EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial).

BACKGROUND & AIMS: Several studies have compared primary endoscopic ultrasound (EUS)-guided biliary drainage to endoscopic retrograde cholangiopancreatography (ERCP) with insertion of metal stents in unresectable malignant distal biliary obstruction (MDBO) and the results were conflicting. The aim of the current study was to compare the outcomes of the procedures in a large-scale study. METHODS: This was a multicenter international randomized controlled study. Consecutive patients admitted for obstructive jaundice due to unresectable MDBO were recruited. Patients were randomly allocated to receive EUS-guided choledocho-duodenostomy (ECDS) or ERCP for drainage. The primary outcome was the 1-year stent patency rate. Other outcomes included technical success, clinical success, adverse events, time to stent dysfunction, reintervention rates, and overall survival. RESULTS: Between January 2017 and February 2021, 155 patients were recruited (ECDS 79, ERCP 76). There were no significant differences in 1-year stent patency rates (ECDS 91.1% vs ERCP 88.1%, P = .52). The ECDS group had significantly higher technical success (ECDS 96.2% vs ERCP 76.3%, P < .001), whereas clinical success was similar (ECDS 93.7% vs ERCP 90.8%, P = .559). The median (interquartile range) procedural time was significantly shorter in the ECDS group (ECDS 10 [5.75-18] vs ERCP 25 [14-40] minutes, P < .001). The rate of 30-day adverse events (P = 1) and 30-day mortality (P = .53) were similar. CONCLUSION: Both procedures could be options for primary biliary drainage in unresectable MDBO. ECDS was associated with higher technical success and shorter procedural time then ERCP. Primary ECDS may be preferred when difficult ERCPs are anticipated. This study was registered to Clinicaltrials.gov NCT03000855.

Percutaneous insertion of long-covered biliary stents in patients with malignant duodenobiliary stricture.

OBJECTIVE: To investigate the technical feasibility, safety, and efficacy of a long-covered biliary stent in patients with malignant duodenobiliary stricture. METHODS: This retrospective study enrolled 57 consecutive patients (34 men, 23 women; mean age, 64 years; range, 32-85 years) who presented with malignant duodenobiliary stricture between February 2019 and November 2020. All patients were treated with a long (18 or 23 cm)-covered biliary stent. RESULTS: The biliary stent deployment was technically successful in all 57 patients. The overall adverse event rate was 17.5% (10 of 57 patients). Successful internal drainage was achieved in 55 (96.5%) of 57 patients. The median patient survival and stent patency times were 99 days (95% confidence interval [CI], 58-140 days) and 73 days (95% CI, 60-86 days), respectively. Fourteen (25.5%) of the fifty-five patients presented with biliary stent dysfunction due to sludge (n = 11), tumor overgrowth (n = 1), collapse of the long biliary stent by a subsequently inserted additional duodenal stent (n = 1), or rapidly progressed duodenal cancer (n = 1). A univariate Cox proportional hazards model did not reveal any independent predictor of biliary stent patency. CONCLUSIONS: Percutaneous insertion of a subsequent biliary stent was technically feasible after duodenal stent insertion. Percutaneous insertion of a long-covered biliary stent was safe and effective in patients with malignant duodenobiliary stricture. CLINICAL RELEVANCE STATEMENT: In patients with malignant duodenobiliary stricture, percutaneous insertion of a long-covered biliary stent was safe and effective regardless of duodenal stent placement. KEY POINTS: • Percutaneous insertion of long-covered biliary stents in patients with malignant duodenobiliary stricture is a safe and effective procedure. • Biliary stent deployment was technically successful in all 57 patients and successful internal drainage was achieved in 55 (96.5%) of 57 patients. • The median patient survival and stent patency times were 99 days and 73 days, respectively, after placement of a long-covered biliary stent in patients with duodenobiliary stricture.

Factors Associated With Difficult Endoscopic Ultrasonography-guided Biliary Drainage.

BACKGROUND AND AIMS: When endoscopic retrograde cholangiopancreatography-guided biliary drainage is challenging, endoscopic ultrasound-guided biliary drainage (EUS-BD) can be used as an alternate treatment; however, this method requires operator expertise. Therefore, this study aimed to clarify the factors that are associated with a difficult EUS-BD. PATIENTS AND METHODS: Patients who successfully underwent EUS-BD were enrolled in this study. The patients were divided into the easy group and difficult group depending on whether the procedural time was more than 60 minutes, which was the cutoff value elicited from past reports. Patient characteristics and procedural factors were compared between the two groups. The factors associated with difficult procedures were also investigated. RESULTS: The patient characteristics were not significantly different between the easy group (n=22) and the difficult group (n=19). The diameter of the punctured bile duct was significantly different between the two groups. In the multivariate analysis, the diameter of the punctured bile duct was the only factor associated with a difficult EUS-BD (odds ratio 0.65, 95% confidence interval 0.46-0.91, P value=0.012). The cutoff value for the diameter of the punctured bile duct in predicting a difficult EUS-BD was 7.0 mm (area under the curve: 0.83, sensitivity 84.2%, specificity 86.4%). CONCLUSIONS: A nondilated bile duct might be a predictive factor for a difficult EUS-BD. For beginners of EUS-BD, the cutoff value for the punctured bile duct diameter found in this study, 7.0 mm, might become a barometer for puncture point selection.

Elastography for Evaluation of Regression in Liver Fibrosis After Surgical Biliary Drainage for Benign Biliary Strictures: A Practical Possibility?

BACKGROUND: Hepatic fibrosis and secondary biliary cirrhosis are consequences of long-standing benign biliary strictures. Evidence on the reversibility of fibrosis after the repair is incongruous. METHODOLOGY: A prospective observational study on patients who underwent Roux-en-Y hepaticojejunostomy for benign biliary stricture. A liver biopsy was performed during repair and correlated with preoperative elastography. The improvement in liver functions and regression of fibrosis was compared with preoperative liver function tests and elastography. RESULTS: A Total of 47 patients [mean age-38.9 y (Range: 21 to 66)] with iatrogenic benign biliary stricture were included. A strong female preponderance was noted. High strictures (type III and IV) comprised 72.7% of the study group. The median interval (injury to repair) was 7 months (2 to 72 mo). The median duration of jaundice was 3 months (1 to 20 mo). Both factors had a significant correlation with the stage of fibrosis ( P =0.001 and P =0.03, respectively). Liver biopsy revealed stage I, II, III, and IV fibrosis in 26 (55.3%), 11 (23.4%), 2 (4.3%), and 2(4.3%), respectively. The remaining 6 (12.8%) had no fibrosis. The severity of fibrosis had a good correlation with preoperative liver stiffness measurement-value on FibroScan. Significant improvement in liver function tests (bilirubin-3.55±3.48 vs. 0.59±0.52; Albumin-3.85±0.61 vs. 4.14±0.37; ALP-507.66±300.65 vs. 167±132.07; P value 0.00) and regression of fibrosis (liver stiffness measurement; 10.42±5.91 vs. 5.85±3.01, P value 0.00) was observed after repair of the strictures. CONCLUSION: Improved biliary function and regression of liver fibrosis can be achieved with timely repair of benign biliary stricture and it is feasible to be evaluated using elastography.

Endoscopic ultrasound-guided hepaticoduodenostomy versus percutaneous drainage for right intrahepatic duct dilatation in malignant hilar obstruction.

