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
  Purpose

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 Intervention
Pancreatic Cyst
Pancreatic Intraductal Papillary-Mucinous Neoplasm
Cystadenoma, Mucinous
Papillary Mucinous Cystadenoma, Borderline Malignancy
Procedure: 98% Ethanol & Paclitaxel injection

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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.


Enrollment: 22
Study Start Date: September 2009
Estimated Study Completion Date: June 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643460

Locations
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202-5121
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: John M. DeWitt, MD Indiana University Hospital, Indianapolis, IN 46202
  More Information

No publications provided by Indiana University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01643460     History of Changes
Other Study ID Numbers: 0812-57
Study First Received: June 28, 2012
Last Updated: November 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Intraductal papillary mucinous neoplasms (IPMNs)
Mucinous cystadenomas [MCN])
Invasive IPMNs or mucinous cystadenocarcinomas) tumors

Additional relevant MeSH terms:
Neoplasms
Cysts
Pancreatic Cyst
Cystadenoma
Cystadenoma, Mucinous
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Cystic, Mucinous, and Serous
Paclitaxel
Ethanol
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014