Elsevier

Gastrointestinal Endoscopy

Volume 81, Issue 2, February 2015, Pages 282-290
Gastrointestinal Endoscopy

Original article
Clinical endoscopy
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

https://doi.org/10.1016/j.gie.2014.10.009Get rights and content

Background

Characterization of indeterminate biliary strictures remains problematic. Tissue sampling is the criterion standard for confirming malignancy but has low sensitivity. Probe-based confocal laser endomicroscopy (pCLE) showed excellent sensitivity in a registry; however, it has not been validated in a prospective study.

Objective

To prospectively validate pCLE in real time during ERCP for indeterminate biliary strictures.

Design

Prospective, international, multicenter study.

Setting

Six academic centers.

Patients

A total of 136 patients with indeterminate biliary strictures.

Interventions

Investigators provided a presumptive diagnosis based on the patient history, ERCP impression, and pCLE during the procedure before and after tissue sampling results were available. A presumptive diagnosis also was made separately by a blinded investigator during ERCP and after tissue sampling to estimate care without pCLE. Follow-up was at least 6 months.

Main Outcome Measurements

Accuracy, sensitivity, and specificity during ERCP alone, ERCP with pCLE, and ERCP with pCLE and tissue sampling.

Results

A total of 112 patients were evaluated (71 with malignant lesions). Tissue sampling alone was 56% sensitive, 100% specific, and 72% (95% confidence interval [CI], 63%-80%) accurate. pCLE with ERCP was 89% sensitive, 71% specific, and 82% (95% CI, 74%-89%) accurate. After tissue sampling returned, strictures could be characterized with 88% (95% CI, 81%-94%) accuracy.

Limitations

No randomization of care maps. pCLE not blinded.

Conclusion

pCLE provided a more accurate and sensitive diagnosis of cholangiocarcinoma compared with tissue sampling alone. Incorporation of pCLE into the diagnostic armamentarium of patients with indeterminate biliary strictures may allow for a more accurate assessment, potentially reducing delays in diagnosis and costly repeat testing. (Clinical trial registration number: NCT01392274.)

Section snippets

Study setting

We performed a prospective, international, multicenter trial sequentially evaluating the diagnostic performance of ERCP, pCLE, and tissue sampling for the characterization of indeterminate biliary strictures. Over a 12-month period, we prospectively enrolled 136 consecutive adult patients undergoing outpatient ERCP for the diagnosis of indeterminate biliary stricture at 6 international referral centers, all academic medical centers. Patients either were coming in for a first ERCP procedure

Clinical features of the study population

From May 2012 to September 2013, a total of 136 patients were included in the study. Among those, 1 did not receive a complete ERCP, 8 were screen failures, 5 did not receive the pCLE procedure, 2 were lost to follow-up, and 8 were proven to have ampullary lesions (Fig. 4). The evaluable population consisted of 112 patients, with 71 (63%) of them later proven to have a cholangiocarcinoma. Among the patient population, 89 (82%) were referred from another institution. Patient demographics at

Discussion

Cholangiocarcinoma is a debilitating, progressive, and fatal disease, with an increasing incidence in the Western population. Optimal clinical management of patients with biliary strictures depends on accurately differentiating between benign conditions and cancer to spare patients with benign lesions from the unnecessary risk of a surgical intervention and patients with malignant lesions from the unnecessary delays and costs associated with inconclusive diagnostic testing. Despite advances in

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DISCLOSURE: This study was funded by a research grant from Mauna Kea Technologies. A. Slivka does research for Mauna Kea Technologies, research and consulting for Boston Scientific, and research for Wilson-Cook. I. Gan is a speaker for Mauna Kea Technologies. P. Jamidar does research for Mauna Kea Technologies and is a consultant and speaker for Boston Scientific. M. Giovannini does research for Mauna Kea Technologies and Wilson-Cook. M. Kahaleh does research for Mauna Kea Technologies, research and consulting for Boston Scientific, and research for MI Tech, Apollo, Emcision, and Pinnacle. No other financial relationships relevant to this article were disclosed.

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