Endoscopic Ultrasound as an Early Diagnostic Tool for Primary Sclerosing Cholangitis

October 19, 2014 updated by: Tischendorf, Jens, M.D.

Pilot Study of Endoscopic Ultrasound as an Early Diagnostic Tool for Evaluation of Suspected 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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Northrhine-Westfalia
      • Aachen, Northrhine-Westfalia, Germany, 52074
        • Medical Department III, University Hospital RWTH Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tischendorf, Jens, M.D.

Investigators

  • Principal Investigator: Jens JW Tischendorf, M.D., Medical Department III, University Hospital RWTH Aachen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

March 11, 2012

First Submitted That Met QC Criteria

March 15, 2012

First Posted (Estimate)

March 16, 2012

Study Record Updates

Last Update Posted (Estimate)

October 21, 2014

Last Update Submitted That Met QC Criteria

October 19, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ti-EUS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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