Stereotactic Radiation to Decrease Pancreatic Secretions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Iannitti, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01656486
First received: August 1, 2012
Last updated: February 14, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Decreased Secretions [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pancreatic fistula
  • Non-surgical candidate

Exclusion Criteria:

  • Surgical candidate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: David Iannitti, MD, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01656486     History of Changes
Other Study ID Numbers: 07-12-16EM
Study First Received: August 1, 2012
Results First Received: February 14, 2014
Last Updated: February 14, 2014
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
Digestive System Diseases
Digestive System Fistula
Pancreatic Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 29, 2014