Endoscopic procedures in hepatology: Current trends and new developments.

Gastrointestinal endoscopy has long been a reliable backbone in the diagnosis and management of hepatobilary disorders and their complications. However, with evolving non-invasive testing, personalised medicine has reframed the utility and necessity of endoscopic screening. Conversely, the growing interest and use of endoscopic ultrasound (EUS) and advanced endoscopy within gastrointestinal units has also opened novel diagnostic and therapeutic avenues for patients with various hepatobiliary diseases. The integration of "advanced endoscopy" within the practice of hepatology is nowadays referred to as "endo-hepatology". In essence, endo-hepatology consists of two pillars: one focusing primarily on disorders of the liver parenchyma, vascular disorders, and portal hypertension, which is mainly captured via EUS, while the other targets the hepatobiliary tract via endoscopic retrograde cholangiopancreatography and advanced imaging. Applications under the umbrella of endo-hepatology include, amongst others, EUS-guided liver biopsy, EUS-guided portal pressure gradient measurement, coil and glue embolisation of gastric varices as well as cholangioscopy. As such endo-hepatology could become an attractive concept wherein advanced endoscopy might reinforce the medical management of patients with hepatobiliary disorders and their complications after initial basic work-up. In this review, we discuss current trends and future developments within endo-hepatology and the remaining hurdles to overcome.

Multimodal Convolutional Neural Network-Based Algorithm for Real-Time Detection and Differentiation of Malignant and Inflammatory Biliary Strictures in Cholangioscopy: a Proof of Concept Study with Video.

BACKGROUND AND AIMS: Deep learning algorithms gained attention for detection (CADe) of biliary tract cancer (BTC) in digital single-operator cholangioscopy (dSOC). We developed a multimodal convolutional neural network (CNN) for detection (CADe) characterization and discriminating (CADx) between malignant, inflammatory and normal biliary tissue in raw dSOC videos. In addition, clinical metadata was included in the CNN algorithm to overcome limitations of image-only models. METHODS: Based on dSOC videos and images of 111 patients (total of 15,158 still frames), we developed and validated a real-time CNN-based algorithm for CADe and CADx. We established an image-only model and metadata injection approach. In addition, we validated frame-wise and case-based predictions on complete dSOC video sequences. Model embeddings were visualized and class-activation maps highlighted relevant image regions. RESULTS: The concatenation-based CADx approach achieved a per-frame AUC of 0.871, sensitivity of 0.809 (95% CI: [0.784-0.832]), specificity of 0.773 [0.761-0.785], PPV of 0.450 [0.423-0.467], and NPV of 0.946 [0.940-0.954] with respect to malignancy on 5,715 test frames from complete videos of 20 patients. For case-based diagnosis using average prediction scores, six out of eight malignant cases and all twelve benign cases were identified correctly. CONCLUSION: Our algorithm distinguishes malignant and inflammatory bile duct lesions in dSOC videos, indicating the potential of CNN-based diagnostic support systems for both, CADe and CADx. The integration of non-image data can improve CNN based support systems, targeting current challenges in the assessment of biliary strictures.

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.

Evaluation of the effectiveness and safety of single-operator cholangiopancreatoscopy with the SpyGlass™ system.

BACKGROUND AND STUDY AIMS: The single-operator cholangiopancreatoscopy (SOCP) with the SpyGlass™ system is a endoscopy technique whose use has grown exponentially in recent years. The aims of this study were to evaluate the efficacy and safety of SOCP with SpyGlass™ and determine the factors related to the onset of adverse events (AEs). PATIENTS AND METHODS: Retrospective study at a single tertiary institution with inclusion of all consecutive patients undergoing SOCP with SpyGlass™ from February-2009 to December-2021. No exclusion criteria were considered. A descriptive statistical analysis was performed. The factors associated with the existence of AE were analyzed using Chi-square and Student's t-test. RESULTS: A total of 95 cases were included. The most common indications were biliary strictures (BS) evaluation (66.3%) or treatment of difficult common bile duct stones (27.4%). Technical and clinical success was attained in 98.9%. Single-session stone clearance was obtained in 84%. The AE rate was 7.4%. To detect malignancy in BS, optical diagnosis presents a sensitivity and specificity of 100% and 91.2%, respectively; while histology results were 36.4% and 100% respectively. A previous endoscopic sphincterotomy was associated with a lower rate of AEs (2.4% vs 41.7%; p<0.001). CONCLUSIONS: SOCP with SpyGlass™ is a safe and effective technique to diagnose and treat pancreatobiliary pathology. The presence of sphincterotomy performed prior to the procedure could improve the technique's safety.

Endoscopic Management of Difficult Biliary Stones: An Evergreen Issue.

Choledocholithiasis is one of the most common indications for endoscopic retrograde cholangiopancreatography (ERCP) in daily practice. Although the majority of stones are small and can be easily removed in a single endoscopy session, approximately 10-15% of patients have complex biliary stones, requiring additional procedures for an optimum clinical outcome. A plethora of endoscopic methods is available for the removal of difficult biliary stones, including papillary large balloon dilation, mechanical lithotripsy, and electrohydraulic and laser lithotripsy. In-depth knowledge of these techniques and the emerging literature on them is required to yield the most optimal therapeutic effects. This narrative review aims to describe the definition of difficult bile duct stones based on certain characteristics and streamline their endoscopic retrieval using various modalities to achieve higher clearance rates.

Safety Parameters for the Use of Holmium:YAG Laser in the Treatment of Biliary Calculi: The Ex-Vivo Model.

Background and Objectives: While studies have demonstrated the efficacy of cholangioscopy-guided Holmium-Yttrium aluminum garnet (Ho:YAG) laser lithotripsy for the treatment of refractory bile duct stones, data regarding the safety of the operating parameters for laser lithotripsy are lacking. The aim of this study was to determine safe, yet effective, energy settings for Ho:YAG laser in the ex-vivo model. Materials and Methods: This ex vivo experimental study utilized the Ho:YAG laser on porcine bile duct epithelium and human gallstones. Ho:YAG laser lithotripsy was applied in different power settings from 8 to 15 Watts (W) to six explanted porcine bile ducts. Settings that appeared safe were then utilized to fragment seventy-three human gallstones. Results: The median bile duct perforation times with the Ho:YAG laser between 8-15 W were: >60 s (8 W); 23 s (9 W); 29 s (10 W); 27 s (12 W); 12 s (14 W); and 8 s (15 W). Statistically significant differences in the median perforation times were noted between 8 W vs. 15 W, 9 W vs. 15 W, 10 W vs. 15 W, and 12 W vs. 15 W (p < 0.05). When using a 365 µm Ho:YAG laser probe at 8-12 W, the fragmentation rates on various size stones were: 100% (<1.5 cm); 80-100% (1.6-2.0 cm) and 0-32% (>2.0 cm). Optimal fragmentation was seen utilizing 12 W with high energy (2.4 J) and low frequency (5 Hz) settings. Using a larger 550 µm probe at these settings resulted in 100% fragmentation of stones larger than 2 cm. Conclusions: The Ho:YAG laser appears to be safe and effective in the treatment of large bile duct stones when used between 8-12 W in 5 s bursts in an ex vivo model utilizing porcine bile ducts and human gallstones.

[Retrograde cholangioscopy in differential diagnosis of parasitic invasion]. / Retrogradnaya kholangioskopiya v differentsial'noi parazitarnoi invazii. Klinicheskii sluchai.

The authors present differential diagnosis of parasitic invasion of the common bile duct. A 52-year-old patient admitted with malignant bile duct obstruction, mechanical jaundice, cholestatic hepatitis and cholangitis. Bile duct tumor was preliminary diagnosed according to anamnesis, complaints, physical, laboratory and instrumental data. Retrograde cholangiopancreatography, endoscopic papillotomy and revision of the common bile duct were performed. There was occlusion at the level of the upper third of the common bile duct. Retrograde cholangioscopy was performed to clarify the nature of obstruction and tumor. Cholangioscopy revealed parasites in the common bile duct that required extraction. The patient was sent to the infectious disease hospital.

