Endoscopic Ultrasound as an Early Diagnostic Tool for Primary Sclerosing Cholangitis

NCT01556412 | Completed

• 1 other identifier: Ti-EUS
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Sclerosing Cholangitis

Keywords

endoscopic ultrasound; primary sclerosing cholangitis; EUS; cholestatic hepatopathy

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to a single tertiary clinic center with chronic cholestatic hepatopathy

You may qualify if:

• cholestatic hepatopathy defined by elevation of gamma-GT and alkalic phosphatase and
• elevated pANCA and / or medical history of inflammatory bowel disease

You may not qualify if:

• sign of significant intrahepatic cholestasis or any other cause of necessity of cholangiography on transabdominal ultrasound

Sponsors & Collaborators

• Tischendorf, Jens, M.D.: lead

Study Sites (1)

Medical Department III, University Hospital RWTH Aachen

Aachen, Northrhine-Westfalia, 52074, Germany

Location

Related Publications (3)

• 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.

  PMID: 21860672 BACKGROUND

• 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.

  PMID: 18609164 BACKGROUND

• 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.

  PMID: 16500387 BACKGROUND

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Jens JW Tischendorf, M.D.

  Medical Department III, University Hospital RWTH Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2012
• First Posted: March 16, 2012
• Study Start: March 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 21, 2014

Record last verified: 2014-10

Locations

DE (1)