How Artificial Intelligence Will Transform Clinical Care, Research, and Trials for Inflammatory Bowel Disease.

Artificial intelligence (AI) refers to computer-based methodologies that use data to teach a computer to solve pre-defined tasks; these methods can be applied to identify patterns in large multi-modal data sources. AI applications in inflammatory bowel disease (IBD) includes predicting response to therapy, disease activity scoring of endoscopy, drug discovery, and identifying bowel damage in images. As a complex disease with entangled relationships between genomics, metabolomics, microbiome, and the environment, IBD stands to benefit greatly from methodologies that can handle this complexity. We describe current applications, critical challenges, and propose future directions of AI in IBD.

Comparative Effectiveness of Upadacitinib and Tofacitinib in Ulcerative Colitis: A US Propensity-Matched Cohort Study.

INTRODUCTION: There are limited real-world data comparing the effectiveness of upadacitinib and tofacitinib in patients with ulcerative colitis (UC). METHODS: We conducted a retrospective cohort study using TriNetX, a multi-institutional database, to compare the effectiveness of upadacitinib and tofacitinib in patients with UC. The primary aim was to assess the risk of a composite outcome of hospitalization requiring intravenous steroids and/or colectomy within 6 and 12 months. One-to-one propensity score matching was performed for demographics, comorbid conditions, mean hemoglobin, C-reactive protein, albumin, and calprotectin, and prior UC medications including recent oral or intravenous steroid use between the cohorts. Risk was expressed as adjusted odds ratio (aOR) with 95% confidence intervals (CI). RESULTS: There were 526 patients in the upadacitinib cohort (mean age 40.4 ± 16.3, 44.8% female sex, 76.6% White race) and 1,149 patients in the tofacitinib cohort (mean age 42 ± 17.1, 41.9% female sex, 76% White race). After propensity score matching, there was no significant difference in the risk of the composite outcome of need for intravenous steroids and/or colectomy within 6 months (aOR 0.75, 95% CI 0.49-1.09). However, there was a lower risk of the composite outcome (aOR 0.63, 95% CI 0.44-0.89) in the upadacitinib cohort compared with the tofacitinib cohort within 12 months. There was no difference in the risk of intravenous steroid use (aOR 0.70, 95% CI 0.48-1.02) but lower risk of colectomy (aOR 0.46, 95% CI 0.27-0.79). In sensitivity analysis, there was also a lower risk of the composite outcome (aOR 0.64, 95% CI 0.44-0.94), including lower risk of intravenous steroid use (aOR 0.67, 95% CI 0.45-0.99) and colectomy (aOR 0.49, 95% CI 0.26-0.92) in the upadacitinib cohort compared with the tofacitinib cohort within 12 months. DISCUSSION: This study utilizing real-world data showed that upadacitinib was associated with improved disease-specific outcomes at 12 months compared with tofacitinib in patients with UC.

The Natural History After Ileal Pouch-Anal Anastomosis for Ulcerative Colitis: A Population-Based Cohort Study From the United States.

INTRODUCTION: There are limited data regarding the natural history after ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC). The principal objectives of this study were to identify 4 key outcomes in the natural history after IPAA within 1, 3, 5, and 10 years: the incidence of pouchitis, Crohn's-like disease of the pouch, use of advanced therapies after IPAA, and pouch failure requiring excision in a network of electronic health records. METHODS: We performed a retrospective cohort study in TriNetX, a research network of electronic health records. In addition to evaluating incidence rates, we also sought to identify factors associated with pouchitis and advanced therapy use within 5 years of IPAA after 1:1 propensity score matching, expressed as adjusted hazard ratios (aHRs). RESULTS: Among 1,331 patients who underwent colectomy with IPAA for UC, the incidence of pouchitis increased from 58% in the first year after IPAA to 72% at 10 years after IPAA. After propensity score matching, nicotine dependence (aHR 1.61, 95% confidence interval [CI] 1.19-2.18), antitumor necrosis factor therapy (aHR 1.33, 95% CI 1.13-1.56), and vedolizumab prior to colectomy (aHR 1.44, 95% CI 1.06-1.96) were associated with an increased risk of pouchitis in the first 5 years after IPAA. The incidence of Crohn's-like disease of the pouch increased to 10.3% within 10 years of IPAA while pouch failure increased to 4.1%. The incidence of advanced therapy use peaked at 14.4% at 10 years after IPAA. DISCUSSION: The incidence of inflammatory conditions of the pouch remains high in the current era, with 14% of patients requiring advanced therapies after IPAA.

Patients With Inflammatory Bowel Disease Are at Increased Risk of Hospitalization Due to Respiratory Syncytial Virus.

INTRODUCTION: Patients with inflammatory bowel disease (IBD) are at increased risk of developing respiratory infections. Respiratory syncytial virus (RSV) is a common respiratory virus with adverse outcomes in older adults. This study aimed to determine whether patients with IBD are at increased risk of a serious infection due to RSV. METHODS: We conducted a retrospective study using the multi-institutional research network TriNetX to assess the risk of hospitalization in a cohort of patients with IBD compared with that in a non-IBD control cohort with RSV infection from January 1, 2007, to February 27, 2023. One-to-one (1:1) propensity score matching was performed for demographic variables and RSV risk factors between the 2 cohorts. Risk was expressed as adjusted odds ratio (aOR) with 95% confidence interval (CI). RESULTS: There were 794 patients in the IBD-RSV cohort and 93,074 patients in the non-IBD-RSV cohort. The mean age of the IBD-RSV cohort was 55.6 ± 20 years, 59% were female, 80% were White, and 56.9% had Crohn's disease. The IBD-RSV cohort was at an increased risk of hospitalization (aOR 1.30, 95% CI 1.06-1.59). There was no difference in the risk (aOR 0.83, 95% CI 0.58-1.19) of a composite outcome of hospitalization-related complications between the 2 cohorts. Recent systemic corticosteroid use (<3 months) was associated with an increased risk of hospitalization (aOR 1.86, 95% CI 1.30-2.59) in the IBD-RSV cohort. DISCUSSION: We found that adult patients with IBD and RSV infection are at an increased risk of hospitalization and may benefit from the new RSV vaccine recommended for adults aged 60 years and older.

Adverse events of the single-operator cholangioscopy system: a Manufacturer and User Facility Device Experience database analysis.

BACKGROUND AND AIMS: The SpyGlass (Boston Scientific, Marlborough, Mass, USA) single-operator cholangioscopy (SOC) system is generally considered to be safe but adds additional risks to those associated with standard ERCP. METHODS: We evaluated adverse events (AEs) associated with the SpyGlass system reported in the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database between January 2016 and August 2023. RESULTS: From the database, 2311 device problems (SpyGlass DS, 1301; SpyGlass DS II, 1010) were reported. An optical problem was the most reported issue (SpyGlass DS, 83; SpyGlass DS II, 457). Patient-related events were found in 62 of 1743 reports (3.5%): 33 with the SpyGlass DS and 29 with the SpyGlass DS II. The most common AEs were bleeding/hemorrhage followed by perforation; infection, fever, or sepsis; and pancreatitis. CONCLUSIONS: Our findings add to the existing literature and provide a fuller picture of potential problems associated with the SpyGlass SOC.

Endoscopic diagnosis and management of adult inflammatory bowel disease: a consensus document from the American Society for Gastrointestinal Endoscopy IBD Endoscopy Consensus Panel.

Endoscopy plays a key role in diagnosis, monitoring of disease activity, assessment of treatment response, dysplasia surveillance, postoperative evaluation, and interventional therapy for patients with inflammatory bowel disease (IBD). Clinical practice patterns in the endoscopic management of IBD vary. A panel of experts consisting of IBD specialists, endoscopists, and GI pathologists participated in virtual conferences and developed this modified Delphi-based consensus document to address endoscopic aspects of IBD management.

Effect of Bariatric Surgery on Disease Outcomes in Patients With Inflammatory Bowel Disease: A US-based Propensity Matched Cohort Study.

INTRODUCTION AND AIM: A growing body of evidence suggests a negative impact of obesity on the disease activity of inflammatory bowel disease (IBD). The primary aim of the study was to evaluate disease outcomes of IBD in patients after bariatric surgery (BS). METHODS: Patients with IBD and morbid obesity who underwent BS were compared with patients with IBD and morbid obesity without BS in a retrospective, propensity-score matched cohort study using TriNetX, a multi-institutional database. The primary aim was to assess the 2-year risk of a composite of disease-related complications, which included intravenous steroid use or IBD-related surgery. Risk was expressed as adjusted odds ratios (aOR) with 95% confidence intervals (CI). RESULTS: In all, 482 patients (3.4%) with IBD and morbid obesity underwent BS (mean age 46.9±11.2 y old, mean BMI 42.1±7.72 kg/m 2 , Crohn's disease 60%). After propensity-score matching, the BS cohort had a lower risk (aOR 0.31, 95% CI 0.17-0.56) of a composite of IBD-related complications compared with the control cohort. After propensity-score matching, the BS cohort with sleeve gastrectomy had a decreased risk (aOR 0.45, 95% CI 0.31-0.66) of a composite of IBD-related complications. There was no difference in the risk (aOR 0.77, 95% CI 0.45-1.31) of a composite of IBD-related complications between the BS cohort with Roux-en-Y gastric bypass (RYGB) compared with the control cohort. CONCLUSION: Sleeve gastrectomy but not Roux-en-Y gastric bypass is associated with improved disease-specific outcomes in patients with IBD and morbid obesity.

Safety and Effectiveness of Vedolizumab in Elderly Patients with Inflammatory Bowel Disease: A Systematic Review & Meta-Analysis.

BACKGROUND: There is limited data on Vedolizumab utilization in elderly patients. Our study aims to assess the effectiveness and safety of Vedolizumab in this subset population. MATERIALS AND METHODS: Databases including Cochrane Central, Embase, Medline (via Ovid), Scopus, and Web of Science were searched in August 2022 to identify studies that assessed Vedolizumab therapy in elderly patients. Pooled proportion and risk ratios (RR) were calculated. RESULTS: Total 11 studies with 3546 IBD patients (1314 elderly and 2232 young) were included in the final analysis. Pooled rate of overall and serious infections in the elderly cohort was 8.45% (95% CI=6.27-11.29; I 2 23%) and 2.59% (95% CI=0.78-8.29; I 2 76%), respectively. However, there was no difference in overall infection rates between elderly and young patients. Pooled rate of endoscopic, clinical, and steroid-free remission for elderly IBD patients was 38.45% (95% CI=20.74-59.56; I 2 93%), 37.95% (95% CI=33.08-43.06; I 2 13%), and 38.8% (95% CI=31.6-46.4; I 2 77%), respectively. Elderly patients had lower steroid-free remission rates [RR 0.85, 95% CI=0.74-0.99; I 2 0%, P =0.03]; however, there was no difference in rates of clinical (RR 0.86, 95% CI=0.72-1.03; I 2 0%, P =0.10) or endoscopic remission (RR 1.06, 95% CI=0.83-1.35; I 2 0%, P =0.63) compared with younger patients. Pooled rate of IBD-related surgery and IBD-related hospitalizations was 9.76% (95% CI=5.81-15.92; I 2 78%) and 10.54% (95% CI=8.37-13.2; I 2 0%), respectively for the elderly cohort. There was no statistical difference in IBD-related surgeries between elderly and young IBD patients, RR 1.20 (95% CI=0.79-1.84; I 2 16%), P =0.4. CONCLUSIONS: Vedolizumab is equally safe and effective for clinical and endoscopic remission in elderly and younger populations.

Prophylactic pancreatic duct stenting to reduce the risk of post-ampullectomy pancreatitis: a comprehensive review and meta-analysis of 1858 patients.

BACKGROUND: The effectiveness of prophylactic pancreatic duct stenting (PPDS) in preventing post-ampullectomy pancreatitis (PAP) at the time of endoscopic ampullectomy (EA) has been reported, however, results are conflicting. We conducted a systematic review and meta-analysis looking at the use of PPDS in reducing PAP as well as overall post-ampullectomy complications. METHODS: Multiple databases were searched through May 2023 for studies reporting on EA. Meta-analysis was performed to determine pooled proportions and relative risk (RR) with 95% confidence intervals (CI) of PAP, with and without PPDS. Pooled rates of adverse events including perforation, delayed bleeding, cholangitis, and procedure related mortality were assessed. Random effects model was used for our meta-analysis and heterogeneity was assessed using the I2 statistics. RESULTS: Thirty-four studies (14 case series, 18 cohort studies and 2 randomized controlled trials) with 1868 patients were included. The overall pooled rate of PAP was 12.3% (CI 10.3-14.5). We found no statistically significant difference in rates of PAP among patients with PPDS, 11.9% (CI 8.9-15.7) and without PPDS, 16.6% (CI 13.4-20.4), RR 0.8 (CI 0.51-1.28), p = 0.4. In terms of severe PAP, we found no difference between the two groups. The overall pooled rates of successful en-bloc and piecemeal resection were 74.8% (CI 67.3-81.1) and 25.1% (CI 19-32.4). Additionally, pooled rates of ampullary stenosis, post procedural bleeding, perforation, cholangitis, and procedure related mortality were 3.6%, 11.1%, 4.2%, 3.5%, and 1.3%, respectively. CONCLUSIONS: Our analysis shows that PPDS at the time of EA does not offer a significant protective effect against PAP. While the incidence of PAP was higher among the no PPDS group, it is plausible that this is more likely due to variation among studies in terms of lesion size, length/size of pancreatic stent used and etiology of ampullary lesions. Future well-designed randomized controlled trials are needed to validate our findings.

Effectiveness and safety of stag beetle knife (SB knife) in management of Zenker's diverticulum: a systematic review and meta-analysis.

Stag Beetle Knife (SB Knife) is increasingly being utilized for Zenker's Diverticulectomy (ZD). Our study assessed the effectiveness and safety of the SB Knife for the management of ZD. Ovid EBM reviews, Ovid Embase, Ovid Medline, ClinicalTrials.gov, Scopus, and Web of Science were searched to identify studies that utilized SB knife for ZD. Pooled proportions (PP) were calculated using the random-effects model. Heterogeneity was evaluated using I2 statistics. A total of 7 studies with 268 patients were included in the final analysis. Dysphagia and regurgitation were the most common clinical symptoms. The mean size of the ZD was 2.8 ± 0.7 cm and 28 (of 148) patients had undergone previous treatments. The PP of technical success was 98% (95% CI: 92.3-99.5; I20) with a mean procedure duration of 26.2 ± 8.3 minutes. The PP of clinical response at first follow-up and relapse after index procedure was 87.9% (95% CI: 81.6-92.3; I219) and 13.5% (95% CI: 9.6-18.6; I22), respectively. At final follow-up, the PP of clinical remission was 96.2% (95% CI: 91-98.4; I230.6) while the PP of procedure failure was 3.6% (95% CI: 1.6-8.1; I20). No severe adverse events (AEs) were noted while using the SB Knife. However, the PP of intraprocedural and postprocedural AEs was 13.2% (95% CI: 9.6-17.8; I20) and 9.3% (95% CI: 5.7-14.9; I2 < 20.9), respectively. SB Knife is highly safe and effective for Zenker's Diverticulectomy with a failure rate of only 3.6%.

The Comparative Effectiveness of Ciprofloxacin and Metronidazole for an Initial Episode of Pouchitis: A Propensity-Matched Study.

INTRODUCTION: There is minimal evidence regarding the comparative effectiveness of individual antibiotics in the treatment of pouchitis. We sought to evaluate the comparative effectiveness of ciprofloxacin monotherapy, metronidazole monotherapy, and combination therapy (ciprofloxacin and metronidazole) in the treatment of an initial episode of pouchitis after ileal pouch-anal anastomosis for ulcerative colitis (UC). METHODS: We performed a retrospective cohort study in TriNetX, a global federated research network of electronic health records. Primary outcomes were failure of initial antibiotic therapy and the development of recurrent pouchitis in the first 12 months after an initial episode of pouchitis. One-to-one propensity score matching was performed for age, sex, race, primary sclerosing cholangitis, nicotine dependence, obesity, and previous exposure to tumor necrosis factor inhibitors between the cohorts. RESULTS: Among 271 patients who developed pouchitis (mean age at ileal pouch-anal anastomosis 35.8 years, male sex 57%) and were treated with ciprofloxacin, metronidazole, or combination therapy, 190 (70%) developed recurrent pouchitis. After propensity score matching, there was no significant difference in the odds of early relapse or nonresponse with ciprofloxacin compared with metronidazole monotherapy (adjusted odds ratio 0.56, 95% confidence interval 0.23-1.34) or when either monotherapy was compared with combination therapy. There was also no significant difference in odds of recurrent pouchitis when comparing patients treated with ciprofloxacin with metronidazole monotherapy (adjusted odds ratio 0.86, 95% confidence interval 0.40-1.84) or either monotherapy with combination therapy. DISCUSSION: In this retrospective cohort study, we demonstrated no significant difference in the real-world effectiveness of ciprofloxacin, metronidazole, or combination therapy for the initial episode of pouchitis.

The Real-World Effectiveness and Safety of Ustekinumab in the Treatment of Crohn's Disease: Results From the SUCCESS Consortium.

INTRODUCTION: We evaluated the real-world effectiveness and safety of ustekinumab (UST) in patients with Crohn's disease (CD). METHODS: This study used a retrospective, multicenter, multinational consortium of UST-treated CD patients. Data included patient demographics, disease phenotype, disease activity, treatment history, and concomitant medications. Cumulative rates of clinical, steroid-free, endoscopic, and radiographic remissions were assessed using time-to-event analysis, and clinical predictors were assessed by using multivariate Cox proportional hazard analyses. Serious infections and adverse events were defined as those requiring hospitalization or treatment discontinuation. RESULTS: A total of 1,113 patients (51.8% female, 90% prior antitumor necrosis factor exposure) were included, with a median follow-up of 386 days. Cumulative rates of clinical, steroid-free, endoscopic, and radiographic remissions at 12 months were 40%, 32%, 39%, and 30%, respectively. Biologic-naive patients achieved significantly higher rates of clinical and endoscopic remissions at 63% and 55%, respectively. On multivariable analyses, prior antitumor necrosis factor (hazard ratio, 0.72; 95% confidence interval, 0.49-0.99) and vedolizumab exposure (hazard ratio, 0.65; 95% confidence interval, 0.48-0.88) were independently associated with lower likelihoods of achieving endoscopic remission. In patients who experienced loss of remission, 77 of 102 (75%) underwent dose optimization, and 44 of 77 (57%) achieved clinical response. An additional 152 of 681 patients (22.3%) were dose-optimized because of primary nonresponse incomplete response to UST, of whom 40.1% (61 of 152) responded. Serious infections occurred in 3.4% of patients while other noninfectious adverse events (lymphoma [n = 1], arthralgia [n = 6], rash [n = 6], headache [n = 3], hepatitis [n = 3], hair loss [n = 3], neuropathy [n = 1], and vasculitis [n = 1]) occurred in 2.4% of patients. DISCUSSION: UST represents a safe and effective treatment option for CD, with 40% of patients from a highly refractory cohort achieving clinical remission by 12 months. The greatest treatment effect of UST was seen in biologic-naive patients, and dose escalation may recapture clinical response.

Diagnostic accuracy of convolutional neural network-based machine learning algorithms in endoscopic severity prediction of ulcerative colitis: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Endoscopic assessment of ulcerative colitis (UC) can be performed by using the Mayo Endoscopic Score (MES) or the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). In this meta-analysis, we assessed the pooled diagnostic accuracy parameters of deep machine learning by means of convolutional neural network (CNN) algorithms in predicting UC severity on endoscopic images. METHODS: Databases including MEDLINE, Scopus, and Embase were searched in June 2022. Outcomes of interest were the pooled accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Standard meta-analysis methods used the random-effects model, and heterogeneity was assessed using the I2statistics. RESULTS: Twelve studies were included in the final analysis. The pooled diagnostic parameters of CNN-based machine learning algorithms in endoscopic severity assessment of UC were as follows: accuracy 91.5% (95% confidence interval [CI], 88.3-93.8; I2 = 84%), sensitivity 82.8% (95% CI, 78.3-86.5; I2 = 89%), specificity 92.4% (95% CI, 89.4-94.6; I2 = 84%), PPV 86.6% (95% CI, 82.3-90; I2 = 89%), and NPV 88.6% (95% CI, 85.7-91; I2 = 78%). Subgroup analysis revealed significantly better sensitivity and PPV with the UCEIS scoring system compared with the MES (93.6% [95% CI, 87.5-96.8; I2 = 77%] vs 82% [95% CI, 75.6-87; I2 = 89%], P = .003, and 93.6% [95% CI, 88.7-96.4; I2 = 68%] vs 83.6% [95% CI, 76.8-88.8; I2 = 77%], P = .007, respectively). CONCLUSIONS: CNN-based machine learning algorithms demonstrated excellent pooled diagnostic accuracy parameters in the endoscopic severity assessment of UC. Using UCEIS scores in CNN training might offer better results than the MES. Further studies are warranted to establish these findings in real clinical settings.

