Optimal Number of To-and-fro Motion in EUS-guided Fine Needle Aspiration for Pancreatic Masses

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Do Hyun Park, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01576497
First received: April 7, 2012
Last updated: April 11, 2012
Last verified: April 2012

April 7, 2012
April 11, 2012
October 2011
May 2012   (final data collection date for primary outcome measure)
Diagnostic accuracy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

The diagnostic accuracy of pancreatic masses at each sample according to EUS-FNA with suction or without suction/ different number of to-and-fro motion will be measured.

Diagnostic accuracy of EUS-FNA with suction and 10, 15, and 20 to-and-fro motion vs.Diagnostic accuracy of EUS-FNA without suction and 10, 15, and 20 to-and-fro motion.

Same as current
Complete list of historical versions of study NCT01576497 on ClinicalTrials.gov Archive Site
Blood contamination in each sample [ Time Frame: 1 year ] [ Designated as safety issue: No ]

The amount of blood contamination at each sample according to EUS-FNA with suction or without suction/ different number of to-and-fro motion will be measured.

The amount of blood contamination of EUS-FNA with suction and 10, 15, and 20 to-and-fro motion vs. The amount of blood contamination of EUS-FNA without suction and 10, 15, and 20 to-and-fro motion.

Same as current
Not Provided
Not Provided
 
Optimal Number of To-and-fro Motion in EUS-guided Fine Needle Aspiration for Pancreatic Masses
Optimal Number of To-and-fro Motion in EUS-guided Fine Needle Aspiration for Pancreatic Masses in Terms of Suction or Without Suction: Prospective Randomized Single Blinded Trial

EUS-FNA is the standard of care for diagnosing pancreatic masses. According to the operator's preference, EUS-FNA with suction or without suction technique has been used. To date, little is known about optimal number of to-and-fro motion during each needle pass. As usual 10-15 to-and-fro motions was used for EUS-FNA with suction technique. Theoretically, more number of to-and-fro motions may be required in EUS-FNA without suction. In this circumstance, the contamination of blood in specimen and possible adverse event may occur. To determine optimal number of to-and-fro motion in EUS-guided FNA for pancreatic masses in terms of with suction or without suction, this prospective single-blinded randomized trial was conducted.

For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction.

First hypothesis: There is difference in the diagnostic accuracy of pancreatic masses according to EUS-FNA with suction or without suction/ different number of to-and-fro motion.

Second hypothesis: There is difference in the amount of blood in samples obtained by EUS-FNA with suction or without suction/ different number of to-and-fro motion.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Pancreatic Masses
  • Procedure: EUS-FNA
    EUS-FNA with suction/10, 15, 20 to-and-fro motion vs. EUS-FNA without suction/10, 15, 20 to-and-fro motion Visual assessment as stoping rule: 20 to-and-fro motion at different site will be performed when EUS-FNA sampling with 10, 15, 20 to-and-fro motion is unsatisfactory.
    Other Name: FNA with or without suction
  • Device: EUS-FNA with suction
    For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction.
    Other Name: FNA with suction
  • Device: EUS-FNA without suction
    For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction.
    Other Name: FNA without suction
  • Active Comparator: EUS-FNA with suction
    EUS-FNA with suction/10, 15, 20 to-and-fro motion vs. EUS-FNA with suction/10, 15, 20 to-and-fro motion Visual assessment as stoping rule: 20 to-and-fro motion at different site will be performed when EUS-FNA sampling with 10, 15, 20 to-and-fro motion is unsatisfactory.
    Intervention: Device: EUS-FNA with suction
  • Active Comparator: EUS-FNA without suction
    EUS-FNA with suction/10, 15, 20 to-and-fro motion vs. EUS-FNA without suction/10, 15, 20 to-and-fro motion Visual assessment as stoping rule: 20 to-and-fro motion at different site will be performed when EUS-FNA sampling with 10, 15, 20 to-and-fro motion is unsatisfactory.
    Interventions:
    • Procedure: EUS-FNA
    • Device: EUS-FNA without suction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
June 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 19 years Solid pancreatic mass lesions

Exclusion Criteria:

  • Age < 19 years Coagulopathy Unable to consent
Both
18 Years to 85 Years
No
Contact: Do Hyun Park, MD, PhD 82-2-3010-3194 dhpark@amc.seoul.kr
Korea, Republic of
 
NCT01576497
2012-0018
No
Do Hyun Park, Asan Medical Center
Asan Medical Center
Not Provided
Principal Investigator: Do Hyun Park, MD, PhD Asan Medical Center
Asan Medical Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP