Clinical trial NCT04404647: Irreversible Electroporation of Unresectable Liver Tumors
Official title: Irreversible Electroporation of Unresectable Liver Tumors - a Phase I Study of Safety and Feasibility
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Liver Metastases
Hepatocellular Carcinoma
Bile Duct Cancer
Keywords: irreversible electroporation
primary liver cancer
secondary liver cancer
colorectal liver metastases
NanoKnife
ablation
IRE
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 90-day complication rate and severity
timeFrame: 90 days after intervention (last patient)
Secondary outcomes:
measure: Technical success rate
timeFrame: 90 days after intervention (last patient)
measure: Technical efficacy rate (1 month) (according to SIR)
timeFrame: 90 days after intervention (last patient)
measure: Median local progression free survival from IRE
timeFrame: 2 years after intervention (last patient)
measure: Median overall survival (OS) from IRE
timeFrame: 2 years after intervention (last patient)
measure: Longitudinal changes in perceived quality of life
timeFrame: 2 years after intervention (last patient)
measure: Longitudinal changes in pain perception
timeFrame: 2 years after intervention (last patient)
measure: Periprocedural pain perception
timeFrame: 90 days after intervention (last patient)
measure: Longitudinal changes in Eastern Cooperative Oncology Group (ECOG) performance status
timeFrame: 2 years after intervention (last patient)
measure: Longitudinal changes in nutritional status assessment
timeFrame: 2 years after intervention (last patient)
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Gastrointestinal Surgery, Aalborg University Hospital
Study officials:
affiliation: Department of Gastrointestinal Surgery, Aalborg University Hospital
name: Ole Thorlacius-Ussing, Professor, DMSc
role: STUDY_DIRECTOR
References: