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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Radiation | Experimental | Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Decreased Secretions | Measurement of pancreatic panel, decreased Pancreatic Secretions | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Sindram, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Radiation | Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Radiation | Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Decreased Secretions | Measurement of pancreatic panel, decreased Pancreatic Secretions | Posted | Number | participants | 1 year |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stereotactic Radiation | Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Iannitti, MD | Carolinas Medical Center | 704-446-2772 | david.iannitti@carolinashealthcare.org |
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| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D005402 | Fistula |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| years |
|
| Sex: Female, Male | Gender, Male/Female | Count of Participants | Participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |