Irreversible Electroporation of Unresectable Liver Tumors
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|ClinicalTrials.gov Identifier: NCT04404647|
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Liver Metastases Hepatocellular Carcinoma Bile Duct Cancer||Procedure: Irreversible electroporation||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Irreversible Electroporation of Unresectable Liver Tumors - a Phase I Study of Safety and Feasibility|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||March 30, 2025|
|Estimated Study Completion Date :||March 30, 2025|
Selected patients who choose to participate will undergo ablation of the target lesion using irreversible electroporation.
Procedure: 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.
Other Name: NanoKnife(TM)
- 90-day complication rate and severity [ Time Frame: 90 days after intervention (last patient) ]Adverse events will be registered and scaled according to the Clavien-Dindo classification.
- Technical success rate [ Time Frame: 90 days after intervention (last patient) ]The rate of patients were it is possible to place needles according to the treatment plan and deliver 90 electrical pulses per electrode pair
- Technical efficacy rate (1 month) (according to SIR) [ Time Frame: 90 days after intervention (last patient) ]The rate of patients showing no residual tumor on contrast enhanced computed tomography (ceCT)
- Median local progression free survival from IRE [ Time Frame: 2 years after intervention (last patient) ]The median time from the intervention to progressive disease of the treated lesion, according to RECIST 1.1 or modified RECIST (mRECIST) (only for HCC).
- Median overall survival (OS) from IRE [ Time Frame: 2 years after intervention (last patient) ]The median time from the intervention to death.
- Longitudinal changes in perceived quality of life [ Time Frame: 2 years after intervention (last patient) ]Quality of life questionnaire - Core 30 is used to assess the quality of life in the included patients. Raw scores will be calculated according to the manual. Items will be grouped in: Global health status (range 0 - 100, high is good), Functional scales (range 0 - 100, high is good) and symptom scales (range 0 - 100 low is good). Differences in each scales during the course of the trial will be calculated separately.
- Longitudinal changes in pain perception [ Time Frame: 2 years after intervention (last patient) ]Long term pain will be assessed using the modified Danish version of the Brief Pain Inventory - short form. The outcomes assessed will be an average score of pain severity items and interference items in accordance with the manual. The scales range from 0 to 10 (lower is less pain).
- Periprocedural pain perception [ Time Frame: 90 days after intervention (last patient) ]Perioperative pain will be scores using the visual analogue pain scale (range 0 - 10, low score is less pain).
- Longitudinal changes in Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: 2 years after intervention (last patient) ]Physicians assessment of global functioning using the "Eastern Cooperative Oncology Group" performance status scale (range 0 - 5, low score is better)
- Longitudinal changes in nutritional status assessment [ Time Frame: 2 years after intervention (last patient) ]Nutritional status assessment using the Scored Patient-Generated Subjective Global Assessment (short form). The short form includes only patient reported measures and will be combined into a single score according to the manual (range 0 - 37, low score is better).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404647
|Contact: Rasmus Virenfeldt Flak, MDfirstname.lastname@example.org|
|Contact: Mogens Tornby Stender, MD, PhDemail@example.com|
|Department of Gastrointestinal Surgery, Aalborg University Hospital||Recruiting|
|Aalborg, Denmark, 9000|
|Contact: Rasmus Virenfeldt Flak, MD +4597661181 firstname.lastname@example.org|
|Study Director:||Ole Thorlacius-Ussing, Professor, DMSc||Department of Gastrointestinal Surgery, Aalborg University Hospital|