Malignant Biliary Strictures Research Articles

S165 Differential Outcomes of ERCP in Malignant and Benign Biliary Strictures: A National Inpatient Sample Analysis

S165 Differential Outcomes of ERCP in Malignant and Benign Biliary Strictures: A National Inpatient Sample Analysis

COMPARATIVE OUTCOMES OF ERCP IN BENIGN VERSUS MALIGNANT BILIARY OBSTRUCTION

Background: The causes of biliary obstruction include choledocholithiasis, which is a non malignant condition, and malignant conditions like cholangiocarcinoma or pancreatic cancer. ERCP is a common procedure that is undertaken in diagnosing and managing these obstructions and depending on the type of obstruction, the results vary. Objectives: The purpose of this work is to assess the success rate, endoscopic modalities and complications of ERCP in cases of benign and malignant blockage of common bile duct. Study design : A prospective study Place and duration of study: July 2023 to December 2023 Jinnah Postgraduate Medical Centre, Karachi Gastroenterology Department. Methods: A prospective study was done in 100 patients of Biliary obstruction 50 benign and 50 malignant. After performing the ERCP on the patients, various factors were documented which include; success rate of the procedure, any adverse effects that may have occurred after the procedure and final results. Data analysis included using mean, standard deviation and ‘P’ value in order to determine the differences between the two groups. Results: In the benign group, the overall success rate of ERCP was 92 % and the overall complication rate was 8%. In the malignant group it was 78% of success and 18% complications. The length of the hospital stay was 3. 4 (±1. 1) for benign group and 5. 2 (±1. 5) days for the malignant group. There was found statistical significance of the complication rate difference, p=0. 03. Conclusions: ERCP is very beneficial in both primary benign and malignant biliary strictures, but patients with malignant strictures have greater complication rates and hospital stays than patients with benign strictures. Hence early management and rigorous screening of the patients involved will go a long way in ensuring better results are achieved.

Morphologic and molecular diagnostic criteria of malignancies in biliary strictures.

The differential diagnosis of benign and malignant biliary strictures is not always feasible and still represents a major diagnostic challenge, mainly due to the scarcity of the tissue retrieved for proper cytological or histopathological diagnosis. The present review focuses on morphological criteria in the diagnosis of biliary strictures, in the course of primary sclerosing cholangitis and other pathologies, starting from the limits of the cytological and histological evaluation, as well as the ancillary methodologies currently available in Pathology laboratories The current guidelines suggest fluorescence in situ hybridization for the analysis of chromosomes 3, 7, and 17 polysomies and deletion of the 9p21 locus; however, other more promising techniques are on the horizon for both patient care and research purposes, such as Next-Generation Sequencing, able to analyze multiple genes simultaneously in a cost-effective fashion. Lastly, the most recent approaches proposed in the literature for the differential diagnosis of biliary stricture are described, such as circulating tumor DNA, miRNAs, and DNA methylation, among others.

ThP6.2 - Benign and malignant biliary strictures encountered during single session laparoscopic cholecystectomy and bile duct exploration. Rationalising preoperative imaging and relying on routine cholangiography can optimise outcomes

Abstract Aim To review causes, diagnostic features and operative strategies of biliary strictures discovered on routine cholangiography (IOC) during single session treatment of bile duct stones. Methods A prospective database of cholecystectomies and bile duct explorations spanning 30 years was analysed. Cross sectional imaging and ERCP play a limited role in patients with confirmed gall stones except in suspected malignancies. Results 53/6140 patients (0.86%) had strictures on IOC.Malignant Strictures 27 (%)Benign strictures 26 (%)Females18 (66.6)12 (46)Age Median7262Emergency admission24 (88.8)15 (57.7)Presentation: Jaundice22 (81.5)15 (57.7)USS: GB Thick or contracted6 (22.2)4 (15.4)Bile duct dilatation16 (59.2)14 (53.8)Suspected CBD stones23 (85.2)24 (92.3)Preoperative imaging: MRCP1 (3.7)6 (23)CT6 (22.2)4 (15.4)ERCP1 (3.7)5 (19.2)Gall bladder conditionMucocele10 (37)3 (11.5)Acute/Empyema6 (22.2)4 (15.4)Contracted5 (18.5)9 (34.6)Cholangiography abnormality:Strictures + dilated ducts12 (44.4)22 (84.6)Dilated ducts/stones/no flow15 (55.5)4 (15.4)Bile Duct Exploration:Choledochotomy17 (63)10 (38.4)Transcystic5 (18.5)11 (42.3)NONE5 (18.5)5 (19.2)Choledochoscopy21 (77.7)20 (76.9)Biliary drains13 (48)18 (69)Stents9 (33.3)3 (11.5)Operative time (median)135 min135Open conversion1 Bilioenteric anastomosis0Morbidity4 (14.8)7 (26.9)Hospital stay median1413Postoperative ERCP11 (40.7)11 (42.3)Postoperative surgery322 year survival122 Conclusions Careful clinical assessment and exclusion of risk of malignancy optimises preoperative imaging and maximise benefits of single session management of suspected CBD stones.

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

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. 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. 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. 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.

Prophylactic endoscopic transpapillary gallbladder stenting to prevent acute cholecystitis induced after metallic stent placement for malignant biliary strictures: a retrospective study in Japan.

Endoscopic biliary drainage using self-expandable metallic stents (SEMSs) for malignant biliary strictures occasionally induces acute cholecystitis (AC). This study evaluated the efficacy of prophylactic gallbladder stents (GBS) during SEMS placement. Among 158 patients who underwent SEMS placement for malignant biliary strictures between January 2018 and March 2023, 30 patients who attempted to undergo prophylactic GBS placement before SEMS placement were included. Technical success was achieved in 21 cases (70.0%). The mean diameter of the cystic duct was more significant in the successful cases (6.5 mm vs. 3.7 mm, p<0.05). Adverse events occurred for 7 patients (23.3%: acute pancreatitis in 7; non-obstructive cholangitis in 1; perforation of the cystic duct in 1 with an overlap), all of which improved with conservative treatment. No patients developed AC when the GBS placement was successful, whereas 25 of the 128 patients (19.5%) without a prophylactic GBS developed AC during the median follow-up period of 357 days (p=0.043). In the multivariable analysis, GBS placement was a significant factor in preventing AC (hazard ratio, 0.61; 95% confidence interval, 0.37-0.99; p=0.045). GBS may contribute to the prevention of AC after SEMS placement for malignant biliary strictures.

Comparative performance of methylation DNA markers, brushing cytology, and FISH in diagnosing malignant biliary strictures.

Comparative performance of methylation DNA markers, brushing cytology, and FISH in diagnosing malignant biliary strictures.

Effect of modified biopsy forceps on the diagnosis of malignant biliary strictures: A randomized controlled trial.

Effect of modified biopsy forceps on the diagnosis of malignant biliary strictures: A randomized controlled trial.

Utility of methylated DNA markers for the diagnosis of malignant biliary strictures.

Early identification of malignant biliary strictures (MBS) is challenging, with up to 20% classified as indeterminants after preliminary testing and tissue sampling with endoscopic retrograde cholangiopancreatography (ERCP). We aimed to evaluate the use of methylated DNA markers (MDM) from biliary brushings to enhance MBS detection in a prospective cohort. Candidate MDMs were evaluated for their utility in MBS diagnosis through a series of discovery and validation phases. DNA was extracted from biliary brushing samples, quantified, bisulfite-converted, and then subjected to methylation-specific Droplet Digital Polymerase Chain Reaction (ddPCR). Patients were considered to have no malignancy if the sampling was negative and there was no evidence of malignancy after 1 year or definitive negative surgical histopathology. Fourteen candidate MDMs were evaluated in the discovery phase, with top-performing and new markers evaluated in the technical validation phase. The top four MDMs were TWIST1, HOXA1, VSTM2B, and CLEC11A, which individually achieved AUC values of 0.82, 0.81, 0.83, and 0.78, respectively, with sensitivities of 59.4%, 53.1%, 62.5%, and 50.0%, respectively, at high specificities for malignancy of 95.2-95.3% for the final biologic validation phase. When combined as a panel, the AUC was 0.86, achieving 73.4% sensitivity and 92.9% specificity, which outperformed cytology and fluorescent in situ hybridization (FISH). The selected methylated DNA markers demonstrated improved performance characteristics for the detection of MBS compared to cytology and FISH. ​ Therefore, MDMs should be considered viable candidates for inclusion in diagnostic testing algorithms.​.

