Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

This study is currently recruiting participants.
Verified September 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Mark Topazian, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01057355
First received: January 26, 2010
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Neoplasms, Cystic, Mucinous, and Serous
Pancreatic Neoplasms
Ultrasonography, Interventional
Procedure: EUS and/or ERCP with ethanol injections of pancreatic cyst
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Occurrence of adverse events requiring treatment or hospitalization [ Time Frame: 3 days, 30 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: January 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cyst ethanol lavage
Subjects receiving the study intervention
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057355

Contacts
Contact: Magdalen Clemens 507-778-2555 clemens.magdalen@mayo.edu
Contact: Mark Topazian, M.D. 507-266-6931 topazian.mark@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Magdalen Clemens    507-538-2555    clemens.magdalen@mayo.edu   
Contact: Mark Topazian, MD    507-266-6931    topazian.mark@mayo.edu   
Principal Investigator: Mark Topazian, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mark Topazian, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Mark Topazian, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01057355     History of Changes
Obsolete Identifiers: NCT01100229
Other Study ID Numbers: 009-004705
Study First Received: January 26, 2010
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Intraductal papillary mucinous neoplasm
Mucinous cystic neoplasm
Endoscopic ultrasound
Endoscopic retrograde cholangiopancreatography
Pancreatic cyst
Pancreas cyst
Alcohol

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ethanol
Pancrelipase
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 16, 2014