Direct visualization of indeterminate pancreaticobiliary strictures with probe-based confocal laser endomicroscopy: a multicenter experience - 26/10/11

Doi : 10.1016/j.gie.2011.05.009

Alexander Meining, MD ^1,^⁎, Yang K. Chen, MD ^{^{†
Deceased.},}², Douglas Pleskow, MD ³, Peter Stevens, MD ⁴, Raj J. Shah, MD ², Ram Chuttani, MD ³, Joel Michalek, PhD ⁵, Adam Slivka, MD ⁶
¹ II Medical Klinik, Klinikum rechts der Isar, Munich, Germany
² Division of Gastroenterology and Hepatology, University of Colorado Hospital, Denver, Colorado
³ Division of Gastroenterology, Beth Israel Deaconess Hospital, Boston, Massachusetts
⁴ Division of Digestive and Liver Diseases, Columbia-Presbyterian Hospital, New York, New York
⁵ Department of Epidemiology & Biostatistics, University of Texas Health Science Center, Austin, Texas, USA
⁶ Division of Gastroenterology and Hepatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA

Reprint requests: Professor Alexander Meining, II. Med. Klinik, Klinikum rechts der Isar, Ismaningerstr. 22, 81675 München, Germany

Résumé

Background

Because of the low sensitivity of current ERCP-guided tissue sampling methods, management of patients with indeterminate pancreaticobiliary strictures is a challenge. Probe-based confocal laser endomicroscopy (pCLE) enables real-time microscopic visualization of strictures during an ongoing ERCP.

Objective

To document the utility, performance, and accuracy of real-time pCLE diagnosis compared with histopathology.

Design

Prospective observational study within the framework of a multicenter registry.

Setting

Five academic centers.

Patients

This study involved 102 patients with indeterminate pancreaticobiliary strictures.

Intervention

Clinical information, ERCP findings, tissue sampling results, and pCLE videos were collected prospectively. Investigators were asked to provide a presumptive diagnosis based on pCLE during the procedure before pathology results were available. All patients received at least 30 days of follow-up until definitive diagnosis of malignancy was established or 1-year follow-up if index tissue sampling was benign.

Main Outcome Measurements

Diagnostic accuracy, sensitivity, specificity of ERCP-guided pCLE compared with ERCP with tissue acquisition.

Results

There were no pCLE-related adverse events in the study. We were able to evaluate 89 patients, of whom 40 were proven to have cancer. The sensitivity, specificity, positive-predictive value, and negative-predictive value of pCLE for detecting cancerous strictures were 98%, 67%, 71%, and 97%, respectively, compared with 45%, 100%, 100%, and 69% for index pathology. This resulted in an overall accuracy of 81% for pCLE compared with 75% for index pathology. Accuracy for combination of ERCP and pCLE was significantly higher compared with ERCP with tissue acquisition (90% vs 73%; P = .001).

Limitations

Investigators had access to all relevant clinical information, which may have biased the predictive characteristics of pCLE.

Conclusion

Probe-based CLE provides reliable microscopic examination and has excellent sensitivity and negative predictive value. The significantly higher accuracy of ERCP and pCLE compared with ERCP with tissue acquisition may support supplementing ERCP with pCLE.

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Abbreviations : CLE, pCLE, NPV, PPV

Plan

Investigator pre-enrollment training

Data acquisition

Statistical analysis

Results

Clinical features of study population

Primary study aim: accuracy of pCLE

Secondary study aim: cholangiopancreaticoscopy versus catheter delivery of pCLE probe

Secondary study aim: learning curve of pCLE

Clinical impact

Discussion

DISCLOSURE: A. Meining, D. Pleskow, P. Stevens, R. J. Shah, R. Chuttani, J. Michalek, and A. Slivka received research funding from Maunakea Tech. A. Meining is a patent holder for CholangioFlex probes. No other financial relationships relevant to this publication were disclosed.