Confocal laser endomicroscopy improved detection of biliary cancer

When combined with tissue sampling, using probe-based confocal laser endomicroscopy during endoscopic retrograde cholangio-pancreatography diagnosed cholangiocarcinoma with greater accuracy and sensitivity compared with standard procedures, according to new research data.

Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies) has recently been cited as a useful diagnostic alternative in American Society for Gastrointestinal Endoscopy guidelines on management of biliary neoplasia.

“This important study (the FOCUS trial) prospectively and statistically confirms the superiority of pCLE-enhanced ERCP over traditional ERCP,” Adam Slivka, MD, professor of medicine and associate chief of the division of gastroenterology, hepatology & nutrition at University of Pittsburgh Medical Center, and study investigator, said in a press release. “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.”

Slivka and colleagues sequentially evaluated the diagnostic performance of ERCP, pCLE and tissue sampling for characterization of indeterminate biliary strictures in 136 patients undergoing outpatient ERCP at six international academic medical centers from May 2012 to September 2013. A presumptive diagnosis was made based on patient history, ERCP and pCLE during the procedure before and after pathology results, and a separate presumptive diagnosis was made by a blinded physician during the procedure and after tissue sampling.

The 12-month follow-up period is ongoing, so investigators reported findings after at least 6 months of follow up. Among the 112 patients included in the final evaluation, 67% had cholangiocarcinoma. The investigators found that for tissue sampling alone, sensitivity was 56% (95% CI, 45% to 68%), specificity was 100% (95% CI, 91% to 100%) and overall accuracy was 72% (95% CI, 63% to 80%). For pCLE with ERCP sensitivity was 89% (95% CI, 79% to 95%), specificity was 71% (95% CI, 54% to 85%) and overall accuracy was 82% (95% CI, 74% to 89%). After biopsy histology results became available, overall accuracy increased to 88% (95% CI, 81% to 94%).

In an accompanying editorial, John Baillie, MB, ChB, FASGE, from the Virginia Commonwealth University Medical Center, said that this study “pushes the boundaries of diagnosis in indeterminate biliary strictures,” and that its authors “have done their best to eliminate the biases that frequently creep into multicenter studies, especially international ones.”

“More thought and fewer nondiagnostic ERCPs before specialist referral are clearly needed in the management of patients who may have [cholangiocarcinoma],” he concluded.

For more information:

Baillie J. Gastrointest Endosc. 2015;81:291-293.

Slivka A. Gastrointest Endosc. 2015;81:282-290.

Disclosure: Slivka reports various financial ties with Boston Scientific, Mauna Kea Technologies and Wilson-Cook. See the study for a full list of the other researchers’ relevant financial disclosures. Baillie reports no relevant financial disclosures.