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Completed

NCT Number: NCT01576497

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

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.

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Key information

Conditions

Pancreatic Masses

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 19 years Solid pancreatic mass lesions

Exclusion criteria

  • Age < 19 years Coagulopathy Unable to consent

Treatment and study plan

EUS-FNA

Procedure

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 names: FNA with or without suction

EUS-FNA with suction

Device

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 names: FNA with suction

EUS-FNA without suction

Device

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 names: FNA without suction

Primary outcomes

  1. Diagnostic accuracy

    Time frame: 1 year

    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.

Secondary outcomes

  1. Blood contamination in each sample

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Apr 12, 2012
Registry last updated
May 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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