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

Recruiting

• Conditions: Pancreatic Tumor
• Interventions: Procedure: Pancreatic radiofrequency

• Registration Number: NCT05871164
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-23
• Study Start: 2023-06-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2030-05
• Study Completion: 2030-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient to be treated for a tumor of the pancreas	Pancreatic radiofrequency	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

Primary Outcome Measures

Name	Time	Method
Carcinological efficacy of pancreatic radiofrequency	5 years	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.

Trial Locations

Locations (1)

CHI Toulon La Seyne; 🇫🇷 Toulon, France