About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Patient with a contraindication to radiofrequency treatment;
Pregnant or breastfeeding women
Trial population
Patient over 18 to be treated for pancreatic tumor by ultrasound-guided radiofrequency with fine needle
Trial design
Cohort
Prospective
Treatments tested in this trial
Pancreatic radiofrequency
Procedure/SurgeryPancreatic 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead sponsor
Euraxi Pharma
Collaborator