Diagnostic Utility of Digital Single-Operator Cholangioscopy for Risk-Enriched Detection and Surveillance of Intraductal Neoplasms of the Bile Duct: SPY-SCREEN Study (with Videos).

The objective of this report was to study the sensitivity of indicators used for predicting bile duct stones and their endoscopic removal before laparoscopic cholecystectomy. A retrospective study was conducted on 104 patients who successfully underwent endoscopic retrograde cholangiopancreatogram (ERCP) before laparoscopic cholecystectomy at Riyadh Medical Complex between 1992 and 1994 (1412H-1414H). Six indicatorsâjaundice, biliary pancreatitis, stones in bile duct on sonography, dilated bile duct (>7 mm) on ultrasonography, dilated bile duct with deranged liver function test, and deranged liver function test without jaundiceâwere used for suspecting choledocholithiasis and endoscopic removal before laparoscopic cholecystectomy. Ultrasound correctly predicted bile duct stone in 75%, followed by dilated bile duct with deranged liver function test (46%). Clinical jaundice and biliary pancreatitis were equally sensitive indicators (42% each). Sensitivity of only dilated bile duct on ultrasonography in predicting duct stone was 36%. Deranged liver function without jaundice was the least sensitive (22%) of the predictors. Overall, these indicators correctly diagnosed bile duct stones in 34% of patients. Until laparoscopic exploration of bile duct or a noninvasive technique, such as magnetic resonance cholangiopancreatogram (MRCP), is widely available, these predictors will help in selecting patients with bile duct stones for preoperative removal. Other workers have suggested combining these indicators to improve the predictive value.

Efficacy and Safety of Digital Single-Operator Cholangioscopy for Difficult Biliary Stones

Background: Intraductal Papillary Neoplasm of the Bile Duct (IPNB) is a rare disease that is characterized by papillary lesions in the intra and extrahepatic biliary tree. Traditional imaging studies may show biliary dilation and/or filling defects. Endoscopic retrograde cholangiopancreatography can demonstrate diffuse bile duct dilatation as well as amorphous filling defects, however visualization of the biliary system can be limited by obstruction by the papillary lesions or mucin. Digital single operator cholangioscopy can be used to aid in diagnosis.Case Presentation: We report two elderly Caucasian males that presented with fatigue and obstructive jaundice. In both cases, the diagnosis of IPNB of was made. In one case, digital single operator cholangioscopy was used successfully to make the diagnosis.Conclusions: We present two cases of IPNB as well as a review of the clinical characteristics of IPNB and the utility of digital single operator cholangioscopy to aid in diagnosis. In IPNB, timely diagnosis is paramount. Traditional imaging studies can be inadequate, digital single operator cholangioscopy allows for quick diagnosis and, if indicated, further intervention.

Background and study aims The use of fluoroscopy during pregnancy should be minimized given that a clear-cut safe radiation dose in pregnancy is unknown. The role of digital single-operator cholangioscopy (D-SOC) as an alternative to standard enodoscopic retrograde cholangiopancreatography (ERCP) in pregnant patients has not been comprehensively studied. This study assessed1Technical success defined as performance of ERCP with D-SOC without the use of fluoroscopy in pregnant patients;2safety of D-SOC in pregnancy; and3maternal and neonatal outcomes after D-SOC during/after pregnancy.Patients and methodsThis was an international, multicenter, retrospective study at 6 tertiary centers. Pregnant patients who underwent D-SOC for the treatment of bile duct stones and/or strictures were included.Results A total of 10 patients underwent D-SOC. Indications for ERCP were choledocholithiasis, strictures, previous stent removal, and choledocholithiasis/stent removal. Bile duct cannulation without fluoroscopy was achieved in 10 of 10 patients (100 %). Moreover, 50 % of patients (5/10) completed a fluoroless ERCP with D-SOC. Mean fluoroscopy dose and fluoroscopy time were 3.4 ± 7.2 mGy and 0.5 ± 0.8 min, respectively. One case of mild bleeding and one case of moderate post-ERCP pancreatitis occurred. The mean gestational age at delivery was 36.2 ± 2.6 weeks. Median birth weight was 2.5 kg [IQR: 2.2–2.8]. No birth defects were noted.Conclusion ERCP guided by D-SOC appears to be a feasible and effective alternative to standard ERCP in pregnant patients. It enables avoidance of radiation in half of cases.

Background and study aims Digital single-operator cholangioscopy (DSOC) allows the diagnosis of biliary duct disorders and treatment for complicated stones. However, these technologies have limitations such as the size of the probe and working channel, excessive cost, and low image resolution. Recently, a novel DSOC system (eyeMAX, Micro-Tech, Nanjing, China) was developed to address these limitations. We aimed to evaluate the usefulness and safety of a novel 9F and 11F DSOC system in terms of neoplastic diagnostic accuracy based on visual examination, ability to evaluate tumor extension and to achieve complete biliary stone clearance, and procedure-related adverse events (AEs). Patients and methods Data from ≥ 18-year-old patients who underwent DSOC from July 2021 to April 2022 were retrospectively recovered and divided into a diagnostic and a therapeutic cohort. Results A total of 80 patients were included. In the diagnostic cohort (n = 49/80), neovascularity was identified in 26 of 49 patients (46.9%). Biopsy was performed in 65.3% patients with adequate tissue sample obtained in 96.8% of cases. Biopsy confirmed neoplasia in 23 of 32 cases. DSOC visual impression achieved 91.6% sensitivity and 87.5% specificity in diagnosing neoplasms. In the therapeutic cohort (n = 43/80), 26 of 43 patients required lithotripsy alone. Total stone removal was achieved in 71% patients in the first session. Neither early nor late AEs were documented in either the diagnostic or therapeutic cohort. Conclusions The novel DSOC device has excellent diagnostic accuracy in distinguishing neoplastic biliary lesions as well as therapeutic benefits in the context of total stone removal, with no documented AEs.

Vascularity can distinguish neoplastic from non-neoplastic bile duct lesions during digital single-operator cholangioscopy

Efficacy of digital single-operator cholangioscopy and factors affecting its accuracy in the evaluation of indeterminate biliary stricture

A novel approach to common bile duct stone extraction

In clinical practice, standard endoscopic treatment of biliary stones fails in up to 10% of patients, and more invasive procedures such as percutaneous trans-hepatic interventions or surgery might become necessary. The aim of this multicenter retrospective study, based on prospectively-collected data, was to evaluate both the efficacy and the safety of digital-single operator cholangioscopy (D-SOC) to treat difficult biliary stones in cases with a previous failure of conventional endoscopic methods. Only patients with a previous failure of endoscopic standard treatment and a D-SOC-based biliary stone treatment using electrohydraulic lithotripsy (EHL) or laser lithotripsy (LL) were included. The primary endpoint was to evaluate the stone clearance rate per procedure and per patient. Out of 1258 ERCP performed at our centers, 31 cholangioscopes in 21 patients were solely performed for the treatment of difficult biliary stones using EHL or LL. A complete biliary stone removal was achieved in 67.7% (21/31) of all procedures including initial and repeated examinations, while in 35.4% (11/31) of all procedures an incomplete removal was accomplished of which 36.3% had a partial stone removal. In 22 procedures EHL was adopted as techniques to fragment and remove biliary stones, while in 9 procedures LL was used. In both the techniques, the complete stone removal rate and the incomplete stone removal rate were similar (75% vs. 77.7%, P>0.05). Furthermore, the success rate of digital D-SOC to treat difficult biliary stones was assessed per patient: overall, 100% of patients with difficult biliary stones were successfully treated using D-SOC. Only one patient experienced mild cholangitis classified ad mild adverse event following ASGE (American Society of Gastrointestinal Endoscopy) lexicon. Our data indicate that digital D-SOC assisted biliary stone treatment is highly efficient for the treatment of difficult biliary stones even in such patients in whom previous conventional endoscopic methods to treat biliary stones have failed. Therefore, D-SOC might be considered the new standard of care for these patients, being both, effective and safe.

We evaluated colonoscopic neoplastic yield (adenomas and cancers) in a rural endoscopic unit alongside several key performance indicators known to influence yield. A second aim was to compare neoplastic yield according to colonoscopic indication.Methods - We retrospectively audited 371 colonoscopies (163 male, 208 female) undertaken over six months (2007-2008) at the Mersey Hospital, Tasmania.ResultsCaecal intubation rate was 86.79% (males 90.8%, females 83.65%); bowel preparation judged as good (56.87%), fair (22.37%), poor (13.48%), not recorded (7.28%). Adenoma Detection Rate (ADR) was 11.86% (males 18.4%, females 6.7%). Inclusion of cancers - Significant Neoplastic Lesion Rate (SNL) was 15.9% (males 20.86%, females 12.02%). Mean withdrawal time to anus was 5.76 minutes with significantly higher ADR for 6-10, 11-15 and >15 minutes than 0-5 minutes (p<0.0001).SNL detection rates for major presenting indications were expressed as number needed to screen (NNS) with 95% confidence intervals (CI). Results: PR bleeding, NNS = 5, CI 3.45-7.69; Anaemia, NNS = 9.5, CI = 4-25; Abdominal Pain, NNS = 12.76, CI 5.26-33; Change in bowel habit, NNS = 6, CI 3.33-12.5; Family history colorectal cancer, NNS = 4.83, CI 3.03-8.33; Positive Faecal Occult Blood, NNS = 4.26, CI = 2.94-6.67, without significant sex differences amongst groups (p=0.5186)ConclusionsADR fell short of benchmark standards (25% males, 15% females); with slightly lower than recommended caecal intubation rate (e90%). Adequacy of bowel preparation was comparable to reference ranges. A statistically-significant trend between rapid withdrawal times and lower ADR was found, although caution should be exercised in interpretation.

Due to the need for improvement in the diagnosis and minimally invasive therapy of the bile duct disorders new technologies for cholangioscopy have been recently developed. Per-oral cholangioscopy has become an important diagnostic and therapeutic tool leading to avoidance of aggressive and unnecessary surgery in many clinical scenarios. This paper focuses on the newly developed SpyGlass DS technology, its advantages, and the technique of single-operator cholangioscopy (SOC), biliary indications and possible adverse events. We also review the available literature; discuss the limitations and future expectations. Digital SOC (D-SOC) is a useful technique, which provides endoscopic imaging of the biliary tree, optical diagnosis, biopsy under direct vision and therapeutic interventions. The implementations are diagnostic and therapeutic. Diagnostic indications are indeterminate biliary strictures, unclear filling defects, staging of cholangiocarcinoma, staging of ampullary tumors (extension into the common bile duct), unclear bile duct dilation, exploring cystic lesions of the biliary tree, unexplained hemobilia, posttransplant biliary complications. Therapeutic indications are lithotripsy of difficult stones, retrieval of migrated stents, foreign body removal, guide wire placement, transpapillary gallbladder drainage and endoscopic tumor ablative therapy. Most studied and established indications are the diagnosis of indeterminate biliary stricture and intraductal lithotripsy of difficult stones. The adverse events are not different and more common compared to those of Endoscopic retrograde cholangiopancreatography (ERCP) alone. D-SOC is a safe and effective procedure, adjunct to the standard ERCP and the newly available digital technology overcomes many of the limitations of the previous generations of cholangioscopes.

P042] Single operator cholangioscopy reduces patient radiation exposure in the management of difficult bile duct stones and indeterminate bile duct structures: A single center comparison study

Background:Digital single-operator cholangioscopy (DSOC) enhances biliary stricture diagnosis, but the collection of quality samples can be difficult due to the small diameter of the working channel.Objectives:A new DSOC system (EyeMAX™ 11Fr; Micro-Tech Endoscopy, Nanjing, China) with a 2.0-mm working channel, accommodating pediatric forceps (1.6 mm), has been introduced in France. This study reports on the first French experience.Design:A retrospective, multicenter observational study.Methods:The study on DSOC was conducted across five endoscopy units within the French Society of Private Hepato-Gastroenterology (SFHGL-CREGG). Satisfaction and procedural evaluations were recorded using a visual analog scale (VAS) and compared with the Spyglass™ DS II (Boston Scientific, Marlborough, MA, USA).Results:Among 28 patients, 71.5% had undergone prior endoscopic sphincterotomy. Indications were biliary strictures in 26 patients and lithiasis in 2. Strictures were located in the bile duct (41%) or hilum (59%). The mean satisfaction score was 8.69 out of 10, with the EyeMAX 11Fr rated as superior to the SpyGlass DS II in 86% of cases. The mean biopsy count was 8.52 in 13.19 min, with 100% procedural success. Pathology specimens were rich (24%), adequate (52%), low (12%), or absent (12%). Sensitivity for cholangiocarcinoma was 73.7% (14/19). Benign strictures regressed in all cases. Procedure-related complications included pain twice (7.1%), fever once (3.6%), infection once (3.6%), and pancreatitis twice (7.1%), all of which were resolved rapidly.Conclusion:This first study on the EyeMAX 11Fr DSOC highlights its ease of use, superior biopsy facilitation, and high user satisfaction, achieving 73.7% sensitivity for cholangiocarcinoma diagnosis.Trial registration:ClinicalTrials.gov ID: NCT06933576.

Digital single-operator cholangioscopy (DSOC) has revolutionized the endoscopic diagnosis and treatment of various hepato-pancreaticobiliary diseases, such as indeterminate biliary strictures and large balloon dilation-refractory common bile duct (CBD) stones, using either a retrograde or antegrade approach.1,2 Direct visualization provided by DSOC has furthermore paved the road towards minimally invasive treatment of intraductal neoplasms, although little evidence is available in this specific context. A 70-year-old patient was admitted following several episodes of colicky abdominal discomfort, mixed liver function abnormalities and non-intentional weight loss. Abdominal CT revealed predominantly extrahepatic bile duct dilation, after which EUS was performed, identifying a sessile obstructive intraductal lesion (Figure 1, left). ERCP subsequently confirmed presence of a distal polypoid lesion, which could be luxated out of the CBD using an extraction balloon (Figure 1, right). As intraductal extension was suspected and the exact dimensions could not be optimally evaluated, the patient was referred for DSOC. On introduction of the cholangioscope, a granulomatous sessile lesion was identified, without significant intraductal extension. The decision was made to remove the lesion using cholangioscopy-assisted cold snare resection. The polyp was dislocated into the duodenum using a dedicated cholangioscopy snare (Figure 2, left), followed by simple cold snare resection and complete removal of the lesion (Figure 2, right).

Animal model of bile duct dilatation created with minimally invasive surgery