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

Adam Slivka; Ian Gan; Priya Jamidar; Guido Costamagna; Paola Cesaro; Marc Giovannini; Fabrice Caillol; Michel Kahaleh

doi:10.1016/j.gie.2014.10.009

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

Gastrointest Endosc. 2015 Feb;81(2):282-90. doi: 10.1016/j.gie.2014.10.009.

Authors

Adam Slivka¹, Ian Gan², Priya Jamidar³, Guido Costamagna⁴, Paola Cesaro⁴, Marc Giovannini⁵, Fabrice Caillol⁵, Michel Kahaleh⁶

Affiliations

¹ Division of Gastroenterology, Hepatology & Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
² Digestive Disease Institute, Gastroenterology and Hepatology Colorectal cancer, Virginia Mason Bellevue Clinic, Seattle, Washington, USA.
³ Section of Digestive Diseases, New Haven, Connecticut, USA.
⁴ Ambulatorio di Endoscopia e Fisiopatologia Digestiva Chirurgica, Policlinico Policlinico Universitario Agostino Gemelli, Roma, Italy.
⁵ Service d'Endoscopie, Institut Paoli Calmettes, Marseille, France.
⁶ Division of Gastroenterology & Hepatology, Weill Cornell Medical College, New York, New York, USA.

PMID: 25616752
DOI: 10.1016/j.gie.2014.10.009

Abstract

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.).

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't
Validation Study

MeSH terms

Aged
Aged, 80 and over
Bile Duct Neoplasms / complications
Bile Duct Neoplasms / diagnosis*
Bile Ducts, Intrahepatic*
Cholangiocarcinoma / complications
Cholangiocarcinoma / diagnosis*
Cholangiopancreatography, Endoscopic Retrograde*
Cholestasis / diagnostic imaging
Cholestasis / etiology*
Cholestasis / pathology
Constriction, Pathologic
Female
Humans
Male
Microscopy, Confocal*
Middle Aged
Prospective Studies
Reproducibility of Results
Sensitivity and Specificity

Associated data

ClinicalTrials.gov/NCT01392274