Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients admitted to a single tertiary clinic center with chronic cholestatic hepatopathy
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jens JW Tischendorf, M.D. | Medical Department III, University Hospital RWTH Aachen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Department III, University Hospital RWTH Aachen | Aachen | Northrhine-Westfalia | 52074 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21860672 | Background | 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. | |
| 18609164 | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015209 | Cholangitis, Sclerosing |
| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 16500387 | 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. |