Dr. Adam Slivka discusses the results of the study.
Mauna Kea Technologies announced positive results from FOCUS, a pivotal clinical trial on the use of probe-based Confocal Laser Endomicroscopy (pCLE) in biliary cancer detection. This trial enrolled 112 patients in 6 centers, 4 in the U.S., one in France, and one in Italy.
The publication appears in this month's issue of GIE as the highlighted paper with an accompanying editorial "Distinguishing malignant from benign biliary strictures: can confocal laser endomicroscopy close the gap?"
Thanks to the addition of pCLE during standard interventional procedures, the sensitivity of cancer detection jumps from 56% for ERCP + biopsies to 89% for ERCP + pCLE.
Of note, most of the patients end up with an indeterminate diagnosis after the standard procedure (70 out of 112). This number drops to 16 when pCLE is added to the procedure, helping physicians detect cancer earlier for 24 patients and ruling out cancer for 30 others. This can have a strong impact on both patient care and healthcare costs, which can be significantly reduced thanks to pCLE.
Dr. Adam Slivka, the principal investigator of FOCUS said: “This important study prospectively and statistically confirms the superiority of pCLE-enhanced ERCP over traditional ERCP. This provides strong support for pCLE to be added to the armamentarium of therapeutic endoscopists when performing ERCP and evaluating patients with indeterminate biliary strictures.” Dr Slivka also presents these results in a video on the GIE website.
As the associate editor GIE - the official journal of the American Society of Gastrointestinal Endoscopy - points out, "the authors are to be congratulated on a well-organized and executed study that pushes the boundaries of diagnosis in indeterminate biliary strictures."