Comparison of Biliary Forceps Biopsy and Brush Cytology

Not Applicable

Completed

• Conditions: Cholangiocarcinoma
• Interventions: Device: double-balloon enteroscopy forceps biopsy; Device: Transpapillary brush cytology

• Registration Number: NCT01145248
• Lead Sponsor: University of Ulm

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-05
• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-15
• Last Update Submitted: 2010-06-15
• Study First Posted: 2010-06-16
• Last Update Posted: 2010-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• biliary stenosis with suspected malignancy

Exclusion Criteria

• no definite diagnosis available

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Malignant biliary disease	double-balloon enteroscopy forceps biopsy	-
Malignant biliary disease	Transpapillary brush cytology	-
Benign biliary disease	double-balloon enteroscopy forceps biopsy	-
Benign biliary disease	Transpapillary brush cytology	-

Primary Outcome Measures

Name	Time	Method
Biopsy versus brush cytology for diagnosing CCC	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.

Trial Locations

Locations (1)

Department of Internal Medicine I, Ulm University Hospital; 🇩🇪 Ulm, BW, Germany