EUS-guided RFA for Pancreatic Neoplasms
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|ClinicalTrials.gov Identifier: NCT03218345|
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : December 13, 2019
Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung, kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows EUS-guided treatment of pancreatic neoplasms. The procedure has been shown to be feasible in the porcine pancreas and was used to treat small groups of patients that are not suitable for surgery suffering from pancreatic neoplasms.
The aim of the current study is to perform a multi-center prospective study on EUS-guided radiofrequency ablation (RFA) of solid pancreatic neoplasms. The hypothesis is that EUS-guided RFA is safe, feasible and effective for treating solid pancreatic neoplasms.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms||Procedure: EUS-guided RFA||Not Applicable|
RFA causes tissue destruction through the application of a high frequency alternating current, generating local temperatures above 60°C and leading to coagulative necrosis. The technique has been widely used in many solid organ tumors and has been shown to result in 5-year survival rates comparable to surgery. The technique is currently the standard therapy in hepatocellular carcinoma and colorectal pulmonary metastasis particular in patients that are not suitable for surgery.
This study is a multi-center prospective study involving four high volume international institutions. Consecutive patients suffering from pancreatic neuroendocrine tumors and pancreatic cancers would be recruited. EUS-guided RFA would be performed using a 19-gauge RFA electrode and a generator. The primary outcome would be the overall adverse events rate. Secondary outcomes include mortality, technical success rate, completion ablation rate, 1 & 3 year overall and disease-free survival.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Pancreatic Neoplasms|
|Actual Study Start Date :||August 2016|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Experimental: EUS-guided RFA
EUS-guided RFA would be performed using a 19-gauge RFA electrode and a VIVA RF generator (STARmed, Korea)
Procedure: EUS-guided RFA
EUS-guided RFA would be performed using a 19-gauge RFA electrode and a generator
- Severe adverse events [ Time Frame: 30 days ]Adverse events specific to RFA would be graded according to the lexicon of endoscopic adverse events 24. Potential adverse events specific to RFA include: post-RFA syndrome, pancreatitis, pancreatic leak, thermal injury
- Technical success rates [ Time Frame: 1 week ]defined as successful puncture of the lesion with the RFA needle and completion of the ablation cycle.
- Procedural times [ Time Frame: 1 day ]Duration of the procedure
- Hospital stay [ Time Frame: 30 days ]Duration of hospital stay
- Radiological response [ Time Frame: 1 year ]Based on modified RECIST criterion
- Number of re-interventions [ Time Frame: 1 year ]Number of re-interventions after the procedure
- Survival [ Time Frame: 3 years ]Duration of survival after the procedure
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): NCT03218345
|Contact: Anthony YB Teoh, Professorfirstname.lastname@example.org|
|Department of Surgery, Prince of Wales Hospital||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Anthony YB Teoh, FRCSEd(Gen) 85226322953 email@example.com|
|Principal Investigator: Anthony YB Teoh|
|Principal Investigator:||Anthony YB Teoh, Professor||Chinese University of Hong Kong|