Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions

Pancreatic Solid Lesions Clinical Trial

Official title:

Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936467
• Other study ID #: NA_00079301
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2013
• Last updated: January 22, 2015
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pancreatic Mass
• Pancreatic Solid Lesions

Intervention

Device:
• Standard technique EUS-FNA
Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
• Capillary suction technique for EUS FNA
Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Howard County General Hospital	Columbia	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield	Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.; Sensitivity is defined as percentage of true positive specimens. Gold standard will be histological diagnosis of surgical specimen for those patients that go to surgery.	2 years	No