Management of Incidentally Discovered Pancreatic Cysts
Primary Purpose
Pancreatic Cyst
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ethanol lavage
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cyst focused on measuring pancreatic cyst, ethanol injection
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
A
B
Arm Description
Observation of pancreatic cysts
Ethanol lavage of pancreatic cysts
Outcomes
Primary Outcome Measures
Patients not progressing to operation due to the development of symptoms, growth to a maximum diameter of >3cm, or development of a mural nodule.
Secondary Outcome Measures
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)?
Full Information
NCT ID
NCT00550108
First Posted
October 24, 2007
Last Updated
June 23, 2008
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00550108
Brief Title
Management of Incidentally Discovered Pancreatic Cysts
Official Title
A Prospective Study of the Management of Incidentally Discovered Pancreatic Cysts
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Terminated
Why Stopped
Inability to enroll subjects.
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
The appropriate management of patients with cystic lesions of the pancreas is controversial. The identification of small asymptomatic pancreatic cysts is increasing due to an improvement in the quality of radiologic imaging and the frequency that imaging is obtained. However, the natural history of these lesions is unknown1. The current consensus guidelines established at the International Consensus Conference in Sendai, Japan in 2005 suggest that branch chain IPMNs and mucinous cystic neoplasms that cause no symptoms, measure <3cm, and have no nodules can be observed with periodic imaging. However, the time course of these pre malignant mucinous lesions, intraductal papillary mucinous neoplasms (IPMN) or mucinous cystadenomas, from benign to malignant has not been determined. Due to the unknown natural history, and diagnostic uncertainty, some authors have recommended routine resection2, 3. Resection, despite improvements in surgical outcomes after pancreatectomy at high volume centers, carries a mortality and morbidity of 1-6% and 35-51%, respectively4-6. More recently studies are reporting a more selective approach to avoid the risk of operation in patients with benign lesions7. Improved radiographic and endoscopic studies have been able to identify some lesions with increased malignant potential8, 9. Thus, most patients will undergo pancreas specific radiologic imaging and endoscopic ultrasound with cyst aspiration. Since the natural history of cystic lesions is poorly understood no clear guidelines for surgical resection have been established. Some of the cysts will grow over time, with an increase in the cumulative risk of malignancy. Therefore, the therapeutic alternatives are to wait and watch for a change in the cyst morphology or to treat preemptively, which has been restricted to surgical resection. Based on the pilot study performed by Dr. William Brugge, at Massachusetts General Hospital, ethanol lavage of pancreatic cysts is safe and will result in a decrease in cyst diameter in 61% of patients. Additionally, if patients elect to not be treated preemptively it is unclear how to best follow these patients in terms of the type and the frequency of follow up studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cyst
Keywords
pancreatic cyst, ethanol injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
No Intervention
Arm Description
Observation of pancreatic cysts
Arm Title
B
Arm Type
Experimental
Arm Description
Ethanol lavage of pancreatic cysts
Intervention Type
Other
Intervention Name(s)
Ethanol lavage
Intervention Description
Ethanol lavage of pancreatic cysts.
Primary Outcome Measure Information:
Title
Patients not progressing to operation due to the development of symptoms, growth to a maximum diameter of >3cm, or development of a mural nodule.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
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)?
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina R Ferrone, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12686529
Citation
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.
Results Reference
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Management of Incidentally Discovered Pancreatic Cysts
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