EUS-guided RFA for Solid Abdominal Neoplasms
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|ClinicalTrials.gov Identifier: NCT03221335|
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : November 15, 2018
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 solid abdominal 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 cancers.
The aim of the current study is to perform a multi-center prospective study on EUS-guided radiofrequency ablation (RFA) of solid abdominal neoplasms. The hypothesis is that EUS-guided RFA is safe, feasible and effective for treating solid abdominal neoplasms.
|Condition or disease||Intervention/treatment||Phase|
|Digestive System Neoplasms||Device: 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 tumours 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.
The current study would be a multi-center prospective study involving four high volume international institutions. Consecutive patients suffering from solid neoplasms of the liver, stomach and adrenals would be recruited. EUS-guided RFA would be performed using a 19-gauge RFA electrode and a VIVA RF generator (STARmed, Korea). 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 Abdominal Neoplasms.|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: EUS-guided RFA
EUS-guided RFA would be performed using a 19-gauge RFA electrode and a VIVA RF generator (STARmed, Korea).
Device: EUS-guided RFA
All patients would undergo EUS with a linear array echoendoscope. The location and size of the lesion would be assessed for suitability of treatment. After locating the lesion, the 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. The duration of ablation would be according to the size of the lesion.
- 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 and 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 after the procedure
- Radiological response [ Time Frame: 1 year ]Based on a modified RECIST criterion
- Number of re-interventions [ Time Frame: 1 year ]The number of re-interventions after RFA
- Survival [ Time Frame: 3 years ]The 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): NCT03221335
|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|