Clinical Trials Logo

Clinical Trial Summary

The duodenoscopes currently used for Endoscopic Retrograde Cholangio - and Pancreaticography (ERCP) examinations are reusable and are therefore washed and disinfected after each use. Despite this, these endoscopes sometimes remain contaminated with bacteria. Several reports of outbreaks linked to contaminated duodenoscopes have been published worldwide. Recently, the Food and Drug Administration (FDA) advised manufacturers and health care professionals to transition away from fixed endcap duodenoscopes and instead focus more on the use of duodenoscopes with disposable components or fully disposable duodenoscopes. Single-use endoscopes have been developed, but they are not yet widely used, partly because of the extra costs that these endoscopes add to the examination. A possible interim solution, is to only use these disposable endoscopes in patients who carry multi-resistant bacteria in order to prevent the spread of these bacteria. For this, it is important to know how many people who undergo an ERCP carry multi-resistant bacteria. The primary objective of this study is to measure the prevalence of multi-resistant bacteria in patients undergoing ERCP in four different countries: India, the Netherlands, Italy and the United States. In the Netherlands, some secondary outcomes will be investigated with regard to the prevalence of duodenoscope contamination, the risk of bacterial transmission via a contaminated duodenoscope and the presence of multi-resistant bacteria in the duodenum.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Cholangiopancreatography, Endoscopic Retrograde

NCT number NCT05303662
Study type Observational
Source Erasmus Medical Center
Contact K. van der Ploeg, MD
Phone +31650032327
Email k.ploeg@erasmusmc.nl
Status Recruiting
Phase
Start date January 31, 2022
Completion date October 15, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05035433 - Effect of the Sequence of Dilatation and Lithotripsy on the Treatment of Choledocholithiasis With ERCP N/A
Completed NCT02985164 - Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography Phase 3
Completed NCT05533944 - Fast-tracking ERCP Learning: Does Training on a Mechanical Simulator Improve Trainee's Clinical Performance? N/A
Suspended NCT04559867 - Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial N/A
Active, not recruiting NCT05592795 - Explore the Effects and Mechanisms of ERCP and EST on Biliary Microecology
Enrolling by invitation NCT04572711 - Prospective Evaluation of Biliary Tissue Sampling With ERCP
Enrolling by invitation NCT04719117 - Retrograde Cholangiopancreatography AI Assisted System Validation on Effectiveness and Safety
Completed NCT03263481 - Intraductal Secretin Stimulation Test: What Is the Proper Collection Time? N/A
Completed NCT03292627 - Non-invasive Monitor in Endoscopic Invasive Procedure
Recruiting NCT06265311 - IDUS in CBD Stone Recurrence High Risk Patients N/A
Completed NCT06031363 - The Optimal Dose of Indomethacin Suppository for Preventing Post-ERCP Pancreatitis N/A
Recruiting NCT05261997 - Endotherapy for Painless Chronic Pancreatitis N/A
Completed NCT02698137 - Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)
Recruiting NCT05246657 - EUS-guided Entero-biliary Anastomosis for Therapeutic Access in Benign Biliary Obstructions
Recruiting NCT04910087 - The Effect of Anesthesia Management on Optic Nerve Sheath Diameter in the Ercp Procedures N/A
Terminated NCT05129449 - A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
Completed NCT03561441 - Tailored Hydration for the Prevention of Post-ERCP Pancreatitis N/A
Not yet recruiting NCT06196164 - A RCT of Low MBO Drainage Strategies N/A
Terminated NCT01792466 - RCT of the Double Wire Technique for Sphincterotomy N/A
Completed NCT03490383 - Study of Microbiota in Bile From Patients With Common Bile Duct Stone During ERCP