Computer-assisted Tumor Ablation for Patients With Liver Cancer

Hepatocellular Carcinoma Clinical Trial

Official title:

Stereotactic Image-Guided Microwave Ablation for Hepatocellular Carcinoma - Does Computer-assistance Broaden Eligibility and Efficacy of Ablative Treatment?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630068
• Other study ID #: SIGMAHCC_1
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: August 2019
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 30, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Lack of general consent for data usage

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Stereotactic percutaneous image-guided microwave ablation
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

Locations

Country	Name	City	State
Switzerland	Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (12)

Bolondi 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. Review. — View Citation

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. Review. — View Citation

Bruix 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. — View Citation

Cho 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. Review. — View Citation

Engstrand 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. — View Citation

Engstrand 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. — View Citation

Forner 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. Review. — View Citation

Lau 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. Review. — View Citation

Sala M, Llovet JM, Vilana R, Bianchi L, Solé M, Ayuso C, Brú C, Bruix J; Barcelona Clínic Liver Cancer Group. Initial response to percutaneous ablation predicts survival in patients with hepatocellular carcinoma. Hepatology. 2004 Dec;40(6):1352-60. — View Citation

van 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. Epub 2006 Mar 17. — View Citation

Wang 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. — View Citation

Widmann 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Kaplan-Meier method	Through study completion, an average of 1 year
Primary	Recurrence-free survival	Kaplan-Meyer method. Local recurrence defined as radiological suspicion of active tumor tissue within 10mm of the ablated lesions	Through study completion, an average of 1 year
Secondary	Local tumor progression rate	Number of patients with local recurrences	Through study completion, an average of 1 year
Secondary	Need for further liver-specific treatment	Number and type of re-interventions (ablations, resections, transplantation)	Through study completion, an average of 1 year
Secondary	Accuracy of ablation probe positioning	Deviation of ablation probe position as compared to planned ablation probe trajectory in the navigation system, reported in millimeters	Intraoperative
Secondary	Procedural efficiency	Time for planning/targeting/validation process of procedure and overall duration of procedure, reported in minutes	Intraoperative
Secondary	Clinical and radiological complications		At 90 days