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Comparison of Biliary Forceps Biopsy and Brush Cytology

This study has been completed.
Sponsor:
Collaborator:
Heidelberg University
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT01145248
First received: June 14, 2010
Last updated: June 15, 2010
Last verified: May 2010

June 14, 2010
June 15, 2010
January 2006
July 2009   (final data collection date for primary outcome measure)
Biopsy versus brush cytology for diagnosing CCC [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01145248 on ClinicalTrials.gov Archive Site
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Comparison of Biliary Forceps Biopsy and Brush Cytology
A Combination of Endoscopic Transpapillary Brush Cytology and a Novel Method of Forceps Biopsy to Diagnose Proximal Biliary Malignancies

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.

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Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cholangiocarcinoma
  • Device: double-balloon enteroscopy forceps biopsy
    An endoscopic retrograde cholangiography (ERC) with a duodenoscope Olympus TFJ 160-R (Olympus Corp., Tokyo, Japan) and endoscopic sphincterotomy with an Olympus papillotome (Olympus) is performed under analgosedation . Then, the cannulation of the bile duct is performed by a pusher using a guidewire/guiding catheter. Subsequently, 2 histology samples are taken via a double-balloon enteroscopy (DBE) forceps (BF1725DF, Fujinon GmbH, Willich, Germany), which is placed under the guidance of the pusher.
  • Device: Transpapillary brush cytology
    An endoscopic retrograde cholangiography (ERC) with a duodenoscope Olympus TFJ 160-R (Olympus Corp., Tokyo, Japan) and endoscopic sphincterotomy with an Olympus papillotome (Olympus) is performed under analgosedation . The region of interest is then brushed five times in both directions to obtain cytology specimen.
  • Experimental: Malignant biliary disease
    Interventions:
    • Device: double-balloon enteroscopy forceps biopsy
    • Device: Transpapillary brush cytology
  • Experimental: Benign biliary disease
    Interventions:
    • Device: double-balloon enteroscopy forceps biopsy
    • Device: Transpapillary brush cytology
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • biliary stenosis with suspected malignancy

Exclusion Criteria:

  • no definite diagnosis available
Both
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No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01145248
BilBiop_001
No
Professor Hasan Kulaksiz, Department of Internal Medicine I, Ulm University
University of Ulm
Heidelberg University
Principal Investigator: Hasan Kulaksiz, Professor Department of Internal Medicine I, Ulm University Hospital
University of Ulm
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP