Introduction

Magnetic resonance cholangiopancreatography (MRCP) has continuously evolved to enhance visualization capabilities. However, diagnosing biliary ductal system pathology, particularly early Primary sclerosing cholangitis (PSC), remains challenging.

Aims & Methods

This study investigates the influence of intramuscular glucagon (IMG) administration on final image quality and pancreato-biliary ductal system diameter in MRCP.
Forty patients (57.5% female; average age 34.45 ± 8.2) referred for Magnetic Resonance Enterography (MRE) underwent MRCP before and 8-12 minutes after IMG administration. Coronal T2-weighted fast spin-echo high-resolution 3D MRCP images were analyzed quantitatively and qualitatively by two independent MRI specialists. Quantitative assessments included transverse diameter measurements of 5 predefined biliary ductal (CBD, LHD, RHD…) and 3 pancreatic duct segments (head, body, tail). Qualitative evaluation used a five-point Likert-type scale (1=perfect visualization; 5=not visible) for the respective predefined segments. Interobserver variation was assessed using the Intraclass Correlation Coefficient (ICC).

Results

Following IMG administration, the diameters of all corresponding biliary and pancreatic segments significantly increased, with consistently strong interobserver agreement demonstrated pre and post IMG administration. Moreover, in qualitative analysis, post-IMG administration scores indicated a significant decrease (P < 0.01) in visualization scores, signifying improved visualization at all corresponding points for both radiologists compared to the pre-glucagon administration scores. The ICC scores pre and post IMG administration demonstrated moderate to strong agreement.

Conclusion

IMG administration improves MRCP imaging parameters by increasing ductal diameters and enhancing biliary tree visualization, underscoring its potential to aid in the detection of subtle or early pathological changes.

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

Laparoscopic cholecystectomy (LC) is one of the most performed surgeries worldwide. Biliary tract injuries are among the most feared complications after LC. The primary cause of biliary injuries during LC is the incorrect identification of the biliary tract anatomy. Near-infrared fluorescence (NIRF) imaging, following intravenous (IV) injection of indocyanine green (ICG), shows promise for simplifying the intraoperative visualization of biliary anatomy. This technique enables real-time identification of the cystic duct and common bile duct, potentially enhancing the outcomes of LC. This systematic review and meta-analysis aimed to investigate the effects of NIRF-ICG on LC outcomes.

Aims & Methods

This meta-analysis followed the Cochrane Handbook for Systematic Reviews of Interventions guidelines. We searched PubMed, Embase, Cochrane Library, Web of Science, and Scopus until May 23^rd, 2024. We included randomized-controlled trials and retrospective studies comparing NIRF-ICG LC and conventional LC. Statistical analysis was performed using Review Manager 5.3 software.

Results

Fifteen studies with 1581 patients (41.1%) in the NIRF-ICG group and 2264 (58.9%) in the control group were included. The NIRF-ICG was associated with statistically significant reduced overall complications, bile leakage, and duct drainage (risk ratio (RR) = 0.62, 95% CI: [0.40, 0.95], P = 0.03; Fig 1), (RR = 0.34, 95% CI: [0.14, 0.83], P = 0.02; Fig 2), and (RR = 0.64, 95% CI: [0.44, 0.91]), P = 0.01; Fig 3), respectively. Common bile duct (CBD), cystic duct- CBD junction, and common hepatic duct visualization rates were better with the NIRF-ICG, (RR= 3.67, 95% CI: [2.62, 5.15], P < 0.001), (RR = 3.00, 95% CI: [2.03, 4.43], P < 0.001), and (RR = 2.87, 95% CI: [1.94, 4.25], P < 0.001), respectively. There was no significant difference in cystic duct visualization rate (RR = 1.40, 95% CI: [0.71, 2.78], P = 0.33).

Conclusion

NIRF following administration of ICG in LC offers better visualization of biliary tract anatomy and is associated with reduced overall complications, bile leakage, and bile duct drainage.

