Endoscopic Ultrasound as an Early Diagnostic Tool for Primary Sclerosing Cholangitis

Completed

• Conditions: Primary Sclerosing Cholangitis

• Registration Number: NCT01556412
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2012-03-11
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-16
• Primary Completion: 2012-05
• Study Completion: 2012-11
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-19
• Last Update Posted: 2014-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Suspicion of PSC in endosonographic ultrasound	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.

Trial Locations

Locations (1)

Medical Department III, University Hospital RWTH Aachen; 🇩🇪 Aachen, Northrhine-Westfalia, Germany