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CLINICAL UPDATE

 
Clinical update on pCLE for indeterminate biliary strictures
 
 

Positive results from FOCUS pivotal clinical trial on use of probe-based Confocal Laser Endomicroscopy (pCLE) in biliary cancer detection

In the recently published multicentric international FOCUS study(1), which enrolled 112 patients, pCLE enabled physicians to correctly diagnose 88% of patients (Accuracy: 88%, Sensitivity: 89%, Specificity: 88%, Positive Predictive Value: 93%, Negative Predictive Value: 82%) when combined with the standard diagnostic armamentarium. In particular, within the large group of patients with indeterminate tissue sampling (70 out of 112), pCLE enabled the detection of 24 additional patients with cholangiocarcinoma, and correctly ruled out cancer in 30 patients with benign strictures.


These results corroborate previously published prospective studies reporting the performance of pCLE for the characterization of indeterminate biliary lesions, with sensitivity values ranging between 83% and 98%(2,3,4). pCLE thus has the potential to  overcome the inherent limitations of tissue sampling techniques, and offers the ability to improve patient management. 

 

Illustration-Focus

«We conclude that pCLE should be added to the armamentarium of therapeutic endoscopists when performing ERCP and evaluating patients with indeterminate biliary stricture» said Dr. Adam Slivka, associate chief for the Division of Gastroenterology, Hepatology & Nutrition at the University of Pittsburgh School of Medicine, and principal investigator of the FOCUS study.

 

View the GIE author interview of Dr. Adam Slivka presenting the FOCUS study:

(Please note: It is the second video from the top)

  Click here to view the interview

(1): Validation of the diagnostic accuracy of probe-based confocal laser endomicroscopy for the characterization of indeterminate biliary strictures: results of a prospective multicenter international study. Slivka A, Gan I, Jamidar P, Costamagna G, Cesaro P, Giovannini M, Caillol F, Kahaleh M. Gastrointest Endoscopy, 2015.
http://dx.doi.org/10.1016/j.gie.2014.10.009

(2): Detection of cholangiocarcinoma in vivo using miniprobe-based confocal fluorescence microscopy. Meining A, Frimberger E, Becker V, Von Delius S, Von Weyhern CH, Schmid RM, Prinz C. Clinical Gastroenteroly & Hepatology, 2008.
http://dx.doi.org/10.1016/j.cgh.2008.04.014 show

(3): Direct visualization of indeterminate pancreaticobiliary strictures with probe-based confocal laser endomicroscopy: a multicenter experience. Meining A, Chen YK, Pleskow D, Stevens P, Shah RJ, Chuttani R, Michalek J, Slivka A. Gastrointest Endoscopy, 2011.
http://dx.doi.org/10.1016/j.gie.2011.05.009

(4): Evaluation of pCLE in the bile duct: final results of EMID study : pCLE: impact in the management of bile duct strictures. Caillol F, Bories E, Autret A, Poizat F, Pesenti C, Ewald J, Turrini O, Delpero JR, Monges G, Giovannini M. Surgical Endoscopy, 2014 Dec 10. [Epub ahead of print] 
http://www.ncbi.nlm.nih.gov/pubmed/25492449


   




 

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