BACKGROUND AND AIM: Endoscopic ultrasound (EUS)-guided biliary drainage is being increasingly performed as an alternative to percutaneous transhepatic biliary drainage (PTBD) to treat malignant hilar obstruction (MHO) after failed endoscopic retrograde cholangiopancreatography (ERCP). However, no study has compared EUS-guided hepaticoduodenostomy (EUS-HDS) with PTBD for right intrahepatic duct (IHD) obstruction after failed ERCP in patients with unresectable MHO. METHODS: We retrospectively reviewed the data of consecutive patients with right IHD obstruction developed by unresectable MHO who underwent EUS-HDS or PTBD after a previous placement of a stent in the left and/or right IHD between March 2018 and October 2021. Technical success, clinical success, stent or tube-related adverse events, frequency of reintervention, and stent patency were evaluated. RESULTS: A total of 42 patients (18 EUS-HDS, 24 PTBD) were analyzed. Both groups did not show significant differences in technical success (EUS-HDS, 94% vs PTBD, 100%; P = 0.429), clinical success (83% vs 83%; P = 0.999), early adverse events (24% vs 46%; P = 0.144), and stent or tube-related late adverse events (29% vs 54%; P = 0.116). During follow-up, the EUS-HDS group had a longer median duration of patency (131 days vs 58.5 days; P = 0.041), and lower mean frequency of reinterventions per patient (0.35 vs 1.92; P = 0.030) than the PTBD group. CONCLUSIONS: EUS-HDS showed comparable efficacy and safety to PTBD for drainage of the right biliary system and produced longer duration of patency and lower frequency of reinterventions in patients with unresectable MHO.

A Novel Method of Calculating the Drained Liver Volume Using a 3D Volume Analyzer for Biliary Drainage of Unresectable Malignant Hilar Biliary Obstruction.

OBJECTIVES: In patients with unresectable malignant hilar biliary obstruction (UMHBO), drainage of ≥ 50% liver volume correlates with better clinical outcomes. Accurately measuring the liver volume to be drained by biliary stents is required. We aimed to develop a novel method for calculating the drained liver volume (DLV) using a 3D volume analyzer (3D volumetry), and assess the usefulness for drainage in patients with UMHBO. METHODS: Three-dimensional volumetry comprises the following steps: (1) manual tracing of bile duct using 3D imaging system; (2) 3D reconstruction of bile duct and liver parenchyma; and (3) calculating DLV according to the 3D distribution of bile ducts. Using 3D volumetry, we reviewed data of patients who underwent biliary drainage for UMHBO, calculated the DLV, and determined the association between DLV and biliary drainage outcome. RESULTS: There were 104 eligible cases. The mean DLV was 708 ± 393 ml (53% ± 21%). and 65 patients (63%) underwent drainage of ≥50% liver volume. The clinical success rate was significantly higher in patients with DLV ≥ 50% than in patients with DLV < 50% (89% vs. 28%, P < 0.001). The median time to recurrence of biliary obstruction (TRBO) and survival time were significantly longer in patients with DLV ≥ 50% than in patients with DLV < 50% (TRBO, 292 vs. 119 days, P = 0.03; survival, 285 vs. 65days, P = 0.004, log-rank test, respectively). CONCLUSIONS: Three-dimensional volumetry, a novel method to calculate DLV accurately according to bile duct distribution was useful for drainage in UMHBO patients.

Management of anastomotic biliary stricture through utilizing percutaneous transhepatic cholangioscopy.

