NCT01656486

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 1, 2014

Completed
Last Updated

June 10, 2022

Status Verified

February 1, 2014

Enrollment Period

4 months

First QC Date

August 1, 2012

Results QC Date

February 14, 2014

Last Update Submit

June 8, 2022

Conditions

Pancreatic Fistulae

Keywords

PancreasPancreatic fistulaStereotactic radiation

Outcome Measures

Primary Outcomes (1)

  • Decreased Secretions

    Measurement of pancreatic panel, decreased Pancreatic Secretions

    1 year

Study Arms (1)

Stereotactic Radiation

EXPERIMENTAL

Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.

Radiation: Stereotactic Radiation

Interventions

Stereotactic RadiationRADIATION

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.

Stereotactic Radiation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pancreatic fistula
  • Non-surgical candidate

You may not qualify if:

  • Surgical candidate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Results Point of Contact

Title
David Iannitti, MD
Organization
Carolinas Medical Center
david.iannitti@carolinashealthcare.org
704-446-2772

Study Officials

  • David Sindram, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2012

First Posted

August 3, 2012

Study Start

July 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

June 10, 2022

Results First Posted

April 1, 2014

Record last verified: 2014-02

Locations

US(1)