Comparison of Biliary Forceps Biopsy and Brush Cytology

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 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

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