Confocal Microscopy Imaging Technology Improves Bile Duct Cancer Detection

A new imaging system that allows clinicians to study tissue at the cellular level from inside the body may now enable them to more effectively diagnose cancer of the bile ducts, according to a new study.

This tumor, called a cholangiocarcinoma, is one of the most difficult to detect and treat. "Accurate diagnosis and staging of cancer of the bile duct remains a challenge despite advanced imaging methods and the introduction of tissue sampling methods,” said lead investigator Dr. Alexander Meining, from the Technical University of Munich Germany). "Adding this noninvasive tool that allows us to view abnormal bile duct tissue while it's still inside the body increases diagnostic accuracy of cancer of the bile duct.”

Dr. Meining and his colleagues conducted the 14-patient study to evaluate the ability of the Cellvizio, Inc. (Fort Washington, PA, USA) confocal microscopy system to detect neoplasia (an abnormal growth of cells that can be benign, precancerous, or cancerous) in biliary tract tissue by examining tissue at the cellular level during endoscopic retrograde cholangiopancreatography (ERCP), a procedure used to diagnose cancer of the bile ducts and pancreas.

The researchers found that Cellvizio predicted neoplasia with a sensitivity of 83%, significantly better than the 50% seen with conventional histopathologic analysis of biopsied tissue taken from strictures. Moreover, Cellvizio predicted neoplasia with an accuracy rate of 86%, which was superior to the 79% accuracy rate of standard histopathology. "We believe Cellvizio also might facilitate the detection of other cancers arising from ductal structures in the pancreas, breast, and urogenital area,” Dr. Meining added.

The researchers also reported that Cellvizio images captured with the dye fluorescein enabled them to better differentiate between patients with bile duct cancer and those without it by allowing them to see abnormal blood vessels present only in patients with cancer.

The specially designed Cellvizio CholangioFlex Miniprobe enables the Cellvizio system to be used during ERCP procedures. Cellvizio is the first and only confocal microscopy system that is compatible with most endoscopes, including cholangioscopes and advanced endoscopic modalities. Cellvizio has 510(k) clearance from the U.S. Food & Drug Administration and the European CE-Marking for use in the gastrointestinal and pulmonary tracts. Over 1,500 Cellvizio procedures have been completed to date.

Cholangiocarcinoma is a cancer of the bile ducts, which drain bile from the liver into the small intestine. With a yearly incidence rate of one to two cases per 100,000 in the Western world, this disease has been steadily increasing over the past several decades. Risk factors include inflammation of the bile ducts and liver malfunctions. Symptoms include jaundice, weight loss, and generalized itching. This disease is diagnosed through a combination of blood tests, imaging, endoscopy, and sometimes, surgical exploration. To date, surgery is the only potentially curative treatment.

Cellvizio is a leader in the growing in vivo cellular imaging market enabling clinicians to visualize, diagnose, and treat pathologies that can not be seen using other imaging techniques. The Cellvizio system provides microscopic visualization of mucosal tissue and improves clinical outcomes by increasing the diagnostic yield of existing endoscopic procedures.

The investigators published their findings in the September 2008 issue of the journal Clinical Gastroenterology and Hepatology.

Related Links:
Technical University of Munich
Cellvizio