[Intraductal radiofrequency ablation under endosonography and cholangioscopy for residual adenoma of the major duodenal papilla with intraductal component]. / Vnutriprotokovaya radiochastotnaya ablyatsiya pod kontrolem endosonografii i kholangioskopii pri rezidual'noi adenome bol'shogo sosochka dvenadtsatiperstnoi kishki s vnutriprotokovym komponentom. Obzor literatury.

All adenomas of the major duodenal papilla (MDP) require resection regardless of morphological structure due to high risk of malignancy. Currently, intraluminal endoscopic interventions are preferable for these adenomas. MDP neoplasms with intraductal spread (type III and IV) are of particular difficulty for endoscopic techniques. Intraductal radiofrequency ablation provides new opportunities for minimally invasive treatment of patients with MDP adenomas and intraductal component. A 72-year-old patient after previous endoscopic papillectomy for MDP adenoma admitted to the Vishnevsky National Research Medical Center of Surgery due to residual adenomatous growths within the papillectomy zone extending to the common bile duct throughout 13 mm. The patient underwent intraductal RFA under endosonography and cholangioscopy. Despite difficult localization of residual growths extending to the common bile duct, endosonography-guided intraductal RFA provided total destruction of residual tumor that was confirmed by cholangioscopy. Length of treatment was 4 months, relapse-free period - 10 months. Minimally invasive endoscopic technology for residual MDP adenoma provided good clinical results.

Cholangioscopy-guided electrohydraulic lithotripsy versus laser lithotripsy for the treatment of choledocholithiasis: a systematic review.

BACKGROUND: Endoscopic management of large bile duct stones may be challenging and refractory to standard endoscopic retrograde cholangiopancreatography (ERCP) techniques. To this end, per-oral cholangioscopy (POC)-guided electrohydraulic lithotripsy (EHL) or laser lithotripsy (LL) has been increasingly utilized during ERCP. There are limited data, however, comparing EHL and LL in the management of choledocholithiasis. Therefore, the aim was to analyze and compare the efficacy of POC-guided EHL and LL for the treatment of choledocholithiasis. METHODS: A database search on PubMed was performed selecting prospective English-language articles published by September 20th, 2022, in accordance with PRISMA guidelines. Studies selected included bile duct clearance as an outcome. RESULTS: A total of 21 prospective studies (15 using LL, 4 using EHL, and 2 both) including 726 patients were included for analysis. Complete ductal clearance was achieved in 639 (88%) patients with 87 (12%) patients having incomplete ductal clearance. Patients treated with LL had an overall median stone clearance success rate of 91.0% (IQR, 82.7-95.5), whereas EHL achieved a median stone clearance success rate of 75.8% (IQR, 74.0-82.4), [p = .03]. CONCLUSIONS: LL is a highly effective form of POC-guided lithotripsy for the treatment of large bile duct stones, particularly when compared to EHL. However, direct, head-to-head randomized trials are needed to identify the most effective form of lithotripsy for treating refractory choledocholithiasis.

Cholangioscopy under direct visualization: skill progress during a dedicated Image-Guided Surgery Course.