References

1. J. Van Den Bos et al., “Near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy (FALCON): an international multicentre randomized controlled trial,” Surg Endosc, vol. 37, no. 6, pp. 4574–4584, Jun. 2023, doi: 10.1007/s00464-023-09935-6.
2. W. H. She et al., “Routine use of ICG to enhance operative safety in emergency laparoscopic cholecystectomy: a randomized controlled trial,” Surg Endosc, vol. 36, no. 6, pp. 4442–4451, Jun. 2022, doi: 10.1007/s00464-021-08795-2.
3. J. K. Koong, G. H. Ng, K. Ramayah, P. S. Koh, and B. K. Yoong, “Early identification of the critical view of safety in laparoscopic cholecystectomy using indocyanine green fluorescence cholangiography: A randomised controlled study,” Asian Journal of Surgery, vol. 44, no. 3, pp. 537–543, Mar. 2021, doi: 10.1016/j.asjsur.2020.11.002.

Introduction

Pruritus associated with primary biliary cholangitis (PBC) affects sleep and, social and emotional wellbeing. The impact of itch severity on quality of life (QoL) using the EuroQol-5-Dimension 5-Level (EQ-5D-5L) health utility score was explored and quantified in a post hoc analysis of the Phase 2b GLIMMER study of linerixibat for the treatment of pruritus in PBC (NCT02966834). Pruritus (particularly severe pruritus) was previously found to have a significant negative impact on QoL and health utility: mean (standard deviation [SD]) baseline utility was 0.69 (0.23); patients with mild or moderate pruritus at baseline had similar utilities (0.75 [0.17] and 0.76 [0.17], respectively) whereas patients with severe pruritus at baseline had notably worse utility (0.49 [0.28]).

Aims & Methods

Here we look in detail at factors impacting QoL in patients with PBC and pruritus. Patients in GLIMMER completed the EQ-5D-5L and Beck Depression Inventory (BDI-II) at baseline, which followed a 4-week single-blind placebo run-in period. EQ-5D-5L is a generic, standardised and simple health-related QoL instrument. Scores range from 1 “perfect health” to 0 “death”. BDI is a 21-item, self-rated scale that evaluates key symptoms of depression. An overall score of 0–9 is classed as minimal depression, 10–18 mild, 19–29 moderate, and 30–63 severe depression. Patients were classified as having mild (<4, at baseline all mild were ≥3 to <4), moderate (≥4 to <7) or severe pruritus (≥7 to 10) using the mean worst daily itch score. Sleep disturbance severity was based on the same numerical rating scale thresholds as those used for pruritus.

Results

There were striking associations between itch severity, sleep disturbance and health utility, and between itch severity, depression and health utility. Overall mean (SD) health utility was highest in those with mild sleep disturbance 0.83 (0.126). Those with severe sleep disturbance had a much lower score and those with severe itch and severe sleep disturbance even lower (0.52 [0.30] and 0.47 [0.31], respectively). For patients with mild itch, 60% had mild sleep disturbance; the remaining 40% of patients had moderate sleep disturbance. In patients with severe itch, 34% experienced moderate sleep disturbance, while 66% had severe sleep disturbance. Thus, no patients with mild itch had severe sleep disturbance and no patients with severe itch had mild sleep disturbance. As might be expected, health utility was lower with worse depression; from 0.81 (0.18) with minimal depression to 0.39 (0.31) for those with severe depression; amongst those with moderate or severe depression the incremental impact of severe pruritus on health utility was striking, with utilities of 0.32 and 0.26, respectively. In mild and moderate itch, the distribution of depression severity was similar, with over 80% having minimal or mild depression. However, in the group with severe itch, 49% had moderate or severe depression.

Conclusion

Pruritus in PBC significantly impacts QoL. Severe sleep disturbance and moderate and severe depression were far more common in patients with severe pruritus. In patients suffering with both severe pruritus and moderate to severe depression, health utility was severely impaired.
Funding: GSK (201000).
Encore statement: This abstract was previously presented at the European Association for the Study of the Liver (EASL) 2023 congress, held 21–24 June, 2023. This encore is presented on behalf of the original authors with their permission.

References

N/A

Disclosure

HTS, MMM, AR, and PJFT are employees of, and hold shares in GSK. SD is an employee of GSK. AEK has received grant/research support from Intercept Pharmaceuticals and provided paid consultancy for AbbVie, Bristol Myers Squibb, CymaBay Therapeutics, Eisai, Escient, Falk, Gilead, GSK, Intercept Pharmaceuticals, Janssen, Lilly, Mirum, MSD, Vifor, Zambon. DJ has received grant/research support from GSK, Intercept Pharmaceuticals, Falk, Pfizer, Abbott, Novartis.

Introduction

Endoscopic retrograde cholangiopancreatography /ERCP/ is the standard technique in the treatment of unresectable malignant biliary obstruction/MBO/, unfortunately, a failure rate of 3% up to 12 % and a rate of complications up to 6,85% have been reported in the literature. Endoscopic ultrasound-guided biliary drainage/EUS – BD/ is a feasible alternative for biliary drainage, applicable especially with surgically altered anatomy. With several techniques available, hepaticogastrostomy /EUS - HGS/ and choledochoduodenostomy/EUS - CDS/ are most commonly performed amongst them.

Aims & Methods

To compare the most commonly used techniques for endoscopic ultrasound-guided biliary drainage in terms of efficacy and safety.
Methods:Retrospective analysis of a prospective database of patients undergoing EUS -BD in a single tertiary referral center. EUS–BD was performed after the failure of ERCP or as a first choice of drainage procedure in patients with altered anatomy. 102 patients were included in the EUS-HGS group 94,12%(n=96) with malignant biliary obstruction and 5.12%(n=6) with benign underlying disease. Of 24 patients included in the EUS–CDS group 95,83% (n=23) had underlying malignancy against one patient with benign disease.

Results

Considering the application of EUS – BD as a first choice of drainage procedure for patients with surgically altered anatomy we had 46 patients in the HGS group (45.1%) against 16.67%(n=4) for the CDS group. In 56/44,44%/ cases EUS BD was performed during the same session after unsuccessful cannulation. Evaluating results in terms of technical success rate, defined as successful stent placement – we found a 98,04 % success rate for the EUS-HGS group and 95,83% in the EUS–CDS group. We defined clinical success as a drop in the bilirubin levels by one-half in the first week following the procedure. The results between the two groups were not significantly different - 80.46% for the HGS against 80,95% for the CBS group. Concerning adverse events during the procedure, we found a ratio of 7.84% for the patients undergone HGS and 4,76% for EUS – CDS with no significant difference. The most common AE found was proximal stent misdeployment/n=3/. All of the events were managed either conservatively or during the same session with the placement of fully covered SEMS. Concerning early AE /during the first 7 days / we experienced 14,71% early adverse events in the HGS group/n=15/ and 16,67% /n=4/ in the CDS group with most common event postprocedure infection with no significant difference.

Conclusion

The two most common transluminal techniques for EUS biliary drainage - HGS and CDS are a promising tool with comparable technical and clinical success rates, adverse events, and overall survival. Both procedures are valid alternatives after failed ERCP or as a first step especially in patients with surgically altered anatomy.

Introduction

Indeterminate biliary strictures pose a significant diagnostic challenge, as they can result from a wide spectrum of both benign and malignant conditions. Differentiating between these is crucial due to different management strategies. Conventional methods like endoscopic retrograde cholangiopancreatography (ERCP) with brush cytology have limited sensitivity, often leading to repeated procedures and delays in treatment. Peroral cholangioscopy (POC) offers direct bile duct visualization and targeted biopsies, improving diagnostic accuracy. Modern systems, like the SpyGlass™ DS, enhance procedure feasibility and image quality.

Aims & Methods

Aims: The aim of our study is to assess the effectiveness of single-operator peroral cholangioscopy system (POCS) with its digital version SpyGlass^TM Direct Visualization System with SpyBite biopsies as a promising modality for accurate diagnosis of biliary strictures.
Method: We performed a two-center retrospective analysis of prospective database from March 2019 to March 2025. Each patient underwent peroral cholangioscopy using SpyGlass^TM Direct Visualization System with SpyBite biopsies for the diagnosis of indeterminate biliary strictures.

Results

We identified 162 patients who underwent peroral cholangioscopy during the study period (96 males and 66 females). The medium age of the patients was 63.04 years. There was 100 % technical success of the procedure. All patients underwent POCS due to indeterminate biliary strictures. Before the procedure CT scan was performed and positive for biliary stenosis in 115 (70.9%) of the cases. The biliary stenoses were located as follows: 20 (12.3%) in the distal common bile duct, 29 (17.9%) in the proximal common bile duct, 102 (62.9%) at the hepatic hilum and 11 (6.7%) in the intrahepatic bile ducts.
Benign disease was diagnosed in 39 (24.07 %) of the patients. Visual impression for malignant desease (at least one of the following- tortuous dilated vessels, friability and easily bleeding, infiltrative stricture, polipoid mass, nodular eleveted lesion, vegetative mass, fish-egg lesion, finger - like villiform lesion and irregular papillary or granular lesion) was found in 123 (75.9%) of the patients. The most reliable correlation with malignancy was found to be the presence of infiltrative strictures - 113 (69.7%) patients. A final diagnosis of cholagiocarinoma was established in 84
(51.8%) of them. In 39 (24.07%) patients, no tumor cells were found in the specimen. Visual impression accuracy with SpyGlass was 100% (with 100% sensitivity and 100% specificity). SpyBite biopsies accuracy was 69.05 % (with 68. 3% sensitivity and 100% specificity).

Conclusion

POC has proven valuable in evaluating indeterminate biliary strictures, offering advantages over ERCP by allowing real-time visualization and targeted biopsies. Our study supports POC's superior accuracy, especially in identifying malignant lesions, with visual impression achieving up to 100% sensitivity and specificity. However, POC adoption is limited by operator expertise, the need for standardized interpretation, and availability. While adverse events are rare (<10%), careful patient selection is essential. In conclusion, POC holds substantial promise as a key diagnostic tool for indeterminate biliary strictures, with ongoing improvements enhancing its clinical role.

Disclosure

No conflict of interest

Introduction

Endoscopic Retrograde Cholangiopancreatography (ERCP) is pivotal in managing complex biliary strictures due to various causes like Cholangiocarcinoma (CCA), Primary Sclerosing Cholangitis (PSC), and mass-related intrahepatic strictures. Traditional ERCP relies on two-dimensional (2D) X-ray imaging, which often presents challenges in accurately localizing and selectively cannulating specific intrahepatic ducts. This study aims to assess the feasibility and effectiveness of three-dimensional (3D) fluoroscopic ERCP in diagnosing and treating complex biliary strictures.

Aims & Methods

We conducted a prospective pilot study, approved by the Institutional Review Board. Adult patients scheduled for ERCP for complex biliary strictures were enrolled. Exclusions included inability or unwillingness to consent, existing percutaneous biliary drainage, or unfeasible selective trans-papillary biliary cannulation.
Performance of 3D ERCP Patients were positioned on a 3D fluoroscopic table. ERCP followed standard protocols, with high-volume contrast injections opacifying bile ducts. After achieving full biliary tree opacification, a balloon was inflated in the distal bile duct in preparation for 3D imaging. To minimize radiation exposure to staff, the endoscope was fixed in a holder, and the room was evacuated before 3D image acquisition. These images were reconstructed to produce detailed 3D visuals of the target area, aiding real-time therapeutic maneuvers like selective intrahepatic duct cannulation.
Data Collection and Analysis Data included continuous variables (mean ± standard deviation) and categorical variables (percentages). Radiation exposure was quantified separately for ERCP and 3D reconstruction, using thermoluminescent dosimeters. Results were reported as Effective Surface Dose (ESD) in mGY and Dose Area Product in mGY.cm^2.

Results

Eighteen patients (median age 66.6) underwent 3D ERCP. 40% had a malignant biliary structure etiology, with 50% showing both intrahepatic and extrahepatic bile duct involvement. 3D reconstruction facilitated successful selective wire cannulation in 80% of cases, previously unachievable with conventional ERCP. One case provided crucial imaging for liver resection planning. The additional radiation dose was 16.44 mGY.cm².

Conclusion

This pilot study proves the feasibility of 3D ERCP in managing complex biliary strictures. This first-of-its-kind study highlights the utility of 3D reconstruction in ERCP. While significantly aiding selective intrahepatic duct cannulation and surgical planning for cholangiocarcinoma resections, it doubles the procedure's radiation exposure, potentially raising cancer risk to 1 in 1000. However the dose needed is significantly lower the IR guided biliary interventions.Further larger studies are required to evaluate the clinical efficacy of 3D ERCP.