Hepatocellular CarcinomaNCT03630068
Computer-assisted Tumor Ablation for Patients With Liver Cancer
An observational study of Hepatocellular Carcinoma, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
In patients with primary liver cancer arising from the liver cells, several treatment options are available according to the stage of the disease. Thermal ablation is a treatment modality using the deposition of thermal energy via an ablation probe to locally destroy the tumor tissue. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Stereotactic percutaneous image-guided microwave ablation
- Type of treatment
- Surgery or procedure
- How many people
- 87 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2015to 30 Jun 2018
- 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: Patients with hepatocellular carcinoma deemed amenable to percutaneous microwave ablation at the Multi-Disciplinary Team conference of the Department of Visceral Surgery and Medicine of the University Hospital of Bern, Switzerland
Who may be able to join
- All patients who underwent stereotactic percutaneous image-guided microwave ablation of hepatocellular carcinoma from 01.01.2015 to 31.12.2017 at Inselspital University Hospital of Bern Switzerland
Who cannot join
- Lack of general consent for data usage
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, 3010
About this study
Official title: Stereotactic Image-Guided Microwave Ablation for Hepatocellular Carcinoma - Does Computer-assistance Broaden Eligibility and Efficacy of Ablative Treatment?
In patients with primary liver cancer arising from the liver cells, several treatment options are available according to the stage of the disease. Thermal ablation is a treatment modality using the deposition of thermal energy via an ablation probe to locally destroy the tumor tissue. It has been accepted as being equally effective as surgical resection in patients with very small tumors, as well as for patients with more advanced disease who are not surgical candidates or who are awaiting liver transplantation. Treatment success of thermal ablation is linked to the completeness of the tumor ablation and thus to the precision with which the ablation probes can be placed within the tumors. In recent years, novel computer-assister technology has been introduced to augment accuracy in ablation probe positioning, and first reports describing the safety and efficiency of these procedures have been described in the literature. However, very few works describe the oncological outcomes of patients when using this technology for thermal ablation. In this study, the investigators aim to describe local tumor control and the oncological follow-up of patients when using computer-assisted technology for thermal ablation of liver cancer.
Read the detailed description
Curative treatment options for patients with early-stage hepatocellular carcinoma (HCC) include surgical resection, liver transplantation and local ablation. While only 20-25% of patients with HCC qualify for surgical resection or liver transplantation, local thermal ablation using radiofrequency or microwave energy represents a more tissue-sparing therapy with promising results. Thermal ablation has been accepted as valid alternative to resection in patients with very small solitary tumors (BCLC stage 0) with equally good survival rates up to 75 % at 5 years. It further represents a valid treatment modality for patients with limited tumor burden (BCLC stage A) who are not surgical candidates due to associated comorbidities. More recently, indications for thermal ablation have also been widened for patients with more advanced disease but still limited tumor burden (BCLC stage B1), as well as for use within combined treatment strategies and as bridging therapy in patients awaiting liver transplantation.
The major advantage of thermal ablation lies in its tissue-sparing yet locally destructive therapeutic character, which when combined with a minimally invasive access leads to low treatment-associated tissue trauma and morbidity. Regarding treatment efficiency, initial complete response is an independent predictive factor for survival for HCC patients treated with ablation. Hence, the precision of ablative therapy is crucial for treatment success, and relies directly on the accuracy of ablation probes positioning within the tumor target. To address this issue, advanced image-guided navigation technology has been introduced for use in liver-directed therapies. While first works reporting on the safety and accuracy of stereotactic percutaneous image-guided ablation of liver tumors are available, only few studies reporting on the oncological outcomes in liver tumors exist. No data on the oncological follow-up after stereotactic image-guided ablation of HCC is available to date, leaving the understanding of the clinical impact when using such novel navigation technology for ablative treatment in these patients scarce.
