Training in basic gastrointestinal endoscopic procedures: a European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) Position Statement.

This ESGE Position Statement provides structured and evidence-based guidance on the essential requirements and processes involved in training in basic gastrointestinal (GI) endoscopic procedures. The document outlines definitions; competencies required, and means to their assessment and maintenance; the structure and requirements of training programs; patient safety and medicolegal issues. 1: ESGE and ESGENA define basic endoscopic procedures as those procedures that are commonly indicated, generally accessible, and expected to be mastered (technically and cognitively) by the end of any core training program in gastrointestinal endoscopy. 2: ESGE and ESGENA consider the following as basic endoscopic procedures: diagnostic upper and lower GI endoscopy, as well as a limited range of interventions such as: tissue acquisition via cold biopsy forceps, polypectomy for lesions ≤ 10 mm, hemostasis techniques, enteral feeding tube placement, foreign body retrieval, dilation of simple esophageal strictures, and India ink tattooing of lesion location. 3: ESGE and ESGENA recommend that training in GI endoscopy should be subject to stringent formal requirements that ensure all ESGE key performance indicators (KPIs) are met. 4: Training in basic endoscopic procedures is a complex process and includes the development and acquisition of cognitive, technical/motor, and integrative skills. Therefore, ESGE and ESGENA recommend the use of validated tools to track the development of skills and assess competence. 5: ESGE and ESGENA recommend incorporating a multimodal approach to evaluating competence in basic GI endoscopic procedures, including procedural thresholds and the measurement and documentation of established ESGE KPIs. 7: ESGE and ESGENA recommend the continuous monitoring of ESGE KPIs during GI endoscopy training to ensure the trainee's maintenance of competence. 9: ESGE and ESGENA recommend that GI endoscopy training units fulfil the ESGE KPIs for endoscopy units and, furthermore, be capable of providing the dedicated personnel, infrastructure, and sufficient case volume required for successful training within a structured training program. 10: ESGE and ESGENA recommend that trainers in basic GI endoscopic procedures should be endoscopists with formal educational training in the teaching of endoscopy, which allows them to successfully and safely teach trainees.

Markers of cardiac dysfunction associated with inflammation in a cohort of patients with acute decompensation of cirrhosis.

BACKGROUND AND AIMS: Inflammation underpinning acute decompensation (AD) of liver disease is an important driver for the development of acute-on-chronic liver failure or death. We aimed to investigate associations between inflammatory biomarkers and impaired cardiac function in patients admitted for AD of cirrhosis. METHODS: This is a retrospective analysis of a well-characterized prospective cohort of patients with AD of liver disease admitted to a tertiary referral center. All patients had echocardiographic assessment of cardiac function and serum samples at admission. We reclassified patients according to the CLIF-C AD score, measured inflammatory (IL-6, IL-8, TNF-ɑ, CD206) and cardiac-specific (NT-proBNP, troponin T) biomarkers and tested for associations with echocardiographic parameters of cardiac function. We explored the impact on outcome of these factors in multivariate analysis. RESULTS: We included 70 patients (58 ±â€…10 years, 28 women), with a mean CLIF-C AD score of 47 ±â€…7. Thirty-nine patients (56%) fulfilled the echocardiographic criteria for cardiac dysfunction. We found associations between parameters of diastolic dysfunction and serum concentrations of IL-6 and CD206. Echocardiographic parameters of cardiac function were not associated with markers of liver dysfunction such as the CLIF-C AD score. In multivariate analysis higher MELD, higher NT-proBNP, and IL-8 concentrations as well as the absence of echocardiographic criteria for cardiac dysfunction significantly associated with death during follow-up. CONCLUSION: We found evidence in favor of a clinically relevant link between serum biomarkers of inflammation (IL-6, CD206) and echocardiographic signals of cardiac dysfunction in patients with acutely decompensated cirrhosis.

Assessing the impact of center volume on the cost-effectiveness of centralizing ERCP.