AIMS: Training programs are essential to introduce new methods for bile duct clearance. Visual examination via cholangioscopy is ideal to diagnose and treat biliary tract diseases such as cancer and choledocholithiasis. However, surgeons rarely use cholangioscopes. Specific training is required to master laparoscopic and percutaneous cholangioscopy. This study aims to assess skill acquisition and retention during cholangioscopy training in the Image-Guided Therapies Masterclass. METHODS: This prospective study enrolled 17 physicians undergoing training in interventional treatments of biliary diseases. A novel disposable cholangioscope and access kit were used with a biliary tract model including two simulated common bile duct (CBD) stones. The curriculum required visualization of all critical structures before removal of one stone with a Dormia basket. After informed consent, demographic data and time to exercise completion were recorded on each of two subsequent training days. Task-specific questions were measured at the completion of training using a Likert scale (strongly disagree to strongly agree, 1-5 points). RESULTS: All participants successfully completed the task (6F/11 M, age 36 ± 5 years; 13 surgeons, 4 interventional radiologists; median experience with percutaneous procedures 2 years, range 0-20). Significant improvement in mean task completion time was observed (day 1: 172 ± 59 s, day 2: 89 ± 45 s; P < 0.0001). All task-specific questions were answered with a median rating of 5/5: "The platform facilitates cholangioscopy" and "This training method accelerates gain in proficiency and is useful for residents/fellows" (IQR 5-5), "This platform is useful to measure the proficiency level" and "There is an application for simulation in percutaneous surgery training" (IQR 4.5-5), "The platform is user-friendly" and "The model quality recreates realistic scenarios" (IQR 4-5). CONCLUSION: Cholangioscopic bile duct exploration and stone retrieval were achieved by all participants using a dedicated training program and physical simulator. Significant skill progress was observed during 2 days of dedicated training.

PERcutaneous transhepatic CHOLangioscopy using a new single-operator short cholangioscope (PERCHOL): European feasibility study.

OBJECTIVES: 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. CONCLUSION: 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.

Endoscopic evaluation of indeterminate biliary strictures: Cholangioscopy, endoscopic ultrasound, or both?

Accurate and timely diagnosis of biliary strictures can be challenging. Because the diagnostic sensitivity and accuracy of standard endoscopic retrograde cholangiopancreatography-based tissue sampling for malignancy are suboptimal, additional endoscopic evaluation by cholangioscopy and/or endoscopic ultrasound (EUS) is often necessary to differentiate between malignant and benign biliary strictures to guide clinical management. While direct visualization by cholangioscopy and/or high-resolution imaging by EUS are often the first step in the evaluation of an indeterminate biliary stricture (IDBS), tissue diagnosis by cholangioscopy-guided biopsy and/or EUS-guided fine-needle tissue acquisition is the preferred modality to establish a diagnosis of malignancy. Because each modality has its own strengths and limitations, selection of cholangioscopy and EUS is best guided by the biliary stricture location and local expertise. Artificial intelligence-assisted diagnosis, biopsy forceps with improved design, contrast-enhanced EUS, and dedicated fine-needle biopsy devices are recent technological advances that may further improve the diagnostic performance of cholangioscopy and EUS in patients with IDBS.

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.

SEED Consensus Document on SpyGlass-DS. / Documento de consenso de la Sociedad Española de Endoscopia Digestiva sobre SpyGlass-DS.

Endoscopic retrograde cholangiopancreatography (ERCP) is the technique of choice for the treatment of biliopancreatic pathology. However, fluoroscopic imaging does not always allow an adequate diagnosis. On the other hand, some large stones cannot be removed by the usual methods. In these situations, cholangioscopy has proven to be an essential tool for the diagnosis of biliary strictures and the treatment of large stones. Its role in pancreatic pathology is also increasing. The development of a single-operator, disposable cholangioscope has made it possible to expand the technique to a large number of hospitals that perform ERCP. For this reason, the Spanish Society of Digestive Endoscopy has developed this consensus document on the use of the Spyglass-DS cholangioscope. The document has been prepared by a group of endoscopists with expertise in cholangioscopy, reviewing the scientific evidence on the main current indications for cholangiopancreatoscopy.

Acute hemorrhagic cholecystitis as a rare cause of hemobilia.

Hemobilia is an unusual type of gastrointestinal bleeding most frequently due to iatrogenic injury, trauma, or neoplasia. Acute cholecystitis as a cause of hemobilia is rare. We present the case study of a patient with bleeding from eroded gallbladder mucosa in the setting of severe calculous cholecystitis. The hemorrhagic episode was preceded by acute ERCP due to obstructive icterus with extraction of the calculi, followed by the development of severe acute pancreatitis. These factors initially misled the diagnosis. The bleeding was not hemodynamically important and routine diagnostic methods did not reveal its exact source. Direct choledochoscopy (SpyGlassTM) proved to be helpful in determining the right diagnosis, as it ruled out any injury or tumor in the main bile ducts and considerably supported the assumption of intrabladder bleeding. Surgical revision confirmed the cause, and subsequent cholecystectomy solved the whole problem.

[Endoscopic treatment of obstructive jaundice in patients with Klatskin tumor]. / Endoskopicheskoe lechenie patsientov s mekhanicheskoi zheltukhoi pri opukholi Klatskina.

OBJECTIVE: To improve treatment outcomes in patients with Klatskin tumor and obstructive jaundice by using of endoscopic bilioduodenal stenting. MATERIAL AND METHODS: There were 1904 transpapillary interventions between August 2017 and February 2022. Endoscopic bilioduodenal stenting was performed in 250 patients including 25 (10%) ones with Klatskin tumor. RESULTS: Bilioduodenal plastic and self-expanding stents were installed in 19 (76%) and 6 (24%) patients, respectively. In Klatskin tumor type I, 11 patients (44%) underwent bilioduodenal stenting of common hepatic duct with plastic stent; 5 (20%) patients with Klatskin tumor type II received self-expanding stents. In case of tumor type IIIA, 3 (12%) patients underwent stenting of the right lobar duct with plastic stent. Four (16%) patients with Klatskin tumor type III B underwent stenting of the left lobar duct. Two 2 (8%) patients with Klatskin tumor type IV underwent bilateral bilioduodenal stenting with plastic and bifurcation self-expanding stents. Peroral cholangioscopy using the SpyGlass DS system was performed in 4 (16%) patients. No intraoperative complications were identified. One (4%) patient developed gastrointestinal bleeding in 2 postoperative days after retrograde intervention that did not require surgery. Moreover, 1 (4%) patient with distal dislocation of plastic bilioduodenal stent required redo bilioduodenal stenting. Three (12%) patients died from multiple organ failure despite adequate biliary decompression, and 22 (88%) patients were discharged in 8±5 days after retrograde intervention. CONCLUSION: Bilioduodenal stenting as minimally invasive and physiological method was highly effective for obstructive jaundice in patients with Klatskin tumor. Peroral cholangioscopy using the SpyGlass system provides effective and safe direct visualization of the biliary tract, as well as biopsy for morphological verification and prescription of chemotherapy in patients with intraductal growth of tumor.

[The first Russian experience of radiofrequency ablation in the treatment of adenoma of the major duodenal papilla with intraductal growth in the common bile duct]. / Pervyi v Rossii opyt primeneniya radiochastotnoi ablyatsii v lechenii adenomy bol'shogo sosochka dvenadtsatiperstnoi kishki s vnutriprotokovym rostom v kholedokh.

Adenoma of the major duodenal papilla can cause bile flow blockade and obstructive jaundice. We present successful endoscopic radiofrequency ablation for adenoma of the major duodenal papilla with intraductal growth in the common bile duct.

A Preliminary Study on the Efficacy of Single-Operator Cholangioscopy with a New Basket for Residual Stone Retrieval After Mechanical Lithotripsy.

BACKGROUND AND AIM: 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.

Digital Cholangioscopic Interpretation: When North Meets the South.

BACKGROUND: Digital single-operator cholangioscopy (DSOC) (SpyGlass DS™, Boston Scientific, MA, USA) allows for high-definition imaging of the biliary tree. The superior visualization has led to the development of two different sets of criteria to evaluate and classify indeterminate biliary strictures: the Monaco criteria and the criteria in Carlos Robles-Medranda's publication (CRM). Our objective was to assess the interrater agreement (IA) of DSOC interpretation for indeterminate biliary strictures using the two newly published criteria. METHODS: Forty de-identified DSOC video recordings were sent to 15 interventional endoscopists with experience in cholangioscopy. They were asked to score the videos based on the presence of Monaco Classification criteria: stricture, lesion, mucosal changes, papillary projections, ulceration, white linear bands or rings, and vessels. Next, they scored the videos using CRM criteria: villous pattern, polypoid pattern, inflammatory pattern, flat pattern, ulcerate pattern and honeycomb pattern. The endoscopists then diagnosed the recordings as neoplastic or non-neoplastic based on the criteria. Intraclass correlation (ICC) analysis was done to evaluate interrater agreement for both criteria set and final diagnosis. RESULTS: Recordings of 26 malignant lesions and 14 benign lesions were scored. The IA using both the Monaco criteria and CRM criteria ranged from poor to excellent (range 0.1-0.76) and (range 0.1-0.62), respectively. Within the Monaco criteria, IA was excellent for lesion (0.75) and fingerlike papillary projections (0.74); good for tortuous vessels (0.7), mucosal features (0.62), uniform papillary projections (0.53), and ulceration (0.58); and fair for white linear bands (0.4). Within the CRM criteria, the IA was good for villous pattern (0.62), flat pattern (0.62), and honeycomb pattern; fair for ulcerated pattern (0.56), polypoid pattern (0.52) and inflammatory pattern (0.54). The diagnostic IA using Monaco criteria was good (0.65), while the diagnostic IA using CRM was fair (0.58). The overall diagnostic accuracy using the Monaco classification was 61% and CRM criteria were 57%. CONCLUSION: The IOA and accuracy rate of DSOC using visual criteria from both Monaco Criteria and CRM are similar. However, some criteria from both sets suffer from poor IA, thus affecting the overall diagnostic accuracy. More formal training and refinements in visual criteria with additional validation are needed to improve diagnostic accuracy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02166099.

Diagnostic performance of digital and video cholangioscopes in patients with suspected malignant biliary strictures: a systematic review and meta-analysis.

BACKGROUND: Per-oral cholangioscopy (POC) has evolved over the past decade from fiberoptic to digital and video imaging systems. Nowadays, only direct per-oral cholangioscopy (DPOC) and digital single-operator cholangioscopy (DS) are performed in daily practice. With better image resolution, POC is increasingly used as diagnostic tools in patients with suspected malignant biliary stricture (MBS). We aimed to evaluate the diagnostic yield of digital/video cholangioscopes for the diagnosis of MBS. METHODS: A systematic search was performed in MEDLINE, Embase, and ISI Web of Knowledge databases until April 2020, to identify randomized controlled trials and prospective studies using digital or video POC. The meta-analysis of diagnostic accuracy study was performed to calculate summary estimates of the primary outcomes, including pooled sensitivity, and specificity of POC to diagnose MBS using bivariate random-effects models. Tissue histopathology was used as the reference standard for MBS diagnosis. For benign stricture, negative tissue histopathology and at least 6 months clinical follow-up were required. RESULTS: Thirteen original articles with 876 patients were identified. The overall pooled sensitivity and specificity were 88 (95% CI 83-91) and 95 (95% CI 89-98), respectively. The area under the curve (AUROC) was 0.94 (95% CI 0.92-0.96). Subgroup analysis showed that cholangioscopic image impression provided significantly higher sensitivity (93% (95% CI 88-96) vs 82% (95% CI 76-87); p = 0.007), but lower specificity 86% (95% CI 75-92) vs 98 (95% CI 95-99); p < 0.001) than the tissue diagnosis from cholangioscopic-guided biopsy. In addition, biopsy obtained from DPOC had significantly higher sensitivity than that of DS (92% (95% CI 81-97) vs 79% (95% CI 72-84); p = 0.004). Diagnostic performance under image-enhanced endoscopy was not significantly better from white light endoscopy. CONCLUSIONS: Digital/video POC has very high diagnostic performance to diagnose MBS. While image diagnosis provides higher sensitivity than biopsy, its specificity drops as a trade-off.