negative resection margin, which means that no tumor cells are at the boundary of the resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasm
- What is being tested?
- Stereotactic image-guided resection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Jun 2020to 16 Feb 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients which are regularly scheduled for an open surgical liver resection
- At least one tumor considered for non-anatomical resection
- Lesion is visible on ultrasound imaging
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Age >= 18 years
Who cannot join
- Other clinically condition or disease that would (as deemed by the operating surgeon) significantly increase the risk of surgery
- Lesion is close to major vessel (< 10 mm)
- Lesion is too large to be visualized on ultrasound imaging
- Emergency
- Subjects not able to give informed consent (dementia)
- Women of childbearing potential (less than 1 year post-menopausal)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern
Bern
About this study
In a non-anatomical resection of a liver tumor, only the part of the liver with the tumor and a safety margin of 5 - 10 mm are resected. This is done to ensure a negative resection margin, which means that no tumor cells are at the boundary of the resection. These non-anatomical resections can be performed repeatedly in case of recurrence. However, compared to anatomical resections, it is more challenging to keep a negative resection margin as anatomical landmarks cannot be used for intra-operative guidance.
In this study, the investigators aim to clinically evaluate a 3d navigation system, where navigated intra-operative ultrasound data is used to create a virtual model and a surgical plan.
Read the detailed description
Surgical resection is the current gold standard for curative care of primary and metastatic hepatic tumors. This procedure involves the removal of the part of the liver where the tumor is located. This is typically achieved by removing the segments containing the tumor, so called anatomical resections. The downside of this technique is that it also removes a large part of healthy liver tissue. Recently, non-anatomical resections are becoming more popular, as they spare more healthy liver tissue than anatomical resections with similar oncological outcomes. In a non-anatomical resection, only the part of the liver with the tumor and a safety margin of 5 - 10 mm are resected. This is done to ensure a negative resection margin, which means that no tumor cells are at the boundary of the resection. These non-anatomical resections can be performed repeatedly in case of recurrence. However, compared to anatomical resections, it is more challenging to keep a negative resection margin as anatomical landmarks cannot be used for intra-operative guidance.
In the beginning of a non-anatomical resection, a resection line is drawn onto the liver surface to visualize where the resection shall be started. During the resection process, intra-operative ultrasound is used to confirm a safe distance to the tumor. Finally, once the depth is reached, the distance to the tumor is again confirmed on ultrasound and the tumor is removed. This is a challenging process which depends on the operator's ability and experience with mentally reconstructing the spatial relationships of the ultrasound image and the intra-operative scene. Additionally, the resection margin introduces artifacts and makes it harder to visualize the safety distance to the tumor on ultrasound.
To overcome these challenges, image-guidance systems have been introduced into the surgical workflow. These systems measure the pose of the surgical instruments and display their position on a virtual model of the anatomy. They mainly rely on a registration process to align a preoperative model with the patient's anatomy intraoperatively. This process is time-consuming, complex and error prone which is the main reason why such systems are rarely used.
In this study, the investigators aim to clinically evaluate a different approach, where navigated intra-operative ultrasound data is used to create a virtual model and a surgical plan on the spot. This does not require a separate registration process. With this approach a virtual draft of the surgical plan is created, which serves as a rough guidance map through the procedure. The investigators hypothesize that using such an intra-operative surgical draft allows the surgeon to acquire a negative resection margin.
- Conditions
- Liver Neoplasm
- Being tested
- Stereotactic image-guided resection
- Keywords
- Image-Guidance, Liver Neoplasm
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic image-guided resectionDevice
Stereotactic image-guided resection with an ultrasound-based image-guidance system.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Stereotactic image-guided non-anatomical resection Receives: Device: Stereotactic image-guided resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Assessed by histopathological examination of the resected specimen. R0 is defined as a negative resection margin of >1 mm.
Measured: 30 days
Secondary outcomes (8)
Number of re-resections
Measured: intra-operative, expected to be up to 4 hours
Resection margin in mm
Measured: 30 days
Correlation with tumor size
Measured: pre-operative, expected to be up to 30 days
Correlation with tumor volume
Measured: pre-operative, expected to be up to 30 days
Correlation with tumor type
Measured: pre-operative, expected to be up to 30 days
Correlation with tumor location
Measured: pre-operative, expected to be up to 30 days
Time for planning of the resection
Measured: intra-operative, expected to be up to 4 hours
Time for resection
Measured: intra-operative, expected to be up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start17 Jun 2020
- Primary completion16 Feb 2022
- Study completion16 Feb 2022
Why it stopped: Difficulties with recruiting participants for the study due to the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized, non-controlled, single-arm feasibility study of intraoperative ultrasound-based navigation for non-anatomical liver resections
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Anja Lachenmayer, MD, Principal investigator, Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187937
- Sponsor's protocol ID
- USGR
- Status last verified
- May 2022
- First submitted
- 3 Dec 2019
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moris D, Tsilimigras DI, Kostakis ID, Ntanasis-Stathopoulos I, Shah KN, Felekouras E, Pawlik TM. Anatomic versus non-anatomic resection for hepatocellular carcinoma: A systematic review and meta-analysis. Eur J Surg Oncol. 2018 Jul;44(7):927-938. doi: 10.1016/j.ejso.2018.04.018. Epub 2018 Apr 30.
PubMed 29751946Banz VM, Muller PC, Tinguely P, Inderbitzin D, Ribes D, Peterhans M, Candinas D, Weber S. Intraoperative image-guided navigation system: development and applicability in 65 patients undergoing liver surgery. Langenbecks Arch Surg. 2016 Jun;401(4):495-502. doi: 10.1007/s00423-016-1417-0. Epub 2016 Apr 28.
PubMed 27122364Lango T, Vijayan S, Rethy A, Vapenstad C, Solberg OV, Marvik R, Johnsen G, Hernes TN. Navigated laparoscopic ultrasound in abdominal soft tissue surgery: technological overview and perspectives. Int J Comput Assist Radiol Surg. 2012 Jul;7(4):585-99. doi: 10.1007/s11548-011-0656-3. Epub 2011 Sep 3.
PubMed 21892604Kingham TP, Jayaraman S, Clements LW, Scherer MA, Stefansic JD, Jarnagin WR. Evolution of image-guided liver surgery: transition from open to laparoscopic procedures. J Gastrointest Surg. 2013 Jul;17(7):1274-82. doi: 10.1007/s11605-013-2214-5. Epub 2013 May 4.
PubMed 23645420
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Ultrasound-based Navigation for Non-anatomical Liver Resections
- ClinicalTrials.gov ID
- NCT04187937
- Acronym / sponsor ID
- USGR
- Conditions
- Liver Neoplasm
- Keywords
- Image-Guidance, Liver Neoplasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with recruiting participants for the study due to the COVID-19 pandemic.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 5 Dec 2019 (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.
In a non-anatomical resection of a liver tumor, only the part of the liver with the tumor and a safety margin of 5 - 10 mm are resected. This is done to ensure a negative resection margin, which means that no tumor cells are at the boundary of the resection. These non-anatomical resections can be performed repeatedly in case of recurrence. However, compared to anatomical resections, it is more challenging to keep a negative resection margin as anatomical landmarks cannot be used for intra-operative guidance.
In this study, the investigators aim to clinically evaluate a 3d navigation system, where navigated intra-operative ultrasound data is used to create a virtual model and a surgical plan.
Detailed description
Surgical resection is the current gold standard for curative care of primary and metastatic hepatic tumors. This procedure involves the removal of the part of the liver where the tumor is located. This is typically achieved by removing the segments containing the tumor, so called anatomical resections. The downside of this technique is that it also removes a large part of healthy liver tissue. Recently, non-anatomical resections are becoming more popular, as they spare more healthy liver tissue than anatomical resections with similar oncological outcomes. In a non-anatomical resection, only the part of the liver with the tumor and a safety margin of 5 - 10 mm are resected. This is done to ensure a negative resection margin, which means that no tumor cells are at the boundary of the resection. These non-anatomical resections can be performed repeatedly in case of recurrence. However, compared to anatomical resections, it is more challenging to keep a negative resection margin as anatomical landmarks cannot be used for intra-operative guidance.
In the beginning of a non-anatomical resection, a resection line is drawn onto the liver surface to visualize where the resection shall be started. During the resection process, intra-operative ultrasound is used to confirm a safe distance to the tumor. Finally, once the depth is reached, the distance to the tumor is again confirmed on ultrasound and the tumor is removed. This is a challenging process which depends on the operator's ability and experience with mentally reconstructing the spatial relationships of the ultrasound image and the intra-operative scene. Additionally, the resection margin introduces artifacts and makes it harder to visualize the safety distance to the tumor on ultrasound.
