Longitudinal, Prospective, French, Multicenter Cohort Study on Pancreatic Radiofrequency

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the oncological efficacy of pancreatic radiofrequency by the objective response rate (complete and partial responses according to RECIST 1.1.), 5 years after the end of treatment.

Detailed Description
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This is a prospective, longitudinal, open, non-randomized, non-interventional, multicenter study on ultrasound-guided radiofrequency endoscopy for the treatment of pancreatic tumours. The study will be offered prospectively to all patients in need of treatment. They will be taken care of in accordance with current practice. The patient will be seen again 7 times after the end of the pancreatic radiofrequency (which will include one or two sessions): the follow-ups will be done according to current practice on D15 ± 7 days, M6 ± 14 days, M12 ± 1 month then annually until M60 ± 1 month. The study consists to evaluate the oncological efficacy at 5 years of pancreatic radiofrequency delivered by means of a needle guided by ultrasound endoscopy.

Official Title
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Longitudinal, Prospective, French, Multicenter Cohort Study on Pancreatic Radiofrequency

Conditions
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Pancreatic Tumor

Intervention / Treatment
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* Procedure: Pancreatic radiofrequency


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old; Patient to be treated for a pancreatic tumor by ultrasound-guided RF with a fine needle; Indication of pancreatic radiofrequency validated in a Multidisciplinary Consultation Meeting; Patient able to understand the information related to the study; Patient accepting study follow-up visits; Patient having been informed and agreeing to participate in the study. Exclusion Criteria: Patient with a contraindication to radiofrequency treatment; Pregnant or breastfeeding women

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient to be treated for a tumor of the pancreas<br>Patient to be treated for a tumor of the pancreas by ultrasound-guided radiofrequency with a fine needle, with Indication of pancreatic radiofrequency validated in a Multidisciplinary Consultation Meeting | Procedure: Pancreatic radiofrequency<br>* Pancreatic radiofrequency is similar to a puncture under echoendoscopy. The lesion is located then punctured by transgastric or transduodenal route either using a 19 gauge needle with exchange of the stylet for a probe, or using a 19 gauge needle whose distal end of 5-10 mm corresponds to the active part, connected to a generator with an integrated cooling system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carcinological efficacy of pancreatic radiofrequency | The primary endpoint of the study is the oncological efficacy of pancreatic radiofrequency, which will be assessed by the objective response rate (complete and partial responses according to RECIST 1.1.), 5 years after treatment. | 5 years |