Irreversible Electroporation of Unresectable Liver Tumors

STATUS

Recruiting
End date

Mar 30, 2025
participants needed

15
sponsor

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

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Updated on 19 February 2024

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cancer

metastasis

liver tumor

hepatoma

biliary tract cancer

irreversible electroporation

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.

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.

Details

Condition	Bile duct carcinoma, Adenocarcinoma, Adenocarcinoma, Biliary neoplasm, HEPATIC NEOPLASM, liver cancer, HEPATOCELLULAR CARCINOMA, Liver Metastases, liver cancer
Age	18-100 years
Treatment	Irreversible electroporation
Clinical Study Identifier	NCT04404647
Sponsor	Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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Irreversible Electroporation of Unresectable Liver Tumors