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Trial record 12 of 92 for:    Primary Sclerosing Cholangitis

Endoscopic Ultrasound as an Early Diagnostic Tool for Primary Sclerosing Cholangitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01556412
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : October 21, 2014
Information provided by (Responsible Party):
Tischendorf, Jens, M.D.

Brief Summary:
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.

Condition or disease
Primary Sclerosing Cholangitis

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of Endoscopic Ultrasound as an Early Diagnostic Tool for Evaluation of Suspected Primary Sclerosing Cholangitis
Study Start Date : March 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : November 2012

Chronic hepatopathy suspicious of PSC

All patients with chronic hepatopathy of unknown origin and a high risk of primary sclerosing cholangitis as the underlying disease for chronic hepatopathy.

This group includes all patients with cholestatic hepatopathy (predominantly elevated gamma-glutamyltransferase and alkalic phosphatase) and positive ANCAs (Anti-neutrophil cytoplasmic antibodies) and/or inflammatory bowel disease in medical history.

Other explanations of cholestatic hepatopathy (like pancreatic tumor or cholelithiasis) must not be apparent in patients eligible for this study.

Furthermore, infection oder extrahepatic cholestasis already proven by laboratory results or percutaneous ultrasound, which make endoscopic retrograde cholangiography necessary, are exclusion criteria in this study.

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to a single tertiary clinic center with chronic cholestatic hepatopathy

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01556412

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Medical Department III, University Hospital RWTH Aachen
Aachen, Northrhine-Westfalia, Germany, 52074
Sponsors and Collaborators
Tischendorf, Jens, M.D.
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Principal Investigator: Jens JW Tischendorf, M.D. Medical Department III, University Hospital RWTH Aachen

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Responsible Party: Tischendorf, Jens, M.D. Identifier: NCT01556412     History of Changes
Other Study ID Numbers: Ti-EUS
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: October 21, 2014
Last Verified: October 2014
Keywords provided by Tischendorf, Jens, M.D.:
endoscopic ultrasound
primary sclerosing cholangitis
cholestatic hepatopathy
Additional relevant MeSH terms:
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Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases