RAFPAN2: Longitudinal, Prospective, French, Multicenter Cohort Study on Pancreatic Radiofrequency
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-A00247-38