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Comparison of Biliary Forceps Biopsy and Brush Cytology

U

University of Ulm

Status

Completed

Conditions

Cholangiocarcinoma

Treatments

Device: double-balloon enteroscopy forceps biopsy
Device: Transpapillary brush cytology

Study type

Interventional

Funder types

Other

Identifiers

NCT01145248
BilBiop_001

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • biliary stenosis with suspected malignancy

Exclusion criteria

  • no definite diagnosis available

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

43 participants in 2 patient groups

Malignant biliary disease
Experimental group
Treatment:
Device: Transpapillary brush cytology
Device: double-balloon enteroscopy forceps biopsy
Benign biliary disease
Experimental group
Treatment:
Device: Transpapillary brush cytology
Device: double-balloon enteroscopy forceps biopsy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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