Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts
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|ClinicalTrials.gov Identifier: NCT01643460|
Recruitment Status : Recruiting
First Posted : July 18, 2012
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment|
|Pancreatic Cyst Pancreatic Intraductal Papillary-Mucinous Neoplasm Cystadenoma, Mucinous Papillary Mucinous Cystadenoma, Borderline Malignancy||Procedure: 98% Ethanol & Paclitaxel injection|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2022|
|Experimental: 98% Ethanol with Paclitaxel injection||
Procedure: 98% Ethanol & Paclitaxel injection
Pancreatic cyst injection via Endoscopic Ultrasound (EUS)of 98% Ethanol with Paclitaxel (dose determined in relation to cyst size & amount of fluid aspirated from the cyst.
Other Name: Pancreatic cyst injection of Paclitaxel.
- Cyst resolution [ Time Frame: 6 months ]1. Patients will undergo EUS-guided cyst ablation with ethanol +/- paclitaxel as indicated for their scheduled procedure. 2. Patients will return 3 months after initial ablation for a repeat EUS, and ablation will be repeated if cyst size is >10mm in diameter. 3. CT or MRI imaging will be performed 3 months after the second procedure to assess for cyst resolution.
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): NCT01643460
|Contact: Kathleen A. McGreevy, RNfirstname.lastname@example.org|
|United States, Indiana|
|Indiana University Hospital||Recruiting|
|Indianapolis, Indiana, United States, 46202-5121|
|Contact: Kathleen McGreevy, RN 317-944-5392 email@example.com|
|Principal Investigator: John M DeWitt, MD|
|Principal Investigator:||John M. DeWitt, MD||Indiana University Hospital, Indianapolis, IN 46202|