Overall, the investigators hypothesize that stereotactic image-guided microwave ablation allows a more precise and thus effective ablative treatment of HCC when compared to using conventional image-guidance techniques. This is due to the possibility of i) planning of targeting trajectories even for difficult-to-target lesions, ii) placement of ablation probes in multiple parallel needle configurations for larger lesions, iii) immediate intraoperative knowledge of treatment success through overlapping of pre- and post-ablation images with the possibility of re-ablation, and iv) reproducibility and standardization of the treatment technique. In this first retrospective analysis, the investigators aim to report therapeutic efficacy in terms local tumor control and short-term survival when using stereotactic image-guided microwave ablation for treatment of HCC, and further report procedural efficiency in terms of targeting accuracy and required time consumption.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Stereotactic percutaneous image-guided microwave ablation
- Keywords
- Liver Neoplasms, Hepatocellular Carcinoma, Ablation Techniques, Stereotaxic Techniques, Computer-Assisted Therapy, Computer-Assisted Surgery, Interventional Radiology
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic percutaneous image-guided microwave ablationProcedure or surgery
Stereotactic percutaneous image-guided microwave ablation implies the use of computer-assisted navigation technology for 3D trajectory planning and stereotactic placement of ablation probes, before applying local microwave ablation therapy
| Study group | Role | What they receive |
|---|---|---|
| Patients with hepatocellular carcinoma treated with microwave | Not described Receives: Procedure: Stereotactic percutaneous image-guided microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Kaplan-Meier method
Measured: Through study completion, an average of 1 year
Recurrence-free survival
Kaplan-Meyer method. Local recurrence defined as radiological suspicion of active tumor tissue within 10mm of the ablated lesions
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
Local tumor progression rate
Number of patients with local recurrences
Measured: Through study completion, an average of 1 year
Need for further liver-specific treatment
Number and type of re-interventions (ablations, resections, transplantation)
Measured: Through study completion, an average of 1 year
Accuracy of ablation probe positioning
Deviation of ablation probe position as compared to planned ablation probe trajectory in the navigation system, reported in millimeters
Measured: Intraoperative
Procedural efficiency
Time for planning/targeting/validation process of procedure and overall duration of procedure, reported in minutes
Measured: Intraoperative
Clinical and radiological complications
Measured: At 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Jan 2015
- Primary completion31 Dec 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascale Tinguely, MD, Principal investigator, Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, SwitzerlandAnja Lachenmayer, MD, Study director, Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, SwitzerlandVanessa Banz, MD PhD, Study director, Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, SwitzerlandDaniel Candinas, Professor, MD, Study chair, Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630068
- Sponsor's protocol ID
- SIGMAHCC_1
- Status last verified
- Aug 2019
- First submitted
- 8 Aug 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bruix J, Reig M, Sherman M. Evidence-Based Diagnosis, Staging, and Treatment of Patients With Hepatocellular Carcinoma. Gastroenterology. 2016 Apr;150(4):835-53. doi: 10.1053/j.gastro.2015.12.041. Epub 2016 Jan 12.
PubMed 26795574Bruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available.
PubMed 21374666Cho YK, Kim JK, Kim MY, Rhim H, Han JK. Systematic review of randomized trials for hepatocellular carcinoma treated with percutaneous ablation therapies. Hepatology. 2009 Feb;49(2):453-9. doi: 10.1002/hep.22648.
PubMed 19065676Forner A, Llovet JM, Bruix J. Hepatocellular carcinoma. Lancet. 2012 Mar 31;379(9822):1245-55. doi: 10.1016/S0140-6736(11)61347-0. Epub 2012 Feb 20.
PubMed 22353262Bolondi L, Burroughs A, Dufour JF, Galle PR, Mazzaferro V, Piscaglia F, Raoul JL, Sangro B. Heterogeneity of patients with intermediate (BCLC B) Hepatocellular Carcinoma: proposal for a subclassification to facilitate treatment decisions. Semin Liver Dis. 2012 Nov;32(4):348-59. doi: 10.1055/s-0032-1329906. Epub 2013 Feb 8.
PubMed 23397536Wang X, Hu Y, Ren M, Lu X, Lu G, He S. Efficacy and Safety of Radiofrequency Ablation Combined with Transcatheter Arterial Chemoembolization for Hepatocellular Carcinomas Compared with Radiofrequency Ablation Alone: A Time-to-Event Meta-Analysis. Korean J Radiol. 2016 Jan-Feb;17(1):93-102. doi: 10.3348/kjr.2016.17.1.93. Epub 2016 Jan 6.
