Clinical Trial: Endoscopic Ultrasound as an Early Diagnostic Tool for Primary Sclerosing Cholangitis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary:

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.


Sponsor: Tischendorf, Jens, M.D.

Current Primary Outcome: 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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Tischendorf, Jens, M.D.

Dates:
Date Received: March 11, 2012
Date Started: March 2009
Date Completion:
Last Updated: October 19, 2014
Last Verified: October 2014