Computer-assisted Tumor Ablation for Patients With Liver Cancer

August 26, 2019 updated by: University Hospital Inselspital, Berne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with hepatocellular carcinoma treated with microwave
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Through study completion, an average of 1 year
Kaplan-Meier method
Through study completion, an average of 1 year
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
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local tumor progression rate
Time Frame: Through study completion, an average of 1 year
Number of patients with local recurrences
Through study completion, an average of 1 year
Need for further liver-specific treatment
Time Frame: Through study completion, an average of 1 year
Number and type of re-interventions (ablations, resections, transplantation)
Through study completion, an average of 1 year
Accuracy of ablation probe positioning
Time Frame: Intraoperative
Deviation of ablation probe position as compared to planned ablation probe trajectory in the navigation system, reported in millimeters
Intraoperative
Procedural efficiency
Time Frame: Intraoperative
Time for planning/targeting/validation process of procedure and overall duration of procedure, reported in minutes
Intraoperative
Clinical and radiological complications
Time Frame: At 90 days
At 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Pascale Tinguely, MD, Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
  • Study Director: Anja Lachenmayer, MD, Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
  • Study Director: Vanessa Banz, MD PhD, Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
  • Study Chair: Daniel Candinas, Professor, MD, Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

August 8, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIGMAHCC_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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