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OpenTrials
Completed

NCT Number: NCT01556412

Endoscopic Ultrasound as an Early Diagnostic Tool for Primary Sclerosing Cholangitis

Primary sclerosing cholangitis (PSC) is a rare chronic cholestatic liver disease, typically affecting middle aged men and is frequently associated with inflammatory bowel disease. Establishing diagnosis in early stages of cholestatic hepatopathy is still a clinical challenge and based on invasive diagnostic procedures: endoscopic retrograde cholangiography (ERC) or percutaneous liver biopsy are needed when magnetic resonance cholangiopancreaticography remains inconclusive. As these procedures are associated with significant risks for the patient, the goal of this study is to evaluate, if endoscopic ultrasound (EUS) of the biliary tract is a useful diagnostic tool in suspected PSC.

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Key information

Conditions

Primary Sclerosing Cholangitis Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Department III, University Hospital RWTH Aachen

Aachen, Northrhine-Westfalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Suspicion of PSC in endosonographic ultrasound

    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)

    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.

Sponsors and collaborators

Lead sponsor

Tischendorf, Jens, M.D.

Indiv

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 16, 2012
Registry last updated
Oct 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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