AIM: Occurrence of anastomotic biliary stricture (AS) remains an essential issue following hepatobiliary surgeries, and percutaneous transhepatic cholangioscopy (PTCS) has great therapeutic significance in handling refractory AS for patients with altered gastrointestinal anatomy after cholangio-jejunostomy. This present study aimed to investigate feasibility of PTCS procedures in AS patients for therapeutic indications. MATERIALS AND METHODS: This study was a single-center, retrospective cohort study with a total number of 124 consecutive patients who received therapeutic PTCS due to AS. Clinical success rate, required number, and adverse events of therapeutic PTCS procedures as well as patients survival state were reviewed. RESULTS: These 124 patients previously underwent choledochojejunostomy or hepatico-jejunostomy, and there was post-surgical altered gastrointestinal anatomy. Overall, 366 therapeutic PTCS procedures were performed for these patients through applying rigid choledochoscope, and the median time of PTCS procedures was 3 (1-11). Among these patients, there were 34 cases (27.32%) accompanied by biliary strictures and 100 cases (80.65%) were also combined with biliary calculi. After therapeutic PTCS, most patients presented with relieved clinical manifestations and improved liver functions. The median time of follow-up was 26 months (2-86 months), and AS was successfully managed through PTCS procedures in 104 patients (83.87%). During the follow-up period, adverse events occurred in 81 cases (65.32%), most of which were tackled through supportive treatment. CONCLUSION: PTCS was a feasible, safe and effective therapeutic modality for refractory AS, which may be a promising alternative approach in clinical cases where the gastrointestinal anatomy was changed after cholangio-jejunostomy.

Impact of sarcopenia on recurrent biliary obstruction after EUS-guided biliary drainage in patients with malignant biliary obstruction.

BACKGROUND AND AIMS: Sarcopenia is an important prognostic factor for cancer patients. The aim of this study was to assess the ability of sarcopenia to predict recurrent biliary obstruction (RBO) in patients with unresectable cancer after EUS-guided biliary drainage (EUS-BD). METHODS: The study enrolled 113 patients who underwent EUS-BD using the self-expandable metal stent (SEMS) for unresectable malignant biliary obstruction (MBO) between April 2016 and December 2021 at Wakayama Medical University Hospital. The skeletal muscle index at the third lumbar spine level (L3) was calculated from computed tomography images. We analyzed the cumulative incidence of RBO at 180 days after stent insertion. Univariate and multivariate analyses were performed to identify variables significantly associated with RBO. RESULTS: Seventy-six patients were assigned to the sarcopenia group, and 37 were assigned to the non-sarcopenia group. The 180-day cumulative incidence of RBO was 11% in the non-sarcopenia group and 29% in the sarcopenia group (p = 0.034). The time to RBO was significantly shorter for the sarcopenia group (p = 0.028; Gray's test). Multivariate analyses identified sarcopenia as an independent prognostic factor for RBO (present vs absent; HR 4.61; 95% CI 1.76-12.10, p = 0.001). The rates of biliary sludge/food impaction were significantly higher in the sarcopenia group for the causes of RBO (p = 0.048). There were no significant differences between the sarcopenia and the non-sarcopenia groups with respect to related EUS-BD adverse events. CONCLUSION: Sarcopenia is an independent indicator of RBO in patients with MBO who receive EUS-BD with SEMS.

A practical approach to the endoscopic management of biliary strictures after liver transplantation.

Biliary tract complications are an important cause of morbidity and mortality after liver transplantation (LT) occurring in 5% to 25% of patients. The most common biliary complication in LT recipients are strictures representing approximately half of these biliary adverse events. Bile duct strictures can be divided into anastomotic biliary strictures (ABS) and non-anastomotic biliary strictures (NABS) depending on their location in the biliary tree, being ABS the most encountered type. Several risk factors identified in previous studies can predispose to the development of ABS and NABS, especially those related to surgical techniques and donor characteristics. Magnetic resonance cholangiopancreatography (MRCP) is the recommended noninvasive imaging test for detecting post-LT biliary strictures, given its high sensitivity and specificity. Once the diagnosis of a biliary stricture after LT has been made, endoscopic retrograde cholangiopancreatography (ERCP) is the preferred initial therapy with good short and long-term results. Biliary sphincterotomy plus balloon dilation (BD) with placement of multiple plastic stents (MPS) has been the classic endoscopic approach for treating ABS, although fully-covered metallic stents (FCSEMS) have emerged as an alternative thanks to shorter total duration of stenting and fewer endoscopic procedures compared to MPS. In this review, we provide a practical update on the management of biliary strictures after LT, focusing our attention on the available evidence in the endoscopic therapy.

