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

A Randomized Trial Evaluating the Number of Passes Required for Diagnostic Cell Block During Endoscopic Ultrasound-Fine Needle Aspiration of Solid Pancreatic Mass Lesions

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01809028

Enrollment

Registered

2013-03-12

Start date

2013-02-28

Completion date

2014-01-31

Last updated

2017-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

cell block, number of passes

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.

Detailed description

Primary Aim: To compare the number of passes required for obtaining adequate cell block material during EUS-guided FNA of solid pancreatic mass lesions. Primary Research Hypothesis: More specimen is required to obtain definitive diagnosis on cell block. This translates to less need for repeat procedures (due to nondiagnostic index procedure due to inadequate FNA passes), prompt treatment to patients and better use of health care resources. Therefore, we will be comparing 2 versus 4 FNA passes to determine which number of FNA pases will yield an adequate diagnostic cell block. Secondary Aims: To compare the rate of complications when performing 2 versus 4 EUS-FNA passes of solid pancreatic mass lesions. Secondary Research Hypothesis: EUS-guided FNA is a safe procedure with a complication rate of \< 1%. By performing more (four) NA passes one is likely to yield a better quality cell block while at the same time without compromising patient safety.

Interventions

PROCEDUREEUS FNA with 2 passes

biopsy with 2 passes

PROCEDUREEUS FNA with 4 passes

biopsy with 4 passes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to 89 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

1. Age \<19 years 2. Unable to safely undergo EUS for any reason 3. Coagulopathy (INR \>1.6, Prothrombin Time \>18secs, Thrombocytopenia \<80,000 cells/ml) 4. Unable to consent 5. Non-English speaking patients. 6. Participation in any other Clinical Trial (excluding registries and databases)

Design outcomes

Primary

Measure	Time frame	Description
number of passes	up to 12 months	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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026