Clinical trial NCT01556412: Endoscopic Ultrasound as an Early Diagnostic Tool for Primary Sclerosing Cholangitis
Official title: Pilot Study of Endoscopic Ultrasound as an Early Diagnostic Tool for Evaluation of Suspected Primary Sclerosing Cholangitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Sclerosing Cholangitis
Keywords: endoscopic ultrasound
primary sclerosing cholangitis
EUS
cholestatic hepatopathy
Lead sponsor: Tischendorf, Jens, M.D.
Sponsor class: INDIV
First posted: 2012-03-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to a single tertiary clinic center with chronic cholestatic hepatopathy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Suspicion of PSC in endosonographic ultrasound
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Medical Department III, University Hospital RWTH Aachen
state: Northrhine-Westfalia
Study officials:
affiliation: Medical Department III, University Hospital RWTH Aachen
name: Jens JW Tischendorf, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lutz HH, Tischendorf JJ. Management of primary sclerosing cholangitis. World J Hepatol. 2011 Jun 27;3(6):137-41. doi: 10.4254/wjh.v3.i6.137.
citation: Kirchner GI, Tischendorf JJ, Bleck J, Wagner S, Caselitz M, Klempnauer J, Manns MP, Gebel M. Perihilar lymph nodes in patients with primary sclerosing cholangitis with and without cholangiocellular carcinoma. Scand J Gastroenterol. 2008;43(11):1366-70. doi: 10.1080/00365520802200002.
citation: Mesenas S, Vu C, Doig L, Meenan J. Duodenal EUS to identify thickening of the extrahepatic biliary tree wall in primary sclerosing cholangitis. Gastrointest Endosc. 2006 Mar;63(3):403-8. doi: 10.1016/j.gie.2005.10.040.