A therapeutic ERCP in an only 5.9 kg infant with obstruction jaundice using JF-260V duodenoscope.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) has found extensive use in pediatric patients; however, challenges persist in the application of therapeutic ERCP in infants. CASE PRESENTATION: This case report details the presentation of a 5.9-kilogram infant with obstructive jaundice and suspected hemolytic anemia who underwent ERCP to alleviate biliary obstruction. The infant was admitted due to clay-colored stools, jaundice, and liver injury. Ultrasound and magnetic resonance cholangiopancreatography (MRCP) revealed dilation of the common bile duct (CBD) accompanied by the presence of stones. ERCP was conducted using a JF-260V duodenoscope under general anesthesia. Successful stone extraction and biliary drainage were achieved. CONCLUSIONS: In centers with considerable expertise in ERCP and pediatric anesthesia, the use of a conventional adult duodenoscope for therapeutic ERCP in infants can be considered safe and feasible, provided careful and stringent patient selection criteria are applied. In the future, clear guidelines and standardized protocols for the indications and procedures of pediatric ERCP should be established.

Brain imaging in children with neonatal cholestatic liver disease: A systematic review.

AIM: To determine if children with neonatal cholestatic liver disease had concurrent and later findings on brain imaging studies that could be attributed and the cholestasis to contribute to the understanding of the impaired neuropsychological development. METHODS: Ovid MEDLINE and EMBASE were searched on July 21, 2022, and updated on March 26, 2023. Studies with children under 18 years of age with neonatal cholestasis and a brain scan at the time of diagnosis or later in life were included. Excluded studies were non-English, non-human, reviews or conference abstracts. Data were extracted on demographics, brain imaging findings, treatment and outcome. The results were summarised by disease categories. Risk of bias was assessed using JBI critical appraisal tools. RESULTS: The search yielded 12 011 reports, of which 1261 underwent full text review and 89 were eligible for inclusion. Haemorrhage was the most common finding, especially in children with bile duct obstruction, including biliary atresia. Some findings were resolved after liver transplantation. CONCLUSION: Children with neonatal cholestasis had changes in brain imaging, which might play a role in impaired neuropsychological development, but longitudinal clinical research with structured assessment is needed to better qualify the aetiology of the impairment.

Managing dysfunctions and reinterventions in endoscopic ultrasound-guided choledochoduodenostomy with lumen apposing metal stents: Illustrated technical review (with videos).

Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) with lumen apposing metal stent is emerging both as a rescue strategy and a primary treatment for distal malignant biliary obstruction. The large-scale diffusion of the procedure and improved overall survival of patients with pancreatobiliary neoplasms is resulting in a growing population of long-term EUS-CDS lumen apposing metal stent carriers. Recent studies have reported a need for reintervention during follow-up as high as 55%, and the Leuven-Amsterdam-Milan Study Group classification has been developed, identifying five mechanisms of stent dysfunction and 11 possible rescue strategies aimed at restoring biliary drainage. This illustrated technical review aims to further dissect the recent classification through a comprehensive analysis of nine illustrative cases, offering insights into the pathophysiology underlying dysfunction and clinical reasoning behind rescue interventions, as well as technical considerations and practical tips and tricks. By exploring mechanisms of dysfunction, this review also assists clinicians in selecting the ideal candidates for EUS-CDS while identifying patients deemed high risk for dysfunction or clinical failure.

Endoscopic ultrasound-guided gallbladder drainage as a first approach for jaundice palliation in unresectable malignant distal biliary obstruction: Prospective study.

OBJECTIVES: Endoscopic retrograde cholangiopancreatography (ERCP) represents the gold standard for jaundice palliation in patients with distal malignant biliary obstruction (DMBO). Biliary drainage using electrocautery lumen apposing metal stent (EC-LAMS) is currently a well-established procedure when ERCP fails. In a palliative setting the endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) could represent an easy and valid option. We performed a prospective study with a new EC-LAMS with the primary aim to assess the clinical success rate of EUS-GBD as a first-line approach to the palliation of DMBO. METHODS: In all, 37 consecutive patients undergoing EUS-GBD with a new EC-LAMS were prospectively enrolled. Clinical success was defined as bilirubin level decrease >15% within 24 h and >50% within 14 days after EC-LAMS placement. RESULTS: The mean age was 73.5 ± 10.8 years; there were 17 male patients (45.9%). EC-LAMS placement was technically feasible in all patients (100%) and the clinical success rate was 100%. Four patients (10.8%) experienced adverse events, one bleeding, one food impaction, and two cystic duct obstructions because of disease progression. No stent-related deaths were observed. The mean hospitalization was 7.7 ± 3.4 days. Median overall survival was 4 months (95% confidence interval 1-8). CONCLUSION: Endoscopic ultrasound-guided gallbladder drainage with the new EC-LAMS is a valid option in palliative endoscopic biliary drainage as a first-step approach in low survival patients with malignant jaundice unfit for surgery. A smaller diameter EC-LAMS should be preferred, particularly if the drainage is performed through the stomach, to avoid potential food impaction, which could result in stent dysfunction.

Is ERCP still the elective primary biliary drainage technique in patients with malignant distal biliary obstruction?

Endoscopic retrograde cholangiopancreatography (ERCP) has been established as the first line therapy for the resolution of biliary and pancreatic diseases. The main disadvantage of the procedure is the rate of adverse events, around 10%1. So, despite being a minimally invasive procedure, ERCP has a non-negligible rate of adverse effects (AEs) and secondary mortality.

Identification of patients with malignant biliary strictures using a cholangioscopy-based deep learning artificial intelligence (with video).

BACKGROUND AND AIMS: Accurately diagnosing malignant biliary strictures (MBSs) as benign or malignant remains challenging. It has been suggested that direct visualization and interpretation of cholangioscopy images provide greater accuracy for stricture classification than current sampling techniques (ie, brush cytology and forceps biopsy sampling) using ERCP. We aimed to develop a convolutional neural network (CNN) model capable of accurate stricture classification and real-time evaluation based solely on cholangioscopy image analysis. METHODS: Consecutive patients with cholangioscopy examinations from 2012 to 2021 were reviewed. A CNN was developed and tested using cholangioscopy images with direct expert annotations. The CNN was then applied to a multicenter, reserved test set of cholangioscopy videos. CNN performance was then directly compared with that of ERCP sampling techniques. Occlusion block heatmap analyses were used to evaluate and rank cholangioscopy features associated with MBSs. RESULTS: One hundred fifty-four patients with available cholangioscopy examinations were included in the study. The final image database comprised 2,388,439 still images. The CNN demonstrated good performance when tasked with mimicking expert annotations of high-quality malignant images (area under the receiver-operating characteristic curve, .941). Overall accuracy of CNN-based video analysis (.906) was significantly greater than that of brush cytology (.625, P = .04) or forceps biopsy sampling (.609, P = .03). Occlusion block heatmap analysis demonstrated that the most frequent image feature for an MBS was the presence of frond-like mucosa/papillary projections. CONCLUSIONS: This study demonstrates that a CNN developed using cholangioscopy data alone has greater accuracy for biliary stricture classification than traditional ERCP-based sampling techniques.

Best Practices in Pancreatico-biliary Stenting and EUS-guided Drainage.

Indications for endoscopic placement of endoluminal and transluminal stents have greatly expanded over time. Endoscopic stent placement is now a well-established approach for the treatment of benign and malignant biliary and pancreatic diseases (ie, obstructive jaundice, intra-abdominal fluid collections, chronic pancreatitis etc.). Ongoing refinement of technical approaches and development of novel stents is increasing the applicability and success of pancreatico-biliary stenting. In this review, we discuss the important developments in the field of pancreatico-biliary stenting, with a specific focus on endoscopic retrograde cholangiopancreatography and endoscopic ultrasound-associated developments.