PubMed 26798221Lau WY, Lai EC. The current role of radiofrequency ablation in the management of hepatocellular carcinoma: a systematic review. Ann Surg. 2009 Jan;249(1):20-5. doi: 10.1097/SLA.0b013e31818eec29.
PubMed 19106671Sala M, Llovet JM, Vilana R, Bianchi L, Sole M, Ayuso C, Bru C, Bruix J; Barcelona Clinic Liver Cancer Group. Initial response to percutaneous ablation predicts survival in patients with hepatocellular carcinoma. Hepatology. 2004 Dec;40(6):1352-60. doi: 10.1002/hep.20465.
PubMed 15565564van Duijnhoven FH, Jansen MC, Junggeburt JM, van Hillegersberg R, Rijken AM, van Coevorden F, van der Sijp JR, van Gulik TM, Slooter GD, Klaase JM, Putter H, Tollenaar RA. Factors influencing the local failure rate of radiofrequency ablation of colorectal liver metastases. Ann Surg Oncol. 2006 May;13(5):651-8. doi: 10.1245/ASO.2006.08.014. Epub 2006 Mar 17.
PubMed 16538411Engstrand J, Toporek G, Harbut P, Jonas E, Nilsson H, Freedman J. Stereotactic CT-Guided Percutaneous Microwave Ablation of Liver Tumors With the Use of High-Frequency Jet Ventilation: An Accuracy and Procedural Safety Study. AJR Am J Roentgenol. 2017 Jan;208(1):193-200. doi: 10.2214/AJR.15.15803. Epub 2016 Oct 20.
PubMed 27762601Widmann G, Schullian P, Haidu M, Bale R. Stereotactic radiofrequency ablation (SRFA) of liver lesions: technique effectiveness, safety, and interoperator performance. Cardiovasc Intervent Radiol. 2012 Jun;35(3):570-80. doi: 10.1007/s00270-011-0200-4. Epub 2011 Jun 14.
PubMed 21671150Engstrand J, Nilsson H, Jansson A, Isaksson B, Freedman J, Lundell L, Jonas E. A multiple microwave ablation strategy in patients with initially unresectable colorectal cancer liver metastases - A safety and feasibility study of a new concept. Eur J Surg Oncol. 2014 Nov;40(11):1488-93. doi: 10.1016/j.ejso.2014.05.003. Epub 2014 May 20.
PubMed 24933395
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Image-Guided Microwave Ablation for Hepatocellular Carcinoma - Does Computer-assistance Broaden Eligibility and Efficacy of Ablative Treatment?
- ClinicalTrials.gov ID
- NCT03630068
- Acronym / sponsor ID
- SIGMAHCC_1
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Liver Neoplasms, Hepatocellular Carcinoma, Ablation Techniques, Stereotaxic Techniques, Computer-Assisted Therapy, Computer-Assisted Surgery, Interventional Radiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 14 Aug 2018 (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 patients with primary liver cancer arising from the liver cells, several treatment options are available according to the stage of the disease. Thermal ablation is a treatment modality using the deposition of thermal energy via an ablation probe to locally destroy the tumor tissue. It has been accepted as being equally effective as surgical resection in patients with very small tumors, as well as for patients with more advanced disease who are not surgical candidates or who are awaiting liver transplantation. Treatment success of thermal ablation is linked to the completeness of the tumor ablation and thus to the precision with which the ablation probes can be placed within the tumors. In recent years, novel computer-assister technology has been introduced to augment accuracy in ablation probe positioning, and first reports describing the safety and efficiency of these procedures have been described in the literature. However, very few works describe the oncological outcomes of patients when using this technology for thermal ablation. In this study, the investigators aim to describe local tumor control and the oncological follow-up of patients when using computer-assisted technology for thermal ablation of liver cancer.
Detailed description
Curative treatment options for patients with early-stage hepatocellular carcinoma (HCC) include surgical resection, liver transplantation and local ablation. While only 20-25% of patients with HCC qualify for surgical resection or liver transplantation, local thermal ablation using radiofrequency or microwave energy represents a more tissue-sparing therapy with promising results. Thermal ablation has been accepted as valid alternative to resection in patients with very small solitary tumors (BCLC stage 0) with equally good survival rates up to 75 % at 5 years. It further represents a valid treatment modality for patients with limited tumor burden (BCLC stage A) who are not surgical candidates due to associated comorbidities. More recently, indications for thermal ablation have also been widened for patients with more advanced disease but still limited tumor burden (BCLC stage B1), as well as for use within combined treatment strategies and as bridging therapy in patients awaiting liver transplantation.
