Endoscopic Ultrasound as an Early Diagnostic Tool for Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556412
• Other study ID #: Ti-EUS
• Status: Completed
• Phase: N/A
• First received: March 11, 2012
• Last updated: October 19, 2014
• Start date: March 2009
• Est. completion date: November 2012

Study information

• Verified date: October 2014
• Source: Tischendorf, Jens, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis

Locations

Country	Name	City	State
Germany	Medical Department III, University Hospital RWTH Aachen	Aachen	Northrhine-Westfalia

Sponsors (1)

Lead Sponsor	Collaborator
Tischendorf, Jens, M.D.

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suspicion of PSC in endosonographic ultrasound	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.	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)	No