Pilot Study of Endoscopic Ultrasound as an Early Diagnostic Tool for Evaluation of Suspected Primary Sclerosing Cholangitis
Different parameters of the common bile duct (wall thickness and irregularity, irregularity
of the common bile duct and enlarged lymph nodes) are measured in patients with cholestatic
hepatopathy of unknown causes via endoscopic ultrasound (EUS).
This EUS of the CBD is performed from the bulbar position in the duodenum and at least 5 cm
of bile duct had to be visualized to correctly analyze bile duct structure.
Further diagnostic work-up of these patients is performed following current guidelines, and
definite diagnosis is compared with results of EUS parameters measured. Thus, diagnostic
yield of EUS in patients with suspected PSC is further evaluated.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Suspicion of PSC in endosonographic ultrasound
Endosonographic ultrasound of the common bile duct Four different diagnostic parameters evaluated during endosonographic ultrasound are evaluated in predicting primary sclerosing cholangitis: Wall thickening ≥ 1.5 mm Irregular wall structure of the common bile duct Irregular caliber of the common bile duct Lymph nodes proven in the perihilar region of at least 10 mm diameter were defined as enlarged. With 2 of 4 criteria positive, patients were classified as suspected diagnostic PSC by means of EUS.
From date of endosonographic ultrasound until the date of definite diagnosis of cholestatic hepatopathy, up to 3 months (participants will be followed as outclinic patients in our center for an expected average of 6 weeks until definite diagnosis)
No
Jens JW Tischendorf, M.D.
Principal Investigator
Medical Department III, University Hospital RWTH Aachen
Germany: Federal Institute for Drugs and Medical Devices
Ti-EUS
NCT01556412
March 2009
November 2012
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