NCT01576497

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Masses

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-10-01
• Completion: 2013-03-01
• First posted: 2012-04-12
• Last updated: 2014-05-29

Locations

1 site across 1 country: South Korea