Irreversible Electroporation of Unresectable Liver Tumors

NCT ID: NCT04404647

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2025-03-30

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.

Conditions

Liver Metastases; Hepatocellular Carcinoma; Bile Duct Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Irreversible electroporation

Intervention Type: PROCEDURE

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.

Interventions

Irreversible electroporation

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.

Intervention Type: PROCEDURE

Other Intervention Names

NanoKnife(TM)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

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

Professor of surgery, Consultant surgeon, DMSc

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ole Thorlacius-Ussing, Professor, DMSc

Role: STUDY_DIRECTOR

Department of Gastrointestinal Surgery, Aalborg University Hospital

Locations

Department of Gastrointestinal Surgery, Aalborg University Hospital

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

N-20190072

Identifier Type: -

Identifier Source: org_study_id