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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 : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
John DeWitt, Indiana University

June 28, 2012
July 18, 2012
April 10, 2018
September 2009
January 2020   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01643460 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
22
Same as current
January 2022
January 2020   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact: John M. DeWitt, MD 317-944-5392 jodewitt@iu.edu
United States
 
 
NCT01643460
0812-57
No
Not Provided
Not Provided
John DeWitt, Indiana University
Indiana University
Not Provided
Principal Investigator: John M. DeWitt, MD Indiana University Hospital, Indianapolis, IN 46202
Indiana University
April 2018

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