The major advantage of thermal ablation lies in its tissue-sparing yet locally destructive therapeutic character, which when combined with a minimally invasive access leads to low treatment-associated tissue trauma and morbidity. Regarding treatment efficiency, initial complete response is an independent predictive factor for survival for HCC patients treated with ablation. Hence, the precision of ablative therapy is crucial for treatment success, and relies directly on the accuracy of ablation probes positioning within the tumor target. To address this issue, advanced image-guided navigation technology has been introduced for use in liver-directed therapies. While first works reporting on the safety and accuracy of stereotactic percutaneous image-guided ablation of liver tumors are available, only few studies reporting on the oncological outcomes in liver tumors exist. No data on the oncological follow-up after stereotactic image-guided ablation of HCC is available to date, leaving the understanding of the clinical impact when using such novel navigation technology for ablative treatment in these patients scarce.
Overall, the investigators hypothesize that stereotactic image-guided microwave ablation allows a more precise and thus effective ablative treatment of HCC when compared to using conventional image-guidance techniques. This is due to the possibility of i) planning of targeting trajectories even for difficult-to-target lesions, ii) placement of ablation probes in multiple parallel needle configurations for larger lesions, iii) immediate intraoperative knowledge of treatment success through overlapping of pre- and post-ablation images with the possibility of re-ablation, and iv) reproducibility and standardization of the treatment technique. In this first retrospective analysis, the investigators aim to report therapeutic efficacy in terms local tumor control and short-term survival when using stereotactic image-guided microwave ablation for treatment of HCC, and further report procedural efficiency in terms of targeting accuracy and required time consumption.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hepatocellular carcinoma treated with microwave | – | Procedure: Stereotactic percutaneous image-guided microwave ablation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hepatocellular carcinoma deemed amenable to percutaneous microwave ablation at the Multi-Disciplinary Team conference of the Department of Visceral Surgery and Medicine of the University Hospital of Bern, Switzerland
Key inclusion criteria (1 listed)
- All patients who underwent stereotactic percutaneous image-guided microwave ablation of hepatocellular carcinoma from 01.01.2015 to 31.12.2017 at Inselspital University Hospital of Bern Switzerland
Key exclusion criteria (1 listed)
- Lack of general consent for data usage
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 percutaneous image-guided microwave ablationStereotactic percutaneous image-guided microwave ablation implies the use of computer-assisted navigation technology for 3D trajectory planning and stereotactic placement of ablation probes, before applying local microwave ablation therapy | Procedure or surgery | Patients with hepatocellular carcinoma treated with microwave |
Primary outcome
Overall survival
Time frame: Through study completion, an average of 1 year
Kaplan-Meier method
Recurrence-free survival
Time frame: Through study completion, an average of 1 year
Kaplan-Meyer method. Local recurrence defined as radiological suspicion of active tumor tissue within 10mm of the ablated lesions
5 secondary outcomes
Local tumor progression rate
Time frame: Through study completion, an average of 1 year
Need for further liver-specific treatment
Time frame: Through study completion, an average of 1 year
Accuracy of ablation probe positioning
Time frame: Intraoperative
Procedural efficiency
Time frame: Intraoperative
Clinical and radiological complications
Time frame: At 90 days
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 28 Aug 2019.
- Background: PubMed 26795574Bruix J, Reig M, Sherman M. Evidence-Based Diagnosis, Staging, and Treatment of Patients With Hepatocellular Carcinoma. Gastroenterology. 2016 Apr;150(4):835-53. doi: 10.1053/j.gastro.2015.12.041. Epub 2016 Jan 12.
- Background: PubMed 21374666Bruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available.
- Background: PubMed 19065676Cho YK, Kim JK, Kim MY, Rhim H, Han JK. Systematic review of randomized trials for hepatocellular carcinoma treated with percutaneous ablation therapies. Hepatology. 2009 Feb;49(2):453-9. doi: 10.1002/hep.22648.
