Original article
Clinical endoscopy
Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos)

Presented in preliminary form at the 15th United European Gastroenterology Week, Paris, France, October 27-31, 2007; Digestive Disease Week, San Diego, California, May 17-22, 2008; Digestive Disease Week, Chicago, Illinois, May 30-June 4, 2009; and 17th United European Gastroenterology Week, London, UK, November 21-25, 2009.
https://doi.org/10.1016/j.gie.2011.04.016Get rights and content

Background

The feasibility of single-operator cholangioscopy (SOC) for biliary diagnostic and therapeutic procedures was previously reported.

Objective

To confirm the utility of SOC in more widespread clinical use.

Design

Prospective clinical cohort study.

Setting

Fifteen endoscopy referral centers in the United States and Europe.

Patients

Two hundred ninety-seven patients requiring evaluation of bile duct disease or biliary stone therapy.

Interventions

SOC examination and, as indicated, SOC-directed stone therapy or forceps biopsy.

Main Outcome Measurements

Procedural success defined as ability to (1) visualize target lesions and, if indicated, collect biopsy specimens adequate for histological evaluation or (2) visualize biliary stones and initiate fragmentation and removal.

Results

The overall procedure success rate was 89% (95% CI, 84%-92%). Adequate tissue for histological examination was secured in 88% of 140 patients who underwent biopsy. Overall sensitivity in diagnosing malignancy was 78% for SOC visual impression and 49% for SOC-directed biopsy. Sensitivity was higher (84% and 66%, respectively) for intrinsic bile duct malignancies. Diagnostic SOC procedures altered clinical management in 64% of patients. Procedure success was achieved in 92% of 66 patients with stones and complete stone clearance during the study SOC session in 71%. The incidence of serious procedure-related adverse events was 7.5% for diagnostic SOC and 6.1% for SOC-directed stone therapy.

Limitations

The study was observational in design with no control group.

Conclusions

Evaluation of bile duct disease and biliary stone therapy can be safely performed with a high success rate by using the SOC system.

Section snippets

Methods

The prospective study was conducted at 10 centers in the United States and 5 centers in Europe. The protocol was approved by the institutional review boards or ethics committees of all participating centers, and all patients provided their informed consent in writing.

Results

A total of 297 patients were enrolled. The characteristics of the patients at study entry are shown in Table 1. A majority of them (64%) underwent study procedures on an outpatient basis. Before the date of the study ERCP and SOC procedures, 86% of the patients had undergone ERCP at least once. The most common preexisting condition was cholangitis, which was present in 16%.

Before the SOC procedure, sphincterotomy had been performed in 78% of patients. Sphincterotomy was performed on the day of

Discussion

Direct visualization of the bile duct is the principal advantage of cholangioscopy compared with other modalities, allowing more thorough examination of the biliary tract, targeted biopsies of suspected malignancies, and interventional procedures such as EHL and laser lithotripsy for removal of difficult stones. Despite these advantages, cholangioscopy has previously failed to gain wider clinical use because of technical and practical obstacles. The SOC system was developed to help overcome

Acknowledgment

The authors gratefully acknowledge the contributions by Jessica K. Musiak, MPH, Roberta S. Cosgrove, John C. Evans, PhD, Vivek Pradhan, and Robert S. Walsh, MD, all of Boston Scientific Corp, in the design and conduct of the study, analysis of the data, and preparation of the manuscript, and by Mahlon M. Wilkes, PhD, and Roberta J. Navickis, PhD, in the analysis of the data and preparation of the manuscript.

References (25)

Cited by (261)

  • History of the Interventional Pancreaticobiliary Endoscopy

    2024, Gastrointestinal Endoscopy Clinics of North America
View all citing articles on Scopus

DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: Drs. Chen, Parsi, Binmoeller, Hawes, Pleskow, Slivka, Haluszka, Petersen, Meisner, and Stevens, consultants to Boston Scientific. The other authors disclosed no financial relationships relevant to this publication. Support for this work was provided by Boston Scientific Corp.

Deceased.

View full text