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Sensitivity of cholangioscopy directed biopsies versus brush cytology in patients with malignant bileduct stenosis

Recruiting
Conditions
bileduct stenosis
bileduct stricture
10018008
10004606
10019815
Registration Number
NL-OMON31613
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

Age >= 18 year
icterus (bilirubine >2xULN)
Cholestasis (GGT or alk fos >2xULN)
dilated bile ducts on imaging with abdominal ultrasound, CT, or MRI

Exclusion Criteria

Distal CBD stenosis
Clinical conditions that do not allow ERCP with sphincterotomy such as uncorrectable coagulopathies
High suspicion of common bile duct stones
Patients unable or not willing to give informed consent

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>1. The difference in sensitivity between brush cytology en cholangioscopic<br /><br>directed biopsy for detection of patients with malignant biliary stricture.<br /><br>2. Cholangioscopic aspect of stricture</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Duration of examination</p><br>
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