Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Indiana University
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
First received: June 28, 2012
Last updated: November 11, 2015
Last verified: November 2015

June 28, 2012
November 11, 2015
September 2009
September 2017   (final data collection date for primary outcome measure)
Cyst resolution [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01643460 on ClinicalTrials.gov Archive Site
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Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts
Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts
The purpose of this study is to track outcomes and complications of patients at IUMC referred by physicians for EUS-guided pancreatic cyst ablation. This information is essential in order to disseminate future published information to physicians about this technique. A database will be created to track these patients undergoing an already scheduled/planned procedure. Phone calls at selected intervals will be made following the procedure to track any complications that occur
Pancreatic cysts represent a wide spectrum of lesions. Many cysts are uniformly benign (pseudocysts) or have negligible malignant potential (serous cystadenomas). However, others represent premalignant (i.e. intraductal papillary mucinous neoplasms (IPMNs) or mucinous cystadenomas [MCN]), or malignant (i.e. invasive IPMNs or mucinous cystadenocarcinomas) tumors. Management of pancreatic cysts is challenging but surgery is generally recommended for cysts that are symptomatic, premalignant (except possibly branch duct IPMNs) or demonstrate malignancy by imaging features and/or biopsy. However, even in experienced hospitals, surgical resection or enucleation of pancreatic cystic tumors is associated with significant perioperative morbidity and mortality rates of 20-40% and up to 2%, respectively.
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pancreatic Cyst
  • Pancreatic Intraductal Papillary-Mucinous Neoplasm
  • Cystadenoma, Mucinous
  • Papillary Mucinous Cystadenoma, Borderline Malignancy
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.
Experimental: 98% Ethanol with Paclitaxel injection
Intervention: Procedure: 98% Ethanol & Paclitaxel injection
DeWitt JM, Al-Haddad M, Sherman S, LeBlanc J, Schmidt CM, Sandrasegaran K, Finkelstein SD. Alterations in cyst fluid genetics following endoscopic ultrasound-guided pancreatic cyst ablation with ethanol and paclitaxel. Endoscopy. 2014 Jun;46(6):457-64. doi: 10.1055/s-0034-1365496. Epub 2014 Apr 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2018
September 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients referred between January 2009 and February 2016 to EUS at IUMC for pancreatic cyst ablation and with no contraindications for anticipated safe and successful performance of the procedure.
  2. Patient at least 18 years of age.

Exclusion Criteria:

  1. Investigator deems cyst does not meet safety or need for cyst ablation.
  2. Subject not competent to sign consent
18 Years and older
Contact: Kathleen A. McGreevy, RN 317-944-5392 kmcgreev@iupui.edu
United States
Indiana University
Indiana University
Not Provided
Principal Investigator: John M. DeWitt, MD Indiana University Hospital, Indianapolis, IN 46202
Indiana University
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP