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

Pancreatic Tumor Clinical Trial

— RAFPAN2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05871164
• Other study ID #: 2023-A00247-38
• Status: Recruiting
• Start date: June 12, 2023
• Est. completion date: May 2030

Study information

• Verified date: June 2023
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Bertrand NAPOLEON, MD
• Phone: 428636969
• Email: dr.napoleon[@]wanadoo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2030
• Est. primary completion date: May 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Pancreatic Tumor

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	CHI Toulon La Seyne	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years