search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


DETECT Study: Duodenoscopes and linear echo-endoscopes: efficacy of ATP tests compared to visual inspection


- candidate number27534
- NTR NumberNTR6564
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jul-2017
- Secondary IDsMEC-2017-291 METC Erasmus MC
- Public TitleDETECT Study: Duodenoscopes and linear echo-endoscopes: efficacy of ATP tests compared to visual inspection
- Scientific TitleDuodenoscopes and linear echo-endoscopes: efficacy of ATP tests compared to visual inspection
- ACRONYMDETECT Study
- hypothesisContaminated duodenoscopes can cause large-scale outbreaks. There is a need for rapid assessment methods to confirm the adequacy of the cleaning phase to improve the quality, safety and logistics of complex flexible endoscope reprocessing. The ATP test can give a rapid indication if organic residue is still present. Implementation of such an ATP test might reduce the number of contaminated duodenoscopes and linear echo-endoscopes (DLE). The primary objective of this study is to assess if the use of ATP tests in DLE, after manual cleaning combined with re-cleaning protocols, lowers the number of clinically relevant positive cultures.
- Healt Condition(s) or Problem(s) studiedDuodenoscope, Echoendoscope, Endoscopic ultrasound (EUS), Endoscopic retrograde cholangiopancreatography (ERCP)
- Inclusion criteriaA potential subject who meets the following criteria is eligible for participation in this study:
- ERCP duodenoscopes and linear echo-endoscopes that are:
o Reprocessed, including up to 2 ATP tests during the intervention period.
o Cultured
o Inclusion of duodenoscopes and linear echo-endoscopes is regardless of:
 Manufacturer
 Type
 Age in years
 Usage (in number of previous procedures)
 Repair history
 Ownership:
Endoscopes owned by centers
Endoscopes that are temporarily borrowed from manufacturers
 Type of procedure: both diagnostic and therapeutic procedures
 ATP testing in the control period
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
- Flexible endoscope that is any other type than a duodenoscope or linear echo-endoscope.
- Duodenoscopes and linear echo-endoscopes that were not reprocessed
- Duodenoscopes and linear echo-endoscopes that were not ATP tested during the intervention period
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 11-jul-2017
- planned closingdate1-jul-2018
- Target number of participants870
- InterventionsTo assess the primary study objective, baseline contamination rates will be determined during the control period and the effect of usage of ATP tests on the contamination rate will be evaluated in the intervention period. DLE will be tested on ATP and manually cleaned again if the ATP value is above the cutoff.
- Primary outcomeTo assess if usage of ATP tests in complex endoscopes, i.e. duodenoscopes and linear echo-endoscopes, after manual cleaning combined with re-cleaning protocols, lowers the number of clinically relevant positive cultures.
- Secondary outcome2) To assess the relation between the level of organic residue on DLE after manual cleaning, expressed as the amount of ATP in RLU, and the microbiological load on DLE after HLD, expressed as the number of colony forming units.
3) To assess if the use of ATP tests after manual cleaning combined with re-cleaning protocols, facilitates a learning curve in the manual cleaning of duodenoscopes and linear echo-endoscopes, represented by a lower level of organic residue after manual cleaning.
4) To assess which variables affect the costs of using ATP tests after manual cleaning of duodenoscopes and linear echo-endoscopes and the costs of microbial surveillance.
- TimepointsEndoscopic procedure specifics: after procedure
ATP-test: after manual cleaning
Microbial sampling: after disinfection
- Trial web siten/a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESprof. dr. Margreet C. Vos
- CONTACT for SCIENTIFIC QUERIESprof. dr. Margreet C. Vos
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
3M Health Care - Infection Prevention Division
- Publicationsn/a
- Brief summaryWe aim to assess if the use of ATP tests in DLE, after manual cleaning combined with re-cleaning protocols, lowers the number of clinically relevant positive cultures. Therefore we will conduct a prospective single center intervention study using DLE in a single tertiary academic center: the Erasmus MC. In the intervention period DLE will be tested on ATP and manually cleaned again if the ATP value is above the cutoff. Efficacy of ATP tests will be assessed by the number of contaminated DLE, with special attention to clinically relevant positive cultures i.e. contaminated with indicator microorganisms.
- Main changes (audit trail)
- RECORD11-jul-2017 - 6-aug-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl