Combined endoscopic retrograde and endosonography-guided (CERES) cholangiography for interventional repair of transected bile ducts after cholecystectomy: treatment approaches and outcomes.

BACKGROUND: Post-cholecystectomy transected bile ducts (TBDs) are not amenable to standard endoscopic management. Combined ERCP and endosonography (CERES) including EUS-guided hepaticoenterostomy enhance therapeutic biliary endoscopy. CERES treatment of post-cholecystectomy TBDs is evaluated. METHODS: Among 165 consecutive patients who underwent ERCP for post-cholecystectomy bile duct injury (Amsterdam A/B/C/D grades [%] = 47/30/7/16) between January 2009-November 2020 at a tertiary-care center, 10/26 (38%) with TBDs (6 female; 32-92 years old) underwent CERES before attempted endoscopic repair (staged CERES, n = 7) or surgical repair (preoperative CERES, n = 1), or as destination therapy (definitive CERES, n = 2). Short-term clinical success rate, final clinical success rate and comprehensive complication index (CCI) were retrospectively determined. Additionally, number of follow-up procedures, adverse events, recurrences, final patency grades and definitive cure rate were determined in patients with staged CERES. RESULTS: Index CERES (hepaticogastrostomy, 60%; hepaticoduodenostomy, 40%) achieved bile leak and jaundice resolution in 10 patients (100% short-term clinical success rate). Overall, 9/10 patients maintained good/excellent biliary drainage over a median 3.2 years without any unplanned percutaneous/surgical procedures (90% final clinical success rate; median CCI = 8.7). Staged CERES using recanalization (n = 6) or diversion (n = 1) strategies achieved Grade A patency in 5/7 (71%) patients after a median of 2 follow-up procedures over a median 12-month treatment period; 2 failed recanalization patients were salvaged by indefinite hepaticoenterostomy stent or elective surgery, respectively. Among staged CERES, 2 treatment-related cholangitis occurred (29%) and 2 recurring strictures (29%) developed over a median 8.4 year follow-up; recurring strictures were endoscopically remodeled (n = 1) or indefinitely stented (n = 1); final Grade A/B biliary patency was achieved in 5/7 (71%) and definitive cure in 4/7 (57%). CONCLUSIONS: CERES controls acute symptoms in selected post-cholecystectomy TBD patients allowing subsequent staged endoscopic therapy. Definitive cure or long-term biliary drainage is possible in most cases and elective surgery can be facilitated in the remainder.

Real-world long-term effectiveness of ustekinumab in Crohn's disease: results from the ENEIDA registry.

BACKGROUND: Data on the long-term administration of ustekinumab in recommended doses are limited. AIM: To assess the real-world, long-term effectiveness of ustekinumab in refractory Crohn's disease (CD). METHODS: Multi-centre study of CD patients starting ustekinumab at the recommended dose, followed for 1 year. Values for the Harvey-Bradshaw Index (HBI), endoscopic activity, C-reactive protein (CRP), and faecal calprotectin (FC) were recorded at baseline and at weeks 26 and 52. Demographic and clinical data, previous treatments, adverse events (AEs) and hospitalisations were documented. Potential predictors of remission were examined. RESULTS: A total of 407 patients were analysed. The initial maintenance dose of 90 mg SC was administered every 12, 8 and 4 weeks in 56 (14%), 347 (85%) and 4 (1%) patients, respectively. After 52 weeks, treatment was discontinued in 112 patients (27.5%). At baseline, 295 (72%) had an HBI >4 points. Of these, 169 (57%) and 190 (64%) achieved clinical remission at weeks 26 and 52, respectively. FC levels returned to normal in 44% and 54% of patients at weeks 26 and 52, and CRP returned to normal in 36% and 37% of patients at weeks 26 and 52, respectively. AEs were recorded in 60 patients. The use of fewer previous anti-TNFα agents and ileal localisation were associated with clinical remission, and endoscopic severity was associated with poor response. No factors correlated with endoscopic remission. CONCLUSION: After 52 weeks, ustekinumab demonstrated effectiveness in inducing clinical and endoscopic remission in patients with refractory CD.

