NCT01145248

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2010-06-16
• Last updated: 2010-06-16

Locations

1 site across 1 country: Germany