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Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

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ClinicalTrials.gov Identifier: NCT01057355
Recruitment Status : Withdrawn (slow accural)
First Posted : January 27, 2010
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):
Mark Topazian, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE January 26, 2010
First Posted Date  ICMJE January 27, 2010
Last Update Posted Date September 19, 2014
Study Start Date  ICMJE January 2010
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2010)
  • Occurrence of adverse events requiring treatment or hospitalization [ Time Frame: 3 days, 30 days ]
  • Decrease in volume of the pancreatic cyst by cross-sectional imaging studies (CT or MR) performed before and after treatment [ Time Frame: 6 months, 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01057355 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
Official Title  ICMJE Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
Brief Summary Pancreatic cysts are common, and some pancreas cysts have malignant potential. Usual treatment of these cysts is either observation or surgical removal of part or all of the pancreas. Minimally invasive treatment via endoscopy has been described, using endoscopic ultrasound (EUS) guided ethanol injections. Such studies exclude cysts that communicate with the main pancreatic duct, to avoid burning the main pancreatic duct with ethanol. In this study, pancreas cysts communicating with the main pancreas duct are treated with ethanol via endoscopic retrograde cholangiopancreatography (ERCP) and/or EUS.
Detailed Description Subjects will undergo EUS and/or ERCP as outpatients. For cysts shown to communicate with the main pancreas duct, a balloon catheter will be placed in the main pancreatic duct via ERCP. The balloon catheter will isolate the cyst from the main pancreatic duct, allowing ethanol injections of the cyst. A pancreatic duct stent will be placed in some patients, requiring repeat endoscopy for removal at another time.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasms, Cystic, Mucinous, and Serous
  • Pancreatic Neoplasms
  • Ultrasonography, Interventional
Intervention  ICMJE Procedure: EUS and/or ERCP with ethanol injections of pancreatic cyst
Lavage of cyst with 80% ethanol
Other Names:
  • Alcohol lavage
  • Alcohol injection
  • Ethanol lavage
  • Ethanol injection
  • Endoscopic treatment
  • Pancreas cyst ablation
Study Arms  ICMJE Experimental: Cyst ethanol lavage
Subjects receiving the study intervention
Intervention: Procedure: EUS and/or ERCP with ethanol injections of pancreatic cyst
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 17, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2010)
25
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Presence of a pancreatic cystic lesion, at least 2 cm in maximum diameter
  • Cyst may communicate, or definitely communicates, with the pancreatic duct (based on prior CT, MR, ERCP, or EUS images)
  • Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy
  • Age at least 18 years
  • Able to give informed consent
  • Surgical treatment has been considered and a surgical consultation offered to the patient, OR the subject's cyst does not meet consensus criteria for surgical resection. (Current consensus criteria for resection are one or more of the following: cyst is symptomatic, ≥ 3 cm in diameter, contains a mural nodule, cytology of cyst fluid is positive for malignancy, or main pancreatic duct diameter is > 6 mm.)

Exclusion Criteria:

  • Known or suspected pregnancy, or nursing
  • History of pancreatitis within 3 months prior to study endoscopy procedures
  • Cyst has a primarily microcystic architecture on EUS
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01057355
Other Study ID Numbers  ICMJE 009-004705
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark Topazian, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Topazian, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date September 2014

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