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A Prospective, Randomized Study Evaluating the Effect of Biliary Stenting on EAU-FNA in Patients With Suspected Malignant Biliary Obstruction


Phase 4
18 Years
N/A
Not Enrolling
Both
Jaundice

Thank you

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 HealthWinston-Salem, North Carolina  27157