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Yield of Endoscopic Ultrasound Guided Fine Needle Aspiration (EUS-FNA) With and Without the Use of a Stylet in the Biopsy Needle

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01241799
First received: November 12, 2010
Last updated: November 22, 2010
Last verified: November 2010
  Purpose

Purpose:

To compare the diagnostic yield of endoscopic ultrasound guided fine needle aspiration biopsy (EUS-FNA) in patient with pancreatic masses with and without the use of a stylet in place within the biopsy needle.

Hypothesis:

In patients undergoing an EUS FNA for pancreatic indications, patients having a fine needle aspiration biopsy (FNA) without the internal stylet will have a greater diagnostic yield compared to those with the internal stylet.

Justification:

EUS-FNA is an increasingly important means of obtaining tissue samples from lesions within the thorax and abdomen. In experienced hands EUS-FNA is a safe alternative to more invasive procedures such as mediastinoscopy or laparoscopy. EUS-FNA can be used for sampling suspected cholangiocarcinoma, pancreatic masses or cysts, submucosal gastric lesions, peripancreatic, perigastric or mediastinal lymph nodes and in some cases adrenal or liver masses. Therefore, it is a powerful tool for both diagnosis and tumour staging. For example, for the diagnosis of pancreatic adenocarcinoma, which is a common indication for EUS-FNA, the sensitivity varies from 75 to >90%, with a specificity of 82-100% and a mean accuracy of 85%. Improving the diagnostic yield may lead to an earlier diagnosis with a reduced number of investigations and earlier institution of treatment for the patient.

The FNA needle system consists of a 22 or 19 gauge needle which is manipulated by a handle piston that attaches to the biopsy channel of the endoscopic ultrasound (EUS) linear scope. The tip of the needle has grooves to disperse ultrasound waves making the tip of the needle easily seen. The sample is taken by inserting a specially designed needle into the area of interest under EUS guidance. Inside the needle is a removable stylet with a rounded or bevelled tip to facilitate the passage of the needle into the tissue. The usual practice is for the stylet to be extracted after the needle has been passed into its optimum position within the tissue and for it to be re-inserted before each pass. However, a recent prospective trial with 111 patients, published in abstract form, found this approach was associated with a significant reduction in the proportion of adequate samples compared to when the stylet was removed before passing the needle. Although there was no significant difference in the diagnostic yield between the two groups this study raises the issue that the stylet left in place is to the detriment of the tissue sample and, ultimately, may reduce the diagnostic yield or increase the number of passes needed to obtain a satisfactory sample.

One limitation to this study includes the heterogenous patient population. Yields of EUS-FNA vary considerably depending on the type of tissue being biopsied. The second limitation is that consecutive patients were randomized to having the stylet removed versus having the stylet not removed at the time of FNA. There is no control group from which to compare the two groups. An improvement in the study design would be to have each patient to be their own control group. Successive passes of the FNA needle can increase the bloodiness of the sample, so randomization of the order in which each group is done will help eliminate potential bias.

It is clear from the current published literature that removing the stylet increases the cellularity of the sample. However, this increased cellularity may be the result of more contamination from the GI tract through which the FNA needle needs to pass in order to get an extra-luminal sample. Blood or a traumatic FNA can also lead to increased cellularity that can compromise diagnostic accuracy.

Diagnostic yield depends on both adequacy of the sample and enough cells from the lesion to interpret. A preliminary result based on an air dried slide often can lead to fewer FNA passes if a diagnosis can be made. If this is not possible, a cell block preparation is made from all the washings from the EUS-FNA needle. No study has examined the diagnostic accuracy of these two types of samples using an EUS-FNA needle with and without the stylet within the same patient.

Objectives:

To determine if the diagnostic yield of EUS-FNA is increased if the stylet is removed from the FNA needle compared with leaving it in place.


Condition Intervention
Pancreatic Mass on Imaging
Procedure: Endoscopic ultrasound guided fine needle aspiration biopsy
Procedure: Stylet out FNA first, Stylet in FNA second

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: A Prospective, Single Blinded, Randomized, Controlled Study to Compare the Yield of Endoscopic Ultrasound Guided Fine Needle Aspiration (EUS-FNA) With and Without the Use of a Stylet in the Biopsy Needle

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The primary endpoint of our study will be the number of samples with a positive diagnosis in each group [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: December 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Pancreatic biopsy with stylet in then stylet out
Procedure: Endoscopic ultrasound guided fine needle aspiration biopsy
22 gauge fine needle aspiration biopsy of the pancreatic mass with the stylet in. Vacuum suction applied. 12 intra mass needle passes done. A new 22 gauge FNA biopsy needle with the style out is then used to biopsy the pancreatic mass. Vacuum suction applied. 12 intra mass needle masses done.
Experimental: 2
Pancreatic biopsy with stylet out then stylet in
Procedure: Stylet out FNA first, Stylet in FNA second
22 gauge FNA biopsy of pancreatic mass with the stylet out. Vacuum suction applied. 12 intra mass needle passes done. A new 22 gauge FNA biopsy needle with the stylet in is used to biopsy the pancreatic mass. Vacuum suction applied. 12 intra mass needle passes done.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 19 years of age and older
  2. Patients undergoing EUS FNA for solid lesions in the pancreas

Exclusion Criteria:

  1. Pancreatic cystic lesions without significant mass effect
  2. Pancreatic masses that cannot be accessed by transduodenal FNA in surgically resectable cases
  3. Known chronic pancreatitis with pancreaticolithiasis
  4. History of acute pancreatitis in the preceding 4 weeks
  5. History of gastric surgery or symptoms of gastric outlet obstruction
  6. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241799

Locations
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Eric Lam, Dr. University of British Columbia
Study Director: Jennifer Telford, Dr. University of British Columbia
Study Director: Mark McLoughlin, Dr. University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Eric Lam, University of British Columbia
ClinicalTrials.gov Identifier: NCT01241799     History of Changes
Other Study ID Numbers: H08-01481
Study First Received: November 12, 2010
Last Updated: November 22, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
endoscopic ultrasound guided fine needle aspiration (EUS-FNA)
pancreatic biopsy
randomized
single blind
fine needle aspiration (FNA) adequacy
fine needle aspiration (FNA) accuracy

ClinicalTrials.gov processed this record on November 27, 2014