Stereotactic Radiation to Decrease Pancreatic Secretions
Primary Purpose
Pancreatic Fistulae
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Radiation
Sponsored by
About this trial
This is an interventional supportive care trial for Pancreatic Fistulae focused on measuring Pancreas, Pancreatic fistula, Stereotactic radiation
Eligibility Criteria
Inclusion Criteria:
- Pancreatic fistula
- Non-surgical candidate
Exclusion Criteria:
- Surgical candidate
Sites / Locations
- Carolinas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stereotactic Radiation
Arm Description
Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.
Outcomes
Primary Outcome Measures
Decreased Secretions
Measurement of pancreatic panel, decreased Pancreatic Secretions
Secondary Outcome Measures
Full Information
NCT ID
NCT01656486
First Posted
August 1, 2012
Last Updated
June 8, 2022
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01656486
Brief Title
Stereotactic Radiation to Decrease Pancreatic Secretions
Official Title
Utilization of Stereotactic Radiation in Patients With Pancreatic Fistula to Decrease Pancreatic Secretions
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients that have undergone pre-operative radiation for pancreatic carcinoma, that upon pathologic examination of the normal portion of the pancreatic gland that was in the radiation field showed acute and chronic changes in the pancreatic cells. The hypothesis for utilizing stereotactic radiation on pancreatic fistulae is that the treatment will decrease pancreatic secretions, thus decreasing autodigestion.
Detailed Description
Stereotactic radiation for cancer has been utilized to successfully treat the head of the pancreas, which is generally a well-tolerated procedure with minimal complications. Upon further investigation under the microscope, after resection during a complex Whipple operation, it is noted that particularly the exocrine glandular tissue atrophied substantially. Based on this information, the hypothesis for utilizing stereotactic radiation on the remaining pancreas is production of a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland. The use of stereotactic radiation will be performed on individuals that are non-surgical candidates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Fistulae
Keywords
Pancreas, Pancreatic fistula, Stereotactic radiation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stereotactic Radiation
Arm Type
Experimental
Arm Description
Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Radiation
Intervention Description
Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland.
Primary Outcome Measure Information:
Title
Decreased Secretions
Description
Measurement of pancreatic panel, decreased Pancreatic Secretions
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pancreatic fistula
Non-surgical candidate
Exclusion Criteria:
Surgical candidate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Sindram, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stereotactic Radiation to Decrease Pancreatic Secretions
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