الفهرس 
Chapter (1): BILIARY STRICTURESOnly 14 pages are availabe for public view
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Abstract
Patients who were 18 years or older, referred to UCLA Medical
Center for the evaluation of indeterminate biliary strictures using
SpyGlass™ Cholangioscopy were included in the study. Patients referred
for Digital SpyGlass™ Cholangioscopy were prospectively enrolled in
the study cohort between May 2015 - May 2017 (Digital SpyGlass™
Cholangioscopy Group). Patients who have undergone Fiberoptic
SpyGlass™ Cholangioscopy were retrospectively enrolled in the study
cohort dating back to January 2012 (Fiberoptic SpyGlass™
Cholangioscopy Group).
In total, 73 patients with indeterminate biliary strictures were
included in this study, 40 patients in the Digital SpyGlass group and 33
patients in the Fiberoptic SpyGlass group.
It was found that:
• The mean age of patients was 59.715.5 and 64.813.9 years in the
Digital SpyGlass group and the Fiberoptic SpyGlass group,
respectively. Patients were mostly males and of white Caucasian race
in both groups.
• Thirty-Six (90%) and 31 (93.9%) patients had history of prior ERCP
with a mean of 1.71.3 and 21.6 procedures in the Digital
SpyGlass group and the Fiberoptic SpyGlass group, respectively.
The mean interval between the SpyGlass procedure and the latest
ERCP procedure was 7.730.2 and 4.48.9 months in the Digital
SpyGlass group and the Fiberoptic SpyGlass group, respectively.
• Twenty-Two (55%) and 25 (75.8%) patients had history of prior nonconclusive
stricture sampling in the Digital SpyGlass group and the
Fiberoptic SpyGlass group, respectively.
• Thirty-Seven (92.5%) and 32 (97%) patients had history of nondiagnostic
imaging in the form of transabdominal US in 28 (70%) and
17 (51.5%) patients, CT scan in 12 (30%) and nine (27.3%) patients,
and MRCP in 15 (37.5%) and six (18.2%) patients in the Digital
SpyGlass group and the Fiberoptic SpyGlass group, respectively.
• No statistically significant differences were observed in the baseline
demographics and characteristics between the two groups, except for
the interval between the SpyGlass procedure and the latest EUS
procedure (p=0.044).
• The SpyGlass™ Cholangioscopy was technically successful in 37/40
(92.5%) and 29/33 (87.9%) of the subjects in the Digital SpyGlass
group and the Fiberoptic SpyGlass group, respectively.
• Intrahepatic biliary strictures were more visualized in the Digital
SpyGlass group than the Fiberoptic SpyGlass group with a
statistically significant difference (25% vs. 6.1%, respectively; pvalue=
0.03).
• A mean of 9.77.5 SpyBites were acquired in 34 (85%) patients in
the Digital SpyGlass group, compared to a mean of 4.51.7
SpyBites in 30 (90.9%) patients in the Fiberoptic SpyGlass group.
• Subjects were followed-up for a mean of 94.6 months in the Digital
SpyGlass group, compared to a mean of 34.17.3 months in the
Fiberoptic SpyGlass group.
• Overall, six (15%) adverse events were encountered with the Digital
SpyGlass Cholangioscopy, compared to three (9.1%) with the
Fiberoptic SpyGlass Cholangioscopy, a finding that didn’t reach
statistical significance. In the Digital SpyGlass group, three patients
(7.5%) developed cholangitis, two patients encountered pancreatitis
(5%), and one patient (2.5%) had mild self-limited oozing. On the
other hand, one patient (3%) had blood oozing, and two patients
(6.1%) has non-specific abdominal pain in the Fiberoptic SpyGlass
group.
• The final pathology was confirmed to be malignant in 15 (37.5%) and
nine (27.3%) of the study subjects in the Digital SpyGlass group and
the Fiberoptic SpyGlass group, respectively.
• The sensitivity, specificity, PPV, NPV, and overall accuracy for the
cholangioscopic biopsies (SpyBites) of indeterminate biliary
strictures were 84.6%, 100%, 100%, 91.3%, and 94.1% vs. 55.6%,
95.2%, 83.3%, 83.3%, and 83.3% in the Digital vs. Fiberoptic
SpyGlass Cholangioscopy groups, respectively.
• The sensitivity, specificity, PPV, NPV, and overall accuracy for the
visual impression of indeterminate biliary strictures were 100%,
91.7%, 90.9%, 100%, and 95.5% vs. 66.7%, 100%, 100%, 87.5% and
90% in the Digital vs. Fiberoptic SpyGlass Cholangioscopy groups,
respectively.
• The sensitivity, specificity, PPV, NPV, and overall accuracy of the
visual impression combined with the cholangioscopic biopsies
(SpyBites) of indeterminate biliary strictures were 100%, 95.7%,
93.8%, 100%, and 97.4% vs. 55.6%, 95.7%, 83.3%, 84.6%, and
Summary and Conclusion
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84.4% in the Digital vs. Fiberoptic SpyGlass Cholangioscopy
groups, respectively. The combined sensitivity was significantly
higher in the Digital SpyGlass Cholangioscopy group (pvalue=
0.012).
• The sensitivity, specificity, PPV, NPV, and overall accuracy of ERCP
brushings for the diagnosis of malignancy in indeterminate biliary
strictures were 13.3%, 100%, 100%, 62.9%, and 64.9%, respectively.
• The sensitivity, specificity, PPV, NPV, and overall accuracy of
fluoroscopic-guided biopsies were 20%, 100%, 100%, 69.2%, and
71.4% for the diagnosis of malignancy in indeterminate biliary
strictures, respectively.
• The sensitivity, specificity, PPV, NPV, and overall accuracy of EUSFNA
for the diagnosis of malignancy in indeterminate biliary
strictures were 60%, 80%, 81.8%, 57.1%, and 68%, respectively.
In conclusion, Digital SpyGlass™ Cholangioscopy appears to be a
promising endoscopic modality for the evaluation of indeterminate
biliary strictures.
Our study shows that Digital SpyGlass™ Cholangioscopy had a
higher yield in the diagnosis of malignancy in patients with
indeterminate biliary strictures, compared to the Fiberoptic
SpyGlass™ Cholangioscopy system.
We believe the higher yield can be attributed to the improved visual
optics of the SpyGlass DS™ system as well as the better
maneuverability that allows for a more accurate cholangioscopic
biopsy acquisition.
SpyGlass DS™ is also safe in this subset of patients, and the higher
rate of adverse events observed with the new system did not reach
statistical significance.
Both systems, the Digital and the Fiberoptic SpyGlass™, performed
better than all other conventional tissue acquisition endoscopic
modalities, including ERCP brushings, fluoroscopic-guided
intraductal biopsies, and EUS-FNA.