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

NCT ID: NCT05871164

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-12
• Study Completion Date: 2030-05-31

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.

Conditions

Pancreatic Tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient to be treated for a tumor of the pancreas

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

Pancreatic radiofrequency

Intervention Type: PROCEDURE

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.

Interventions

Pancreatic radiofrequency

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Euraxi Pharma

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHI Toulon La Seyne

Toulon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Bertrand NAPOLEON, MD

Role: CONTACT

dr.napoleon@wanadoo.fr

428636969 ext. +33

Facility Contacts

Philippe AH-SOUNE, MD

Role: primary

philippe.ah-soune@ch-toulon.fr

Other Identifiers

2023-A00247-38

Identifier Type: -

Identifier Source: org_study_id