Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment Pancreatic NeuroEndocrine Neoplasms (RAPNEN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03834701|
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : July 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors Neuroendocrine Carcinoma Pancreas Neoplasm Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting||Device: EUS guided radiofrequency ablation||Not Applicable|
Pancreatic neuroendocrine neoplasms (PanNENs) are rare, but their incidence has significantly increased in the last decades. The mainstay treatment of PanNENs is surgery, which is associated with a significant benefit in term of survival but also with significant short- and long-term adverse events.
Based on the above data, less invasive alternative therapeutic interventions to avoid short- and long-term adverse events of surgery are needed.
In this context radiofrequency ablation has been reported to be effective in the treatment of these tumors in absence of major adverse events. However, the available studies on the matter are limited by small sample size and lack of standardized criteria for patient selection.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment of Functional and Non-functional Pancreatic NeuroEndocrine Neoplasms: A Multicenter Prospective Study|
|Estimated Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
Experimental: EUS guided radiofrequency ablation
Radiofrequency ablation will be performed using a system that consists of an 19-gauge needle electrode (140-cm long), a radiofrequency generator, and an inner cooling system that circulates chilled saline solution during the RFA procedure.
Device: EUS guided radiofrequency ablation
The EUS-RFA system (Taewoong, Seoul, Korea) utilized for EUS-RFA consists of an 19-gauge needle electrode (140-cm long), a radiofrequency generator, and an inner cooling system that circulates chilled saline solution during the RFA procedure. The inner metal part is insulated over its entire length, with the exception of the terminal 5 to 20mm for energy delivery. The needle electrode is attached to a radio frequency current generator (VIVA RF generator; Taewoong) and to a cooling pump. The generator, in addition to providing radio frequency current, allows the control of physical power and impedance parameters.
- Incidence of adverse events (AEs) after EUS-guided radiofrequency ablation (RFA) [ Time Frame: 1 year ]AEs will be classified as procedural when they occur during the procedure; post-procedural when they will occur up to 14 days after the procedure; late when they will occur more than 14 days after the procedure. Minor AEs will be those that need no therapy and have no sequelae (A) or have minor therapy or consequence, including overnight admission (B). Major events include those that require major therapy or hospitalization (24- 48 hours) (C); major therapy, need unplanned increase in level of care, or hospitalization >48 hours (D); or result in permanent adverse sequelae (E) and death (F).
- Rates of secondary surgery [ Time Frame: 1 year ]Number of patients who will require secondary surgey due to adverse events occurence, no response/failed or partial/recurrence outcome to the RFA treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834701
|Contact: Alberto Larghi, PhDemail@example.com|
|Contact: Carolina Gualtieri||+390630156580|
|Fondazione Policlinico Universitario Agostino Gemelli||Not yet recruiting|
|Roma, RM, Italy, 00168|
|Contact: Carolina Gualtieri 00390630156580 firstname.lastname@example.org|
|Universita' del Sacro Cuore||Not yet recruiting|
|Rome, Italy, 00136|
|Contact: Alberto Larghi, MD +390630156580 email@example.com|
|Principal Investigator:||Alberto Larghi, PhD||Fondazione Policlinico Universitario Agostino Gemelli|