Stereotactic Radiation to Decrease Pancreatic Secretions
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pancreatic Fistulae |
Radiation: Stereotactic Radiation |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Utilization of Stereotactic Radiation in Patients With Pancreatic Fistula to Decrease Pancreatic Secretions |
- Decreased Pancreatic Secretions [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Measurement of pancreatic panel
| Enrollment: | 1 |
| Study Start Date: | July 2012 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Stereotactic Radiation
Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pancreatic fistula
- Non-surgical candidate
Exclusion Criteria:
- Surgical candidate
Contacts and Locations| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28204 | |
| Principal Investigator: | David Sindram, MD | Carolinas Healthcare System |
More Information
No publications provided
| Responsible Party: | David Sindram, MD, Carolinas Healthcare System |
| ClinicalTrials.gov Identifier: | NCT01656486 History of Changes |
| Other Study ID Numbers: | 07-12-16EM |
| Study First Received: | August 1, 2012 |
| Last Updated: | November 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Carolinas Healthcare System:
|
Pancreas Pancreatic fistula Stereotactic radiation |
Additional relevant MeSH terms:
|
Fistula Pancreatic Fistula Pathological Conditions, Anatomical Digestive System Fistula Digestive System Diseases |
Pancreatic Diseases Pancrelipase Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013