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Endoscopic Ultrasound as an Early Diagnostic Tool for Primary Sclerosing Cholangitis

This study is currently recruiting participants.
Verified March 2012 by Tischendorf, Jens, M.D.
Sponsor:
Information provided by (Responsible Party):
Tischendorf, Jens, M.D.
ClinicalTrials.gov Identifier:
NCT01556412
First received: March 11, 2012
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Primary Sclerosing Cholangitis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tischendorf, Jens, M.D.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Study Completion Date: November 2012
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted to a single tertiary clinic center with chronic cholestatic hepatopathy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556412

Contacts
Contact: Jens JW Tischendorf, M.D. 00492418080861 jtischendorf@ukaachen.de
Contact: Holger H Lutz, M.D. 00492418080861 hlutz@ukaachen.de

Locations
Germany
Medical Department III, University Hospital RWTH Aachen Recruiting
Aachen, Northrhine-Westfalia, Germany, 52074
Contact: Holger H Lutz, M.D.     00492418080861     hlutz@ukaachen.de    
Principal Investigator: Jens JW Tischendorf, M.D.            
Sub-Investigator: Holger H Lutz, M.D.            
Sponsors and Collaborators
Tischendorf, Jens, M.D.
Investigators
Principal Investigator: Jens JW Tischendorf, M.D. Medical Department III, University Hospital RWTH Aachen
  More Information

Publications:

Responsible Party: Tischendorf, Jens, M.D.
ClinicalTrials.gov Identifier: NCT01556412     History of Changes
Other Study ID Numbers: Ti-EUS
Study First Received: March 11, 2012
Last Updated: March 15, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Tischendorf, Jens, M.D.:
endoscopic ultrasound
primary sclerosing cholangitis
EUS
cholestatic hepatopathy

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013