Comparison of Biliary Forceps Biopsy and Brush Cytology

NCT01145248 | Completed

• 1 other identifier: BilBiop_001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma

Keywords

Cholangiocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

Malignant biliary disease

EXPERIMENTAL

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

Benign biliary disease

EXPERIMENTAL

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

Interventions

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.

Benign biliary disease; Malignant biliary disease

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.

Benign biliary disease; Malignant biliary disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• biliary stenosis with suspected malignancy

You may not qualify if:

• no definite diagnosis available

Sponsors & Collaborators

• University of Ulm: lead
• Heidelberg University: collaborator

Study Sites (1)

Department of Internal Medicine I, Ulm University Hospital

Ulm, Baden-Wurttemberg, 89081, Germany

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Hasan Kulaksiz, Professor

  Department of Internal Medicine I, Ulm University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 16, 2010
• Study Start: January 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 16, 2010

Record last verified: 2010-05

Locations

DE (1)