NCT04404647

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

4.8 years

First QC Date

May 15, 2020

Last Update Submit

March 24, 2021

Conditions

Liver MetastasesHepatocellular CarcinomaBile Duct Cancer

Keywords

irreversible electroporationprimary liver cancersecondary liver cancercolorectal liver metastasesNanoKnifeablationIRE

Outcome Measures

Primary Outcomes (1)

  • 90-day complication rate and severity

    Adverse events will be registered and scaled according to the Clavien-Dindo classification.

    90 days after intervention (last patient)

Secondary Outcomes (9)

  • Technical success rate

    90 days after intervention (last patient)

  • Technical efficacy rate (1 month) (according to SIR)

    90 days after intervention (last patient)

  • Median local progression free survival from IRE

    2 years after intervention (last patient)

  • Median overall survival (OS) from IRE

    2 years after intervention (last patient)

  • Longitudinal changes in perceived quality of life

    2 years after intervention (last patient)

  • +4 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

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

Procedure: Irreversible electroporation

Interventions

Irreversible electroporationPROCEDURE

The IRE procedure will be carried out as ultrasound guided technique either percutaneously or during laparotomy. Needle spacing and electrical pulse delivery will be performed in a standardized way.

Also known as: NanoKnife(TM)
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastrointestinal Surgery, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularBile Duct Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract Diseases

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesInvestigative TechniquesElectrochemical Techniques

Study Officials

  • Ole Thorlacius-Ussing, Professor, DMSc

    Department of Gastrointestinal Surgery, Aalborg University Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of surgery, Consultant surgeon, DMSc

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 27, 2020

Study Start

June 1, 2020

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

March 26, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)