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

NCT01354795 | Completed DMC

• 1 other identifier: 2010-07-219
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Neoplasm; Neoplasm of Intra-abdominal Lymph Nodes

Keywords

EUS FNA; stylet; suction

Outcome Measures

Primary Outcomes (1)

• Compare the degree of cytologic quality in specimen obtained by EUS-FNA with or without suction, pushing the stylet or injecting air.

  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.

  within 6 months

Secondary Outcomes (1)

• Compare the diagnostic yield in specimen obtained by EUS-FNA with or without suction, pushing the stylet or injecting air.

  within 6 months

Study Arms (2)

1.EUS-FNA with or without suction

EXPERIMENTAL

During EUS FNA is performed, with or without self-retracting 10-mL syringe

Procedure: 1.EUS-FNA with or without suction

2.Pushing the stylet or injecting air

EXPERIMENTAL

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

Interventions

1.EUS-FNA with or without suction PROCEDURE

During EUS-FNA of the peri-pancreatic mass was performed, with or without self-retracting 10-mL syringe applied.

Also known as: EUS-FNA with or without suction

1.EUS-FNA with or without suction

2.Pushing the stylet or injecting air PROCEDURE

EUS-FNA specimen is expelled from a needle with pushing the stylet or injecting air into the needle

Also known as: Pushing the stylet or injecting air

2.Pushing the stylet or injecting air

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe coagulopathy (INR \> 1.5) or thrombocytopenia (platelet count \< 50,000)
• History of acute pancreatitis in the preceding 4 weeks
• Pregnancy
• Inability to provide informed consent

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• Lee JK, Choi JH, Lee KH, Kim KM, Shin JU, Lee JK, Lee KT, Jang KT. A prospective, comparative trial to optimize sampling techniques in EUS-guided FNA of solid pancreatic masses. Gastrointest Endosc. 2013 May;77(5):745-51. doi: 10.1016/j.gie.2012.12.009. Epub 2013 Feb 21.

  PMID: 23433878 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Suction; Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kwang Hyuck Lee, M.D.

  Samsung Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 24, 2011
• First Posted: May 17, 2011
• Study Start: September 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 17, 2011

Record last verified: 2011-05

Locations

KR (1)