BACKGROUND AND AIMS: ERCP is a complex endoscopic procedure in which the center's procedure volume influences outcomes. With the increasing healthcare expenses and limited resources, promoting cost-effective care becomes essential for healthcare provision. This study performed a cost-effectiveness analysis to evaluate the hypothesis that high-volume (HV) centers perform ERCP with higher quality at lower costs than low-volume (LV) centers. METHODS: A baseline case compared the current distribution of ERCPs among HV and LV centers with a hypothetical scenario in which all ERCPs are performed at HV centers. A cost-effectiveness analysis was constructed, followed by one-way and two-way sensitivity analyses and probabilistic sensitivity analysis (PSA) using Monte Carlo simulations. RESULTS: In the baseline case, the ICER was -141,017€/year, due to the hypothetical scenario's lower costs and slightly higher QALYs. The model was most sensitive to changes in the transportation costs (109.34%), probability of significant adverse events (AEs) after successful ERCP at LV centers (42.12%), utility after ERCP with significant AEs (30.10%), and probability of significant AEs after successful ERCP at HV centers (23.53%) but only transportation cost above 3,407€ changed the study outcome. The current ERCP distribution would only be cost-effective if LV centers achieved higher success (≥ 92.4% vs. 89.3%) with much lower significant AEs (≤ 0.5% vs 6.7%). The study's main findings remained unchanged while combining all model parameters in the PSA. CONCLUSIONS: Our findings show that HV centers have high-performance rates at lower costs, raising the need to consider the principle of centralization of ERCPs into HV centers to improve the quality of care.

Safety, Efficacy and Persistence of Advanced Therapies in Inflammatory Bowel Disease: Results from ORIGINS. A Retrospective Observational Study.

BACKGROUND AND AIMS: Real-world assessments of efficacy and safety of advanced therapies used for inflammatory bowel disease (IBD) patients are limited. We aimed to report safety, efficacy and treatment persistence of new molecules (infliximab, adalimumab, vedolizumab, tofacitinib, ustekinumab) in a retrospective multicentric national Romanian analysis. METHODS: We conducted a nationwide, retrospective observational multicentric study. Data were collected retrospectively from electronic and paper files. Patients who started on one of the five investigated molecules during December 2019-December 2021 were included. The main outcome measures were clinical remission, endoscopic healing, persistence on treatment and safety data. RESULTS: A total of 678 adult patients from 24 Romanian IBD centers with a diagnosis of ulcerative colitis or Crohn's disease were included. Participants had previously failure to one (268, 39.5%), two (108, 15%) or more treatment lines and only 38% (259) were biologic naïve. In the 24 months study period, most patients were started on vedolizumab (192, 28%), followed by adalimumab, infliximab, ustekinumab and tofacitinib. In biologic-naïve patients, most physicians (72%) preferred anti-TNF treatment as first line biologic (93 patients started on infliximab, 92 on adalimumab), followed by vedolizumab, ustekinumab and tofacitinib. During follow-up, 71% (470, p=0.05) of patients achieved clinical remission and 36% (134, p=0.03) achieved mucosal healing. The 6 months milestone for persistence was reached in 78% (530) of cases. Almost half of patients (47%, 316 patients) persisted on their current treatment for over 12 months. Overall, an adverse reaction was reported for 67 (10.4%) patients, with no lethal events. CONCLUSIONS: Population of biologic-experienced IBD patients in Romania is increasing and is becoming more difficult to achieve long-term disease control. Discontinuation rates for advanced therapies are high.

The perfect biliary plastic stent: the search goes on.

The introduction of biliary plastic stents has been a landmark achievement in the field of endoscopic retrograde cholangiopancreatography, ensuring minimally invasive and highly effective relief of the obstructed biliary system. Attempts to improve the patency and avoid complications after biliary plastic stenting have led to several innovations, but complications due to stent occlusion are still frequent. Because these complications are clinically relevant, and may guide stent choice and patient management, efforts have been made to elucidate the causes of and ways to prevent occlusion of indwelling stents. In this narrative review we focus on biliary plastic stents and discuss the mechanisms of stent occlusion, existing evidence on salient outcomes, as well as options to overcome existing limitations and prolong plastic stent patency.

