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Stereotactic Radiation to Decrease Pancreatic Secretions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01656486
First Posted: August 3, 2012
Last Update Posted: April 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Iannitti, Carolinas Healthcare System
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Utilization of Stereotactic Radiation in Patients With Pancreatic Fistula to Decrease Pancreatic Secretions

Resource links provided by NLM:


Further study details as provided by David Iannitti, Carolinas Healthcare System:

Primary Outcome Measures:
  • Decreased Secretions [ Time Frame: 1 year ]
    Measurement of pancreatic panel, decreased Pancreatic Secretions


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pancreatic fistula
  • Non-surgical candidate

Exclusion Criteria:

  • Surgical candidate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656486


Locations
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: David Sindram, MD Carolinas Healthcare System
  More Information

Responsible Party: David Iannitti, MD, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01656486     History of Changes
Other Study ID Numbers: 07-12-16EM
First Submitted: August 1, 2012
First Posted: August 3, 2012
Results First Submitted: February 14, 2014
Results First Posted: April 1, 2014
Last Update Posted: April 1, 2014
Last Verified: February 2014

Keywords provided by David Iannitti, 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