Study Stopped
Inability to enroll subjects.
Management of Incidentally Discovered Pancreatic Cysts
A Prospective Study of the Management of Incidentally Discovered Pancreatic Cysts
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to determine the natural history of pancreatic cysts and to determine if these cysts can be effectively treated with a less invasive therapy (ethanol injection vs periodic imaging) rather than surgical resection
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2007
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 24, 2007
CompletedFirst Posted
Study publicly available on registry
October 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJune 26, 2008
June 1, 2008
5 years
October 24, 2007
June 23, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patients not progressing to operation due to the development of symptoms, growth to a maximum diameter of >3cm, or development of a mural nodule.
3 years
Secondary Outcomes (1)
A decrease in size by >1 cm on MRCP Relative decrease in size of cyst after 1 or 2 injections with ethanol Is reduction in size durable (over what length of time)?
3 years
Study Arms (2)
A
NO INTERVENTIONObservation of pancreatic cysts
B
EXPERIMENTALEthanol lavage of pancreatic cysts
Interventions
Eligibility Criteria
You may qualify if:
- Cyst between 1-3cm
- No evidence of a mural nodule, solid component, or septations in the cyst
- For patients with multiple cysts, the largest will be evaluated
You may not qualify if:
- Any imaging or cytology concerning for malignancy
- Pancreatic Pseudocyst
- Gross Cyst \>3cm as measured on MRCP
- Clinically active pancreatitis or serum amylase or lipase \>3x upper limit of normal
- Coagulopathy (INR\>1.5, PTT\>100, Platelets\<50K)
- Inability to tolerate conscious sedation and endoscopy
- Rated ASA IV or greater
- Prior EUS and aspiration of the pancreatic cyst
- Breast feeding
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Fernandez-del Castillo C, Targarona J, Thayer SP, Rattner DW, Brugge WR, Warshaw AL. Incidental pancreatic cysts: clinicopathologic characteristics and comparison with symptomatic patients. Arch Surg. 2003 Apr;138(4):427-3; discussion 433-4. doi: 10.1001/archsurg.138.4.427.
PMID: 12686529BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cristina R Ferrone, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 24, 2007
First Posted
October 26, 2007
Study Start
October 1, 2007
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
June 26, 2008
Record last verified: 2008-06