Prospective Study Comparing Methods of Obtainment of Specimen After EUS-FNA in Patients With Peri-pancreatic Mass

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01354795
First received: April 24, 2011
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

EUS-guided FNA has been proved to be a safe and useful method for tissue sampling of gastrointestinal track lesions and other organ lesions including mediastinal and intra-abdominal lymph nodes, pancreas and hepatobiliary tree. The usefulness of EUS-FNA depends on several factors. For example, experience of the endosonographers, adequate sampling, sample preparing, accurate interpretation by the cytopathologist and on-site cytopathology interpretation. However, in many hospitals, no cytopathologist can be present during EUS-FNA. Therefore, determining appropriate methods to obtain and prepare EUS-guided FNA are important to make correct a diagnosis without on-site cytopathologist.

Suction with a self-retracting 10-mL syringe will likely bring in more cellularity but also more blood. Some endosonographers use no suction, others use constant suction. Usually specimen is expelled from a needle with pushing the stylet into the needle. But use of the stylet during EUS-FNA is difficult and time consuming process. Injecting air was not recommended, because of spraying out uncontrollably, increasing risk of air artifact and specimen clotting. However, there is no further study which one is the appropriate, suction or no suction and pushing the stylet or injecting air until now.

The hypothesis and aim of the prospective randomized controlled trials are as follows:

First hypothesis: There was no difference in the adequacy, cellularity, bloodiness, contamination, air artifact in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.

Aim #1 : To compare the adequacy, cellularity, bloodiness, contamination, air artifact in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.

Second hypothesis: There was no difference in sensitivity, specificity, diagnostic accuracy, positive predictive value, negative predictive value and statistical agreement in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.

Aim #2 : To compare the sensitivity, specificity, diagnostic accuracy, positive predictive value, negative predictive value and statistical agreement in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.


Condition Intervention
Pancreatic Neoplasm
Neoplasm of Intra-abdominal Lymph Nodes
Procedure: 1.EUS-FNA with or without suction
Procedure: 2.Pushing the stylet or injecting air

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Prospective Study Comparing Methods of Obtainment of Specimen After EUS-FNA in Patients With Peri-pancreatic Mass

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Compare the degree of cytologic quality in specimen obtained by EUS-FNA with or without suction, pushing the stylet or injecting air. [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
    The primary endpoint of this study is to determine that there is no difference in cytologic quality of FNA specimens with or without suction, pushing the stylet or injecting air: to compare the adequacy, cellularity, bloodiness, contamination, air artifact in specimen obtained by each methods.


Secondary Outcome Measures:
  • Compare the diagnostic yield in specimen obtained by EUS-FNA with or without suction, pushing the stylet or injecting air. [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
    The secondary endpoint of this study is to determine that there is no difference in diagnostic yield of FNA specimens with or without suction, pushing the stylet or injecting air: to compare the sensitivity, specificity, diagnostic accuracy, positive predictive value, negative predictive value and statistical agreement in specimen obtained by each methods.


Enrollment: 80
Study Start Date: September 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.EUS-FNA with or without suction
During EUS FNA is performed, with or without self-retracting 10-mL syringe
Procedure: 1.EUS-FNA with or without suction
During EUS-FNA of the peri-pancreatic mass was performed, with or without self-retracting 10-mL syringe applied.
Other Name: EUS-FNA with or without suction
Experimental: 2.Pushing the stylet or injecting air
EUS-FNA specimen is expelled from a needle with pushing the stylet into the needle or injecting air
Procedure: 2.Pushing the stylet or injecting air
EUS-FNA specimen is expelled from a needle with pushing the stylet or injecting air into the needle
Other Name: Pushing the stylet or injecting air

Detailed Description:

On-site cytopathology interpretation during EUS-FNA has a significant clinical impact by increasing the diagnostic yield of the FNA. However, many hospitals do not have provision for on- site diagnosis of EUS FNA specimen. Therefore, optimal specimen obtainment and preparation of EUS FNA are is important to accurate diagnosis. EUS FNA is performed with or without self-retracting 10-mL syringe according to endosonographer's preference. In general, if there is too little cellularity on immediate cytologic evaluation, then use more suction, and, conversely, if the samples are too bloody, then use less suction. However, it is hard to determine the quality of specimen without on-site cytopathology interpretation. The actual way material is expressed from the needle may influence yield. Injecting air to express the material is problematic, because the material may spray out uncontrollably, risk of air artifact and specimen clotting may increase . A more controlled method is to pushing the stylet and slowly advance it to the needle tip. But use of the stylet during EUS-FNA is not only difficult and time consuming process but also increasing the risk of accidental needle stick injury. However, there is no firm evidence which one is the appropriate, suction or no suction and pushing the stylet or injecting air. If there was no significant difference between each methods, appropriate methods of obtaining and preparing aspirates undergoing EUS-FNA is no suction and injecting air and EUS FNA may perform more easier and shorter.

In this prospective randomized controlled trial, patients with peripancreatic mass for EUS-FNA will be included. One patient will be underwent at least four puncture during EUS-FNA. The sequence of EUS-FNA with first four methods will be selected by using a randomization scheme obtained from a sealed envelope : (1) negative pressure suction with 10 mL syringe and pushing the stylet; (2) negative pressure suction with 10 mL syringe and injecting air; (3) without negative pressure suction and pushing the stylet; (4) without negative pressure suction and injecting air. EUS FNA will be performed by two experienced endosonographers. All specimens will be read by same experienced pathologist blinded to methods.

The investigators will compare between the four groups in terms of adequacy, cellularity, bloodiness, contamination, air artifact. The sensitivity, specificity, diagnostic accuracy, positive predictive value, negative predictive value and statistical agreement for the different methods will be calculated.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than 18 years
  2. Presence of peri pancreatic mass, mediastinal or intra-abdominal lymphadenopathy confirmed by investigational modality - CT scan, magnetic resonance imaging, EUS.
  3. Capable of providing informed consent

Exclusion Criteria:

  1. Severe coagulopathy (INR > 1.5) or thrombocytopenia (platelet count < 50,000)
  2. History of acute pancreatitis in the preceding 4 weeks
  3. Pregnancy
  4. Inability to provide informed consent
  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: NCT01354795

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Study Director: Kwang Hyuck Lee, M.D. Samsung Medical Center
  More Information

No publications provided by Samsung Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kwang Hyuck Lee / Department of Medicine, Dvision of Gastroenterology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01354795     History of Changes
Other Study ID Numbers: 2010-07-219
Study First Received: April 24, 2011
Last Updated: May 16, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
EUS FNA
stylet
suction

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 29, 2014