Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Biopsy versus brush cytology for diagnosing CCC

Outcome Description:

For this study we recruit patients with proximal biliary stenoses, which are suspect for malignancy. An endoscopic retrograde cholangiography (ERC) will be performed on all patients . During ERC all subjects are undergoing both biopsy (using a double-balloon enteroscopy [DBE] forceps under a guidance of a pusher and guiding catheter with guidewire) and transpapillary brush cytology. The definite clinical diagnosis will be compared to cytological/histological results obtained by biopsy/cytology and accuracy will be evaluated.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Hasan Kulaksiz, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Internal Medicine I, Ulm University Hospital

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

BilBiop_001

NCT ID:

NCT01145248

Start Date:

January 2006

Completion Date:

July 2009

Related Keywords:

• Cholangiocarcinoma
• Cholangiocellular Carcinoma
• Cholangiocarcinoma

Name	Location