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
  Purpose

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.


Condition Intervention
Cholangiocarcinoma
Device: double-balloon enteroscopy forceps biopsy
Device: Transpapillary brush cytology

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Combination of Endoscopic Transpapillary Brush Cytology and a Novel Method of Forceps Biopsy to Diagnose Proximal Biliary Malignancies

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • 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.


Enrollment: 43
Study Start Date: January 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Malignant biliary disease 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: Benign biliary disease 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • biliary stenosis with suspected malignancy

Exclusion Criteria:

  • no definite diagnosis available
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145248

Locations
Germany
Department of Internal Medicine I, Ulm University Hospital
Ulm, BW, Germany, 89081
Sponsors and Collaborators
University of Ulm
Heidelberg University
Investigators
Principal Investigator: Hasan Kulaksiz, Professor Department of Internal Medicine I, Ulm University Hospital
  More Information

No publications provided

Responsible Party: Professor Hasan Kulaksiz, Department of Internal Medicine I, Ulm University
ClinicalTrials.gov Identifier: NCT01145248     History of Changes
Other Study ID Numbers: BilBiop_001
Study First Received: June 14, 2010
Last Updated: June 15, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Ulm:
Cholangiocellular Carcinoma

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 29, 2014