EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Study (EUS)
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|ClinicalTrials.gov Identifier: NCT01902238|
Recruitment Status : Unknown
Verified November 2016 by Do Hyun Park, Asan Medical Center.
Recruitment status was: Active, not recruiting
First Posted : July 18, 2013
Last Update Posted : December 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Efficacy Safety Feasibility||Procedure: EUS-guided ethanol-lipiodol mixture ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Feasibility and Long Term Outcome|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||August 2017|
Experimental: EUS-guided ethanol-lipiodol mixture ablation
By using 3D-volumetric analysis, the optimal volume of ethanol is calculated by computer estimation of areas on each axial image, using EUS software permitting volume calculation. After calculating optimal ethanol volume by 3D volumetric analysis, we advance the needle into the tumor and inject estimated volume of ethanol/lipiodol (1:1 mixture), typically 1 to 1.5 ml.
Procedure: EUS-guided ethanol-lipiodol mixture ablation
By using 3D-volumetric analysis, the optimal volume of ethanol/lipiodol (1:1 mixture) is calculated by computer estimation of areas on each axial image, using EUS software permitting volume calculation. After calculating optimal ethanol volume by 3D volumetric analysis, we advance the needle into the tumor and inject estimated volume of ethanol, typically 1 to 1.5 ml.
- Number of participants with treatment response [ Time Frame: more than 3 years after procedure ]Final tumor viability will be assessed using contrast enhanced CT, and EUS-guided FNA at 3 years after procedure
- The number of participants with post-procedure adverse events [ Time Frame: until 3 months after procedure ]Adverse events were defined as any procedure-related complications during the procedure or within 3 months, including pancreatitis, bleeding, and peripancreatic fluid collection
- Technical feasibility [ Time Frame: at the time of procedure ]Technical success was defined as the ability to access and inject the mixture of ethanol/lipiodol into target tissue.
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): NCT01902238
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Study Director:||Do Hyun Park, MD, PhD||Asan Medical Center, Seoul, Korea, Republic of|