To overcome these challenges, image-guidance systems have been introduced into the surgical workflow. These systems measure the pose of the surgical instruments and display their position on a virtual model of the anatomy. They mainly rely on a registration process to align a preoperative model with the patient's anatomy intraoperatively. This process is time-consuming, complex and error prone which is the main reason why such systems are rarely used.
In this study, the investigators aim to clinically evaluate a different approach, where navigated intra-operative ultrasound data is used to create a virtual model and a surgical plan on the spot. This does not require a separate registration process. With this approach a virtual draft of the surgical plan is created, which serves as a rough guidance map through the procedure. The investigators hypothesize that using such an intra-operative surgical draft allows the surgeon to acquire a negative resection margin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized, non-controlled, single-arm feasibility study of intraoperative ultrasound-based navigation for non-anatomical liver resections
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Stereotactic image-guided resectionStereotactic image-guided non-anatomical resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients which are regularly scheduled for an open surgical liver resection
- At least one tumor considered for non-anatomical resection
- Lesion is visible on ultrasound imaging
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Age >= 18 years
Key exclusion criteria (6 listed)
- Other clinically condition or disease that would (as deemed by the operating surgeon) significantly increase the risk of surgery
- Lesion is close to major vessel (< 10 mm)
- Lesion is too large to be visualized on ultrasound imaging
- Emergency
- Subjects not able to give informed consent (dementia)
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 |
|---|---|---|
| Stereotactic image-guided resectionStereotactic image-guided resection with an ultrasound-based image-guidance system. | Device | Experimental |
Primary outcome
R0 resection rate
Time frame: 30 days
Assessed by histopathological examination of the resected specimen. R0 is defined as a negative resection margin of >1 mm.
8 secondary outcomes
Number of re-resections
Time frame: intra-operative, expected to be up to 4 hours
Resection margin in mm
Time frame: 30 days
Correlation with tumor size
Time frame: pre-operative, expected to be up to 30 days
Correlation with tumor volume
Time frame: pre-operative, expected to be up to 30 days
Correlation with tumor type
Time frame: pre-operative, expected to be up to 30 days
Correlation with tumor location
Time frame: pre-operative, expected to be up to 30 days
Time for planning of the resection
Time frame: intra-operative, expected to be up to 4 hours
Time for resection
Time frame: intra-operative, expected to be up to 4 hours
Results and safety
The study was stopped early (reason given: Difficulties with recruiting participants for the study due to the COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Background: PubMed 29751946Moris D, Tsilimigras DI, Kostakis ID, Ntanasis-Stathopoulos I, Shah KN, Felekouras E, Pawlik TM. Anatomic versus non-anatomic resection for hepatocellular carcinoma: A systematic review and meta-analysis. Eur J Surg Oncol. 2018 Jul;44(7):927-938. doi: 10.1016/j.ejso.2018.04.018. Epub 2018 Apr 30.
- Background: PubMed 27122364Banz VM, Muller PC, Tinguely P, Inderbitzin D, Ribes D, Peterhans M, Candinas D, Weber S. Intraoperative image-guided navigation system: development and applicability in 65 patients undergoing liver surgery. Langenbecks Arch Surg. 2016 Jun;401(4):495-502. doi: 10.1007/s00423-016-1417-0. Epub 2016 Apr 28.
- Background: PubMed 21892604Lango T, Vijayan S, Rethy A, Vapenstad C, Solberg OV, Marvik R, Johnsen G, Hernes TN. Navigated laparoscopic ultrasound in abdominal soft tissue surgery: technological overview and perspectives. Int J Comput Assist Radiol Surg. 2012 Jul;7(4):585-99. doi: 10.1007/s11548-011-0656-3. Epub 2011 Sep 3.
- Background: PubMed 23645420Kingham TP, Jayaraman S, Clements LW, Scherer MA, Stefansic JD, Jarnagin WR. Evolution of image-guided liver surgery: transition from open to laparoscopic procedures. J Gastrointest Surg. 2013 Jul;17(7):1274-82. doi: 10.1007/s11605-013-2214-5. Epub 2013 May 4.
- Individual participant dataSharing planned: No
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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.
Anja Lachenmayer, MD principal investigator
Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic image-guided resection in people with Liver Neoplasm, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 1 Jun 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 Switzerland. 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 was stopped early (reason given: Difficulties with recruiting participants for the study due to the COVID-19 pandemic.). Results are not available in the source record.
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?
R0 resection rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04187937, which also lists 4 linked publications.
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 1 Jun 2022.