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Safety and Efficacy of a Newly Developed Baby-sphincterotome for Bile Duct Cannulation

NCT01493076 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1886

Last updated 2011-12-15

No results posted yet for this study

Summary

Precut-sphincterotomy is a well established alternative after repeated futile attempts for common bile duct (CBD) cannulation with standard catheters and/or guide-wires fail. Commonly used devices instruments for pre-cutting are the needle-knife and the Erlangen-type precut-sphincterotome. In 1996 a so called "baby-sphincterotome" (Easy-Cut®, MTW, Wesel, Germany) with a pre-shaped-bended (to facilitate biliary access) small-calibre 3-French tip was developed, which enables cannulation and pre-cutting in one step. Here the investigators report on the clinical evaluation of this device.

Conditions

  • Bile Duct Diseases

Interventions

DEVICE

Primary cannulation/precut sphincterotomie with the Baby-S

At the papilla the ankle for cannulation was optimized due to changes of the position of the sphincterotome, its lay in the working channel and the tension of the "Albaran"-lever and the cutting wire. After successful cannulation, the catheter with the sphincterotome inside was slightly pushed into the duct. If necessary, the baby-sphincterotome was replaced with a guide wire and than conventional endoscopic sphincterotomie was completed with a standard traction-type sphincterotome.

Sponsors & Collaborators

  • Ruhr University of Bochum

    lead OTHER

Principal Investigators

  • Andrea Riphaus, MD, PhD · Ruhr University Bochum, Department of Medicine

  • Riphaus Andrea, MD, PhD · Department of Medicine, Ruhr University Bochum

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-06-30
Primary Completion
2011-11-30
Completion
2011-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01493076 on ClinicalTrials.gov