Mauna Kea Technologies announced publication of the final results of the multi-center international prospective FOCUS clinical trial assessing the use of probe-based confocal laser endomicroscopy (pCLE) in the diagnosis of biliary cancer during endoscopic retrograde cholangio-pancreatography (ERCP). In the FOCUS study a total of 112 patients with indeterminate biliary strictures were treated in six centers around the world. Results were published in the peer-reviewed journal Gastrointestinal Endoscopy, the official journal of the American Society of Gastrointestinal Endoscopy (ASGE).

The FOCUS trial evaluated the diagnostic performance of pCLE with Cellvizio for the characterization of biliary strictures and thus for the presence of biliary cancer (cholangiocarcinoma). Results show a very significant improvement in the sensitivity of detection of cholangiocarcinoma, from 56% for biopsies to 89% for pCLE. Among the 112 patients enrolled in this study, pCLE correctly diagnosed 88% of patients (Accuracy: 88%, Sensitivity: 89%, Specificity: 88%, Positive Predictive Value: 93%, Negative Predictive Value: 82%) when combined with ERCP.

Importantly, tissue sampling (traditional biopsies) was inconclusive for a majority of patients (70 out of 112) while pCLE was inconclusive for only 16 patients, thus helping physicians to correctly identify the condition of 54 of the patients in this indeterminate group. Within this group, pCLE helped identify cancer earlier than traditional methods in 24 patients and correctly ruled out cancer in 30 patients with benign strictures. The information provided by Cellvizio enabled endoscopists to improve patient care by avoiding unnecessary invasive and costly surgical procedures as well as repeat diagnostic procedures.

Studies have shown that up to 50% of patients with indeterminate traditional biopsies undergo invasive bilio-pancreatic surgeries, reducing their long-term survival rates and creating significant unnecessary costs for the healthcare systems.