EUS-guided Fine Needle Tissue Acquisition of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Johns Hopkins University
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events as a Measure of Safety
Study Overview
Brief Summary
This research is being done to investigate if a new technique to biopsy the pancreas will lead to a larger amount tissue material that can be analyzed. Investigators have called the technique the "corkscrew" technique and believe it will allow obtaining a larger biopsy sample during the endoscopic ultrasound examination. The corkscrew technique uses a clockwise rotational movement to drive the needle into the pancreatic mass (like a wine bottle opener twists and buries itself into a cork). It is believed that this will lead to a better biopsy sample than the usual way and therefore result in a higher chance of a diagnosis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •In-patients and out-patients between the age of 18 and 90 years with solid pancreatic masses presenting for EUS-Fine Needle Aspiration (FNTA)
Exclusion Criteria
- •Uncorrectable coagulopathy (INR > 1.5)
- •Uncorrectable thrombocytopenia (platelet < 50,000)
- •Uncooperative patients
- •Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
- •Refusal to consent form
- •Prior negative FNTA
- •In situ metallic biliary stents
- •Predominantly cystic lesions
- •Inaccessible lesions to EUS
Arms & Interventions
Pancreatic mass
Patients with pancreatic mass presenting for EUS-FNA
Intervention: EUS-FNA with Corkscrew technique (Procedure)
Pancreatic mass
Patients with pancreatic mass presenting for EUS-FNA
Intervention: Expect 19 G Flex needle (Device)
Outcomes
Primary Outcomes
Number of Participants With Adverse Events as a Measure of Safety
Time Frame: 30 days
Secondary Outcomes
- Diagnostic Yield of the FNA Using Corkscrew Technique(30 days)