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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pancreatic radiofrequency

    Procedure/Surgery

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patient to be treated for a tumor of the pancreas1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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