Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01057355
First received: January 26, 2010
Last updated: January 14, 2013
Last verified: January 2013
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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:
|
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, M.D., Mayo Clinic Rochester |
| ClinicalTrials.gov Identifier: | NCT01057355 History of Changes |
| Obsolete Identifiers: | NCT01100229 |
| Other Study ID Numbers: | 009-004705 |
| Study First Received: | January 26, 2010 |
| Last Updated: | January 14, 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 May 23, 2013