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

Johns Hopkins University4 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

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

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.