Evaluation of Safety and Feasibility of EUS-guided RFA for Solid Pancreatic Neoplasms
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|ClinicalTrials.gov Identifier: NCT03435770|
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : February 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Pancreatic Neoplasms Pancreatic Adenocarcinoma Pancreatic Neuroendocrine Tumor Pancreatic Ductal Adenocarcinoma||Device: EUSRA RFA needle||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||prospective, open label|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Safety and Feasibility of Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) for Solid Pancreatic Neoplasms|
|Estimated Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||September 1, 2019|
Experimental: EUSRA RFA needle
This procedure is very similar to the standard technique of EUS-guided fine needle aspiration. All patients would undergo EUS with a linear array or therapeutic echoendoscope. The location and size of the lesion would be assessed for suitability of treatment. After locating the lesion, the EUSRA RFA needle would be inserted to the centre of the lesion. RFA would then be initiated and hyperechoic interferences would be observed around the electrode signifying heating of the tissue.
Device: EUSRA RFA needle
A 19-gauge RFA electrode and a RF generator with a electrode that is needle-shaped and echogenic that allows EUS guided puncture of the target lesion. The active electrode tip is 1 cm in length. During ablation, the RF electrode is cooled and perfused internally with circulating chilled saline solution (0°C) delivered via a pump to maintain a constant temperature. A setting of 50W energy would be used for RFA and the duration of application is 10 seconds. Sequential applications of up to 7 times per session are allowed for complete ablation of the lesions.
- To measure the technical success of EUS-guided RFA [ Time Frame: 18 months ]It is defined as successful puncture of the pancreatic lesion with the RFA needle and completion of the ablation cycle.
- To measure side effects and adverse event of EUS-guided RFA [ Time Frame: 18 months ]
Adverse events specific to RFA would be graded according to the lexicon of endoscopic adverse events (PB Cotton GIE 2010). Potential adverse events specific to RFA include:
- Post-RFA syndrome: Combination of flu like symptoms including fever, malaise, pain at the site of ablation, nausea, and/or vomiting and that no other septic source is identified.
- Pancreatitis: Clinical presence of abdominal pain with an increase in amylase level >3 times above the normal serum amylase levels.
- Pancreatic leak: The presence of an abdominal collection with an amylase level that is >3 times normal serum amylase levels.
- Thermal injury: Coagulative necrosis occurring at the site of needle entry within the gastrointestinal tract with or without clinical sequelae.
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): NCT03435770
|Contact: Yung Ka Chin, MBChBfirstname.lastname@example.org|
|Contact: Damein Tan, MBBSemail@example.com|
|Singapore General Hospital|
|Singapore, Singapore, 169856|
|Principal Investigator:||Yung Ka Chin, MBChB||Department of Gastroenterology & Herpetology, Singapore General Hospital|