Introduction

Single-operator cholangioscopy (SOC) has become an important diagnostic utility principally indicated for the diagnosis of indeterminate strictures of the biliary system and for the treatment of difficult biliary or pancreatic stone(s). However, SOC carries additional risks compared to standard endoscopic retrograde cholangiopancreatography.

Aims & Methods

We performed a retrospective analysis of all SOCs between 2015-2023 in three tertiary centres in Slovakia. The primary outcome was the frequency and severity of adverse events (AEs) after SOC according to the AGREE classification. The operating characteristics of the SOC to detect malignant lesions and treat lithiasis with electrohydraulic (EHL) or laser lithotripsy (LL) were also analysed.

Results

A total of 182 SOCs (180 peroral, 2 percutaneous) were performed in 149 patients (pts) [48,9 % female; mean age 59,8 years (range: 20 – 91)]. The main indications for SOC were determination of biliary strictures [92 (51%)] and removal of stones from the common bile duct or the intrahepatic duct stones [82 (45 %)] and pancreatic stone(s) [8 (4%)], whereas in 54% procedures EHL was used for the treatment of stones. Overall, AEs occurred in 14% (25/182); cholangitis 7% (Grade II), pancreatitis 6% (Grade I) and bleeding 1% (Grade II) according to AGREE. AEs occurred more frequently after diagnostic (14/25) compared to therapeutic procedures (11/25). There was no difference in overall AEs between EHL and LL, however, LL was associated with a higher single session disruption and shorter procedure time compared to EHL. Indeterminate stricture was evaluated in 56 non- PCS pts, while PSC stenosis was evaluated in 18 pts. A woman underwent simultaneously peroral and percutaneous SOC to disrupt 60 mm of stone in the same session. Tissue sampling was performed in 74 procedures, diagnostic accuracy for visual and histological assessment achieved 97.8% vs 83.2% respectively.

Conclusion

(1) SOC provides a high diagnostic yield in patients with undetermined biliary stenosis; (2) SOC guided stone lithotripsy was effective in most patients and (3) The most frequent complication was cholangitis in 7% of patients. Additionally, this is the first Slovak analysis of the efficacy and safety of SOC in clinical practice.

Disclosure

Nothing to disclose.

Introduction

Endoscopic retrograde cholangiopancreatography (ERCP), in surgically altered anatomy (SAA), can be challenging and the choice of the optimal technique remains debatable in clinical practice.

Aims & Methods

Aim of the study is to evaluate technical and clinical success of ERCP performed for biliopancreatic adverse events after pancreaticoduodenectomy (PD) using a wide caliber operative working channel (3.8 mm) pediatric colonoscope. It is a retrospective study conducted in a tertiary referral center. Patients who underwent ERCP between 01/02/2012 and 15/11/2022 for biliopancreatic complications after PD were included. Technical success was considered as effective endoscopic treatment of the specific complication including cannulation of pancreatico-jejunal or hepatico-jejunal anastomosis. Clinical success was considered as no need for rescue treatment (surgery or interventional radiology).

Results

During the period study, 129 patients (76 males, mean age 66 y.o., range 23-87 y.o.) underwent a total of 315 ERCP for endoscopic treatment of biliopancreatic complications after PD. The most frequent indications were biliary complications (78 patients, 60.4%, included 44 patients with anastomosis stricture, 27 patients with dehiscence and 7 patients with biliary stones), pancreatic complications (39 patients, 30.2%, included 10 patients with anastomosis strictures and 29 dehiscence) and other complications in the remaining 12 patients (6 patients with recurrence of neoplasia, 6 patients with bowel strictures). Timing between diagnosis of complication and ERCP was significantly shorter in septic patients than in the elective ones (p < 0.0001). In 78 patients (60.4%) ERCP has been performed with pediatric colonoscope; each patients underwent a mean of 2.6 ERCP (median 2 procedures). Concerning this group, anastomosis cannulation has been achieved directly in 69 patients and thanks to EUS-guided entero-enteral bypass approach in 9 patients and the procedure was performed with retrograde approach. Technical success, described as cannulation was obtained in 100% of cases. In 65/78 cases (83.3%) clinical success was obtained retrograde and in 13/78 cases (16.6%) technical success was obtained with anterograde EUS-guided approach: hepaticogastrotomy (6 cases), pancreaticogastrostomy (4 cases) and EUS-guided endoscopic drainage placement (3 cases).
Clinical success was 93,8% (121 patients). 8 patients experienced adverse events: 4 patients had recurrence of acute cholangitis and 4 patients needed rescue treatment (PTBD or surgical).

Conclusion

Endoscopic treatment for adverse events after PD achieved high technical and clinical success rates in tertiary referral centers with specific know-how in ERCP in surgically altered anatomy.

Introduction

Digital single-operator cholangioscopy (DSOC) allows an accurate diagnosis of biliary strictures. Two DSOC-based artificial intelligence (AI) models trained to identify neoplasia were proposed. DSOC-guided pCLE biliary strictures direct visualization, using the Miami and Paris classifications has demonstrated high diagnostic accuracy for neoplasia (higher than expert endoscopists at times). To date, there are no head-to-head studies comparing DSOC-AI vs DSOC-pCLE.

Aims & Methods

We aim to compare the diagnostic accuracy for identifying neoplasia in indeterminate biliary lesions using a novel DSOC-AI model against DSOC-pCLE. Historic cohort-based diagnostic accuracy study in agreement with STARD initiative including patients ≥18 years old who underwent DSOC-pCLE (06/2014 to 11/2021). Patients without available DSOC videos, biopsy, or impossibility for 12-month follow-up were excluded. For DSOC direct visualization, neovasculature constituted neoplasia. For DSOC-pCLE, a higher presence of the Miami classification’s malignancy criteria (thick white and dark bands, dark clumps, epithelium) than the Paris classification’s inflammatory criteria (vascular congestion, roughness aspect, increased inter-glandular space, and thickened reticular structure) constituted neoplasia. For DSOC and pCLE-guided biopsy, corresponding histological findings constituted neoplasia. An offline DSOC-based AI model analysis was performed using the DSOC recorded videos from the selected cases. The DSOC-AI model considered neovasculature as the criterion for neoplasia. The gold standard for neoplasia was based on further clinical evolution, imaging, or surgical specimen findings during a 12-month follow-up. Accuracy of DSOC direct visualization, DSOC-pCLE, DSOC and pCLE-guided biopsy, and DSOC-AI model was calculated in terms of sensitivity, specificity, positive and negative predictive values (PPV and NPV), observed agreement, and area under the curve (AUC). Comparison of obtained diagnostic accuracies were defined through DeLong’s test for two ROC curves.

Results

Ninety patients were selected, median age was 66.4 ± 13.7 years, 56.7% female. Tumour suspicion was the most common indication (55.6%) (Table 1). DSOC-AI reached a 97.7% sensitivity, 75% specificity, 98.8% PPV, 60% NPV and 96.7% observed agreement; whereas, DSOC-pCLE had a 94.2% sensitivity, a 100% specificity, 100% PPV, 44.4% NPV, and 94.4% observed agreement (Table 2). AUC for DSOC-AI was 0.79; for DSOC direct visualization (0.74; P=.763), DSOC-pCLE (0.72; P=.634), and DSOC and pCLE-guided biopsy (0.83; P=.809).

Conclusion

The DSOC-AI model demonstrated an offline diagnostic accuracy similar to DSOC-pCLE. Larger multicentric head-to-head trials with a proportional sample among neoplastic and non-neoplastic cases are advisable for best estimation of obtained results.

References

1. Koda H, Hara K, Nozomi O, Kuwahara T, Nobumasa M, Haba S, et al. High-Resolution Probe-Based Confocal Laser Endomicroscopy for Diagnosing Biliary Diseases. Clin Endosc. 2021;54(6):924–9.
2. Pilonis ND, Januszewicz W, di Pietro M. Confocal laser endomicroscopy in gastro-intestinal endoscopy: Technical aspects and clinical applications. Transl Gastroenterol Hepatol. 2022;7:1–20.
3. Kahaleh M, Raijman I, Gaidhane M, Tyberg A, Sethi A, Slivka A, et al. Digital Cholangioscopic Interpretation: When North Meets the South. Digestive Diseases and Sciences. 2021;67(4):1345–51.
4. Robles-Medranda C, Oleas R, Sánchez-Carriel M, Olmos JI, Alcívar-Vásquez J, Puga-Tejada M, et al. Vascularity can distinguish neoplastic from non-neoplastic bile duct lesions during digital single-operator cholangioscopy. Gastrointestinal Endoscopy. 2021;93(4):935–41.
5. Robles-Medranda C, Valero M, Soria-Alcivar M, Puga-Tejada M, Oleas R, Ospina-Arboleda J, et al. Reliability and accuracy of a novel classification system using peroral cholangioscopy for the diagnosis of bile duct lesions. Endoscopy. 2018;50(11):1059–70.
6. Sethi A, Tyberg A, Slivka A, Adler DG, Desai AP, Sejpal D v., et al. Digital Single-operator Cholangioscopy (DSOC) Improves Interobserver Agreement (IOA) and Accuracy for Evaluation of Indeterminate Biliary Strictures: The Monaco Classification. Journal of Clinical Gastroenterology. 2022;56(2).

Disclosure

Carlos Robles-Medranda is a key opinion leader and consultant for Pentax Medical, Steris, Medtronic, Motus, Micro-tech, G-Tech Medical Supply, CREO Medical, EndoSound, and mdconsgroup. The other authors declare no conflicts of interest.

Introduction

Single-operator cholangioscopy with SpyGlass™ DS Direct Visualization System (Boston Scientific Corp.) allows easier and more effective management of bilio-pancreatic diseases, with a relatively low rate of adverse events. Its main applications are the treatment of difficult biliary lithiasis and the diagnosis of indeterminate biliary strictures, although data confirming its efficacy are still limited. In the present study, we evaluated efficacy and safety of single-operator digital cholangioscopy in a secondary digestive endoscopy centre.

Aims & Methods

We retrospectively evaluated 113 consecutive patients undergoing SpyGlass™ DS cholangioscopy between February 2016 and September 2022 at our centre. Demographic and procedural characteristics and post-procedural outcomes were collected for the purpose of statistical analysis.

Results

A total of 126 SpyGlass™ DS procedures were performed on 113 patients (females 69, 61.1% - males 44, 38.9%) with a mean age of 73.4 ± SD 17 years. 92% of the patients underwent only one procedure, while the remaining 8% required 2 to 4 consecutive procedures. Indications were treatment of difficult biliary stones (85/126, 67.5%), diagnosis of indeterminate biliary strictures (30/126, 23.8%) and others (11/126, 8.7%). Holmium laser lithotripsy was the most frequently used (76/85, 89.4%). Complete clearance was achieved in almost all cases (80/85, 94.1%) with an average number of sessions of 1.05. The complete clearance rate at the first session was 93.75%.
40 diagnostic procedures were performed to characterise indeterminate biliary strictures, since diagnostic cholangioscopy was required for incidental biliary stricture in 10 patients who initially underwent lithotripsy. In 36/40 patients (90%) a stricture was confirmed and among these 72.2% required targeted biopsies with SpyBite™ forceps (21/36, 58.3% malignant biliary strictures - 15/36, 41.7% benign biliary strictures). The sensitivity, specificity and accuracy values at follow-up were 90%, 93% and 92% for the visual impression at cholangioscopic imaging and 86%, 100% and 88% for the histological examination of the targeted biopsy. A total of two cases of cholangioscopy-related adverse events were reported (2/126, 1.59%): one mild pancreatitis and one mild cholangitis.

Conclusion

The data obtained from our experience confirm the therapeutic and diagnostic value of digital single-operator cholangioscopy in the management of bilio-pancreatic diseases. Cholangioscopy-guided lithotripsy has been shown to have a high rate of complete clearance already at the first session. Regarding the management of indeterminate biliary stenosis, sensitivity of visual impression was superior to that of targeted biopsy; conversely, specificity of histological examination by targeted biopsy appeared superior. Prospective and multicentre studies would be advisable to consolidate the role of cholangioscopy in the management of bilio-pancreatic pathology.

Introduction

Digital single-operator cholangioscopy (DSOC) stands as an invaluable diagnostic and therapeutic instrument, offering direct visualization of the biliary ducts. The use of cholangioscopes with higher diameter may raise concerns regarding patient discomfort and safety. Smaller diameter cholangioscopes could offer enhanced maneuverability and decreased risk of adverse events, improving procedural success rates.

Aims & Methods

The aim of this study is to compare the impact of cholangioscope diameter variation on cholangioscopy outcomes, with a focus on procedure success rates. A retrospective, comparative study performed in patients who underwent either diagnostic or therapeutic DSOC from January 2021 to August 2023 were retrospectively collected. A p <0.05 was considered statistically significant.

Results

A total of 128 procedures were performed in 119 patients. Median age was 62.5 (44 – 71) and 46.1% were female. 52.3% of procedures were performed with the 9.3F cholangioscope, 53 (41.4%) were performed with the 11.1F, and 6.2% procedures were performed with the 7F cholangioscope. The 9.3F cholangioscope was used mainly for diagnostic procedures (61.2%) when compared to the 11.1F (39.6%) (P= .01). The most common diagnostic indication was indeterminate biliary stricture (9.3F: 31.3% vs 11.1F: 13.2%) (P= .01). Most lesions were in the common bile duct (CBD). Two procedures performed with the 9.3F scope switched to a lower caliber scope (7F) to surpass the lesions, while 4 procedures performed with 11.1F required the application of a 9.3F to surpass the lesions and finish the procedures (P=.176). The 9.3F allowed the evaluation of the intrahepatic ducts in 6 procedures. More therapeutic procedures were performed with the 11.1F cholangioscope (60.4%), while 38.8% with the 9.3F. The main indication was lithotripsy. Most procedures with a stone size >20mm were performed with the 11.1F (61%) (P=.01), with a total removal of stones of 64.5%. Technical success was higher in the 9.3F (97.0% vs 90.6%), clinical success was higher in the 11.1F (96.2% vs 94.0%). All cases performed with the 7F cholangioscope were diagnostic, 7/8 procedures with 7F allow a complete evaluation of the intrahepatic ducts, 1/8 had a complete post-surgical CBD stenosis, and achieved a 100% technical and clinical success rate.

Conclusion

Cholangioscope diameter should be tailored to the specific diagnostic or therapeutic needs. While the 9.3F cholangioscope is more suitable for diagnostic procedures and has a higher technical success rate, the 11.1F is preferable for therapeutic interventions, particularly for larger biliary stones where higher caliber lithotripter is required. The 7F cholangioscope presents an effective alternative for complete intrahepatic duct evaluations.

References

1. Gerges C, Beyna T, Tang RSY, et al. Digital single-operator peroral cholangioscopy-guided biopsy sampling versus ERCP-guided brushing for indeterminate biliary strictures: a prospective, randomized, multicenter trial (with video). Gastrointestinal Endoscopy. 2020;91(5):1105–13.
2. Kahaleh M, Gaidhane M, Shahid HM, et al. Digital single-operator cholangioscopy interobserver study using a new classification: the Mendoza Classification (with video). Gastrointestinal Endoscopy. 2022;95(2):319–26.

Disclosure

Carlos Robles-Medranda is a key opinion leader and consultant for Pentax Medical, Steris, Medtronic, Motus, Micro-tech, G-Tech Medical Supply, CREO Medical, EndoSound, and mdconsgroup. All other authors have nothing to declare.

Introduction

Cholangiocarcinoma (CCa) is a complex neoplasm with poor prognosis, classified as intrahepatic (iCCa), perihilar (pCCa), or distal (dCCa) in the bile duct. Its variable phenotypes pose diagnostic challenges. Digital single-operator cholangioscopy (DSOC) aids diagnosis but has limitations, including suboptimal biopsy sensitivity, lack of a standardized morphology classification, as well as technical issues. Emerging evidence highlights AI’s potential to enhance DSOC diagnostic capacity, but the differential performance according to tumor characteristics, namely its topography, remains unassessed.

Aims & Methods

This study aimed to evaluate an AI algorithm’s effectiveness in detecting iCCa, pCCa, and dCCa. A deep learning model based on a convolutional neural network (CNN) was designed to automatically predict the malignancy status of biliary strictures. The model was built using DSOC images from four international high-volume centers: Centro Hospitalar Universitário de São João (Porto, Portugal), Hospital Universitario Puerta de Hierro Majadahonda (Madrid, Spain), New York University Langone Hospital (New York, USA) and University of Chicago Medicine (Chicago, USA). Images showing strictures due to cholangiocarcinoma or benign conditions were included. The model was trained with a learning rate of 0.0001, a batch size of 32, and a number of epochs of 10, using PyTorch framework. The detection rate of the algorithm was compared for each location category.

Results

A total of 18166 images from 32 patients from 4 centers. A total of 22 patients were male (69%) and the mean age was 63 years (SD: 11 years). Common bile duct (CBD) strictures represented 44% of the total (n=14) while intrahepatic and perihilar accounted for 22% (n=7) and 34% (n=11), respectively. The algorithm’s DR of strictures representing CCa was 91.6% for iCCa, 89.4% for pCCa and 92.4% for dCCa. Pairwise comparisons revealed a significant difference in the DR for iCCa and pCCa (p<0.05) and dCCa and pCCa (p<0.001).

Conclusion

Topographic characteristics of biliary strictures influence the diagnostic performance of DSOC. While AI shows promise in improving the diagnostic capacity of DSOC, its performance is impacted by DSOC technical limitations. To our knowledge, this is the first multicentric and transatlantic algorithm, capable of providing detection and differentiation of morphologic features of biliary strictures. Developing models should address and control for these issues before widespread clinical integration. Additionally, this evidence stresses the importance of keeping a “human on the loop”, providing clinical reasoning to guide the application of AI algorithms.

Introduction

The evaluation of intraductal extension of perihilar cholangiocarcinoma (pCCA) is extremely challenging and affects the resectability of the disease. Digital Single-Operator Cholangioscopy (D-SOC) and D-SOC-guided biopsies are frequently used for diagnostic assessment of indeterminate biliary strictures.

Aims & Methods

In this study, we evaluated the role of D-SOC and D-SOC-guided biopsies in the pre-operative evaluation of intraductal extension of pCCA. We retrospectively analysed pCCA patients who underwent D-SOC and D-SOC-guided biopsies to assess the intraductal extension of the tumor prior to surgery for potentially resectable disease in our center between 2017 and 2021. The accuracy of endoscopic appearance and histological sampling were compared to surgical samples obtained at surgery.

Results

Among 48 patients who underwent surgery for pCCA, after multidisciplinary discussion, D-SOC and D-SOC-guided biopsies were performed for proximal biliary staging in 6 patients (M:F 5:1, mean age at diagnosis 67 y.o.), which had an unclear ductal extension. A total of 12 D-SOC -guided biopsies were performed (7 from common duct, 2 from right duct and 3 from left duct). Concordance between CS-guided biopsies and surgical samples histological evaluation was 83% (10/12), with 6/6 true positives, 4/6 true negatives and 2/6 false negatives. Among the histological false negatives, the first case had a cholangioscopic appearance compatible with CCA extension, thus the result of D-SOC-guided biopsies did not influence the therapeutic choice. In the second histological false negative, the evaluation of the surgical specimen showed perineural invasion and periductal tumor development. Radical surgery was achieved in all 6 patients.

Conclusion

Despite limited sample size, our preliminary data suggest a very high specificity of D-SOC and D-SOC -guided biopsies in the pre-operative evaluation of intraductal extension of potentially resectable pCCA patients. A multidisciplinary approach and an accurate pre-operative assessment of pCCA remain of paramount importance to correctly diagnose and stage the disease before surgery.