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

Not Applicable

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Procedure: EUS-FNA with Corkscrew technique; Device: Expect 19 G Flex needle

• Registration Number: NCT02116322
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-14
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-16
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-05
• Results First Submitted: 2017-05-25
• Results First Submitted QC: 2017-06-23
• Last Update Submitted: 2017-06-23
• Results First Posted: 2017-07-24
• Last Update Posted: 2017-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pancreatic mass	EUS-FNA with Corkscrew technique	Patients with pancreatic mass presenting for EUS-FNA
Pancreatic mass	Expect 19 G Flex needle	Patients with pancreatic mass presenting for EUS-FNA

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events as a Measure of Safety	30 days

Secondary Outcome Measures

Name	Time	Method
Diagnostic Yield of the FNA Using Corkscrew Technique	30 days	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.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States