Endoscopic Ultrasound as an Early Diagnostic Tool for Primary Sclerosing Cholangitis
|ClinicalTrials.gov Identifier: NCT01556412|
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : October 21, 2014
|Condition or disease|
|Primary Sclerosing Cholangitis|
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|
|Actual Enrollment :||32 participants|
|Official Title:||Pilot Study of Endoscopic Ultrasound as an Early Diagnostic Tool for Evaluation of Suspected Primary Sclerosing Cholangitis|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||November 2012|
U.S. FDA Resources
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556412
|Medical Department III, University Hospital RWTH Aachen|
|Aachen, Northrhine-Westfalia, Germany, 52074|
|Principal Investigator:||Jens JW Tischendorf, M.D.||Medical Department III, University Hospital RWTH Aachen|