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

28 maj 2014 uppdaterad av: Do Hyun Park, Asan Medical Center

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

193

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 85 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Age > 19 years Solid pancreatic mass lesions

Exclusion Criteria:

  • Age < 19 years Coagulopathy Unable to consent

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Enhet: 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.
Andra namn:
  • FNA with suction
Aktiv komparator: 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.
Procedur: 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.
Andra namn:
  • FNA with or without suction
Enhet: 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.
Andra namn:
  • FNA without suction

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Diagnostic accuracy
Tidsram: 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.
1 year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Blood contamination in each sample
Tidsram: 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.
1 year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Asan Medical Center

Utredare

  • Huvudutredare: Do Hyun Park, MD, PhD, Asan Medical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2012

Primärt slutförande (Faktisk)

1 oktober 2012

Avslutad studie (Faktisk)

1 mars 2013

Studieregistreringsdatum

Först inskickad

7 april 2012

Först inskickad som uppfyllde QC-kriterierna

11 april 2012

Första postat (Uppskatta)

12 april 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

29 maj 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 maj 2014

Senast verifierad

1 april 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 2012-0018

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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