Risk of post-sphincterotomy bleeding with antiplatelet and anticoagulant use: a propensity-matched analysis of the U.S. Collaborative Network.

BACKGROUND AND AIMS: GI bleeding after ERCP is a serious adverse event and most commonly occurs after endoscopic biliary and/or pancreatic sphincterotomy. Although the strength of available evidence for post-sphincterotomy GI bleeding risk is high for therapeutic warfarin and heparin, it remains unknown for antiplatelet agents like clopidogrel and prasugrel. We conducted a retrospective United States-based, propensity-matched cohort study to assess the risk of post-sphincterotomy bleeding in patients receiving anticoagulant (AC) and antiplatelet (APT) therapy. METHODS: We analyzed the U.S. Collaborative Network in the TriNetX platform through December 27, 2022, to include patients receiving APT and AC therapy who underwent ERCP within 7 days of hospitalization. One-to-one propensity score matching was performed. The primary outcome was the incidence of GI bleeding within 7 days of sphincterotomy. Secondary outcomes included need for blood transfusion, intensive care unit care, and all-cause mortality within 30 days of bleeding. RESULTS: Overall, 2806 patients (1806 in the AC cohort and 1000 in the APT cohort) underwent ERCP with sphincterotomy. One-to-one propensity score matching was performed for age, body mass index ≥30 kg/m2, gender, race, ethnicity, diabetes mellitus, nicotine dependence, presence and severity of chronic kidney disease, cirrhosis, and thrombocytopenia between the cohorts. Patients in both cohorts had an increased risk of post-sphincterotomy bleeding compared with matched control subjects (adjusted odds ratios of 3.6 [95% confidence interval, 2.58-5.06] and 2.2 [95% confidence interval, 1.43-3.56], respectively). Although heparin bridging therapy and concurrent use of aspirin did not further increase the risk of GI bleeding, resumption of AC within 24 hours' postprocedure did. Neither cohort of patients was at an increased risk for blood transfusion, intensive care unit care, or all-cause mortality. CONCLUSIONS: Our database analysis shows that patients receiving AC and APT therapy are at a higher risk of post-sphincterotomy bleeding compared with matched control subjects. An appropriate drug cessation period or alternative biliary decompression modalities may be used in these patients.

Risk of Complications After Endoscopic Retrograde Cholangiopancreatography in Pregnancy: A Propensity-Matched Analysis.

BACKGROUND: Studies have suggested higher complication rates after endoscopic retrograde cholangiopancreatography (ERCP) in pregnancy. AIMS: We performed a propensity-matched cohort analysis to assess the risk of ERCP-related complications among pregnant women in the United States. METHODS: The TriNetX database was analyzed to identify pregnant and non-pregnant females between 18 and 50 years of age who underwent ERCP. One-to-one propensity score matching was performed for age and race. Outcomes included risk of post-ERCP pancreatitis (PEP), gastrointestinal (GI) bleeding, perforation within 7 days, and infections within 30 days of ERCP. Subgroup analysis was performed to assess the risk of PEP based on indication for ERCP. RESULTS: The risk of PEP was higher in the pregnant cohort compared to controls, 10.3% vs 6.08%, adjusted odds ratio (aOR) 1.77, 95% confidence interval (CI) 1.20-2.61; p = 0.003. We found no difference in the risk of GI bleeding, perforation, and infections between the two cohorts. There was no difference in the risk of PEP in the pregnant cohort compared to controls who underwent ERCP for acute choledocholithiasis (4.2% vs 2.1%, aOR 1.98, 95% CI 0.97-4.03, p = 0.5) or ascending cholangitis (18.6% vs 14.7%, aOR 1.32, 95% CI 0.52-3.39, p = 0.55). There was no difference in the risk of PEP in the pregnant cohort after sensitivity analysis based on age, race, obesity, and indomethacin use. CONCLUSION: Pregnant females are at an increased risk of PEP but not GI bleeding, perforation, and infections when compared to non-pregnant controls. Clinicians should be cautious when proceeding with ERCP during pregnancy.

Efficacy & safety of EUS-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) in Roux-en-Y gastric bypass anatomy: a systematic review & meta-analysis.

BACKGROUND: In patients with Roux-en-Y gastric bypass (RYGB) anatomy, laparoscopic endoscopic retrograde cholangiopancreatography (LA-ERCP) and enteroscopy-assisted ERCP (E-ERCP) have been utilized to achieve pancreaticobiliary access. Endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) has recently emerged as an alternate and efficient approach. As data regarding EDGE continues to evolve, concerns about safety and efficacy remain, limiting wide adoptability. We performed a systematic review and meta-analysis to assess the safety and efficacy of EDGE and compare it to the current standard of care. METHODS: A comprehensive search of major databases (inception to Nov 2022) identified published studies on EDGE. A random-effects model was used to calculate the pooled rates and heterogeneity (I2). Risk ratio (RR) and standardized difference in means (SMD) were utilized for head-to-head comparison analysis between EDGE vs. LA-ERCP and EDGE vs. E-ERCP. Primary outcomes assessed pooled EDGE safety (adverse events) and efficacy (technical/clinical success). Secondary outcomes assessed efficacy and safety profiles via a comparative analysis of EDGE vs. LA-ERCP and EDGE vs. E-ERCP. RESULTS: A total of 16 studies (470 patients) were included. EDGE pooled technical success (TS) rate was 96% (95% CI 92-97.6, I2 = 0), and clinical success was 91% (85-95, I2 = 0). Pooled rate of all adverse events with EDGE was 17% (14-24.6, I2 = 32%). On sub-group analysis, these included failure of fistula closure 17% (10-25.5, I2 = 48%), stent migration 7% (4-12, I2 = 51%), bleeding 5% (3.2-7.9, I2 = 0), post-EDGE weight gain 4% (2-9, I2 = 0), perforation 4% (2.1-5.8, I2 = 0), and post-ERCP pancreatitis 2% (1-5, I2 = 0). EDGE TS was comparable to LA-ERCP (97% vs. 98%; RR, 1.00; CI, 0.85-1.17, p = 0.95) and E-ERCP (100% vs. 66%; RR, 1.26; CI, 0.99-1.6, p = 0.06). No statistical difference was noted in adverse events between EDGE and LA-ERCP (13% vs. 17.6%; RR, 0.61; CI, 0.28-1.35, p = 0.52) and E-ERCP (9.6% vs. 16%; RR, 0.61; CI, 0.28-1.35, p = 0.22). EDGE procedure time and hospital stay were shorter than LA-ERCP and E-ERCP (p < 0.001). CONCLUSION: Our analysis shows that EDGE is safe and efficacious to the current standard of care. Further head-to-head comparative trials are needed to validate our findings.

Recommendations on the Appropriate Management of Steroids and Discharge Planning During and After Hospital Admission for Moderate-Severe Ulcerative Colitis: Results of a RAND Appropriateness Panel.

INTRODUCTION: Limited guidance exists for the postdischarge care of patients with ulcerative colitis hospitalized for moderate-severe flares. METHODS: RAND methodology was used to establish appropriateness of inpatient and postdischarge steroid dosing, discharge criteria, follow-up, and postdischarge biologic or small molecule initiation. A literature review informed on the panel's voting, which occurred anonymously during 2 rounds before and after a moderated virtual session. RESULTS: Methylprednisolone 40-60 mg intravenous every 24 hours or hydrocortisone 100 mg intravenous 3 times daily is appropriate for inpatient management, with methylprednisolone 40 mg being appropriate if intolerant of higher doses. It is appropriate to discharge patients once rectal bleeding has resolved (Mayo subscore 0-1) and/or stool frequency has returned to baseline frequency and form (Mayo subscore 0-1). It is appropriate to discharge patients on 40 mg of prednisone after observing patients for 24 hours in hospital to ensure stability before discharge. For patients being discharged on steroids without in-hospital biologic or small molecule therapy initiation, it is appropriate to start antitumor necrosis factor (TNF) therapy after discharge for anti-TNF-naive patients. For anti-TNF-exposed patients, it is appropriate to start vedolizumab or ustekinumab for all patients and tofacitinib for those with a low risk of adverse events. It is appropriate to follow up patients clinically within 2 weeks and with lower endoscopy within 4-6 months after discharge. DISCUSSION: We provide recommendations on the inpatient and postdischarge management of patients with ulcerative colitis hospitalized for moderate-severe flares.

Therapeutic Endoscopy in Postoperative Pouch Complications.

Ileal pouch-anal anastomosis (IPAA) or "J"-pouch as it is commonly referred to, is the treatment of choice in patients with medically refractory ulcerative colitis. IPAA can have infectious, inflammatory, and mechanical complications. Currently, there are no Food and Drug Administration-approved medical therapies for these complications. Surgery that may be eventually required can have significant morbidities due to the complexity of IPAA. Endoscopy is fast emerging as a leading modality of treatment for some of these pouch complications. Endoscopy in adjunct with medical treatment can help manage the majority of pouch-related disorders and improve the outcome.

Hyperbaric Oxygen Therapy Is Effective in the Treatment of Inflammatory and Fistulizing Pouch Complications.

Ileal pouch-anal anastomosis (IPAA) is the surgical treatment of choice for medically refractory ulcerative colitis. Pouch-related complications, such as pouchitis, cuffitis, or fistulae, occur in up to 50% of patients. Nearly 1 in 5 patients develop pouch-related complications refractory to medical therapy, including biologics. Hypoxia has been suggested as a trigger for these chronic refractory complications, and treating hypoxia may be of therapeutic benefit in this patient population. We investigated the effectiveness of hyperbaric oxygen therapy (HBOT) for patients with medically refractory pouch-related complications.

A Microsimulation Model to Determine the Cost-Effectiveness of Treat-to-Target Strategies for Crohn's Disease.

INTRODUCTION: Cost-effectiveness of biomarker- vs endoscopy-based treat-to-target monitoring in Crohn's disease (CD) is unknown. METHODS: A microsimulation model for CD was built to simulate biomarker (fecal calprotectin) vs endoscopy-based monitoring in a treat-to-target fashion. Published literature in combination with patient-level data from phase 3 clinical trials and population estimates for therapeutic drug monitoring were used to generate transition probabilities, costs, and utilities. Tracker variables were used to modify downstream probabilities and outcomes based on previous exposures, response patterns, and disease-related complications or surgery history. The primary outcome was cost-effectiveness over a 5-year horizon at a willingness-to-pay threshold of $100,000/quality-adjusted life-year. Probabilistic sensitivity analyses in addition to multiple 1-, 2-, and 3-way microsimulation sensitivity analyses were performed. RESULTS: In the base-case model, the endoscopy-based monitoring strategy dominated the biomarker-based monitoring strategy over a 5-year horizon. Over shorter periods of observation, the biomarker-based monitoring strategy became progressively more cost-effective, with cost-effectiveness achieved for this strategy over a 1-year horizon. Therapeutic drug monitoring did not influence short-term cost-effectiveness of biomarker-based monitoring. Once in endoscopic remission, continued biomarker-based vs endoscopy-based monitoring was more cost-effective. A hybrid biomarker-endoscopy-based monitoring strategy dominated the endoscopy-based monitoring strategy over a 5-year horizon. The strongest determinants for cost-effectiveness were cost of colonoscopy and diagnostic performance of fecal calprotectin. DISCUSSION: The most cost-effective approach for treat-to-target monitoring in CD is up-front biomarker-based monitoring followed by endoscopy-based monitoring if not in endoscopic remission by 1 year and then returning to biomarker-based monitoring once in endoscopic remission.