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| Name | Class |
|---|---|
| Euraxi Pharma | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patient over 18 to be treated for pancreatic tumor by ultrasound-guided radiofrequency with fine needle
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bertrand NAPOLEON, MD | Contact | 428636969 | +33 | dr.napoleon@wanadoo.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHI Toulon La Seyne | Recruiting | Toulon | 83056 | France |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |