Stereotactic Radiation to Decrease Pancreatic Secretions

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.

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Key information

Conditions

Pancreatic Fistulae Digestive System Diseases Digestive System Fistula Fistula Pancreatic Diseases Pancreatic Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pancreatic fistula
Non-surgical candidate

Exclusion criteria

Surgical candidate

Treatment and study plan

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.

Primary outcomes

Decreased Secretions

Time frame: 1 year

Measurement of pancreatic panel, decreased Pancreatic Secretions

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Utilization of Stereotactic Radiation in Patients With Pancreatic Fistula to Decrease Pancreatic Secretions

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Aug 3, 2012
Registry last updated: Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed