Comparison of the diagnostic accuracy of peroral video-cholangioscopic visual findings and cholangioscopy-guided forceps biopsy findings for indeterminate biliary lesions: a prospective study

Background: The diagnostic accuracy of peroral video-cholangioscopy for indeterminate biliary lesions has not been determined in a prospective study.

Objective: To evaluate and compare the diagnostic accuracy of the peroral video-cholangioscopic visual findings for indeterminate biliary lesions with that of the cholangioscopy-guided forceps biopsy findings.

Design: Prospective cohort study.

Setting: Tertiary-care referral center.

Patients: Patients who showed indeterminate biliary lesions on endoscopic retrograde cholangiography underwent peroral video-cholangioscopy for diagnosis.

Intervention: Each patient underwent peroral video-cholangioscopy with cholangioscopy-guided forceps biopsy.

Main outcome measurements: The accuracy of diagnosis by the peroral video-cholangioscopic visual findings and cholangioscopy-guided forceps biopsy findings compared with that of the final diagnosis by other methods (malignant or benign).

Results: Thirty-three patients were enrolled, and the final diagnoses revealed that the lesions were malignant in 21 patients. All procedures were technically successful, and fine views were obtained in all patients. Procedure-related complications occurred in 2 patients (6.1%), but these complications were mild. The sensitivity, specificity, and accuracy were 100%, 91.7%, and 97.0%, respectively, for the peroral video-cholangioscopic visual findings and 38.1%, 100%, and 60.6%, respectively, for the cholangioscopy-guided forceps biopsy findings, and a significant difference was observed in the accuracy (P = .0018).

Limitations: This was not a blinded study. No comparison was made with other diagnostic modalities involving tissue sampling.

Conclusion: The diagnostic accuracy of the peroral video-cholangioscopic visual findings for indeterminate biliary lesions was excellent and significantly higher than that of the cholangioscopy-guided forceps biopsy findings. The accuracy of the cholangioscopy-guided forceps biopsy was insufficient, but the technique had an excellent specificity.