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

NCT05871164 | Recruiting

• 1 other identifier: 2023-A00247-38
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Tumor

Outcome Measures

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.

  5 years

Study Arms (1)

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

Procedure: Pancreatic radiofrequency

Interventions

Pancreatic radiofrequency 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.

Patient to be treated for a tumor of the pancreas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient over 18 to be treated for pancreatic tumor by ultrasound-guided radiofrequency with fine needle

You may qualify if:

• 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.

You may not qualify if:

• Patient with a contraindication to radiofrequency treatment;
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Euraxi Pharma: collaborator
• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

CHI Toulon La Seyne

Toulon, 83056, France

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Bertrand NAPOLEON, MD

CONTACT

428636969; dr.napoleon@wanadoo.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 23, 2023
• Study Start: June 12, 2023
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

FR (1)