Safety Study of Radiofrequency Ablation of Locally Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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The purpose of the study is to determine the safety of radiofrequency ablation of locally advanced pancreatic cancer that can not be surgically removed with the current standard procedures. Complications after the operation will be registered. Moreover a pain score will be determined, length of hospital stay, chemotherapy, survival, progression free survival and a tumour marker.

Detailed Description
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Pancreatic cancer is the fourth leading cause of cancer related death in the Western world. At time of diagnosis, 20% of patients present with a resectable tumour, 40% with an irresectable locally advanced tumour (without metastases) and 40% with metastatic disease. The median survival of patients with irresectable locally advanced pancreatic cancer is only 6 months. Currently, there is no effective treatment for these patients. Therefore, there is an urgent need for new therapies. Radiofrequency ablation (RFA) is a technique that has been demonstrated to be effective in the treatment of several irresectable tumours. RFA produces local tumour destruction through high frequency alternating current flowing from an electrode implanted directly into the tumour and causing frictional heating. The purpose of this study is to determine the safety of RFA-pancreas in patients with non-metastasized, irresectable, locally advanced pancreatic cancer.

Official Title
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Phase II Study: Radiofrequency Ablation of Locally Advanced Pancreatic Cancer

Conditions
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Locally Advanced Pancreatic Cancer

Intervention / Treatment
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* Procedure: radiofrequency ablation (RFA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with irresectable locally advanced pancreatic cancer found at laparotomy with histologic diagnosis before start of RFA Patient considered eligible to undergo pancreatic surgery as assessed by the general criteria of the departments of anaesthesiology and surgery of the UMC Utrecht Fully informed written consent given Exclusion Criteria: Patients younger than 18 years Pregnancy Patients with distant metastases Portal vein thrombosis seen on CT preoperatively

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiofrequency ablation<br> | Procedure: radiofrequency ablation (RFA)<br>* RFA with CELON bipolar probes. Settings: Power 30 watts, total energy 15 KJ.<br>* Other names: CELON Power System, CE mark 0197;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | The safety will be specified as the percentage of patients with complications directly related to RFA and the routinely performed double-bypass procedure, requiring re-intervention (i.e. endoscopy, radiology, or surgery). This is also known as a complication of grade III or higher in the Clavien-Dindo classification (internationally accepted classification for surgical complications). Moreover all in-hospital complications or complications developed within 30 days after the RFA procedure will be evaluated according to the Clavien-Dindo classification. | Within 30 days after the RFA procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  | 2 years after RFA procedure | 
| VAS pain score |  | 3 months | 
| length hospital stay |  | 3 months | 
| progression free survival |  | 2 years after RFA procedure | 
| CA19-9 response |  | 2 years after RFA procedure | 
| Chemotherapy | Type, frequency, dosage and duration of chemotherapy will be registered. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, locally advanced, irresectable, Radiofrequency, RFA