Digital, single-operator cholangiopancreatoscopy in the diagnosis and management of pancreatobiliary disorders: a multicenter clinical experience (with video)

Navaneethan, Udayakumar; Hasan, Muhammad; Kommaraju, Kiran kumar; Zhu, Xiang; Hébert‐Magee, Shantel; Hawes, Robert H.; Vargo, John J.; Varadarajulu, Shyam; Parsi, Mansour A.

doi:10.1016/j.gie.2016.03.789

Cited by 203 publications

(233 citation statements)

References 12 publications

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“…19,20 The above-mentioned digital SOC study by Navaneethan and colleagues reported a high sensitivity of 90% in the visual diagnosis of malignancy in 44 patients with indeterminate biliary strictures. 9 In line with this finding, our study demonstrates a sensitivity of 88.9% in 25 patients for visual findings consistent with malignancy. In all studies evaluating the visual aspects during SOC, sensitivity and specificity rates might be biased by the investigator's awareness of the patient's history and prior tissue and imaging results.…”

Section: Discussionsupporting

confidence: 87%

“…9 Of note, onsite evaluation of the biopsies was performed by a cytopathologist, which may at least partially explain the high sensitivity rates. 9,18 We performed no onsite evaluation of biopsies and observed a lower sensitivity of 62.5% in diagnosing malignancy, which is comparable to the sensitivity rates observed in fibre-optic SOC (66.2%). 17 Therefore, we speculate that the sensitivity of targeted biopsies might not be improved significantly by digital image quality; however, the sensitivity could be increased by obtaining more biopsies or by the technique of sample processing.…”

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: Discussionsupporting

confidence: 87%

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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“…The recently launched SpyGlassDS  direct visualization system, a digital SOCS, was reported to be useful for diagnosis with both high-quality images and TB [27,28]. One of the innovations of this new system is the ability to perform aspiration.…”

Section: Discussionmentioning

confidence: 99%