Brief Title
Comparison of Biliary Forceps Biopsy and Brush Cytology
Official Title
A Combination of Endoscopic Transpapillary Brush Cytology and a Novel Method of Forceps Biopsy to Diagnose Proximal Biliary Malignancies
Brief Summary
Cholangiocarcinomas (CCCs) are malignant tumors arising from the biliary epithelium. CCCs are characterised by a high mortality and the only curable therapy is complete tumor resection, if feasible, or in some cases liver transplantation. Since surgery for CCC is a procedure associated with a high mortality itself it needs to be ascertained that an accurate preoperative diagnosis has been established. However, it often appears to be difficult to get a preoperative pathological diagnosis, since it is difficult to obtain tumor specimens using cytologic brushings, biopsy forceps, bile aspiration or endoscopic ultrasonography guided-fine needle aspiration. This is reflected by a nearly 100% specificity but low sensitivity rates. The aim of this study is to compare a new method of biliary biopsy using a double-balloon enteroscopy (DBE) forceps to enable a safe and reliable tissue specimen collection within the proximal biliary tract with cytology brushings in patients with suspected malignant proximal biliary strictures.
Study Type
Interventional
Primary Outcome
Biopsy versus brush cytology for diagnosing CCC
Condition
Cholangiocarcinoma
Intervention
double-balloon enteroscopy forceps biopsy
Study Arms / Comparison Groups
Malignant biliary disease
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
43
Start Date
January 2006
Completion Date
July 2009
Primary Completion Date
July 2009
Eligibility Criteria
Inclusion Criteria: - biliary stenosis with suspected malignancy Exclusion Criteria: - no definite diagnosis available
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Hasan Kulaksiz, Professor, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT01145248
Organization ID
BilBiop_001
Study Sponsor
University of Ulm
Collaborators
Heidelberg University
Study Sponsor
Hasan Kulaksiz, Professor, Principal Investigator, Department of Internal Medicine I, Ulm University Hospital
Verification Date
May 2010