The outcomes and safety of patients undergoing endoscopic retrograde cholangiopancreatography combining a single-use cholangioscope and a single-use duodenoscope: A multicenter retrospective international study.

BACKGROUND: Duodenoscope-related multidrug-resistant organism (MDRO) infections raise concerns. Disposable duodenoscopes have been recently introduced in the market and approved by regulatory agencies with the aim to reduce the risk of endoscopic retrograde cholangiopancreatography (ERCP) associated infections. The aim of this study was to evaluate the outcome of procedures performed with single-use duodenoscopes in patients with clinical indications to single-operator cholangiopancreatoscopy. METHODS: This is a multicenter international, retrospective study combining all patients who underwent complex biliopancreatic interventions using the combination of a single-use duodenoscope and a single-use cholangioscope. The primary outcome was technical success defined as ERCP completion for the intended clinical indication. Secondary outcomes were procedural duration, rate of cross-over to reusable duodenoscope, operator-reported satisfaction score (1 to 10) on performance rating of the single-use duodenoscope, and adverse event (AE) rate. RESULTS: A total of 66 patients (26, 39.4% female) were included in the study. ERCP was categorized according to ASGE ERCP grading system as 47 (71.2%) grade 3 and 19 (28.8%) grade 4. The technical success rate was 98.5% (65/66). Procedural duration was 64 (interquartile range 15-189) min, cross-over rate to reusable duodenoscope was 1/66 (1.5%). The satisfaction score of the single-use duodenoscope classified by the operators was 8.6 ± 1.3 points. Four patients (6.1%) experienced AEs not directly related to the single-use duodenoscope, namely 2 post-ERCP pancreatitis (PEP), 1 cholangitis and 1 bleeding. CONCLUSIONS: Single-use duodenoscope is effective, reliable and safe even in technically challenging procedures with a non-inferiority to reusable duodenoscope, making these devices a viable alternative to standard reusable equipment.

Orlando Protocol for single session ductal clearance of common bile duct stones at endosopic retrograde cholangiopancreatography.

OBJECTIVES: Approach to management of common bile duct stones (CBDS) by endoscopic retrograde cholangiopancreatography (ERCP) is not standardized. We examined outcomes by applying predetermined protocol for CBDS management. METHODS: When standard extraction techniques failed at ERCP, presence of tapered bile duct and stone-duct ratio were calculated. Large balloon sphincteroplasty (LBS) and/or mechanical/single-operator cholangioscopy-guided lithotripsy was performed based on presence of tapered bile duct and stone-duct mismatch. Primary outcome was single-session ductal clearance. Secondary outcome was adverse events. RESULTS: Of 409 patients treated over 16 months, 321 (78.5%) had no tapered bile duct or stone-duct mismatch, and single-session ductal clearance was achieved using standard techniques in 99.7% over median duration of 14 min (interquartile range [IQR] 9-21 min). Of 88 (21.5%) patients with difficult CBDS, tapered duct was seen in 79 (89.8%) and/or stone-duct mismatch in 36 (40.9%). Single-session ductal clearance was achieved in all 88 patients (100%) by LBS in 79 (89.8%), mechanical lithotripsy in 20 (22.7%), and single-operator cholangioscopy-guided lithotripsy in 16 (18.2%) over a median duration of 29 min (IQR 17-47 min). Overall, single-session ductal clearance was achieved in 99.8% with adverse events in 17 (4.2%) that included perforation in two, postsphincterotomy bleeding in one, and mild/moderate post-ERCP pancreatitis in 14 patients. CONCLUSIONS: A predetermined protocol optimized outcomes by enabling single-session ductal clearance of CBDS with high technical success and low adverse events.

Digital single-operator cholangioscopy to guide selective cannulation of complex biliary strictures.

BACKGROUND: Selective cannulation and stenting of complex, tight, and/or angulated biliary strictures under endoscopic retrograde cholangiopancreaticography (ERCP) can be challenging. Digital single-operator cholangioscopy (SOC) may facilitate guidewire advancement through the stricture with endoscopic visual guidance. We aimed to describe a case series on clinical outcomes of this technique for selective cannulation, when used after failed conventional ERCP attempts. METHODS: Consecutive patients who underwent therapeutic digital SOC for selective cannulation of biliary strictures after failed conventional ERCP were retrospectively included. RESULTS: Ten patients with a malignant (n = 6) or benign (n = 4) biliary stricture were included. Digital SOC-assisted selective guidewire insertion and stent placement across the biliary stricture were technically successful in five (50%) patients. Bilirubin levels improved in all patients with technical success. One (10%) patient developed a post-ERCP pancreatitis. CONCLUSIONS: Technically successful cannulation of biliary strictures with digital SOC was achieved in half of patients in whom cannulation with conventional ERCP failed, sparing them more invasive interventions. Stricture opacification during the failed ERCP was seen in all technically successful SOCs.

Diagnostic Accuracy and Therapeutic Efficacy of Digital Single-Operator Cholangioscopy for Biliary Lesions and Stenosis.

BACKGROUND/AIMS: Digital single-operator cholangioscopy (dSOC) has revolutionized bile duct visualization. Interventions like electrohydraulic or laser lithotripsy, inspection of suspicious areas, and targeted biopsies have become possible quick and easy. One main indication for dSOC remains the evaluation of indeterminate biliary strictures. OBJECTIVE AND METHODS: We analyzed 180 consecutive dSOCs procedures performed in a high-volume tertiary center to evaluate sensitivity, specificity as well as positive and negative predictive values (PPV and NPV) for indeterminate strictures. Furthermore, technical success and complications were analyzed. RESULTS: In 92-97%, the region of interest was reached and successfully visualized. In 83-100%, targeted biopsies were obtained from the suspicious area. Only the distal bile duct was less successful with only 84 and 62%, respectively. In general, dSOC procedures were safe. Cholangitis was the main complication. Regarding the diagnostic accuracy of dSOC of indeterminate biliary strictures, we found a sensitivity of 0.87 and specificity of 0.88, over all. Within the whole cohort, the investigators' assessment directly after dSOC had a PPV of 0.63 and a NPV of 0.97. In patients with biliary lesions or stenosis suspicious for malignancy, the dSOC-based visual diagnosis revealed a very high diagnostic accuracy with sensitivity and specificity of 1.0 (95% CI 0.86-1.0) and 0.76 (95% CI 0.56-0.9) with a PPV of 0.77 (95% CI 0.59-0.9) and a high NPV of 1.0 (95% CI 0.85-1.0). CONCLUSIONS: Our study demonstrates that dSOC has a high diagnostic accuracy as well as a favorable safety profile. Therefore, dSOC should be discussed as standard of care during endoscopic retrograde cholangiography for indeterminate biliary lesions.

Single-operator cholangioscopy for the treatment of concomitant gallbladder stones and secondary common bile duct stones.

BACKGROUND AND AIM: This study aims to assess the clinical validity and safety of single-operator cholangioscopy system (SOCS) for the treatment of concomitant gallbladder stones and secondary common bile duct (CBD) stones. METHODS: This retrospective study included 10 consecutive patients who had small-sized stones (< 1 cm) in both the gallbladder and CBD; the patients underwent SOCS treatment from June 2016 to December 2016. The clinical validity of this minimally invasive surgery was determined by the operation success rate, stone removal rate, postoperative hospital stay, hospitalization cost, and contrast images before and after the operation. The clinical safety was evaluated by perioperative complications and outcomes, gallbladder stone recurrence, and gallbladder contractility function. RESULTS: Both the technique success rate and the stone removal rate when using SOCS was 100%. There were no serious complications that occurred during the operation; three patients developed acute cholecystitis, and four patients underwent hyperamylasemia after the surgery. The average postoperative hospital stay was 5.8 ± 1.32 days, and the average hospitalization cost was 7466 ± 566.1 dollars. In the follow-up period, which ranged from 3 to 8 months, there was no stone residuals or recurrences in the gallbladder and CBD, and no patient showed a recurrence of biliary colic. In addition, the gallbladder contractility function was proven to be normal within 3 to 6 months after the operation. CONCLUSIONS: SOCS could successfully manage concomitant gallbladder stones and secondary CBD stones and precisely protect normal biliary function.

Digital single-operator cholangioscopy: a useful tool for selective guidewire placements across complex biliary strictures.

BACKGROUND: Treatment of biliary strictures is challenging. Digital single-operator cholangioscopes (SOCs) equipped with an improved imaging quality, were recently introduced and may be useful for selective guidewire placement in difficult biliary strictures. METHODS: A total of 167 digital SOC procedures performed between 2015 and 2018 were retrospectively analyzed for successful guidewire placements across biliary strictures. Only cases with previous failed conventional guidewire placement approaches were included. RESULTS: In total, 30 examinations with a digital SOC-assisted guidewire placement across biliary strictures, performed in 23 patients, were identified. In 52% of all patients, the stricture was benign with post-liver-transplant strictures (75%) as the most frequent finding; in 48% of all patients the stricture was malignant with cholangiocellular carcinoma as the most frequent type (64%). Guidewire placement was successful in 21 of 30 procedures (70%). According to a subgroup analysis, digital SOC-assisted guidewire placements were significantly more successful in patients with benign strictures than those in patients with malignant strictures (88.2% vs. 46.2%; p = 0.02). Furthermore, the technical success rate tended to be increased in cases of initial examinations (78.3%) than in patients with repeated examinations (42.9%; p = 0.15). Adverse events, such as post-interventional pancreatitis or cholangitis as well as severe bleeding occurred in 16.7% of all examinations. CONCLUSIONS: Digital SOC-assisted guidewire placements have high technical success rates, especially in benign biliary strictures. This technique can help to avoid more invasive procedures such as percutaneous transhepatic or endoscopic ultrasound-guided biliary drainage.

Biliary interventions using single-operator cholangioscopy.

Cholangioscopy provides an opportunity to directly visualize the bile duct for diagnosing biliary lesions and for therapeutic interventions. Although there are different cholangioscopy techniques available, single-operator cholangioscopy has gained widespread acceptance as the standard technique for interventions in the biliary system because of its ease of use and widespread availability. Single-operator cholangioscopy can be used for both diagnostic and therapeutic indications in the biliary tract. Diagnostic cholangioscopy is used for direct evaluation of indeterminate bile duct strictures with biopsies, diagnosing filling defects in the bile ducts observed during endoscopic retrograde cholangiography (ERC) imaging, preoperative mapping of the precise location and extension of tumors of the biliary tract, and diagnosis of intraductal neoplasms. Therapeutic cholangioscopy is used for visually guided treatment of biliary stones that have failed extraction with conventional ERC techniques, residual or impacted stones by using intraductal lithotripsy, ablation of biliary tumors and for facilitation of guidewire advancement into selective intrahepatic ducts for adequate biliary drainage. In this review, we will focus on advances in the single-operator cholangioscopy techniques in the diagnosis and management of biliary disorders.

Digital cholangioscopy: the diagnostic yield and impact on management of patients with biliary stricture.

OBJECTIVES: Biliary strictures frequently present a diagnostic challenge. The aim of this study was to evaluate the impact of digital single-operator cholangioscopy (DSOC) on subsequent treatment of patients with biliary stricture. METHODS: Consecutive patients undergoing DSOC for biliary stricture were enrolled. Gold standard for final diagnosis included histology from surgical resection. In patients without surgery, clinical evaluation methods and repeated imaging studies were used for comparison of DSOC findings and final diagnosis. Patients were followed-up prospectively focusing on subsequent treatment. RESULTS: Among 30 enrolled patients, final diagnosis was malignant in 13 (43%) and benign in 17 (57%). The sensitivity and specificity of visual impression in diagnosing malignant stricture were 100% (95% CI: 75 - 100) and 76% (95% CI: 50 - 93), respectively. The sensitivity and specificity for biopsy were 92% (95% CI: 62 - 100) and 100% (95% CI: 78 - 100), respectively. One (3%) case of complicating cholangitis with fatal outcome occurred. Final treatment included surgery in 7 (23%), endoscopy in 18 (60%) and chemotherapy in 3 (10%) of patients. CONCLUSIONS: In this study, favorable operating characteristics of DSOC were confirmed. Absolute negative predictive value of visual impression provided reassurance to patients with benign strictures who avoided unnecessary surgery in 53%. One (3%) case of cholangitis with fatal outcome occurred.

Usefulness of the single-operator cholangioscopy system SpyGlass in biliary disease: a single-center prospective cohort study and aggregated review.

BACKGROUND AND STUDY AIM: Indeterminate biliary strictures and difficult bile duct stones remain clinically arduous and challenging situations. We aimed to evaluate the utility of the single-operator cholangioscopy (SOC)-system SpyGlass in both conditions in a single-center biliopancreatic interventional unit and in perspective of available aggregated literature. METHODS: Usefulness of SOC was assessed for the above-mentioned indications by means of the combination of successful procedural completion, clinical success and incidence of procedure-related adverse events in our own prospective cohort from 3/2010 to 7/2014 and all available literature till 6/2015. RESULTS: Our single-center cohort constituted of 84 patients undergoing SpyGlass either for indeterminate strictures (n = 45) or difficult stones (n = 39). In addition, a comprehensive literature review yielded 851 patients (from 15 series) for either stenosis (n = 646, 75.9 %) and difficult stones (n = 205, 24.1 %). In our series, overall procedural success amounted to 85.7 % (with 88.9 % for stenosis or 82.1 % for stones) compared to 90.7, 91.5 and 88.3 % in overall literature, respectively. Sensitivity, specificity and accuracy for visual diagnosis in our cohort added up to 83.3, 82.9 and 82.9 % compared to 90.8, 90.9 and 90.8 % in the pooled analysis. Respective figures for SOC-directed biopsies totaled 85.7, 100 and 95.7 % in our cohort and 72.4, 100 and 84 % overall. Overall procedure-related complications varied between 9.4 and 21.4 %. CONCLUSIONS: The SOC-platform SpyGlass can be considered useful in the context of indeterminate biliary strictures and difficult-to-remove biliary stones. In both, SpyGlass-assisted intervention is associated with high procedural success and alters clinical outcome compared to conventional approaches with an acceptable safety profile.

Feasibility, safety and efficacy of endoscopic single-operator cholangioscopy: a retrospective single-center study.

Background: Endoscopic retrograde cholangiopancreaticography (ERCP) is the standard endoscopic procedure for the diagnosis and treatment of diseases of the pancreas and bile ducts. Cholangioscopy provides direct visualization of the bile ducts. It offers the possibility of more detailed diagnostic and therapeutic indications. Today, cholangioscopy is often performed as a single-operator (SOC) procedure. Objectives: We were interested in the clinical efficacy of our SOC procedure in comparison with published studies, and performed this retrospective data analysis of all our consecutive patients from 2016 to 2022 to analyze the feasibility, safety, and efficacy of SOC. Design and Methods: A retrospective single-center analysis of patients undergoing SOC at a tertiary center from 2016 to 2022 (N = 196) was performed. Demographic data, indication for SOC, exam-specific data, efficacy, and complications were included. Sensitivity and specificity for diagnosing indeterminate biliary strictures were calculated. Results: The most common indications for SOC were indeterminate biliary strictures (n = 117; 60%), treatment of biliary stones (n = 45; 23%), and other indications (n = 34; 17%), for example, foreign body removal or intraoperative SOC. In 97% of the SOC (n = 191), the procedure was technically successful. The diagnostic or therapeutic goal was achieved in 91% of SOC (n = 173). In the subgroup where the SOC result was confirmed by subsequent surgery (n = 93), sensitivity was 86%, specificity 99%, and SOC treatment of stones was successful in 89%. Complications occurred in (20%; n = 37). The majority of these patients (n = 18; 10%) had minor bleeding requiring no intervention. Conclusion: SOC is an effective and safe procedure that should be the standard of care when primary diagnostic and/or therapeutic ERCP has failed. The sensitivity and specificity for determining the dignity of biliary strictures and the efficacy for the treatment of difficult-to-treat stones are reproducibly very high.

Feasibility, safety and efficacy of endoscopic biliary endoscopy: a retrospective Single Center study Imaging the bile duct with contrast medium and fluoroscopy as part of endoscopic retrograde cholangiopancreaticography (ERCP) is the gold standard. However, direct visualization of the bile duct using a small camera on a second endoscope (cholangioscope) opens up further diagnostic and therapeutic possibilities. This study is a retrospective study covering the years 2016-2022, with a total of 196 patients. Demographic data, indication for SOC, exam specific data, efficacy, complications were included. The most common indications for direct biliary endoscopy were indeterminate biliary strictures (n=117; 60%), treatment of biliary stones (n=45; 23%) and other indications (n=34; 17%), e.g. foreign body removal or intraoperative biliary endoscopy. In 97% of the direct biliary endoscopy (n=191), the procedure was technically successful. The diagnostic or therapeutic goal was achieved in 91% of direct biliary endoscopy (n=173). In summary, direct biliary endoscopy is an effective and safe procedure that should be the standard of care when primary diagnostic and/or therapeutic ERCP has failed.