Balloon enteroscopy-assisted endoscopic retrograde cholangiography and rendezvous procedures in patients with altered gastrointestinal anatomy.

BACKGROUND: Standard endoscopic retrograde cholangiography (ERC) frequently fails to treat biliary obstruction in patients with altered gastrointestinal anatomy. Balloon enteroscopy-assisted ERC (BE-ERC) and combined percutaneous transhepatic endoscopic rendezvous procedures (PTE-RVs) may offer effective rescue approaches. OBJECTIVE: This study aimed to evaluate the efficacy and safety of BE-ERC and PTE-RV for the treatment of biliary obstruction in patients with altered gastrointestinal anatomy. METHODS: In this observational study, all patients with altered gastrointestinal anatomy underwent BE-ERC between 2003 and 2016 at a tertiary referral center. In case of procedural failure, a combined PTE-RV was performed in selected cases. Endpoints included the success and safety of the procedures. RESULTS: A total of 180 BE-ERC performed in 106 patients with altered gastrointestinal anatomy were included. Of the procedures, 76.7% were performed due to benign and 23.3% due to malignant biliary obstruction. BE-ERC was successful in 53% (96/180) of cases. In case of failure, in 23/32 cases a combined PTE-RV was successfully performed, improving the overall success rate of BE-ERC, including PTE-RV, to 66% (119/180). Benign biliary obstruction and repeated procedures were positive predictors of successful BE-ERC (odds ratio 6.8 (95% CI 2.7-17.0), p < .001 and odds ratio 4.1 (2.1-8.2), p < .001). Complications were significantly more frequent in combined PTE-RVs than in BE-ERC procedures alone (34.4% vs. 7.4%; p < .001). CONCLUSIONS: BE-ERC is effective and safe for the endoscopic management of patients with altered gastrointestinal anatomy and percutaneous transhepatic rendezvous procedures can substantially increase success rates in selected cases.

The use of fully covered self-expandable metal stents in the endoscopic treatment of portal cavernoma cholangiopathy.

BACKGROUND AND AIMS: There are different therapeutic approaches for biliary strictures and reducing portal hypertension in patients with symptomatic portal cavernoma cholangiopathy (PCC). Endoscopic treatment includes endoscopic biliary sphincterotomy (EST), dilation of stricture with a biliary balloon, placement of plastic stent(s) and stone extraction. Fully covered self-expandable metal stent (FCSEMS) is placed as a rescuer in case of haemobilia seen after EST, dilation of stricture and removal of plastic stent rather than the stricture treatment itself. In this retrospective observational study, we sought to assess the clinical outcomes of FCSEMS as the initial treatment for PCC-related biliary strictures. MATERIALS AND METHODS: Twelve symptomatic patients with PCC both clinically and radiologically between July 2009 and February 2019 were examined. Magnetic resonance cholangiopancreatography (MRCP) and cholangiography were employed as the diagnostic imaging methods. Chandra-Sarin classification was used to distinguish between biliary abnormalities in terms of localization. Llop classification was used to group biliary abnormalities associated with PCC. Endoscopic partial sphincterotomy was performed in all the patients. If patients with dominant strictures 6-8-mm balloon dilation was first performed. This was followed by removal of the stones if exist. Finally, FCSEMS placed. The stents were removed 6-12 weeks later. RESULTS: The mean age of the patients was 40.9 ± 10.3 years, and 91.6% of the patients were male. Majority of the patients (n = 9) were noncirrhotic. Endoscopic retrograde cholangiopancreatography (ERCP) findings showed that 11 of the 12 patients were Chandra Type I and one was Chandra Type IIIa. All the 12 patients were Llop Grade 3. All patients had biliary involvement in the form of strictures. Stent placement was successful in all patients. FCSEMSs were retained for a median period of 45 days (30-60). Seven (58.3%) patients developed acute cholecystitis. There was no occurrence of bleeding or other complications associated with FCSEMS replacement or removal. All patients were asymptomatic during median 3 years (1-10) follow up period. CONCLUSIONS: FCSEMS placement is an effective method in biliary strictures in case of PCC. Acute cholecystitis is encountered frequently after FCSEMS, but majority of patients respond to the medical treatment. Patients should be followed in terms of the relapse of biliary strictures.

