Endoscopic Ultrasound as an Early Diagnostic Tool for Primary Sclerosing Cholangitis

T

Tischendorf, Jens, M.D.

Status

Completed

Conditions

Primary Sclerosing Cholangitis

Study type

Observational

Identifiers

NCT01556412
Ti-EUS

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

32 participants in 1 patient group

Chronic hepatopathy suspicious of PSC
Description:
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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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