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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01057355
Other study ID # 009-004705
Secondary ID
Status Withdrawn
Phase Phase 1
First received January 26, 2010
Last updated September 17, 2014
Start date January 2010
Est. completion date June 2013

Study information

Verified date September 2014
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT01100229

Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
EUS and/or ERCP with ethanol injections of pancreatic cyst
Lavage of cyst with 80% ethanol

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of adverse events requiring treatment or hospitalization 3 days, 30 days Yes
Primary Decrease in volume of the pancreatic cyst by cross-sectional imaging studies (CT or MR) performed before and after treatment 6 months, 12 months No
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