A Prospective, Randomized Study Evaluating the Effect of Biliary Stenting on EAU-FNA in Patients With Suspected Malignant Biliary Obstruction
18 Years
N/A
Both
Jaundice
Trial Information
A Prospective, Randomized Study Evaluating the Effect of Biliary Stenting on EAU-FNA in Patients With Suspected Malignant Biliary Obstruction
Inclusion Criteria:
- Subjects must be able to review and sign informed consent.
- Subjects must require biliary stenting for the relief of their symptoms as well as
FNA biopsy for proper diagnosis.
- Suspected mass should be located in the head, uncinate, or neck of the pancreas.
Exclusion Criteria:
- Cannot give and sign informed consent.
- The suspected mass is located in the body or tail of the pancreas.
- The patient may be a candidate for palliative biliary stenting (in which a metal
stent would be placed)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Cytological yield (adequate versus inadequate for diagnosis) of EUS-FNA prior to stent placement vs post stent placement
Outcome Description:
Cytological yield will be defined by the ability of the pathologist to render a diagnosis based on the material supplied to them during the procedure (adequate vs inadequate tissue to make a diagnosis of malignant vs benign disease).
Outcome Time Frame:
1 day
Safety Issue:
No
Principal Investigator
John A Evans, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Wake Forest Baptist Health
Authority:
United States: Institutional Review Board
Study ID:
CCCWFU 01711
NCT ID:
NCT01514058
Start Date:
November 2011
Completion Date:
November 2018
Related Keywords:
- Jaundice
- Jaundice
Name | Location |
|---|---|
| Wake Forest Baptist Health | Winston-Salem, North Carolina 27157 |