A Risk Prediction Model for Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis After Stent Insertion for Malignant Biliary Obstruction: Development and Validation.

OBJECTIVES: Pancreatitis is the most common complication of post-endoscopic retrograde cholangiopancreatography (ERCP). There are currently no prediction models, particularly for post-ERCP pancreatitis (PEP) after biliary stent placement due to malignant biliary obstruction (MBO). To that end, we aim to develop and validate a predictive model for PEP. METHODS: We retrospectively analyzed the data of patients who underwent ERCP for biliary stent placement due to MBO at the Second Affiliated Hospital of Harbin Medical University from January 1, 2014 to August 31, 2021. The eligible patients were randomly allocated to the development and validation cohorts. A prediction model was built using the development cohort, and the model's effect was validated using a validation cohort. RESULTS: A total of 1524 patients were enrolled, including 1016 in the development cohort and 508 in the validation cohort, with an overall PEP rate of 7.1%. The model's predictors included acute pancreatitis history, the absence of pancreatic duct dilation, nonpancreatic cancer, difficult cannulation, and pancreatic injection. The area under the curve (AUC) in the development cohort was 0.810, and the incidence of PEP in the low-risk, medium-risk, and high-risk groups was 1.53%, 9.12%, and 36.36%, respectively. Meanwhile, the AUC of the validation cohort was 0.781, and the incidence of PEP in the low-risk, medium-risk, and high-risk groups was 4.17%, 8.75%, and 41.67%, respectively. CONCLUSIONS: This study was the first to build and validate a risk prediction model, especially for PEP after biliary stent placement due to MBO. Moreover, this model might assist clinicians in identifying high-risk patients and help implement preventive measures in a more timely manner.

Clinical Outcomes of Inside Stents and Conventional Plastic Stents as Bridge-to-Surgery Options for Malignant Hilar Biliary Obstruction.

BACKGROUND: The appropriate method of preoperative endoscopic biliary drainage (EBD) for cholangiocarcinoma with hilar biliary obstruction remains controversial. The inside-stent technique is a method of placing plastic stents entirely inside the bile duct. Several studies of patients with unresectable stage have reported longer stent patency compared with conventional endoscopic biliary stenting (EBS). Inside-stent techniques have been introduced as a bridge-to-surgery option and as an alternative to conventional EBS. AIMS: We aimed to evaluate the clinical outcomes of inside stent use and conventional EBS. METHODS: During this retrospective multicenter study, we reviewed consecutive patients with cholangiocarcinoma who underwent radical surgery after conventional EBS or inside-stent insertion. Adverse event (AE) rates after EBD and post-surgical AEs were compared. A multivariable analysis was performed to identify factors affecting cholangitis after EBD. RESULTS: Conventional EBS and inside-stent procedures were performed for 56 and 73 patients, respectively. Patient backgrounds were similar between groups, except for percutaneous transhepatic portal vein embolization. The waiting time before surgery was similar between groups (28.5 days vs. 30 days). There were no significant differences in the cholangitis rate (21.4% vs. 26.0%; P = 0.68) and all AEs (25.0% vs. 30.1%; P = 0.56) between groups. The post-surgical AE rate was similar between the groups. The multivariable analysis found that preprocedural cholangitis was a risk factor for cholangitis after EBD (odds ratio: 5.67; 95% confidence interval: 1.61-19.9). CONCLUSIONS: The outcomes of inside-stent techniques and conventional EBS for the management of preoperative EBD are comparable for patients with cholangiocarcinoma.