Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Indiana University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01643460
First received: June 28, 2012
Last updated: November 4, 2013
Last verified: June 2012

June 28, 2012
November 4, 2013
September 2009
May 2012   (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
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 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.
 
Active, not recruiting
22
June 2014
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients referred between January 2009 and February 2012 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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01643460
0812-57
No
Indiana University
Indiana University
Not Provided
Principal Investigator: John M. DeWitt, MD Indiana University Hospital, Indianapolis, IN 46202
Indiana University
June 2012

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