Real-World Endoscopic and Histologic Outcomes in Ulcerative Colitis Patients: A Retrospective Cohort Study.

BACKGROUND: Histologic activity has emerged as an aspirational therapeutic goal in ulcerative colitis management. It is not yet a formal treatment target in ulcerative colitis. However, it could be used as an adjunct to mucosal healing to represent a deeper level of healing. We investigated mucosal and histologic remission rates and potential predictors of these outcomes in a cohort of UC patients. METHODS: We conducted a retrospective analysis of data collected from UC patients enrolled in an ongoing prospective cohort study. Mucosal healing was defined as Mayo endoscopic score = 0. RESULTS: A total of 131 patients with ulcerative colitis were enrolled in our study and were prospectively followed for a median length of 2 years (range 0-5 years), totaling 266 study visits. Mucosal healing was recorded for 27 patients at 70 (26%) different study visits. For patients with mucosal healing, histologic remission was achieved in 18/27 (66%) patients. On univariate analysis, sustained clinical remission, SIBDQ scores ≥ 5.5, CRP ≤ 5 mg/dL and absence of corticotherapy were associated with mucosal healing and SIBDQ scores ≥ 5.5 and CRP ≤ 5 mg/dL with histologic healing, respectively. After logistic regression analysis, none of the investigated factors were associated with mucosal and histologic healing. The number of CD8+ intraepithelial lymphocytes (IELs) was significantly greater than the number of CD4+ IELs in periods of disease activity, as well as during mucosal healing (p < 0.01 in both cases). CONCLUSIONS: Mucosal healing and histologic remission rates are low in real-life settings. The results of univariate analysis indicate that a good quality of life (SIBDQ score) and normal inflammatory markers (CRP) are associated with mucosal and histologic healing. However, frequently used patient- and disease-related factors, including mucosal healing, are not reliable predictors for histologic remission. Greater CD8+ lymphocyte involvement and higher CD8+/CD4+ distribution can have a meaningful impact on understanding the pathogenesis and natural history of ulcerative colitis, as well as future treatment options for lymphocyte-targeting medications.

Face and content validity of a biological papilla designed for the Boskoski-Costamagna ERCP simulator.

BACKGROUND AND AIMS: A biological papilla made of chicken heart tissue, incorporated into the Boskoski-Costamagna ERCP Trainer simulator, was recently designed to allow training in sphincterotomy. This study aimed to evaluate the face and content validity of this tool. METHOD: Participants from 2 groups (nonexperienced and experienced [<600 or >600 lifetime ERCPs, respectively]) were invited to perform standardized assignments on the model: sphincterotomy and precut for both groups and papillectomy for the experienced group. Following these assignments, all participants filled out a questionnaire to rate their appreciation of the realism of the model, and experienced endoscopists were also asked to evaluate its didactic value using a 5-point Likert scale. RESULTS: A total of 19 participants were included (nonexperienced, n = 10; experienced, n = 9). Parameters regarding the realism of the tool in terms of general appearance, sphincterotomy, precut, and papillectomy were overall considered realistic (4 of 5), with good agreement rates in terms of overall realism between groups. Experienced operators reported the highest realism for "positioning the scope and needle-knife in the field of view" and "during precut," "cutting in small increments during precut," and "controlling the scope during papillectomy," and they highly agreed that this papilla should be included for training novice and intermediate trainees in sphincterotomy, precut, and papillectomy. CONCLUSIONS: Our results show good face validity and excellent content validity of this biological papilla combined with the Boskoski-Costamagna ERCP Trainer. This new tool provides a useful, inexpensive, versatile, and easy tool for training regarding sphincterotomy, precut, and papillectomy. Future studies should explore whether including this model in real-life training improves the learning curve of endoscopy trainees.

The Role of Lumen Apposing Metal Stents in the Palliation of Distal Malignant Biliary Distal Obstruction.

Malignant biliary obstruction (DMBO) has been traditionally managed by endoscopic retrograde cholangiopancreatography (ERCP). In the case of ERC failure, percutaneous transhepatic biliary drainage (PT-BD) has been widely utilized as a salvage procedure. However, over the last decade, endoscopic ultrasound-guided biliary drainage (EUS-BD) has gained increasing popularity, especially after the advent of electrocautery-enhanced lumen apposing metal stent devices (EC-LAMSs) which enable a one-step procedure, granting prevention of biliary leakage and minimizing occurrence of adverse events (AEs). In parallel, increasing evidence suggests a possible role of EUS-BD in the management of DMBO as a primary palliative drainage modality. In the current paper, we aim to review all the available evidence on the role of EUS-BD performed with EC-LAMSs and discuss salient technical aspects of this type of procedure.

The Role of Artificial Intelligence in Monitoring Inflammatory Bowel Disease-The Future Is Now.

Crohn's disease and ulcerative colitis remain debilitating disorders, characterized by progressive bowel damage and possible lethal complications. The growing number of applications for artificial intelligence in gastrointestinal endoscopy has already shown great potential, especially in the field of neoplastic and pre-neoplastic lesion detection and characterization, and is currently under evaluation in the field of inflammatory bowel disease management. The application of artificial intelligence in inflammatory bowel diseases can range from genomic dataset analysis and risk prediction model construction to the disease grading severity and assessment of the response to treatment using machine learning. We aimed to assess the current and future role of artificial intelligence in assessing the key outcomes in inflammatory bowel disease patients: endoscopic activity, mucosal healing, response to treatment, and neoplasia surveillance.

A simple clinical score to stratify the risk of procedure-related adverse events in ERCP procedures with trainee involvement.

BACKGROUND : Optimal training strategies in endoscopic retrograde cholangiopancreatography (ERCP) remain controversial despite the shift toward competence-based training models, with limited data available on patient safety during training. We aimed to assess whether pre-procedural clinical predictors could identify patients at low risk of developing procedure-related adverse-events (AEs) in a training environment. METHODS : We performed a prospective, multicenter, cohort study in five training centers. A data collection system documenting indication, clinical data, trainee performance (assessed using a validated competence assessment tool), technical outcomes, and AEs over a 30-day follow-up was utilized. We developed a clinical risk score (Trainee Involvement in ERCP Risk Score [TIERS]) for patients undergoing ERCP and compared the rate of AEs in a training environment between low-risk and high-risk groups. The association between trainee performance and AE rate was also evaluated. RESULTS : 1283 ERCPs (409 [31.9 %, 95 %CI 29.3 %-34.4 %] with trainee involvement) performed by 11 trainers and 10 trainees were analyzed. AEs were more frequent in the high-risk compared with the low-risk group: 26.7 % (95 %CI 20.5 %-34.7 %) vs. 17.1 % (95 %CI 12.8 %-22.2 %). TIERS demonstrated a high negative predictive value for AEs (82.9 %, 95 %CI 79.4 %-85.8 %) and was the only predictor of AEs on multivariable analysis (odds ratio 1.38, 95 %CI 1.09-1.75). Suboptimal trainee performance was associated with an increase in AE rates. CONCLUSION : Simple, clinical-based predictive tools could improve ERCP training by selecting the most appropriate cases for hands-on training, with the aim of increasing patient safety.

Wet-suction versus slow-pull technique for endoscopic ultrasound-guided fine-needle biopsy: a multicenter, randomized, crossover trial.

