Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) EUS-FNA Of Solid Pancreatic Mass Lesions Using A Novel Corkscrew Technique: A Pilot Study

Study Overview

Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) EUS-FNA of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study

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 Ȭorkscrew" 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.

N/A

Pancreatic Cancer

PROCEDURE: EUS-FNA with Corkscrew technique
DEVICE: Expect 19 G Flex needle

NA_00090101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-04-14	Results First Submitted 2017-05-25	Last Update Submitted that met QC Criteria 2017-06-23
First Submitted that Met QC Criteria 2014-04-15	Results First Submitted that Met QC Criteria 2017-06-23	Last Update Posted (ACTUAL) 2017-07-24
First Posted (ACTUAL) 2014-04-16	Results First Posted 2017-07-24	Last Verified 2017-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Pancreatic mass Patients with pancreatic mass presenting for EUS-FNA	PROCEDURE: EUS-FNA with Corkscrew technique DEVICE: Expect 19 G Flex needle

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Pancreatic mass

Patients with pancreatic mass presenting for EUS-FNA

PROCEDURE: EUS-FNA with Corkscrew technique

DEVICE: Expect 19 G Flex needle

Primary Outcome Measures	Measure Description	Time Frame
Number of Participants With Adverse Events as a Measure of Safety		30 days

Secondary Outcome Measures	Measure Description	Time Frame
Diagnostic Yield of the FNA Using Corkscrew Technique	Diagnostic yield was defined as the proportion of masses in which the amount of FNA-obtained cellular material was enough for the histopathologist to make the pathological diagnosis.	30 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

In-patients and out-patients between the age of 18 and 90 years with solid pancreatic masses presenting for EUS-Fine Needle Aspiration (FNTA)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Mouen A Khashab, MD, Johns Hopkins University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record