Clinical trial NCT01936467: Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions
Official title: Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Solid Lesions
Pancreatic Mass
Keywords: Pancreatic solid lesions
Pancreatic mass
Pancreatic cancer
Endoscopic Ultrasound
EUS
Fine needle aspiration
FNA
EUS-FNA
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2013-09-06
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare Endoscopic Ultrasound and Fine Needle Aspirate with a standard 22-gauge needle using either "standard-suction" or "capillary suction" methods for solid pancreatic lesions. Investigators hope to discover the best technique for obtaining diagnostic material when patients with a pancreatic mass undergo endoscopic ultrasound and fine needle aspirate procedure.

There are currently several techniques for obtaining tissue during endoscopic ultrasound and fine needle aspirate. The procedure will be performed by either the capillary suction technique or no suction technique.


Eligibility criteria: Inclusion Criteria:

- In-patients and out-patients between the age of 18years and 90 years with pancreatic masses presenting for EUS-FNA

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
* Cystic lesions
* Inaccessible lesions to EUS

Primary outcomes:
measure: Diagnostic Yield of Capillary Technique
timeFrame: up to 6 months
measure: Diagnostic Yield of Standard Technique
timeFrame: up to 6 months
measure: Sensitivity of EUS-FNA With Capillary Technique
timeFrame: 6 months
measure: Sensitivity of EUS-FNA With StandardTechnique
timeFrame: 6 months
measure: Sensitivity of EUS-FNA
timeFrame: 6 months
Secondary outcomes:
measure: First Pass Diagnostic Rate
timeFrame: immediate
measure: Acquisition of Core Tissue
timeFrame: immediate
measure: Diagnostic Accuracy of EUS-FNA
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Columbia
country: United States
facility: Howard County General Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins Univeristy
name: Mouen A Khashab, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saxena P, El Zein M, Stevens T, Abdelgelil A, Besharati S, Messallam A, Kumbhari V, Azola A, Brainard J, Shin EJ, Lennon AM, Canto MI, Singh VK, Khashab MA. Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial. Endoscopy. 2018 May;50(5):497-504. doi: 10.1055/s-0043-122381. Epub 2017 Dec 22.