Evaluating the Number of Passes Required for Diagnostic Cell Block During EUS-FNA of Solid Pancreatic Mass Lesions

NCT01809028 | Completed DMC

• 1 other identifier: 407129
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the amount of tissue, called "cell block", obtained from your pancreas. Patients who are asked to participate in this study have a growth (mass) in the pancreas that needs a biopsy so a diagnosis can be made. Although we usually perform 2 to 4 passes (number of times the doctor biopsies the mass), at this time we do not know the ideal number of passes needed to obtain adequate amount of tissue for making a diagnosis. The purpose of this study is to compare the amount of tissue obtained with 2 passes versus 4 passes.

Conditions

Pancreatic Cancer

Keywords

cell block, number of passes

Outcome Measures

Primary Outcomes (1)

• number of passes

  The primary endpoint of the study is to compare the number of passes required to make definitive diagnosis on cell block. This will be assessed by amount (quantity) of the sample to make the diagnosis proportionate to which group the subject was randomized to (two passes versus four passes).

  up to 12 months

Study Arms (2)

EUS FNA with 2 passes

ACTIVE COMPARATOR

biopsy with 2 passes of the needle

Procedure: EUS FNA with 2 passes

EUS FNA with 4 passes

ACTIVE COMPARATOR

biopsy with 4 passes of the needle

Procedure: EUS FNA with 4 passes

Interventions

EUS FNA with 2 passes PROCEDURE

biopsy with 2 passes

Also known as: Biopsy, FNA

EUS FNA with 2 passes

EUS FNA with 4 passes PROCEDURE

biopsy with 4 passes

Also known as: biopsy, FNA

EUS FNA with 4 passes

Eligibility Criteria

• Age: 19 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions that require FNA.

You may not qualify if:

• Age \<19 years
• Unable to safely undergo EUS for any reason
• Coagulopathy (INR \>1.6, Prothrombin Time \>18secs, Thrombocytopenia \<80,000 cells/ml)
• Unable to consent
• Non-English speaking patients.
• Participation in any other Clinical Trial (excluding registries and databases)

Sponsors & Collaborators

• AdventHealth: lead
• University of Alabama at Birmingham: collaborator

Study Sites (1)

Florida Hospital

Orlando, Florida, 32803, United States

Location

Related Publications (1)

• Varadarajulu S, Bang JY, Holt BA, Hasan MK, Logue A, Hawes RH, Hebert-Magee S. The 25-gauge EUS-FNA needle: Good for on-site but poor for off-site evaluation? Results of a randomized trial. Gastrointest Endosc. 2014 Dec;80(6):1056-63. doi: 10.1016/j.gie.2014.05.304. Epub 2014 Jun 25.

  PMID: 24973173 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration; Biopsy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Shyam Varadarajulu, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 12, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: August 3, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)