Clinical Characteristics, Associated Malignancies and Management of Primary Sclerosing Cholangitis in Inflammatory Bowel Disease Patients: A Multicentre Retrospective Cohort Study.

BACKGROUND AND AIMS: Primary sclerosing cholangitis [PSC] is usually associated with inflammatory bowel disease [IBD]. An increased risk of malignancies, mainly colorectal cancer [CRC] and cholangiocarcinoma [CCA], has been reported in PSC-IBD patients. Our aim was to determine the clinical characteristics and management of PSC in IBD patients, and the factors associated with malignancies. METHODS: PSC-IBD patients were identified from the Spanish ENEIDA registry of GETECCU. Additional data were collected using the AEG-REDCap electronic data capture tool. RESULTS: In total, 277 PSC-IBD patients were included, with an incidence rate of 61 PSC cases per 100 000 IBD patient-years, 69.7% men, 67.5% ulcerative colitis and mean age at PSC diagnosis of 40 ± 16 years. Most patients [85.2%] were treated with ursodeoxycholic acid. Liver transplantation was required in 35 patients [12.6%] after 79 months (interquartile range [IQR] 50-139). It was more common in intra- and extrahepatic PSC compared with small-duct PSC (16.3% vs 3.3%; odds ratio [OR] 5.7: 95% confidence interval [CI] = 1.7-19.3). The incidence rate of CRC since PSC diagnosis was 3.3 cases per 1000 patient-years [95% CI = 1.9-5.6]. Having symptoms of PSC at PSC diagnosis was the only factor related to an increased risk of CRC after IBD diagnosis [hazard ratio= 3.3: 95% CI = 1.1-9.9]. CCA was detected in seven patients [2.5%] with intra- and extrahepatic PSC, with median age of 42 years [IQR 39-53], and presented a lower life expectancy compared with patients without CCA and patients with or without CRC. CONCLUSIONS: PSC-IBD patients with symptoms of PSC at PSC diagnosis have an increased risk of CRC. CCA was only diagnosed in patients with intra- and extrahepatic PSC and was associated with poor survival.

Short and long-term effectiveness and safety of vedolizumab in inflammatory bowel disease: results from the ENEIDA registry.

BACKGROUND: Effectiveness of vedolizumab in real world clinical practice is unknown. AIM: To evaluate the short and long-term effectiveness of vedolizumab in patients with inflammatory bowel disease (IBD). METHODS: Patients who received at least 1 induction dose of vedolizumab were included. Effectiveness was defined based on Harvey-Bradshaw index (HBI) in Crohn's disease (CD) and Partial Mayo Score (PMS) in ulcerative colitis (UC). Short-term response was assessed at week 14. Variables associated with short-term remission were identified by logistic regression analysis. The Kaplan-Meier method was used to evaluate the long-term durability of vedolizumab treatment. Cox model was used to identify factors associated with discontinuation of treatment and loss of response. RESULTS: 521 patients were included (median follow-up 10 months [interquartile range 5-18 months]). At week 14, 46.8% had remission and 15.7% clinical response. CD (vs UC), previous surgery, higher CRP concentration and disease severity at baseline were significantly associated with impaired response. The rate of vedolizumab discontinuation was 37% per patient-year of follow-up (27.6% in UC and 45.3% in CD, P < 0.01). CD (vs UC), anaemia at baseline, steroids during induction and CRP concentration were associated with lower durability of treatment. Seven per cent of patients developed adverse events, infections being the most frequent. CONCLUSIONS: Over 60% of IBD patients respond to vedolizumab. Many patients discontinue treatment over time. CD and disease burden impair both short- and long-term response. Vedolizumab seems to be safe in clinical practice.