Stereotactic Radiation to Decrease Pancreatic Secretions

Not Applicable

Completed

• Conditions: Pancreatic Fistulae
• Interventions: Radiation: Stereotactic Radiation

• Registration Number: NCT01656486
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-02
• Study First Posted: 2012-08-03
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2014-02
• Results First Submitted: 2014-02-14
• Results First Submitted QC: 2014-02-14
• Results First Posted: 2014-04-01
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Pancreatic fistula
• Non-surgical candidate

Exclusion Criteria

• Surgical candidate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Radiation	Stereotactic Radiation	Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.

Primary Outcome Measures

Name	Time	Method
Decreased Secretions	1 year	Measurement of pancreatic panel, decreased Pancreatic Secretions

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States