- Background: PubMed 22353262Forner A, Llovet JM, Bruix J. Hepatocellular carcinoma. Lancet. 2012 Mar 31;379(9822):1245-55. doi: 10.1016/S0140-6736(11)61347-0. Epub 2012 Feb 20.
- Background: PubMed 23397536Bolondi L, Burroughs A, Dufour JF, Galle PR, Mazzaferro V, Piscaglia F, Raoul JL, Sangro B. Heterogeneity of patients with intermediate (BCLC B) Hepatocellular Carcinoma: proposal for a subclassification to facilitate treatment decisions. Semin Liver Dis. 2012 Nov;32(4):348-59. doi: 10.1055/s-0032-1329906. Epub 2013 Feb 8.
- Background: PubMed 26798221Wang X, Hu Y, Ren M, Lu X, Lu G, He S. Efficacy and Safety of Radiofrequency Ablation Combined with Transcatheter Arterial Chemoembolization for Hepatocellular Carcinomas Compared with Radiofrequency Ablation Alone: A Time-to-Event Meta-Analysis. Korean J Radiol. 2016 Jan-Feb;17(1):93-102. doi: 10.3348/kjr.2016.17.1.93. Epub 2016 Jan 6.
- Background: PubMed 19106671Lau WY, Lai EC. The current role of radiofrequency ablation in the management of hepatocellular carcinoma: a systematic review. Ann Surg. 2009 Jan;249(1):20-5. doi: 10.1097/SLA.0b013e31818eec29.
- Background: PubMed 15565564Sala M, Llovet JM, Vilana R, Bianchi L, Sole M, Ayuso C, Bru C, Bruix J; Barcelona Clinic Liver Cancer Group. Initial response to percutaneous ablation predicts survival in patients with hepatocellular carcinoma. Hepatology. 2004 Dec;40(6):1352-60. doi: 10.1002/hep.20465.
- Background: PubMed 16538411van Duijnhoven FH, Jansen MC, Junggeburt JM, van Hillegersberg R, Rijken AM, van Coevorden F, van der Sijp JR, van Gulik TM, Slooter GD, Klaase JM, Putter H, Tollenaar RA. Factors influencing the local failure rate of radiofrequency ablation of colorectal liver metastases. Ann Surg Oncol. 2006 May;13(5):651-8. doi: 10.1245/ASO.2006.08.014. Epub 2006 Mar 17.
- Background: PubMed 27762601Engstrand J, Toporek G, Harbut P, Jonas E, Nilsson H, Freedman J. Stereotactic CT-Guided Percutaneous Microwave Ablation of Liver Tumors With the Use of High-Frequency Jet Ventilation: An Accuracy and Procedural Safety Study. AJR Am J Roentgenol. 2017 Jan;208(1):193-200. doi: 10.2214/AJR.15.15803. Epub 2016 Oct 20.
- Background: PubMed 21671150Widmann G, Schullian P, Haidu M, Bale R. Stereotactic radiofrequency ablation (SRFA) of liver lesions: technique effectiveness, safety, and interoperator performance. Cardiovasc Intervent Radiol. 2012 Jun;35(3):570-80. doi: 10.1007/s00270-011-0200-4. Epub 2011 Jun 14.
- Background: PubMed 24933395Engstrand J, Nilsson H, Jansson A, Isaksson B, Freedman J, Lundell L, Jonas E. A multiple microwave ablation strategy in patients with initially unresectable colorectal cancer liver metastases - A safety and feasibility study of a new concept. Eur J Surg Oncol. 2014 Nov;40(11):1488-93. doi: 10.1016/j.ejso.2014.05.003. Epub 2014 May 20.
- 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.
Pascale Tinguely, MD principal investigator
Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
Anja Lachenmayer, MD study director
Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
Vanessa Banz, MD PhD study director
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?
An observational study of Hepatocellular Carcinoma, 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 1 inclusion and 1 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 28 Aug 2019. 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 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?
Overall survival (time frame: Through study completion, an average of 1 year). 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?
On the ClinicalTrials.gov record for NCT03630068, which also lists 12 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 28 Aug 2019.