Prospective evaluation of digital single‐operator cholangioscope for diagnostic and therapeutic procedures (with videos)

Ogura, Takeshi; Imanishi, Miyuki; Kurisu, Yoshitaka; Onda, Saori; Sano, Tastsushi; Takagi, Wataru; Okuda, Atsushi; Miyano, Akira; Amano, Mio; Nishioka, Nobu; Yamada, Tsuyoshi; Masuda, Daisuke; Takenaka, Mamoru; Kitano, Masayuki; Higuchi, Kazuhide

doi:10.1111/den.12878

Cited by 83 publications

(96 citation statements)

References 29 publications

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“…9,21 In summary, recent studies and our results support an improved imaging quality of digital SOCs that might increase the efficacy of optically diagnosing malignancy; however validated optical criteria for malignancy detection are missing. 6,9,10 The second main indication for cholangioscopy was complex biliary stone disease. In our study, the digital SOC-guided EHL allowed complete biliary stone clearance in all patients (9/9).…”

Section: Discussionmentioning

confidence: 99%

“…Our results are consistent with other digital SOC studies that report stone removal rates of 86-100%. 7,9,10 According to a meta-analysis including 244 cholangioscopies in patients with difficult stone disease, the success rate for fibre-optic SOC was 87%. 22 We conclude that compared with fibre-optic SOC, for complex stone disease, the improved digital imaging quality might not improve biliary stone clearance.…”

Section: Discussionmentioning

confidence: 99%

“…6,9,10 Tissue acquired by forceps biopsy was analyzed by an experienced pathologist and classified as suggestive of malignancy in case of detection of cancer or high-grade cell dysplasia.…”

Section: Diagnostics and Safety Using Digital Socmentioning

confidence: 99%

“…1,5 To date, only a few studies have evaluated digital SOCs. [6][7][8][9][10] Among these reports, three small studies examined the diagnostic and therapeutic efficacy of digital SOCs, but no study performed an in-depth investigation of adverse events (AEs) related to the examination. 6,9,10 Therefore, the aim of this study was to evaluate the diagnostic efficacy, the success of therapeutic procedures and especially the safety of digital SOCs.…”

Section: Introductionmentioning

confidence: 99%

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Safety, diagnostic accuracy and therapeutic efficacy of digital single‐operator cholangioscopy

et al. 2018

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Background: Digital single-operator cholangioscopes (digital SOCs), equipped with an improved image quality, have been recently introduced. Objective: The aim of this study is to evaluate the safety and diagnostic and therapeutic efficacy of digital SOCs (Spyglass TM DS). Methods: Sixty-seven digital SOC procedures performed between 2015 and 2017 were retrospectively analyzed. Results: The most frequent indications for examination were indeterminate biliary strictures (61.2%) and biliary stone disease (23.9%). In 25 patients (37.3), visual findings predicted malignancy with a sensitivity of 88.9%, a specificity of 97.6%, a positive predictive value (PPV) of 96.0% and a negative predictive value (NPV) of 92.9%. For histological analysis, forceps biopsies were performed in 29 patients (43.2%). Compared with visual findings, forceps biopsies yield a lower diagnostic efficacy in diagnosing malignancy (sensitivity 62.5%, specificity 90.0%, PPV 90.9%, NPV 60.0%). Therapeutic interventions were performed in 19 patients with a technical success rate of 89.4%. Adverse events were observed in 17 patients (25.4%). Of these, 11 patients (16.4%) suffered from severe adverse events (pancreatitis, cholangitis or major bleeding), which led to a prolonged hospital stay. Conclusion: Digital SOCs have excellent diagnostic and therapeutic efficacies, but are accompanied by high rates of adverse events; therefore, physicians should use digital SOCs in carefully selected cases. KeywordsCholangioscopy, SpyGlass DS, adverse events, digital single-operator cholangioscopy, indeterminate biliary strictures, complex biliary stone disease Received: 25 November 2017; accepted: 12 February 2018 Key summaryEstablished knowledge:. Digital single-operator cholangioscopes (digital SOCs) have been recently introduced. New findings:. Digital SOCs have an excellent diagnostic accuracy for biliary tract diseases and a high efficacy for therapeutic interventions including treatment of complex biliary stone disease and biliary strictures. . Our results suggest a high incidence (16.4%) of severe adverse events associated with the examination, which is why digital SOCs should only be used in carefully selected cases.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…6,9,10 Tissue acquired by forceps biopsy was analyzed by an experienced pathologist and classified as suggestive of malignancy in case of detection of cancer or high-grade cell dysplasia.…”

Section: Diagnostics and Safety Using Digital Socmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Safety, diagnostic accuracy and therapeutic efficacy of digital single‐operator cholangioscopy

et al. 2018

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“…ERC‐guided pathological examinations for biliary stricture seem to have insufficient accuracy unless a lesion projects into a lumen of the bile duct . A resent prospective study reported that digital cholangioscopy had high accuracy for the diagnosis of biliary disease . However, preoperative pathological diagnosis of CD carcinoma was not made in any of the cases reported.…”

Section: Brief Explanationmentioning

confidence: 99%

Primary cystic duct carcinoma diagnosed by targeted biopsy with digital cholangioscopy

Miyazawa

Matsuda

Fuchizaki

2018

Digestive Endoscopy

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A 79-YEAR-OLD MAN presented to our hospital for obstructive jaundice. Computed tomography (CT) showed stricture of the common bile duct (CBD) and the cystic duct (CD; Fig. 1). Suspicious diagnosis was cholangiocarcinoma. Endoscopic retrograde cholangiography (ERC) showed stricture of the CBD and CD dilatation. Injected contrast media pooled in the CD after insertion of a biliary drainage tube (Fig. 2). Transpapillary biopsy and cytology for the stricture tested negative for malignancy. Intraductal ultrasonography showed that the CBD wall at the stricture had smooth thickening. Normal cysticocholedochal junction was not visualized and a hypoechoic mass of the CD appeared to invade the CBD wall at the stricture. The SpyGlass â Direct Visualization System (Boston Scientific Corp., Natick, MA, USA) showed that the stricture was in the CBD near the cysticocholedochal junction (Video S1). CBD mucosa at the stricture had a cicatricial appearance with dilated vessels. The CD mucosa was reddish and rough, and its lumen was obstructed. Pathologically, targeted biopsy specimen of the mucosa of the CD showed adenocarcinoma. Among the specimens of the stricture of the CBD, one specimen of the mucosa at the side near the CD showed adenocarcinoma and the others showed nonneoplastic inflammation. Final diagnosis was primary CD carcinoma invading the CBD. Because of patient refusal to undergo surgical resection, he received chemotherapy. ERCguided pathological examinations for biliary stricture seem to have insufficient accuracy unless a lesion projects into a lumen of the bile duct. 1 A resent prospective study reported that digital cholangioscopy had high accuracy for the Cystic duct Common bile duct Figure 1 Coronal images of contrast-enhanced computed tomography show wall thickening and stenosis (arrowheads) of both the common bile duct and the cystic duct.

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SpyGlass DS system‐assisted retrieval of proximally migrated pancreatic duct stent in a patient with chronic pancreatitis

Thongpiya,

Lanke,

Yingchoncharoen

et al. 2023

JGH Open

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Prospective evaluation of digital single‐operator cholangioscope for diagnostic and therapeutic procedures (with videos)

Abstract: Although additional cases and a randomized, controlled study with another cholangioscope are needed, diagnostic and therapeutic procedures using SPY-DS appear to be feasible and safe.

Cited by 83 publications

References 29 publications

Safety, diagnostic accuracy and therapeutic efficacy of digital single‐operator cholangioscopy

Safety, diagnostic accuracy and therapeutic efficacy of digital single‐operator cholangioscopy

Primary cystic duct carcinoma diagnosed by targeted biopsy with digital cholangioscopy

SpyGlass DS system‐assisted retrieval of proximally migrated pancreatic duct stent in a patient with chronic pancreatitis

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