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Trial Title:
Longitudinal, Prospective, French, Multicenter Cohort Study on Pancreatic Radiofrequency
NCT ID:
NCT05871164
Condition:
Pancreatic Tumor
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Pancreatic radiofrequency
Description:
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.
Arm group label:
Patient to be treated for a tumor of the pancreas
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.
Criteria for eligibility:
Study pop:
Patient over 18 to be treated for pancreatic tumor by ultrasound-guided radiofrequency
with fine needle
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHI Toulon La Seyne
Address:
City:
Toulon
Zip:
83056
Country:
France
Status:
Recruiting
Contact:
Last name:
Philippe AH-SOUNE, MD
Email:
philippe.ah-soune@ch-toulon.fr
Start date:
June 12, 2023
Completion date:
May 2030
Lead sponsor:
Agency:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Agency class:
Other
Source:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05871164
