Comparison of Biliary Forceps Biopsy and Brush Cytology

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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Key information

Conditions

Cholangiocarcinoma Adenocarcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal Medicine I, Ulm University Hospital

Ulm, Baden-Wurttemberg, 89081, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

biliary stenosis with suspected malignancy

Exclusion criteria

no definite diagnosis available

Treatment and study plan

double-balloon enteroscopy forceps biopsy

Device

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.

Transpapillary brush cytology

Device

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 outcomes

Biopsy versus brush cytology for diagnosing CCC

Time frame: 6 months

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.

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Collaborators

Heidelberg University

Registry information

Official study title

A Combination of Endoscopic Transpapillary Brush Cytology and a Novel Method of Forceps Biopsy to Diagnose Proximal Biliary Malignancies

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Jun 16, 2010
Registry last updated: Jun 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed