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1.
Artigo em Inglês | MEDLINE | ID: mdl-39142543

RESUMO

BACKGROUND AND AIMS: Limited evidence exists regarding the impact of glucagon-like peptide-1 receptor agonists (GLP-1RAs) on upper endoscopy. Therefore, a meta-analysis was conducted to comprehensively review the available evidence on this subject. METHODS: A systematic bibliographic search was carried out until May 2024. Pooled estimates were analyzed using a random-effects model, with results presented as odds ratios (OR) and 95% confidence intervals (CI). The primary outcome assessed was the rate of retained gastric content (RGC), while secondary outcomes included rates of aborted and repeated procedures, adverse event (AE) rate, and rates of aspiration. RESULTS: This analysis included 13 studies involving a total of 84,065 patients. Patients receiving GLP-1RA therapy exhibited significantly higher rates of RGC (OR 5.56, 3.35-9.23), a trend that was consistent among patients with diabetes (OR 2.60, 2.23-3.02). Adjusted analysis, accounting for variables such as sex, age, body mass index (BMI), diabetes, and other therapies, confirmed the elevated rates of RGC in the GLP-1RA user group (aOR 4.20, 3.42-5.15). Furthermore, rates of aborted and repeated procedures were higher in the GLP-1RA user group (OR 5.13, 3.01-8.75, and OR 2.19, 1.43-3.35; respectively). However, no significant differences were found in AE and aspiration rates between the two groups (OR 4.04, 0.63-26.03, and OR 1.75, 0.64-4.77; respectively). CONCLUSION: Use of GLP-1RAs is associated with increased retention of gastric contents and more frequent aborted procedures during upper endoscopy. However, the AEs and aspiration rates do not seem different, therefore adjusting fasting time instead of routinely withholding GLP-1RAs could be reasonable in these patients.

2.
Ann Gastroenterol ; 37(4): 485-492, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38974085

RESUMO

Background: Stent selection in the endoscopic management of post-liver-transplant anastomotic biliary strictures remains controversial. This systematic review and meta-analysis aimed to evaluate the potential differences between available stents. Methods: MEDLINE, Cochrane, and Scopus databases were searched until April 2023 for comparative studies evaluating stricture management using multiple plastic stents (MPS) and self-expandable metal stents (SEMS), including fully-covered (FC)- and intraductal (ID)-SEMS. The primary outcome was stricture resolution, while secondary outcomes included stricture recurrence, stent migration and adverse events. Meta-analyses were based on a random-effects model and the results were reported as odds ratios (OR) with 95% confidence intervals (CI). Subgroup analyses by type of metal stent and a cost-effectiveness analysis were also performed. Results: Nine studies (687 patients) were finally included. Considering stricture resolution, SEMS and MPS did not differ significantly (OR 0.99, 95%CI 0.48-2.01; I 2=35%). Stricture recurrence, migration rates and adverse events were also comparable (OR 1.71, 95%CI 0.87-3.38; I 2=55%, OR 0.73, 95%CI 0.32-1.68; I 2=56%, and OR 1.47, 95%CI 0.89-2.43; I 2=24%, respectively). In the subgroup analysis, stricture resolution and recurrence rates did not differ for ID-SEMS vs. MPS or FC-SEMS vs. MPS. Migration rates were lower for ID-SEMS compared to MPS (OR 0.28, 95%CI 0.11-0.70; I 2=0%), and complication rates were higher after FC-SEMS compared to MPS (OR 1.76, 95%CI 1.06-2.93; I 2=0%). Finally, ID-SEMS were the most cost-effective approach, with the lowest incremental cost-effectiveness ratio: 3447.6 £/QALY. Conclusion: Stent type did not affect stricture resolution and recurrence; however, ID-SEMS placement was the most cost-effective approach compared to the alternatives.

4.
Gastroenterology ; 2024 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-39019405
5.
Best Pract Res Clin Gastroenterol ; 69: 101906, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38749582

RESUMO

Endoscopic retrograde cholangiopancreatography (ERCP) is a common endoscopic procedure which plays a key role in the management of diseases of the bile ducts and the pancreas. Despite ERCP being performed routinely since more than 4 decades, it is still related to a considerable rate of complications with post-ERCP pancreatitis being the most frequent one. Lately, endoscopic techniques have evolved, and numerous modalities have been developed to prevent or manage ERCP-related complications, especially PEP, such as the use of intra-rectal non-steroidal anti-inflammatory drugs (NSAIDs), insertion of prophylactic stents in the pancreatic duct (PD) or intravenous hyperhydration. Knowledge of the various risk factors and applying validated preventive methods are keys in providing a safe procedure and optimizing overall patient care.


Assuntos
Colangiopancreatografia Retrógrada Endoscópica , Pancreatite , Humanos , Anti-Inflamatórios não Esteroides/uso terapêutico , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Pancreatite/prevenção & controle , Pancreatite/etiologia , Fatores de Risco , Stents
6.
Indian J Gastroenterol ; 43(3): 578-591, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38625518

RESUMO

Acute necrotizing pancreatitis is a common gastrointestinal disease requiring hospitalization and multiple interventions resulting in higher morbidity and mortality. Development of infection in such necrotic tissue is one of the sentinel events in natural history of necrotizing pancreatitis. Infected necrosis develops in around 1/3rd of patients with necrotizing pancreatitis resulting in higher mortality. So, timely diagnosis of infected necrosis using clinical, laboratory and radiological parameters is of utmost importance. Though initial conservative management with antibiotics and organ support system is effective in some patients, a majority of patients still requires drainage of the collection by various modalities. Mode of drainage of infected pancreatic necrosis depends on various factors such as the clinical status of the patient, location and characteristics of collection and availability of the expertise and includes endoscopic, percutaneous and minimally invasive or open surgical approaches. Endoscopic drainage has proved to be a game changer in the management of infected pancreatic necrosis in the last decade with rapid evolution in procedure techniques, development of novel metal stent and dedicated necrosectomy devices for better clinical outcome. Despite widespread adoption of endoscopic transluminal drainage of pancreatic necrosis with excellent clinical outcomes, peripheral collections are still not amenable for endoscopic drainage and in such scenario, the role of percutaneous catheter drainage or minimally invasive surgical necrosectomy cannot be understated. In a nutshell, the management of patients with infected pancreatic necrosis involves a multi-disciplinary team including a gastroenterologist, an intensivist, an interventional radiologist and a surgeon for optimum clinical outcomes.


Assuntos
Drenagem , Pancreatite Necrosante Aguda , Humanos , Pancreatite Necrosante Aguda/terapia , Pancreatite Necrosante Aguda/cirurgia , Pancreatite Necrosante Aguda/diagnóstico , Drenagem/métodos , Stents , Antibacterianos/uso terapêutico , Endoscopia/métodos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos
7.
Pancreatology ; 24(3): 363-369, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38431445

RESUMO

OBJECTIVE: Hemin, a heme oxygenase 1 activator has shown efficacy in the prevention and treatment of acute pancreatitis in mouse models. We conducted a randomized controlled trial (RCT) to assess the protective effect of Hemin administration to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in patients at risk. METHODS: In this multicenter, multinational, placebo-controlled, double-blind RCT, we assigned patients at risk for PEP to receive a single intravenous dose of Hemin (4 mg/kg) or placebo immediately after ERCP. Patients were considered to be at risk on the basis of validated patient- and/or procedure-related risk factors. Neither rectal NSAIDs nor pancreatic stent insertion were allowed in randomized patients. The primary outcome was the incidence of PEP. Secondary outcomes included lipase elevation, mortality, safety, and length of stay. RESULTS: A total of 282 of the 294 randomized patients had complete follow-up. Groups were similar in terms of clinical, laboratory, and technical risk factors for PEP. PEP occurred in 16 of 142 patients (11.3%) in the Hemin group and in 20 of 140 patients (14.3%) in the placebo group (p = 0.48). Incidence of severe PEP reached 0.7% and 4.3% in the Hemin and placebo groups, respectively (p = 0.07). Significant lipase elevation after ERCP did not differ between groups. Length of hospital stay, mortality and severe adverse events rates were similar between groups. CONCLUSION: We failed to detect large improvements in PEP rate among participants at risk for PEP who received IV hemin immediately after the procedure compared to placebo. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov number, NCT01855841).


Assuntos
Colangiopancreatografia Retrógrada Endoscópica , Pancreatite , Animais , Humanos , Camundongos , Anti-Inflamatórios não Esteroides/uso terapêutico , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Heme Oxigenase-1 , Hemina/uso terapêutico , Lipase , Pancreatite/etiologia , Pancreatite/prevenção & controle , Administração Intravenosa
8.
Medicina (Kaunas) ; 60(2)2024 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-38399627

RESUMO

Choledocholithiasis is one of the most common indications for endoscopic retrograde cholangiopancreatography (ERCP) in daily practice. Although the majority of stones are small and can be easily removed in a single endoscopy session, approximately 10-15% of patients have complex biliary stones, requiring additional procedures for an optimum clinical outcome. A plethora of endoscopic methods is available for the removal of difficult biliary stones, including papillary large balloon dilation, mechanical lithotripsy, and electrohydraulic and laser lithotripsy. In-depth knowledge of these techniques and the emerging literature on them is required to yield the most optimal therapeutic effects. This narrative review aims to describe the definition of difficult bile duct stones based on certain characteristics and streamline their endoscopic retrieval using various modalities to achieve higher clearance rates.


Assuntos
Coledocolitíase , Cálculos Biliares , Humanos , Resultado do Tratamento , Colangiopancreatografia Retrógrada Endoscópica/métodos , Cálculos Biliares/cirurgia , Cateterismo/métodos , Coledocolitíase/cirurgia
10.
Endoscopy ; 56(5): 355-363, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38278158

RESUMO

BACKGROUND: Gastrointestinal (GI) endoscopy is one of healthcare's main contributors to climate change. We aimed to assess healthcare professionals' attitudes and the perceived barriers to implementation of sustainable GI endoscopy. METHODS: The LEAFGREEN web-based survey was a cross-sectional study conducted by the European Society of Gastrointestinal Endoscopy (ESGE) Green Endoscopy Working Group. The questionnaire comprised 39 questions divided into five sections (respondent demographics; climate change and sustainability beliefs; waste and resource management; single-use endoscopes and accessories; education and research). The survey was available via email to all active members of the ESGE and the European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) in March 2023. RESULTS: 407 respondents participated in the survey (11% response rate). Most participants (86%) agreed climate change is real and anthropogenic, but one-third did not consider GI endoscopy to be a significant contributor to climate change. Improvement in the appropriateness of endoscopic procedures (41%) and reduction in single-use accessories (34%) were considered the most important strategies to reduce the environmental impact of GI endoscopy. Respondents deemed lack of institutional support and knowledge from staff to be the main barriers to sustainable endoscopy. Strategies to reduce unnecessary GI endoscopic procedures and comparative studies of single-use versus reusable accessories were identified as research priorities. CONCLUSIONS: In this survey, ESGE and ESGENA members acknowledge climate change as a major threat to humanity. Further improvement in sustainability beliefs and professional attitudes, reduction in inappropriate GI endoscopy, and rational use of single-use accessories and endoscopes are critically required.


Assuntos
Atitude do Pessoal de Saúde , Endoscopia Gastrointestinal , Humanos , Estudos Transversais , Feminino , Masculino , Inquéritos e Questionários , Adulto , Mudança Climática , Pessoa de Meia-Idade , Conhecimentos, Atitudes e Prática em Saúde , Endoscópios Gastrointestinais
11.
Clin Nutr ; 43(2): 395-412, 2024 02.
Artigo em Inglês | MEDLINE | ID: mdl-38169174

RESUMO

Both acute and chronic pancreatitis are frequent diseases of the pancreas, which, despite being of benign nature, are related to a significant risk of malnutrition and may require nutritional support. Acute necrotizing pancreatitis is encountered in 20 % of patients with acute pancreatitis, is associated with increased morbidity and mortality, and may require artificial nutrition by enteral or parenteral route, as well as additional endoscopic, radiological or surgical interventions. Chronic pancreatitis represents a chronic inflammation of the pancreatic gland with development of fibrosis. Abdominal pain leading to decreased oral intake, as well as exocrine and endocrine failure are frequent complications of the disease. All of the above represent risk factors related to malnutrition. Therefore, patients with chronic pancreatitis should be considered at risk, screened and supplemented accordingly. Moreover, osteoporosis and increased facture risk should be acknowledged in patients with chronic pancreatitis, and preventive measures should be considered.


Assuntos
Desnutrição , Pancreatite Crônica , Humanos , Doença Aguda , Nutrição Enteral/efeitos adversos , Pancreatite Crônica/complicações , Pancreatite Crônica/terapia , Desnutrição/etiologia
13.
Endoscopy ; 56(2): 131-150, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38040025

RESUMO

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.


Assuntos
Gastroenterologia , Humanos , Endoscopia Gastrointestinal/métodos , Endoscópios Gastrointestinais , Sociedades Médicas
14.
Gastrointest Endosc ; 2023 Dec 05.
Artigo em Inglês | MEDLINE | ID: mdl-38061478

RESUMO

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.

15.
Best Pract Res Clin Gastroenterol ; 67: 101859, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38103925

RESUMO

Adequate bowel preparation is of paramount importance for the effectiveness of preventive colonoscopy as it allows visualization of the mucosal surface and adenomas detection, the pre-malignant lesions leading to colon cancer. Still, a considerable portion of patients fail to achieve adequate bowel cleansing, with predictors of inadequate bowel preparation being at the focal point of several studies, so far. Incorporation of these factors within predictive models has been implemented in an effort to promptly identify patients at risk for inadequate bowel preparation and thus, timely adopt practices that have the potential to improve bowel cleansing. Ultimately, this could lead to improved procedural outcomes not only in terms of neoplastic detection rate but also interval repeat procedures, expenses, patient convenience and adverse events risk. Aim of this manuscript is to present an up to date overview of all predictive scores/models addressing bowel cleansing adequacy in everyday clinical practice.


Assuntos
Adenoma , Colonoscopia , Humanos , Colonoscopia/efeitos adversos , Colonoscopia/métodos , Polietilenoglicóis
16.
Ann Gastroenterol ; 36(5): 580-587, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37664233

RESUMO

Background: Multidisciplinary team (MDT) meetings aim to optimize patient management. We evaluated the impact of MDT discussions on the management and diagnosis of focal pancreatic lesions in a single tertiary center. Methods: All patients with an initial diagnosis of solid or cystic pancreatic lesion discussed in our institution's MDT meeting on pancreatic diseases between January 1, 2020, and December 31, 2021, were included. The impact of MDT discussion on patient management, defined as a modification of the initially proposed therapeutic plan after MDT discussion, as well as the criteria leading to this modification, were the primary outcomes. Impact on diagnosis was the secondary outcome. Results: A total of 522 patients were included. Of these, 185 (35.4%) and 337 (64.6%) had an initial diagnosis of cystic or solid lesion, respectively. The most common referral query was regarding the management plan (349/522; 66.9%). Endoscopy was the procedure most often proposed before MDT discussion (109/522; 20.9%). Overall, the MDT discussion led to modification of the management plan in 377/522 patients (72.2%), with a statistically significant difference between cystic and solid lesions (63.2% vs. 77.2%; P<0.001). Management modifications were mainly driven by revision of cross-sectional radiological images. MDT discussion led to modification of the diagnosis in 92/522 patients (17.6%), with a significant difference regarding cystic lesions (35.7% vs. 7.7%; P<0.001). Conclusion: MDT discussion impacts the management of patients with cystic and solid pancreatic lesions, leading to a modification of the initially proposed management in two-thirds of them, mainly through revision of cross-sectional imaging.

17.
Artigo em Inglês | MEDLINE | ID: mdl-37652649

RESUMO

For patients requiring long-term (>4 weeks) jejunal nutrition, jejunal medication delivery, or decompression, a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) or a direct percutaneous endoscopic jejunostomy (DPEJ) may be indicated. PEG-J is the preferred option if a PEG tube is already in place or if simultaneous gastric decompression and jejunal nutrition are needed. DPEJ is recommended for patients with altered anatomy due to foregut surgery, high risk of jejunal extension migration, and whenever PEG-J fails. Successful placement rates are lower for DPEJ but recent publications have reported improvements, partly due to the use of balloon-assisted enteroscopy. Both techniques are contraindicated in cases of active peritonitis, uncorrectable coagulopathy, and ongoing bowel ischaemia, and relative contraindications include, among other, peptic ulcer disease and haemodynamic or respiratory instability. In this narrative review, we present the most recent evidence on indications, contraindications, technical considerations, adverse events, and outcomes of PEG-J and DPEJ.


Assuntos
Nutrição Enteral , Jejunostomia , Humanos , Nutrição Enteral/métodos , Jejunostomia/efeitos adversos , Jejunostomia/métodos , Gastrostomia/efeitos adversos , Gastrostomia/métodos
18.
Cancers (Basel) ; 15(13)2023 Jun 28.
Artigo em Inglês | MEDLINE | ID: mdl-37444495

RESUMO

Pancreatic cancer and cholangiocarcinoma are life threatening oncological conditions with poor prognosis and outcome. Pancreatic cystic lesions are considered precursors of pancreatic cancer as some of them have the potential to progress to malignancy. Therefore, accurate identification and classification of these lesions is important to prevent the development of invasive cancer. In the biliary tract, the accurate characterization of biliary strictures is essential for providing appropriate management and avoiding unnecessary surgery. Techniques have been developed to improve the diagnosis, risk stratification, and management of pancreato-biliary lesions. Endoscopic ultrasound (EUS) and associated techniques, such as elastography, contrasted-enhanced EUS, and EUS-guided needle confocal laser endomicroscopy, may improve diagnostic accuracy. In addition, intraductal techniques applied during endoscopic retrograde cholangiopancreatography (ERCP), such as new generation cholangioscopy and in vivo cellular evaluation through probe-based confocal laser endomicroscopy, can increase the diagnostic yield in characterizing indeterminate biliary strictures. Both EUS-guided and intraductal approaches can provide the possibility for tissue sampling with new tools, such as needles, biopsies forceps, and brushes. At the molecular level, novel biomarkers have been explored that provide new insights into diagnosis, risk stratification, and management of these lesions.

19.
United European Gastroenterol J ; 11(7): 663-689, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37491835

RESUMO

Lifestyle modification comprising calorie restriction (CR) and increased physical activity enabling weight loss is the first-line of treatment for non-alcoholic fatty liver disease (NAFLD). However, CR alone is not optimal and evidence suggests that dietary pattern and composition are also critical in NAFLD management. Accordingly, high consumption of red and processed meat, saturated fat, added sugar, and sweetened beverages are associated with an increased risk of developing NAFLD and hepatocellular carcinoma, while other foods and compounds such as fish, olive oil, and polyphenols are, in contrast, beneficial for metabolic disorders. Therefore, several dietary interventions have been studied in order to determine which strategy would be the most beneficial for NAFLD. The evidence regarding the effectiveness of different dietary interventions such as low carbohydrate/low-fat diet, time-restricted eating diet, CR, and the well-studied Mediterranean diet is summarized.


Assuntos
Padrões Dietéticos , Hepatopatia Gordurosa não Alcoólica , Humanos , Dieta com Restrição de Carboidratos , Exercício Físico , Redução de Peso , Dieta Mediterrânea
20.
Gastrointest Endosc ; 98(5): 822-829.e1, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37390863

RESUMO

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.

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