BACKGROUND : It is unknown whether there is an advantage to using the wet-suction or slow-pull technique during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) with new-generation needles. We aimed to compare the performance of each technique in EUS-FNB. METHODS: This was a multicenter, randomized, single-blind, crossover trial including patients with solid lesions of ≥ 1 cm. Four needle passes with 22 G fork-tip or Franseen-type needles were performed, alternating the wet-suction and slow-pull techniques in a randomized order. The primary outcome was the histological yield (samples containing an intact piece of tissue of at least 550 µm). Secondary end points were sample quality (tissue integrity and blood contamination), diagnostic accuracy, and adequate tumor fraction. RESULTS: Overall, 210 patients with 146 pancreatic and 64 nonpancreatic lesions were analyzed. A tissue core was retrieved in 150 (71.4 %) and 129 (61.4 %) cases using the wet-suction and the slow-pull techniques, respectively (P = 0.03). The mean tissue integrity score was higher using wet suction (P = 0.02), as was the blood contamination of samples (P < 0.001). In the two subgroups of pancreatic and nonpancreatic lesions, tissue core rate and tissue integrity score were not statistically different using the two techniques, but blood contamination was higher with wet suction. Diagnostic accuracy and tumor fraction did not differ between the two techniques. CONCLUSION: Overall, the wet-suction technique in EUS-FNB resulted in a higher tissue core procurement rate compared with the slow-pull method. Diagnostic accuracy and the rate of samples with adequate tumor fraction were similar between the two techniques.

Characteristics and outcomes of patients with COVID-19 and liver injury: a retrospective analysis and a multicenter experience.

Background and aims. Patients with COVID-19 frequently present abnormal elevated liver function tests of unknown clinical significance. We aimed to investigate the characteristics and factors influencing outcome in patients with confirmed SARS-CoV-2 infection and liver injury on admission.Methods. This is a retrospective observational study of patients hospitalized in two COVID units in Romania. Relevant data on clinical and laboratory parameters and medication administered during the admission were analyzed to identify predictors of a negative outcome. Patients with confirmed COVID-19 and liver function tests (LFTs) above the upper limit of normal were included in the analysis.Results. From 1,207 patients, we identified 134 patients (11%) with abnormal LFTs during hospitalization. The majority of patients had mildly elevated levels and a predominantly cholestatic pattern of liver injury. Patients who received lopinavir/ritonavir were more likely to have increased ALAT levels (p<0.0001). Sixteen patients had pre-existing chronic liver disease, and they were more likely to suffer from severe COVID-19 (p=0.009) and have a negative outcome (p<0.001), but on multivariate analysis, only the severity of COVID-19 was predictive of death (OR 69.9; 95% CI 6.4-761.4).Conclusions. Mild liver injury is relatively common in COVID-19 and possibly influenced by medication. Patients with chronic liver disease are at high risk for negative outcome, but the severity of the infection is the only predictor of death.

Dipeptidyl peptidase-3 is associated with severity of liver disease and circulatory complications in patients with cirrhosis.

BACKGROUND: Patients with cirrhosis suffer from a complex multiorgan disturbance and their prognosis is influenced by the development of portal hypertension and systemic circulatory dysfunction. Although non-invasive techniques such as transient elastography aid in early detection, there is an unmet need for reliable markers of these clinically significant complications. METHODS: We conducted an exploratory single-center study investigating dipeptidyl peptidase-3 (DPP3) concentrations in various vascular beds in a cohort of 48 patients with cirrhosis and 16 healthy controls. Liver vein catheterisation with sampling from femoral artery and femoral, renal and hepatic veins as well as measurement of hepatic pressure and liver function via indocyanine green and galactose elimination tests were performed. RESULTS: DPP3 concentrations were higher in cirrhotic patients compared to controls (12.6 vs. 7.4 ng/mL, p = 0.006) and increased according to the severity of cirrhosis. DPP3 associated with MELD-Na score, Child class, indocyanine green clearance, increased DPP3 with the increased hepatic venous pressure gradient (p = 0.015) as well as increased heart rate and reduced systemic vascular resistance. DPP3 concentrations predicted the presence of clinically significant portal hypertension in cirrhotic patients (AUROC 0.78, 95% CI 0.65-0.9). CONCLUSION: DPP3 is a promising marker for portal hypertension and systemic hemodynamic changes in cirrhosis.

Common bile duct size in malignant distal obstruction and lumen-apposing metal stents: a multicenter prospective study.

Background and study aims Feasibility of EUS-guided choledochoduodenostomy (EUS-CDS) using available lumen-apposing stents (LAMS) is limited by the size of the common bile duct (CBD) (≤ 12 mm, cut-off for experts; 15 mm, cut-off for non-experts). We aimed to assess the prevalence and predictive factors associated with CBD size ≥ 12 and 15 mm in naïve patients with malignant distal biliary obstruction (MDBO). Patients and methods This was a prospective cohort study involving 22 centers with assessment of CBD diameter and subjective feasibility of the EUS-CDS performance in naïve jaundiced patients undergoing EUS evaluation for MDBO. Results A total of 491 patients (mean age 69 ±â€Š12 years) with mean serum bilirubin of 12.7 ±â€Š6.6 mg/dL entered the final analysis. Dilation of the CBD ≥ 12 and 15 mm was detected in 78.8 % and 51.9 % of cases, respectively. Subjective feasibility of EUS-CDS was expressed by endosonographers in 91.2 % for a CBD ≥ 12 mm and in 96.5 % for a CBD ≥ 15 mm. On multivariate analysis, age ( P  < 0.01) and bilirubin level ( P  ≤ 0.001) were the only factors associated with both CBD dilation ≥ 12 and ≥ 15 mm. These variables were poorly associated with the extent of duct dilation; however, based on them a prediction model could be constructed that satisfactorily predicted CBD size ≥ 12 mm in patients at least 70 years and a bilirubin level ≥ 7 mg/dL. Conclusions Our study showed that at presentation in a large cohort of patients with MDBO, EUS-CDS can be potentially performed in three quarters to half of cases by expert and less experienced endosonographers, respectively. Dedicated stents or devices with different designs able to overcome the limitations of existing electrocautery-enhanced LAMS for EUS-CDS are needed.

Surrogate markers of mucosal healing in inflammatory bowel disease: A systematic review.

BACKGROUND: Mucosal healing (MH) has emerged as a key therapeutic target in inflammatory bowel disease (IBD), and achievement of this goal is documented by endoscopy with biopsy. However, colonoscopy is burdensome and invasive, and substitution with an accurate noninvasive biomarker is desirable. AIM: To summarize published data regarding the performance of noninvasive biomarkers in assessing MH in IBD patients. METHODS: We conducted a systematic review of studies that reported the performance of biomarkers in diagnosing MH in patients with IBD. The main outcome measure was to review the diagnostic accuracy of serum and fecal markers that showed promising utility in assessing MH. RESULTS: We screened 1301 articles, retrieved 46 manuscripts and included 23 articles for full-text analysis. The majority of the included manuscripts referred to fecal markers (12/23), followed by circulatory markers (8/23); only 3/23 of the included manuscripts investigated combined markers (serum and/or fecal markers). Fecal calprotectin (FC) was the most investigated fecal marker for assessing MH. In ulcerative colitis, for cutoff levels ranging between 58 mcg/g and 490 mcg/g, the sensitivity was 89.7%-100% and the specificity was 62%-93.3%. For Crohn's disease, the cutoff levels of FC ranged from 71 mcg/g to 918 mcg/g (sensitivity 50%-95.9% and specificity 52.3%-100%). The best performance for a serum marker was observed for the endoscopic healing index, which showed a comparable accuracy to the measurement of FC and a higher accuracy than the measurement of serum C-reactive protein. CONCLUSION: Several promising biomarkers of MH are emerging but cannot yet substitute for endoscopy with biopsy due to issues with reproducibility and standardization.