Successful removal of remnant cystic duct stump stone using single-operator cholangioscopy-guided electrohydraulic lithotripsy: two case reports.

Cholecystectomy is the best method for treating gallstone diseases. However, 10%-30% of patients who undergo a cholecystectomy continue to complain of upper abdominal pain, dyspepsia, or jaundice-this is referred to as postcholecystectomy syndrome. Cystic duct stump stones are a troublesome cause of postcholecystectomy syndrome. Conventionally, surgery is mainly performed to remove cystic duct stump stones. However, repeated surgery can cause complications, such as postoperative bleeding, biliary injury, and wound infection. As an alternative method of surgery, endoscopic retrograde cholangiopancreatography is sometimes used to remove cystic duct stump stones, although the success rate is not high due to technical difficulties. Recently, peroral cholangioscopy, which can directly observe the bile duct, has been suggested as an alternative method. We report two cases in which a cystic duct stump stone was successfully removed via a single-operator cholangioscopy, after failure with an endoscopic retrograde cholangiopancreatography.

Cholangioscopy-guided lithotripsy in the treatment of difficult bile ducts stones - Bulgarian and Egyptian experience.

Introduction: Up to 10% of bile duct stones are deemed 'difficult' because they cannot be extracted using standard endoscopic techniques. In these situations, cholangioscopy allows for stone fragmentation under direct visual control.

Digital single-operator cholangioscopy in diagnostic and therapeutic bilio-pancreatic diseases: A prospective, multicenter study.

BACKGROUND AND AIM: Digital single-operator cholangioscopy (D-SOC) is an endoscopic procedure that is increasingly used for the management of bilio-pancreatic diseases. We aimed to investigate the efficacy and safety of D-SOC for diagnostic and therapeutic indications. METHODS: This is a multicenter, prospective study(January 2016-June 2019) across eighteen tertiary centers. The primary outcome was procedural success of D-SOC. Secondary outcomes were: D-SOC visual assessment and diagnostic yield of SpyBite biopsy in cases of biliary strictures, stone clearance rate in cases of difficult biliary stones, rate of adverse events(AEs) for all indications. RESULTS: D-SOC was performed in 369 patients (201(54,5%) diagnostic and 168(45,5%)therapeutic). Overall, procedural success rate was achieved in 360(97,6%) patients. The sensitivity, specificity, PPV, NPV and accuracy in biliary strictures were: 88,5%, 77,3%, 83,3%, 84,1% and 83,6% for D-SOC visual impression; 80,2%, 92,6%, 95,1%, 72,5% and 84,7% for the SpyBite biopsy, respectively. For difficult biliary stones, complete duct clearance was obtained in 92,1% patients (82,1% in a single session). Overall, AEs occurred in 37(10%) cases.The grade of AEs was mild or moderate for all cases, except one which was fatal. CONCLUSION: D-SOC is effective for diagnostic and therapeutic indications.Most of the AEs were minor and managed conservatively, even though a fatal event has happened that is not negligible and should be considered before using D-SOC.

Is it time for global adoption of endoscopic retrograde appendicitis therapy of acute appendicitis?

Acute appendicitis is a common abdominal surgical emergency worldwide. Abraham Groves performed the first documented open appendectomy in 1883. Although appendectomy is still the most effective treatment in cases of acute appendicitis, it causes a range of complications and carries the risk of negative appendectomy. In the awake of covid-19, the latest guidelines recommend antibiotic therapy as an acceptable first line treatment for acute appendicitis. However, patients treated with antibiotics have a recurrence risk of up to 30% at 1 year. Endoscopic retrograde appendicitis therapy (ERAT) has emerged as promising non-invasive treatment modality for acute uncomplicated appendicitis (AUA) which involves cannulation, appedicography, appendiceal stone extraction, appendiceal lumen irrigation, and stent insertion. ERAT aims to relieve the cause of appendicitis (e.g., obstruction or stenosis of the appendiceal lumen) and thus effectively prevent the recurrence of appendicitis. In addition, it can make a definitive diagnosis of acute appendicitis during endoscopic retrograde appendicography. Studies have shown that 93.8 to 95% of AUA patients did not have a recurrence following ERAT. In this study, we aim to summarize the current body of evidence on ERAT to situate it alongside currently established therapies for acute appendicitis, in particular, AUA.

