Background and study aims Patients with primary sclerosing cholangitis (PSC) have a 9% to 20% lifetime incidence of cholangiocarcinoma (CCA). Per-oral cholangioscopy (POCS) added to endoscopic retrograde cholangiography (ERC) could potentially improve detection of CCA occurrence. We prospectively assessed POCS identification of 12-month CCA incidence in PSC patients undergoing ERC. Patients and methods Consecutive patients with PSC, an indication for ERC, and no prior liver transplantation were enrolled. During the index procedure, POCS preceded planned therapeutic maneuvers. The primary endpoint was ability for POCS visualization with POCS-guided biopsy to identify CCA during 12-month follow-up. Secondary endpoints included ability of ERC/cytology to identify CCA, repeat ERC, liver transplantation, and serious adverse events (SAEs). Results Of 42 patients enrolled, 36 with successful cholangioscope advancement were analyzed. Patients had a mean age 43.5±15.6 years and 61% were male. Three patients diagnosed with CCA had POCS visualization impressions of benign/suspicious/suspicious, and respective POCS-guided biopsy findings of suspicious/positive/suspicious for malignancy at the index procedure. The three CCA cases had ERC visualization impressions of benign/benign/suspicious, and respective cytology findings of atypical/atypical/suspicious for malignancy. No additional patients were diagnosed with CCA during median 11.5-month follow-up. Twenty-three repeat ERCs (5 including POCS) were performed in 14 patients. Five patients had liver transplantation, one after CCA diagnosis and four after benign cytology at the index procedure. Three patients (7.1%) had post-ERC pancreatitis. No SAEs were POCS-related. Conclusions In PSC patients, POCS visualization/biopsy and ERC/cytology each identified three cases of CCA. Some patients had a repeat procedure and none experienced POCS-related SAEs.

Background and study aims To assess the outcomes of urgent endoscopic retrograde cholangiopancreatography (ERCP) performed with a single-use duodenoscope (SUD) in patients with moderate-to-severe cholangitis. Patients and methods Between 2021 and 2022 consecutive patients with moderate-to-severe cholangitis were prospectively enrolled to undergo urgent ERCP with SUD. Technical success was defined as the completion of the planned procedure with SUD. Multivariate analysis was used to identify factors related to incidence of adverse events (AEs) and mortality. Results Thirty-five consecutive patients (15 female, age 81.4±6.7 years) were enrolled. Twelve (34.3%) had severe cholangitis; 26 (74.3%) had an American Society of Anesthesiologists (ASA) score ≥3. Twenty-eight patients (80.0%) had a naïve papilla. Biliary sphincterotomy and complete stone clearance were performed in 29 (82.9%) and 30 patients (85.7%), respectively; in three cases (8.6%), concomitant endoscopic ultrasound-gallbladder drainage was performed. Technical and clinical success rates were 100%. Thirty-day and 3-month mortality were 2.9% and 14.3%, respectively. One patient had mild post-ERCP pancreatitis and two had delayed bleeding. No patient or procedural variables were related to AEs. ASA score 4 and leucopenia were related to 3-month mortality; on multivariate analysis, leukopenia was the only variable independently related to 3-month mortality (odds ratio 12.8; 95% confidence interval 1.03-157.2; P =0.03). Conclusions The results of this \"proof of concept\" study suggest that SUD use could be considered safe and effective for urgent ERCP for acute cholangitis. This approach abolishes duodenoscope contamination from infected patients without impairing clinical outcomes.

Digital single-operator cholangioscopy (D-SOC) has enhanced the ability to diagnose indeterminate biliary strictures (BSs). Pilot studies using artificial intelligence (AI) models in D-SOC demonstrated promising results. Our group aimed to develop a convolutional neural network (CNN) for the identification and morphological characterization of malignant BSs in D-SOC. A total of 84,994 images from 129 D-SOC exams in two centers (Portugal and Spain) were used for developing the CNN. Each image was categorized as either a normal/benign finding or as malignant lesion (the latter dependent on histopathological results). Additionally, the CNN was evaluated for the detection of morphologic features, including tumor vessels and papillary projections. The complete dataset was divided into training and validation datasets. The model was evaluated through its sensitivity, specificity, positive and negative predictive values, accuracy and area under the receiver-operating characteristic and precision-recall curves (AUROC and AUPRC, respectively). The model achieved a 82.9% overall accuracy, 83.5% sensitivity and 82.4% specificity, with an AUROC and AUPRC of 0.92 and 0.93, respectively. The developed CNN successfully distinguished benign findings from malignant BSs. The development and application of AI tools to D-SOC has the potential to significantly augment the diagnostic yield of this exam for identifying malignant strictures.

OBJECTIVE: A new short device for percutaneous endoscopic cholangioscopy was recently developed. However, feasibility and safety has not yet been evaluated. The aim of this study was to assess clinical success, technical success, and adverse events (AEs).
METHODS: This observational multicenter retrospective study included all patients who underwent percutaneous cholangioscopy using a short cholangioscope between 2020 and 2022. The clinical success, defined as the complete duct clearance or obtaining at least one cholangioscopy-guided biopsy, was assessed. The histopathological accuracy, technical success, and the AE rate were also evaluated.
RESULTS: Fifty-one patients (60 ± 15 years, 45.1% male) were included. The majority of patients had altered anatomy (n = 40, 78.4%), and biliary stones (n = 34, 66.7%) was the commonest indication. The technique was predominantly wire-guided (n = 44, 86.3%) through a percutaneous sheath (n = 36, 70.6%) following a median interval of 8.5 days from percutaneous drainage. Cholangioscopy-guided electrohydraulic lithotripsy was performed in 29 cases (56.9%), combined with a retrieval basket in eight cases (27.6%). The clinical success was 96.6%, requiring a median of one session (range 1-3). Seventeen patients (33.3%) underwent cholangioscopy-guided biopsies. There were four (7.8%) cholangioscopy-related AEs (cholangitis and peritonitis). Overall, the technical success and AE rates were 100% and 19.6%, respectively, in a median follow-up of 7 months.
CONCLUSIONS: Percutaneous endoscopic cholangioscopy with a new short device is effective and safe, requiring a low number of sessions to achieve duct clearance or accurate histopathological diagnosis.

BACKGROUND: Endoscopic ultrasound-guided antegrade treatment (EUS-AG) and balloon endoscopy-assisted endoscopic retrograde cholangiopancreatography (BE-ERCP) have emerged as useful procedures for managing bile duct stones (BDS) in patients with surgically altered anatomy. However, the comparison between these two procedures has not been well studied. The aim of our study was to compare the clinical outcomes of EUS-AG and BE-ERCP for managing BDS in patients with surgically altered anatomy.
METHODS: The database was retrospectively evaluated at two tertiary care centers to identify patients with surgically altered anatomy who underwent either EUS-AG or BE-ERCP for BDS. Clinical outcomes were compared between the procedures. The success rate of each procedure was evaluated in three steps: endoscopic approach, biliary access, and stone extraction.
RESULTS: Among the 119 identified patients, 23 had EUS-AG, and 96 had BE-ERCP. The overall technical success rates of EUS-AG and BE-ERCP were 65.2% (15/23) and 69.8% (67/96), respectively (P = .80). The comparison of each step between the procedures EUS-AG versus BE-ERCP was as follows: endoscopic approach, 100% (23/23) versus 88.5% (85/96) (P = .11); biliary access, 73.9% (17/23) versus 80.0% (68/85) (P = .57); stone extraction, 88.2% (15/17) versus 98.5% (67/68) (P = .10). The overall adverse event rate was 17.4% (4/23) versus 7.3% (7/96) (P = .22).
CONCLUSIONS: Both EUS-AG and BE-ERCP are effective and relatively safe procedures in the management of BDS in patients with surgically altered anatomy. The challenging steps of each procedure might be different, which could help decide which one to use to manage BDS in patients with surgically altered anatomy.

BACKGROUND: Patients with primary sclerosing cholangitis (PSC) are at a high risk of developing cholestatic liver disease and biliary cancer, and endoscopy is crucial for the complex management of these patients.
OBJECTIVE: To clarify the utility of recently introduced digital single-operator video cholangioscopy (SOVC) for the endoscopic management of PSC patients.
METHODS: In this observational study, all patients with a history of PSC and in whom digital SOVC (using the SpyGlass DS System) was performed between 2015 and 2019 were included and retrospectively analysed. Examinations were performed at a tertiary referral centre in Germany. In total, 46 SOVCs performed in 38 patients with a history of PSC were identified. The primary endpoint was the evaluation of dominant biliary strictures using digital SOVC, and the secondary endpoints were the performance of selective guidewire passage across biliary strictures and the diagnosis and treatment of biliary stone disease in PSC patients.
RESULTS: The 22 of 38 patients had a dominant biliary stricture (57.9%). In 4 of these 22 patients, a cholangiocellular carcinoma was diagnosed within the stricture (18.2%). Diagnostic evaluation of dominant biliary strictures using optical signs showed a sensitivity of 75% and a specificity of 94.4% to detect malignant strictures, whereas SOVC-guided biopsies to gain tissue for histopathological analysis showed a sensitivity of 50% and a specificity of 100%. In 13% of examinations, SOVC was helpful for guidewire passage across biliary strictures that could not be passed by conventional methods (technical success rate 100%). Biliary stone disease was observed in 17.4% of examinations; of these, in 37.5% of examinations, biliary stones could only be visualized by SOVC and not by standard fluoroscopy. Biliary stone treatment was successful in all cases (100%); 25% required SOVC-assisted electrohydraulic lithotripsy. Complications, such as postinterventional cholangitis and pancreatitis, occurred in 13% of examinations; however, no procedure-associated mortality occurred.
CONCLUSIONS: Digital SOVC is effective and safe for the endoscopic management of PSC patients and may be regularly considered an additive tool for the complex endoscopic management of these patients.

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BACKGROUND: Peroral cholangioscopy (POC)-guided lithotripsy is an effective treatment for difficult biliary stones. A clear definition of factors associated with the efficacy of POC-guided lithotripsy in one session and the performance of electrohydraulic lithotripsy (EHL) and laser lithotripsy (LL) have not clearly emerged.
METHODS: This was a non-randomized prospective multicenter study of all consecutive patients who underwent POC lithotripsy (using EHL and/or LL) for difficult biliary stones. The primary endpoint of the study was the number of sessions needed to achieve complete ductal clearance and the factors associated with this outcome. Secondary endpoints included the evaluated efficacies of LL and EHL.
RESULTS: Ninety-four patients underwent 113 procedures of EHL or LL. Complete ductal clearance was obtained in 93/94 patients (98.94%). In total, 80/94 patients (85.11%) achieved stone clearance in a single session. In the multivariate analysis, stone size was independently associated with the need for multiple sessions to achieve complete ductal clearance (odds ratio = 1.146, 95% confidence interval: 1.055-1.244; p = 0.001). Using ROC curves and the Youden index, 22 mm was found to be the optimal cutoff for stone size (95% confidence interval: 15.71-28.28; p < 0.001). The majority of the patients (62.8%) underwent LL in the first session. Six patients failed the first session with EHL after using two probes and therefore were crossed over to LL, obtaining ductal clearance in a single additional session with a single LL fiber. EHL was significantly associated with a larger number of probes (2.0 vs. 1.02) to achieve ductal clearance (p < 0.01). The mean procedural time was significantly longer for EHL than for LL [72.1 (SD 16.3 min) versus 51.1 (SD 10.5 min)] (p < 0.01).
CONCLUSIONS: POC is highly effective for difficult biliary stones. Most patients achieved complete ductal clearance in one session, which was significantly more likely for stones < 22 mm. EHL was significantly associated with the need for more probes and a longer procedural time to achieve ductal clearance.

OBJECTIVE: Digital single-operator cholangioscopy (DSOC) allows direct visualization of the biliary tree for evaluation of biliary strictures. Our objective was to assess the interobserver agreement (IOA) of DSOC interpretation for indeterminate biliary strictures using newly refined criteria.
METHODS: Fourteen endoscopists were asked to review an atlas of reference clips and images of 5 criteria derived from expert consensus. They then proceeded to score 50 deidentified DSOC video clips based on the visualization of the following: (1) tortuous and dilated vessels, (2) irregular nodulations, (3) raised intraductal lesion, (4) irregular surface with or without ulcerations, and (5) friability. The endoscopists then diagnosed the clips as neoplastic or non-neoplastic. Intraclass correlation (ICC) analysis was done to evaluate interrater agreement for both criteria sets and final diagnosis.
RESULTS: Clips of 41 malignant lesions and 9 benign lesions were scored. Three out of 5 revised criteria had almost perfect agreement. ICC was almost perfect for presence of tortuous and dilated vessels (0.86), raised intraductal lesions (0.90), and presence of friability (0.83); substantial agreement for presence of irregular nodulations (0.71); and moderate agreement for presence of irregular surface with or without ulcerations (0.44). The diagnostic ICC was almost perfect for neoplastic diagnosis (0.90) and non-neoplastic (0.90). The overall diagnostic accuracy using revised criteria was 77%, ranging from 64% to 88%.
CONCLUSIONS: The IOA and accuracy rate of DSOC using the new Mendoza criteria shows a significant increase of 16% and 20% compared with previous criteria. The reference atlas helps with formal training and may improve diagnostic accuracy.

OBJECTIVE: The detection of residual or fragmented common bile duct (CBD) stones after lithotripsy can be improved by the high-resolution imaging quality of digital, single-operator cholangioscopy (SOC). However, therapeutic interventions for the removal of residual CBD stones are limited by the lack of appropriate tools. We retrospectively evaluated the role of SOC and the newly developed Dormia basket for the evaluation and removal of stones remaining after lithotripsy.
METHODS: Thirty-four patients who had undergone lithotripsy for retained CBD stones with no evidence of filling defects in occluded balloon cholangiography from March 2017 to October 2018 were included in the study. After balloon cholangiography, the bile duct was evaluated by SOC for complete evacuation of the stones. The detected residual CBD stones were directly retrieved by inserting the newly developed Dormia basket into the working channel of the SOC. The incidence of residual stones detected by SOC and the success rate of residual stone retrieval by SOC were investigated.
RESULTS: Digital SOC was successfully performed in all patients. Of these, 11 patients (32.4%) had residual CBD stones. The residual stones were successfully removed in 10 patients (90.9%) by SOC using the Dormia basket, except in one case of residual stones left in the hepatic duct. There were no adverse events associated with the SOC procedures or direct stone removal.
CONCLUSIONS: Digital SOC combined with the newly developed Dormia basket was useful for the detection and extraction of residual CBD stones under direct visualization after lithotripsy.