Irreversible Electroporation of Unresectable Liver Tumors

Brief Title

Irreversible Electroporation of Unresectable Liver Tumors

Official Title

Irreversible Electroporation of Unresectable Liver Tumors - a Phase I Study of Safety and Feasibility

Brief Summary

      The aim of this study is to evaluate the safety and feasibility of curative intended
      irreversible electroporation (IRE) in the treatment of liver tumors neighboring major vessels
      or bile ducts.
    

Detailed Description

      Patients can be included in the study if they have one or more malignant liver tumors
      unsuitable for resection and thermal ablation (due to proximity of major vessels or bile
      duct) or other established liver directed therapies.

      Prior to inclusion all potential participant will be evaluated by the local multidisciplinary
      team, to insure fulfillment of the above-mentioned criteria. In general, the included patient
      will have tumors with <1 cm of margin to major hepatic vessels or bile ducts, thereby not
      allowing for conventional treatments because of risk of i.e. hemorrhage, biliary tract
      damage, liver failure or ineffective ablation due to heat sink.

      IRE will be done under general anesthesia as an in-patient procedure. Patients will be
      observed for at least 24 hours after IRE.

      Patients will attend CT scans 1, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post-IRE according
      to national guidelines (for follow-up after radiofrequency ablation (RFA)). Patients will
      attend the out-patient clinic after 1, 3, 6, 9, 12, 18 and 24 months. During the follow-up
      period, patients will be asked to fill out electronic forms monitoring pain, quality of life
      and nutritional status. After 24 months the patients will only be followed with CT scans in
      accordance with the mentioned schedule. Data collection for scientific purposes will stop
      when the last included patient has been followed for at least 24 months or when the study
      period concludes.

      In case of multiple liver tumors, where a conventional treatment approach is not possible due
      to a single lesion being too close to major vessels or bile ducts, IRE may be used in
      conjunction to conventional therapy.
    

Study Type

Interventional

Primary Outcome

90-day complication rate and severity

Secondary Outcome

 Technical success rate

Condition

Liver Metastases

Intervention

Irreversible electroporation

Study Arms / Comparison Groups

 Intervention

Description:  Selected patients who choose to participate will undergo ablation of the target lesion using irreversible electroporation.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

15

Start Date

June 1, 2020

Completion Date

March 30, 2025

Primary Completion Date

March 30, 2025

Eligibility Criteria

        Inclusion Criteria:

          -  Primary or secondary cancer of the liver.

          -  Largest tumor diameter ≤5 cm in any plane.

          -  Tumor must be deemed as unresectable and unsuitable for other established curative
             liver directed therapies.

          -  Treatment must be given with curative intent.

          -  Patients must be able to give informed consent.

        Exclusion Criteria:

          -  Radiological signs of synchronous intra- or extrahepatic disease, unless curative
             intended therapy is planned.

          -  Tumor is inaccessible e.g. due to venous dilation etc. (assessed with preoperative
             ultrasound)

          -  American Society of Anesthesiologists (ASA) score >3

          -  Eastern Cooperative Oncology Group (ECOG) performance status >2

          -  Child-Pugh class C

          -  International Normalized Ratio (INR)>1.5

          -  Pregnancy

          -  Persistent atrial fibrillation

          -  Implanted electronic devices e.g. cardiac pacemakers or other electrostimulators.

          -  Metal stents or other metallic objects near the ablation zone (unless the stent can be
             replaced with a plastic stent prior to IRE)

          -  Severe allergies to anesthetic agent, paralytic agent or any of the equipment used
             during treatment.

          -  Patient is referred from a hospital outside of Denmark
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ole Thorlacius-Ussing, Professor, DMSc, +4597661181, [email protected]

Location Countries

Denmark

Location Countries

Denmark

NCT ID

NCT04404647

Organization ID

N-20190072

Responsible Party

Sponsor-Investigator

Study Sponsor

Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery

Study Sponsor

Ole Thorlacius-Ussing, Professor, DMSc, Study Director, Department of Gastrointestinal Surgery, Aalborg University Hospital

Verification Date

May 2020