Present and future role of endoscopic retrograde cholangiography in primary sclerosing cholangitis.

Primary sclerosing cholangitis (PSC) is a rare, inflammatory cholestatic liver disease that causes biliary strictures which can lead to secondary complications. About 30-50% of PSC patients develop dominant strictures (DS) in the biliary tree, which are both the cause of jaundice and bacterial cholangitis as well as predilection spots for development of neoplastic development. Cancer is the most common cause of death in PSC. A central concern is to distinguish malignant from benign strictures, which eventually is done by invasive methods to obtain a brush cytology or biopsy sample, in most cases via endoscopic retrograde cholangiography-pancreatography (ERCP). Since medical therapies, like ursodesoxycholic acid or immunosuppressive drugs have no proven effect, therapeutic ERCP has become the primary management strategy to improve symptoms and in some patients may slow down disease progression. This article aims at outlining the current and emerging methods in ERCP in PSC patients.

Cystic pancreatic lesions, the endless dilemma.

Cystic pancreatic lesions involve a wide variety of pathological entities that include neoplastic and non-neoplastic lesions. The proper diagnosis, differentiation, and staging of these cystic lesions are considered a crucial issue in planning further management. There are great challenges for their diagnostic models. In our time, new emerging methods for this diagnosis have been discovered. Endoscopic ultrasonography-guided fine-needle aspiration cytology with chemical and molecular analysis of cyst fluid and EUS-guided fine needle-based confocal laser endomicroscopy, through the needle microforceps biopsy, and single-operator cholangioscopy/pancreatoscopy are promising methods that have been used in the diagnosis of cystic pancreatic lesions. Hereby we discuss the diagnosis of cystic pancreatic lesions and the benefits of various diagnostic models.

Efficacy and Safety of Digital Single-Operator Cholangioscopy in the Diagnosis of Indeterminate Biliary Strictures by Targeted Biopsies: A Systematic Review and Meta-Analysis.

BACKGROUND: Biliary strictures are frequently encountered in clinical practice. The determination of their nature is often difficult. This study aims to systematically evaluate the efficacy and safety of the second generation of digital single-operator cholangioscopy (SpyGlass DS, DSOC) in indeterminate biliary strictures (IBDS) through biopsies. METHODS: All relative studies published in Medline, the Cochrane Library, Web of Science, and EMBASE were included. The diagnostic tests for IBDS were compared to the surgical histology, autopsy, or long-term clinical follow-up. The methodological quality of the included studies was evaluated by the Quality Assessment of Studies of Diagnostic Accuracy Included in Systematic Reviews (QUADAS-2). RESULTS: A total of 11 studies, which involved 356 patients diagnosed through biopsies, were included. The pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and diagnostic odds ratio were 0.74 (95% CI: 0.67-0.80), 0.98 (95% CI: 0.95-1.00), 10.52 (95% CI: 5.45-20.32), 0.31 (95% CI: 0.23-0.41), and 65.18 (95% CI: 26.79-158.61), respectively. The area under the curve (AUC) was 0.9479, and the pooled adverse event rate was 7%. The sensitivity and specificity in the heterogeneity analysis were I2 = 48.1% and I2 = 25.4%, respectively. CONCLUSION: SpyGlass DS is a safe and effective technique for IBDS. However, future randomized trials are needed to determine optimal number of biopsies.

The utility of digital cholangioscopy (SpyGlass DS) in biliary and pancreatic diseases: A clinical feasibility study at two tertiary care centers in Saudi Arabia (with Videos).

