EUS-guided RFA for Pancreatic Neoplasms

Study Overview
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Brief Summary
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Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung, kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows EUS-guided treatment of pancreatic neoplasms. The procedure has been shown to be feasible in the porcine pancreas and was used to treat small groups of patients that are not suitable for surgery suffering from pancreatic neoplasms. The aim of the current study is to perform a multi-center prospective study on EUS-guided radiofrequency ablation (RFA) of solid pancreatic neoplasms. The hypothesis is that EUS-guided RFA is safe, feasible and effective for treating solid pancreatic neoplasms.

Detailed Description
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RFA causes tissue destruction through the application of a high frequency alternating current, generating local temperatures above 60°C and leading to coagulative necrosis. The technique has been widely used in many solid organ tumors and has been shown to result in 5-year survival rates comparable to surgery. The technique is currently the standard therapy in hepatocellular carcinoma and colorectal pulmonary metastasis particular in patients that are not suitable for surgery. This study is a multi-center prospective study involving four high volume international institutions. Consecutive patients suffering from pancreatic neuroendocrine tumors and pancreatic cancers would be recruited. EUS-guided RFA would be performed using a 19-gauge RFA electrode and a generator. The primary outcome would be the overall adverse events rate. Secondary outcomes include mortality, technical success rate, completion ablation rate, 1 & 3 year overall and disease-free survival.

Official Title
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Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Pancreatic Neoplasms

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Procedure: EUS-guided RFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years-old or above Suffering from pancreatic neuroendocrine tumor or pancreatic ductal carcinoma (<5cm in largest diameter) that was confirmed by fine needle aspiration cytology Unsuitable for surgery, due to one (or more) of the following items: ASA score > II* An alternative advanced malignancy Unsuitable for surgery upon expert's opinion for any other reason Healthy individuals who are not keen for surgical resection Eligible for endoscopic intervention Written informed consent Exclusion Criteria: Coagulopathy (international normalized ratio >1.3, partial thromboplastin time greater than twice that of control), platelet count <50,000x103/uL Pregnancy Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study Patients unwilling to undergo follow-up assessments Patients with liver cirrhosis, portal hypertension and/or gastric varices.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: EUS-guided RFA<br>EUS-guided RFA would be performed using a 19-gauge RFA electrode and a VIVA RF generator (STARmed, Korea) | Procedure: EUS-guided RFA<br>* EUS-guided RFA would be performed using a 19-gauge RFA electrode and a generator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe adverse events | Adverse events specific to RFA would be graded according to the lexicon of endoscopic adverse events 24. Potential adverse events specific to RFA include: post-RFA syndrome, pancreatitis, pancreatic leak, thermal injury | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rates | defined as successful puncture of the lesion with the RFA needle and completion of the ablation cycle. | 1 week | 
| Procedural times | Duration of the procedure | 1 day | 
| Hospital stay | Duration of hospital stay | 30 days | 
| Radiological response | Based on modified RECIST criterion | 1 year | 
| Number of re-interventions | Number of re-interventions after the procedure | 1 year | 
| Survival | Duration of survival after the procedure | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EUS-guided RFA, pancreatic ca, interventional EUS