Longitudinal, Prospective, French, Multicenter Cohort Study on Pancreatic Radiofrequency (RAFPAN2)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: Pancreatic Tumor

Treatments: Procedure: Pancreatic radiofrequency

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05871164

2023-A00247-38

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Patient to be treated for a tumor of the pancreas

Description:

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

Treatment:

Procedure: Pancreatic radiofrequency