Original articleClinical endoscopySingle-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos)
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.
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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.
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Deceased.