search
Back to results

Comparison of Biliary Forceps Biopsy and Brush Cytology

Primary Purpose

Cholangiocarcinoma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
double-balloon enteroscopy forceps biopsy
Transpapillary brush cytology
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cholangiocarcinoma focused on measuring Cholangiocellular Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • biliary stenosis with suspected malignancy

Exclusion Criteria:

  • no definite diagnosis available

Sites / Locations

  • Department of Internal Medicine I, Ulm University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Malignant biliary disease

Benign biliary disease

Arm Description

Outcomes

Primary Outcome Measures

Biopsy versus brush cytology for diagnosing CCC
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.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2010
Last Updated
June 15, 2010
Sponsor
University of Ulm
Collaborators
Heidelberg University
search

1. Study Identification

Unique Protocol Identification Number
NCT01145248
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Ulm
Collaborators
Heidelberg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma
Keywords
Cholangiocellular Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Malignant biliary disease
Arm Type
Experimental
Arm Title
Benign biliary disease
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
double-balloon enteroscopy forceps biopsy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transpapillary brush cytology
Intervention Description
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.
Primary Outcome Measure Information:
Title
Biopsy versus brush cytology for diagnosing CCC
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.
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: biliary stenosis with suspected malignancy Exclusion Criteria: no definite diagnosis available
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan Kulaksiz, Professor
Organizational Affiliation
Department of Internal Medicine I, Ulm University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine I, Ulm University Hospital
City
Ulm
State/Province
BW
ZIP/Postal Code
89081
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Comparison of Biliary Forceps Biopsy and Brush Cytology

We'll reach out to this number within 24 hrs