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Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

This study has been withdrawn prior to enrollment.
(slow accural)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01057355
First Posted: January 27, 2010
Last Update Posted: September 19, 2014
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Mark Topazian, Mayo Clinic
  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: Intervention Model: Single Group Assignment
Masking: None (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 Mark Topazian, Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: January 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01057355


Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mark Topazian, M.D. Mayo Clinic
  More Information

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
First Submitted: January 26, 2010
First Posted: January 27, 2010
Last Update Posted: September 19, 2014
Last Verified: September 2014

Keywords provided by Mark Topazian, 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
Central Nervous System Depressants
Physiological Effects of Drugs
Gastrointestinal Agents