EUS-FNA of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study
Conditions
Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: EUS-FNA with Corkscrew technique Type: Procedure
Name: Expect 19 G Flex needle Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- In-patients and out-patients between the age of 18 and 90 years with solid pancreatic masses presenting for EUS-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
Location
Johns Hopkins Hospital
Baltimore, Maryland, United States
Status: Recruiting
Contact: Ahmed Messallam, MD - amessal1@jhmi.edu
Start Date
April 2014
Completion Date
April 2016
Sponsors
Johns Hopkins University
Source
Johns Hopkins University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page