Trial Comparing 19 and 25-gauge EUS-FNA Needles

AdventHealth

Status: Completed

Conditions: Cancer of Pancreas; Pancreatic Neoplasm

Treatments: Procedure: Histological Samples; Procedure: Pancreatic Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01677312

356077

Details and patient eligibility

About

This study compares the 19G and 25G needles for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures.

Full description

The study compares the median number of passes to establish a definitive diagnosis using the 19G or 25G needles. Also, the ability of both needles to procure a histological core tissue is assessed.

Enrollment: 72 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

(1) Patients with solid pancreatic mass lesions.

Exclusion criteria

1. Age < 19 years
2. Unable to safely undergo EUS for any reason
3. Coagulopathy (INR > 1.6, Prothrombin Time > 18secs, Thrombocytopenia < 80,000 cells/ml)
4. Unable to consent
5. Non-English speaking patients

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

19G FNA needle

Active Comparator group

Description:

Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.

Treatment:

Procedure: Histological Samples

Procedure: Pancreatic Biopsy

25G FNA needle

Active Comparator group

Description:

Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.

Treatment:

Procedure: Histological Samples

Procedure: Pancreatic Biopsy