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Pilot Study of Endoscopic Ultrasound as an Early Diagnostic Tool for Evaluation of Suspected Primary Sclerosing Cholangitis

18 Years
Open (Enrolling)
Primary Sclerosing Cholangitis

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Trial Information

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.

Inclusion Criteria:

- cholestatic hepatopathy defined by elevation of gamma-GT and alkalic phosphatase and

- elevated pANCA and / or medical history of inflammatory bowel disease

Exclusion Criteria:

- sign of significant intrahepatic cholestasis or any other cause of necessity of
cholangiography on transabdominal ultrasound

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Suspicion of PSC in endosonographic ultrasound

Outcome Description:

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.

Outcome Time Frame:

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)

Safety Issue:


Principal Investigator

Jens JW Tischendorf, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Department III, University Hospital RWTH Aachen


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

March 2009

Completion Date:

November 2012

Related Keywords:

  • Primary Sclerosing Cholangitis
  • endoscopic ultrasound
  • primary sclerosing cholangitis
  • EUS
  • cholestatic hepatopathy
  • Cholangitis
  • Cholangitis, Sclerosing