Randomized Trial Comparing the 22-gauge Aspiration and 22-gauge Biopsy Needles for EUS-guided Sampling of Solid Pancreatic Mass Lesions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Neoplasm
- Sponsor
- AdventHealth
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Compare the Median Number of Passes Required to Establish a Diagnosis
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The aim of this research study is to identify the best needle for performing biopsy during EUS procedures. There are two types of needles for performing biopsy: A FNA needle that provides a small sample of tissue for analysis and a 22G ProCore needle that provides larger amount of tissue. It is not clear at this point which of the two needles is superior for performing biopsy. This study will attempt to identify the better needle by assessing the performance of both needles in a randomized fashion.
Detailed Description
In this randomized trial, the 22G standard fine needle aspiration needle was compared with the newly developed 22G ProCore needle for sampling pancreatic mass lesions during endoscopic ultrasound. Patients were randomized into the two needle groups and then various outcomes were compared between the two needle types, including the number of passes needed to establish a diagnosis, the ability to procure enough tissue sample to be able to make a diagnosis, the rates of needle failure and complication rates.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients with solid pancreatic mass lesions
Exclusion Criteria
- •Coaguloapthy,
- •prgenant patients
Outcomes
Primary Outcomes
Compare the Median Number of Passes Required to Establish a Diagnosis
Time Frame: 6 months
Secondary Outcomes
- Diagnosis Achieved With the Needle(6 months)
- Technical Failure(6 months)