BACKGROUND AND STUDY AIM: Since its inception in 2007, single-operator cholangioscopy (SOC) has gained popularity for many diagnostically and therapeutically challenging biliary and pancreatic conditions. Many studies have been published to evaluate the feasibility, usefulness, cost-effectiveness, and safety profile of the first generation. This paper is a descriptive study in which we aim to share the experience of two tertiary care centers with the novel version of SOC, SpyGlass DS. PATIENTS AND METHODS: We retrospectively reviewed the records of all the patients who went through the procedure from October 2015 - July 2019 to explore the scope of biliary and pancreatic conditions in which SOC was utilized. Technical success was defined as the ability to visualize the lesion and complete the procedure as planned, whereas clinical success was determined by the ability to achieve the desired diagnostic/therapeutic outcome. RESULTS: During the period of interest, 66 patients (34 males) went through 84 cholangioscopy procedures. Forty-four patients failed the conventional extraction methods and needed the intervention for the treatment of difficult stones, 24 patients needed a diagnostic evaluation of biliary strictures, and 3 needed an intervention to remove migrated stents. Technical success was achieved in 98.8% (83/84) of the procedures (95% CI: 96-100%). Regarding clinical success, stone breakdown and removal was achieved in 92% of the procedures (49/53; 95% CI: 85-100%). Tissue samples were successfully obtained in 95.8% (23/24) of patients with strictures (95% CI: 88-100%). The biopsy was appropriate to make a histological diagnosis in 83.3% of cases (20/24; 95% CI: 68-98%). The median number of sessions needed to achieve the deisred outcome was one (ranging between 1 and 6 sessions). CONCLUSION: The new version of SOC, SpyGlass DS, provides a feasible and an effective option for the management of difficult cholelithiasis, as well as visually evaluating and obtaining histological samples for indeterminate biliary strictures. However, data from more extensive studies are needed to establish its non-inferiority to the fiberoptic version in terms of short- and long-term outcomes, cost-effectiveness, and complications.

Cholangioscopy and its Role in Primary Sclerosing Cholangitis.

Primary sclerosing cholangitis (PSC) is a cholestatic liver disease characterised by chronic inflammation and fibro-obliteration of the intrahepatic and/or extrahepatic bile ducts. It is associated with numerous hepatobiliary complications including an increased risk of malignancy (in particular, cholangiocarcinoma) and biliary tract stone formation. The evaluation of biliary strictures in patients with PSC is especially challenging, with imaging and endoscopic methods having only modest sensitivity for the diagnosis of cholangiocarcinoma, and treatment of biliary strictures poses a similarly significant clinical challenge. In recent years, peroral cholangioscopy has evolved technologically and increased in popularity as an endoscopic tool that can provide direct intraductal visualisation and facilitate therapeutic manipulation of the biliary tract. However, the indications for and effectiveness of its use in patients with PSC remain uncertain, with only a few studies performed on this small but important subset of patients. In this review, the authors discuss the available data regarding the use of peroral cholangioscopy in patients with PSC, with a focus on its use in the evaluation and management of biliary strictures and stones.

Effect of single operator cholangioscopy on accuracy of bile duct cytology.

INTRODUCTION: This is the first study to evaluate the accuracy of bile duct brushings since the introduction of single operator cholangioscopy SpyGlass DS system in 2015. The primary aim of our study was to compare the accuracy of cytology brushings against biopsies obtained at endoscopic retrograde cholangiopancreatography (ERCP) and cholangioscopy. METHOD: A retrospective search for bile duct brushing specimens was performed and the charts reviewed. The gold standard for definitive diagnosis of malignancy was surgical tissue or compelling clinical evidence of malignancy. Definite negative diagnosis relied on lack of clinical/imaging features of malignancy on follow-up. RESULTS: There was no significant difference in diagnostic accuracy of cytology specimens obtained at different procedures. Overall sensitivity for all methods was 59%, specificity 90% and accuracy of 82%. Notably, all four false-positive cases except for one were from patients with primary sclerosing cholangitis or primary biliary sclerosis. There was no significant difference in sensitivity or specificity between biopsies procured by the two methods. The combined biopsy sensitivity for all modalities was 44% with a specificity of 100%. There was 70% concordance between cytology and biopsy cases. The overall specificity and sensitivity of the combined cytology and biopsy result was 85% and 65.3%, respectively. Ranking of factors that predict clinical diagnosis shows cytology results to surpass other parameters including pancreatic mass, age and stenosis length. Similarly, the presence of two cell populations and three-dimensional clusters was not nearly as predictive of malignancy as single malignant cells. CONCLUSION: Biliary brush cytology specimens performed better than biopsies irrespective of whether they are procured during ERCP or cholangioscopy. The combination of cytology and biopsy had the best accuracy than either one alone.