Safety and effectiveness of consecutive 191 endoscopic ultrasonography-guided biliary drainage procedures: a single-center experience

&lt;b&gt;Background:&lt;/b&gt; The development of endoscopic ultrasonography (EUS) has enabled extra-anatomical transmural access to the bile ducts, thus making it possible to perform endoscopic biliary anastomoses with the gastrointestinal tract and obtain extra-anatomical transpapillary access. EUS provides an alternative to the existing methods of biliary drainage for cases in which endoscopic retrograde cholangiopancreatography (ERCP) is ineffective. Objective: This study aimed to evaluate the efficacy and safety of extraanatomical endoscopic biliary access methods for the treatment of benign and malignant biliary strictures.&lt;b&gt;Material and methods:&lt;/b&gt; This retrospective analysis included treatment results of all patients with obstructive jaundice and biliary strictures who were treated endoscopically in our department between 2016 and 2023. The study group comprised patients in whom EUS-guided transmural access was used during ERCP because of biliary strictures and the lack of transpapillary access.&lt;b&gt;Results:&lt;/b&gt; Twenty-eight patients (14.66%) underwent endoscopic transpapillary biliary stenting via a transmural approach under EUS guidance. The remaining 163 patients (85.34%) underwent extraanatomical transmural biliodigestive anastomosis. Technical success was achieved in 186 of 191 (97.38%) patients. Clinical success was achieved in 170 of 191 (89.01%) patients. Complications were reported for 32 of 191 (16.75%) patients, including fatal complications for 6 of 191 (3.14%) patients.&lt;b&gt;Conclusions:&lt;/b&gt; Advanced endoscopic techniques involving EUS-guided transmural access are effective and safe for biliary strictures. They provide an alternative to other drainage techniques when ERCP is ineffective and improve the quality of life of patients undergoing palliative treatment for biliary strictures with unresectable cancer of the biliopancreatic area.

False-negative factors of percutaneous transluminal clamp biopsy for suspected malignant biliary stricture: 194 cases analyzed from a single center

ObjectiveTo study the predictive factors of false negatives in the diagnosis of biliary stricture (BS) by percutaneous transluminal clamp biopsy (PTCB).MethodFrom January 2016 to January 2021, 194 patients with a high suspicion of malignant tumors due to BS underwent PTCB during biliary drainage at our department. The final diagnosis was confirmed by postoperative pathology, other tissue or cell evidence, or medical imaging follow-up. Univariate and multivariate regression analyses were performed on the pathological results, summarizing the independent risk factors for false-negative value (FNV) to help further clinical diagnosis and treatment.ResultsOf the 194 cases, 176 and 18 cases were finally diagnosed as malignant and benign BS, respectively, compared to 144 and 50 cases by PTCB, including 32 false-negative cases. The sensitivity, specificity, false-positive value, and FNV of PTCB were 81.8%, 100%, 0%, and 18.2%, respectively. Multivariate analysis showed that non-cholangiocarcinoma BS was an independent risk factor for FNV of PTCB (odds ratio 7.5 (95% CI 1.74–32.6), p < 0.01).ConclusionPTCB is an effective minimally invasive interventional technique for BS diagnosis. Non-cholangiocarcinoma BS is an independent risk factor for FNV.Critical relevance statementIdentifying factors that are predictive of false-negative results by percutaneous transluminal clamp biopsy in the setting of biliary stricture may have a guiding effect on clinical practice.Key points• Factors predictive of false negatives in the diagnosis of biliary stricture etiology by PTCB may aid in the interpretation of results.• Non-cholangiocarcinoma BS is an independent risk factor for FNV on PTCB.• PTCB is an effective minimally invasive interventional technique for BS diagnosis.Graphical

The efficacy of bile liquid biopsy in the diagnosis and treatment of biliary tract cancer.

Diagnosing biliary tract cancer is difficult because endoscopic retrograde cholangiopancreatography (ERCP) is performed fluoroscopically, and the sensitivity of bile cytology is low. Liquid biopsy of bile using targeted sequencing is expected to improve diagnosis and treatment, but few studies have been conducted. In this study, we examined whether liquid biopsy of bile improves the diagnostic sensitivity of biliary strictures. A total of 72 patients with biliary strictures who underwent ERCP at Chiba University Hospital between April 2018 and March 2021 were examined. Of these, 43 and 29 were clinically and pathologically diagnosed as having malignant and benign biliary strictures, respectively. We performed targeted sequencing of bile obtained from these patients, and the sensitivity of this method was compared with that of bile cytology. Detection of at least one oncogenic mutation was defined as having malignancy. The sensitivity of bile cytology was 27.9%, whereas that of genomic analysis was 46.5%. Comparing bile cytology alone with the combination of cytology and genomic analysis, the latter was more sensitive (53.5%, p < .001). Among the 43 patients with malignant biliary strictures, mutations with FDA-approved drugs were detected in 11 (26%). Liquid biopsy of bile can potentially diagnose malignancy and detect therapeutic targets.

Diagnostic Efficacy of a Novel Rotating Brush for Endoscopic Sampling of Malignant Biliary Strictures: A Multicenter Prospective Study.

Although cytologic examination of biliary stricture brushings obtained by endoscopic retrograde cholangiopancreatography is commonly used for diagnosing malignant biliary strictures (MBSs), it has low sensitivity. Several new brushes have capabilities that are still being debated. We have developed a novel brush working from conventional back-and-forth movement to rotation in situ (RIS) that may be more efficient for MBS sampling. We aimed to compare the MBS detection sensitivity of our RIS brush with that of the conventional brush. In this multicenter prospective study, we enrolled patients who underwent endoscopic retrograde cholangiopancreatography for suspected MBSs involving biliary stricture brushings obtained using our RIS brush. The historical control group consisted of the 30-brushing arm of our previous randomized trial (patient inclusion, 2018-2020) that used the study design in the same centers and with the same endoscopists as were used in this study. The primary outcome was to compare the sensitivity and specificity of detecting MBSs by cytologic evaluation of biliary stricture brushings between the 2 groups. We enrolled 155 patients in the intent-to-treat analysis. Using the same number of brushing cycles, the RIS brush showed a higher sensitivity than the conventional brush (0.73 vs 0.56, P = 0.003). In per-protocol population, the sensitivity was also higher in the RIS brush group than in the conventional brush group (0.75 vs 0.57, P = 0.002). Multivariate analysis revealed that the RIS brush was the only predictive factor for MBS detection. No significant differences were observed in procedure-related complications between the 2 groups. The RIS brush was a promising tool for effective and safe MBS sampling and diagnosis. Further randomized studies are warranted to confirm our results (Chictr.org.cn, identifier: ChiCTR2100047270).

Sequential comparison of two intraductal biliary brush cytology devices for suspected malignant biliary strictures

BackgroundThe diagnostic performance of endoscopic retrograde cholangiopancreatography brush cytology for malignant strictures is modest. A novel larger more abrasive brush may have improved diagnostic performance. We compared the utility of...

Adjuvant Radiofrequency Ablation Along With Stenting Versus Stenting Alone for Biliary Tree Drainage in Patients With Malignant Biliary Strictures: A Systemic Review and Meta-analysis.

This metanalysis aims to assess the efficacy and safety of biliary stenting along with radiofrequency ablation compared with stents alone to treat malignant biliary obstruction (MBO) due to extrahepatic biliary strictures secondary to cholangiocarcinoma, pancreatic cancer, and metastatic cancer. A systemic search of major databases through April 2022 was done. All original studies were included comparing radiofrequency ablation with stenting versus stenting alone for treating malignant biliary strictures. The primary outcomes of interest were the difference in the mean stent patency and overall survival (OS) days between the 2 groups. The secondary outcome was to compare the adverse events of the 2 groups. The mean difference in the stent patency and OS days was pooled by using a random-effect model. We calculated the odds ratio to compare the adverse events between the 2 groups. A total of 13 studies with 1339 patients were identified. The pooled weighted mean difference in stent patency was 43.50 days (95% CI, 25.60-61.41), favoring the RFA plus stenting. Moreover, the pooled weighted mean difference in OS was 90.53 days (95% CI, 49.00-132.07), showing improved survival in the RFA group. Our analysis showed no statistically significant difference in adverse events between the 2 groups OR 1.13 (95% CI, 0.90-1.42). Our analysis showed that RFA, along with stent, is safe and is associated with improved stent patency and overall patient survival in malignant biliary strictures. More robust prospective studies should assess this association further.

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

Background and study aimsThe 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 methodsRetrospective 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. ResultsA 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). ConclusionsSOCP 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.

A comparison of diagnostic utility of new endoscopic scraper combined cell block method and conventional brush catheter for biliary tract cancer.

The sensitivities of endoscopic trans-papillary pathologic diagnosis of biliary tract cancer (BTC) are unsatisfactory. Recently, the diagnostic utility of the endoscopic scraper device, Trefle for biliary stricture has been reported. The Trefle can be guided to the target biliary stricture over the guidewire and is as easy to use as the conventional brush catheter (CBC). This study evaluated the efficacy and safety of Trefle-assisted tissue acquisition combined cell block method and CBC cytology for biliary strictures due to BTCs. We retrospectively reviewed consecutive patients with biliary strictures in whom CBC cytology or Trefle-assisted tissue acquisition under endoscopic retrograde cholangiopancreatography was performed for suspected BTCs from January 2015 to June 2022 at our institution. 173 patients (CBC group; n = 55, Trefle group; n = 118) were enrolled in this study. The sensitivity, specificity, and accuracy of CBC cytology for BTC were 68.3%/100%/76.4%. On the other hand, the sensitivity, specificity, and accuracy of Trefle-assisted tissue acquisition for BTC were 93.7%/95.7%/94.1%, showing superior sensitivity (p < 0.001) and accuracy (p = 0.002) compared to that of CBC. Compared to CBC cytology, Trefle-assisted tissue acquisition has superior diagnostic performance while maintaining procedural simplicity and is considered useful for diagnosing malignant biliary stricture.

