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Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasms, Cystic, Mucinous, and Serous, Pancreatic Neoplasms, Ultrasonography, Interventional

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Trial Information

Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurrence of adverse events requiring treatment or hospitalization

Outcome Time Frame:

3 days, 30 days

Safety Issue:

Yes

Principal Investigator

Mark Topazian, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

009-004705

NCT ID:

NCT01057355

Start Date:

January 2010

Completion Date:

January 2015

Related Keywords:

  • Neoplasms, Cystic, Mucinous, and Serous
  • Pancreatic Neoplasms
  • Ultrasonography, Interventional
  • Intraductal papillary mucinous neoplasm
  • Mucinous cystic neoplasm
  • Endoscopic ultrasound
  • Endoscopic retrograde cholangiopancreatography
  • Pancreatic cyst
  • Pancreas cyst
  • Alcohol
  • Neoplasms
  • Pancreatic Neoplasms
  • Neoplasms, Cystic, Mucinous, and Serous

Name

Location
Mayo Clinic Rochester, Minnesota  55905