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Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

Primary Purpose

Neoplasms, Cystic, Mucinous, and Serous, Pancreatic Neoplasms, Ultrasonography, Interventional

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
EUS and/or ERCP with ethanol injections of pancreatic cyst
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms, Cystic, Mucinous, and Serous focused on measuring Intraductal papillary mucinous neoplasm, Mucinous cystic neoplasm, Endoscopic ultrasound, Endoscopic retrograde cholangiopancreatography, Pancreatic cyst, Pancreas cyst, Alcohol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cyst ethanol lavage

    Arm Description

    Subjects receiving the study intervention

    Outcomes

    Primary Outcome Measures

    Occurrence of adverse events requiring treatment or hospitalization
    Decrease in volume of the pancreatic cyst by cross-sectional imaging studies (CT or MR) performed before and after treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    January 26, 2010
    Last Updated
    September 17, 2014
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01057355
    Brief Title
    Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
    Official Title
    Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    slow accural
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neoplasms, Cystic, Mucinous, and Serous, Pancreatic Neoplasms, Ultrasonography, Interventional
    Keywords
    Intraductal papillary mucinous neoplasm, Mucinous cystic neoplasm, Endoscopic ultrasound, Endoscopic retrograde cholangiopancreatography, Pancreatic cyst, Pancreas cyst, Alcohol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cyst ethanol lavage
    Arm Type
    Experimental
    Arm Description
    Subjects receiving the study intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    EUS and/or ERCP with ethanol injections of pancreatic cyst
    Other Intervention Name(s)
    Alcohol lavage, Alcohol injection, Ethanol lavage, Ethanol injection, Endoscopic treatment, Pancreas cyst ablation
    Intervention Description
    Lavage of cyst with 80% ethanol
    Primary Outcome Measure Information:
    Title
    Occurrence of adverse events requiring treatment or hospitalization
    Time Frame
    3 days, 30 days
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark Topazian, M.D.
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

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