Use of endoscopic ultrasound-guided gallbladder drainage as a rescue approach in cases of unsuccessful biliary drainage.

This narrative review provides an overview of the utilization of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) as a salvage approach in cases of unsuccessful conventional management. EUS-GBD is a minimally invasive and effective technique for drainage in patients with acute cholecystitis with high risk of surgery. The procedure has demonstrated impressive technical and clinical success rates with low rates of adverse events, making it a safe and effective option for appropriate candidates. Furthermore, EUS-GBD can also serve as a rescue option for patients who have failed endoscopic retrograde cholangiopancreatography or EUS biliary drainage for relief of jaundice in malignant biliary stricture. However, patient selection is critical for the success of EUS-GBD, and proper patient selection and risk assessment are important to ensure the safety and efficacy of the procedure. As the field continues to evolve and mature, ongoing research will further refine our understanding of the benefits and limitations of EUS-GBD, ultimately leading to improved outcomes for patients.

Performance of biliary stents in malignant biliary strictures.

Endoscopic stenting is a commonly applied method of treatment in patients with malignant biliary strictures. It involves the use of self‑expandable metal stents (SEMSs) or plastic stents (PSs). The aim of the study was to compare the effectiveness of SEMSs and PSs in the endoscopic drainage of malignant strictures of the biliary tree and its sequels for future optimalization of this treatment method. Data on 618 consecutive patients with malignant biliary stricture, in whom 1271endoscopic retrograde cholangiopancreatography procedures with biliary stenting have been performed in the years 2012-2017 with at least 3‑year follow‑up, were retrospectively derived from a hospital database. The main indications for stenting were pancreatic cancer (37%) and cholangiocarcinoma (34%). The use of SEMSs resulted in a greater decline of serum bilirubin as compared with PSs (37% vs 32% of baseline concentration; P = 0.01). Consequently, hospital stay was shorter by more than 2 days (mean [SD], 9.5 [5.6] vs 11.8 [7.9] days; P <0.001). The median (interquartile range) patency time of SEMSs was more than 2 times longer than for PSs (118 [56-232] days vs 46 [18-97] days; P <0.001), and procedure‑related complications were less frequent (19.3% vs 12.9%, respectively in the SEMS and PS group; P = 0.001). SEMSs proved also to be more cost‑effective; the hospital profit was 1375 USD for a single hospitalization with SEMS insertion. In patients with malignant strictures of the biliary tree SEMSs outperform PSs. SEMSs should be used as a treatment of choice for biliary drainage in that group of patients.

A machine learning-based predictive model for biliary stricture attributable to malignant tumors: a dual-center retrospective study.

Biliary stricture caused by malignant tumors is known as Malignant Biliary Stricture (MBS). MBS is challenging to differentiate clinically, and accurate diagnosis is crucial for patient prognosis and treatment. This study aims to identify the risk factors for malignancy in all patients diagnosed with biliary stricture by Endoscopic Retrograde Cholangiopancreatography (ERCP), and to develop an effective clinical predictive model to enhance diagnostic outcomes. Through a retrospective study, data from 398 patients diagnosed with biliary stricture using ERCP between January 2019 and January 2023 at two institutions: the First People's Hospital affiliated with Jiangsu University and the Second People's Hospital affiliated with Soochow University. The study began with a preliminary screening of risk factors using univariate regression. Lasso regression was then applied for feature selection. The dataset was divided into a training set and a validation set in an 8:2 ratio. We analyzed the selected features using seven machine learning algorithms. The best model was selected based on the Area Under the Receiver Operating Characteristic (ROC) Curve (AUROC) and other evaluation indicators. We further evaluated the model's accuracy using calibration curves and confusion matrices. Additionally, we used the SHAP method for interpretability and visualization of the model's predictions. RF model is the best model, achieved an AUROC of 0.988. Shap result indicate that age, stricture location, stricture length, carbohydrate antigen 199 (CA199), total bilirubin (TBil), alkaline phosphatase (ALP), (Direct Bilirubin) DBil/TBil, and CA199/C-Reactive Protein (CRP) were risk factors for MBS, and the CRP is a protective factor. The model's effectiveness and stability were confirmed, accurately identifying high-risk patients to guide clinical decisions and improve patient prognosis.