Clinical Outcomes of Digital Cholangioscopy-Guided Procedures for the Diagnosis of Biliary Strictures and Treatment of Difficult Bile Duct Stones: A Single-Center Large Cohort Study

Hirohito Minami, Shuntaro Mukai, Atsushi Sofuni, Takayoshi Tsuchiya, Kentaro Ishii, Reina Tanaka, Ryosuke Tonozuka, Mitsuyoshi Honjo, Kenjiro Yamamoto, Kazumasa Nagai, Yukitoshi Matsunami, Yasutsugu Asai, Takashi Kurosawa, Hiroyuki Kojima, Toshihiro Homma, Takao Itoi, Hirohito Minami, Shuntaro Mukai, Atsushi Sofuni, Takayoshi Tsuchiya, Kentaro Ishii, Reina Tanaka, Ryosuke Tonozuka, Mitsuyoshi Honjo, Kenjiro Yamamoto, Kazumasa Nagai, Yukitoshi Matsunami, Yasutsugu Asai, Takashi Kurosawa, Hiroyuki Kojima, Toshihiro Homma, Takao Itoi

Abstract

Although Spy DS (SpyGlass DS Direct Visualization System) is considered to be useful for the diagnosis of bile duct strictures and the treatment of bile duct stones, there is limited data to date validating its efficacy. We hence retrospectively evaluated the clinical outcomes of the use of Spy DS in a large number of patients. A total of 183 patients who underwent Spy DS-guided procedures for indeterminate bile duct strictures (n = 93) and bile duct stones (n = 90) were analyzed retrospectively. All patients (93/93) with bile duct strictures successfully underwent visual observation, and 95.7% (89/93) of these patients successfully underwent direct biopsy. The sensitivity, specificity, and overall accuracy were 94.7%, 83.3%, and 90.3%, respectively, for visual impression; 80.9%, 100%, and 89.2%, respectively, for histopathological analysis of a direct biopsy; and 96.5%, 91.7%, and 94.6%, respectively, for visual impression combined with biopsy. Successful visualization of the stones was achieved in 98.9% (89/90) of the patients, and complete stone removal was achieved in 92.2% (83/90) of the patients, with an average of 3.3 procedures. The adverse events rate was 17.5% (32/183; cholangitis in 15 patients, fever the following day in 25, pancreatitis in 1, hemorrhage in 1, and gastrointestinal perforation in 1). No administration of antibiotics before the procedure was found to be a statistically significant risk factor for the development of fever after the procedure (p < 0.01). Spy DS-guided procedures are effective for the diagnosis and treatment of bile duct lesions and can be performed with a low risk of serious adverse events.

Keywords: accuracy; adverse event; bile duct stone; cholangiocarcinoma; peroral cholangioscopy.

Conflict of interest statement

The authors declare no conflict of interest associated with this study.

Figures

Figure 1
Figure 1
Indeterminate biliary strictures identified using Spy DS (SpyGlass DS Direct Visualization System). (a) A benign stricture showing a smooth surface and outline with no visible abnormal vessels. (b) A malignant stricture showing villous mucosal projections, irregular mucosal nodularity, and prominent vascularization.

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