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Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01643460
Recruitment Status : Recruiting
First Posted : July 18, 2012
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
John DeWitt, Indiana University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Pancreatic Cyst Pancreatic Intraductal Papillary-Mucinous Neoplasm Cystadenoma, Mucinous Papillary Mucinous Cystadenoma, Borderline Malignancy Procedure: 98% Ethanol & Paclitaxel injection Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: John M. DeWitt, MD 317-944-5392 jodewitt@iu.edu

Locations
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United States, Indiana
Indiana University Hospital Recruiting
Indianapolis, Indiana, United States, 46202-5121
Contact: Kathleen McGreevy, RN    317-944-5392    kmcgreev@iu.edu   
Principal Investigator: John M DeWitt, MD         
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: John M. DeWitt, MD Indiana University Hospital, Indianapolis, IN 46202
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John DeWitt, Director Endoscopic Ultrasound, Indiana University
ClinicalTrials.gov Identifier: NCT01643460    
Other Study ID Numbers: 0812-57
First Posted: July 18, 2012    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Keywords provided by John DeWitt, Indiana University:
Intraductal papillary mucinous neoplasms (IPMNs)
Mucinous cystadenomas [MCN])
Invasive IPMNs or mucinous cystadenocarcinomas) tumors
Additional relevant MeSH terms:
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Cysts
Pancreatic Cyst
Cystadenoma
Pancreatic Intraductal Neoplasms
Cystadenoma, Mucinous
Neoplasms
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Ductal, Lobular, and Medullary
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Endocrine System Diseases
Ethanol
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents