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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01656486
Other study ID # 07-12-16EM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2012
Est. completion date November 2012

Study information

Verified date February 2014
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Pancreatic fistula - Non-surgical candidate Exclusion Criteria: - Surgical candidate

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Stereotactic Radiation
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.

Locations

Country Name City State
United States Carolinas Medical Center Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Decreased Secretions Measurement of pancreatic panel, decreased Pancreatic Secretions 1 year