Intravenous Hemin, a potential heme oxygenase-1 activator, does not protect from post-ERCP acute pancreatitis in humans: Results of a randomized multicentric multinational placebo-controlled trial.

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).

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.

Perspectives and awareness of endoscopy healthcare professionals on sustainable practices in gastrointestinal endoscopy: results of the LEAFGREEN survey.

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.

Endoscopic Management of Difficult Biliary Stones: An Evergreen Issue.

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.

Endoscopic Treatment of Large Bile Duct Stones: A Systematic Review and Network Meta-Analysis.

BACKGROUND & AIMS: Several endoscopic methods have been proposed for the treatment of large biliary stones. We assessed the comparative efficacy of these treatments through a network meta-analysis. METHODS: Nineteen randomized controlled trials (2752 patients) comparing different treatments for management of large bile stones (>10 mm) (endoscopic sphincterotomy, balloon sphincteroplasty, sphincterotomy followed by endoscopic papillary large balloon dilation [S+EPLBD], mechanical lithotripsy, single-operator cholangioscopy [SOC]) with each other were identified. Study outcomes were the success rate of stone removal and the incidence of adverse events. We performed pairwise and network meta-analysis for all treatments, and used Grading of Recommendations, Assessment, Development, and Evaluation criteria to appraise the quality of evidence. RESULTS: All treatments except mechanical lithotripsy significantly outperformed sphincterotomy in terms of stone removal rate (risk ratio [RR], 1.03-1.29). SOC was superior to other adjunctive interventions (vs balloon sphincteroplasty [RR, 1.24; 95% CIs, 1.07-1.45], vs S+EPLBD [RR, 1.23; range, 1.06-1.42] and vs mechanical lithotripsy [RR, 1.34; range, 1.14-1.58]). Cholangioscopy ranked the highest in increasing the success rate of stone removal (surface under the cumulative ranking [SUCRA] score, 0.99) followed by S+EPLBD (SUCRA score, 0.68). SOC and S+EPLBD outperformed the other modalities when only studies reporting on stones greater than 15 mm were taken into consideration (SUCRA scores, 0.97 and 0.71, respectively). None of the assessed interventions was significantly different in terms of adverse event rate compared with endoscopic sphincterotomy or with other treatments. Post-ERCP pancreatitis and bleeding were the most frequent adverse events. CONCLUSIONS: Among patients with large bile stones, cholangioscopy represents the most effective method, in particular in patients with larger (>15 mm) stones, whereas S+EPLBD could represent a less expensive and more widely available alternative.

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.

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.

Impact of center and endoscopist ERCP volume on ERCP outcomes: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Endoscopist experience and center volume might be associated with ERCP outcomes, as in other fields of endoscopy and in surgery. An effort to assess this relationship is important to improve practice. This systematic review and meta-analysis aimed to evaluate these comparative data and to assess the impact of endoscopist and center volume on ERCP procedure outcomes. METHODS: We performed a literature search in PubMed, Web of Science, and Scopus through March 2022. Volume classification included high- and low-volume (HV and LV) endoscopists and centers. The primary outcome was the impact of endoscopist and center volume on ERCP success. Secondary outcomes were the overall adverse event (AE) rate and the specific AE rate. The quality of the studies was assessed using the Newcastle-Ottawa scale. Data synthesis was obtained by direct meta-analyses using a random-effects model; results are presented as odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: Of 6833 relevant publications, 31 studies met the inclusion criteria. Procedure success was higher among HV endoscopists (OR, 1.81; 95% CI, 1.59-2.06; I2 = 57%) and in HV centers (OR, 1.77; 95% CI, 1.22-2.57; I2 = 67%). The overall AE rate was lower for procedures performed by HV endoscopists (OR, .71; 95% CI, .61-.82; I2 = 38%) and in HV centers (OR, .70; 95% CI, .51-.97; I2 = 92%). Bleeding was less frequent in procedures performed by HV endoscopists (OR, .67; 95% CI, .48-.95; I2 = 37%) but did not differ based on center volume (OR, .68; 95% CI, .24-1.90; I2 = 89%). No statistical differences were detected concerning pancreatitis, cholangitis, and perforation rates. CONCLUSIONS: HV endoscopists and centers provide higher ERCP success rates with fewer overall AEs, especially bleeding, compared with respective LV comparators.

Performance and safety of motorized spiral enteroscopy: a systematic review and meta-analysis.

BACKGROUND AND AIMS: The introduction of motorized spiral enteroscopy (mSE) into clinical practice holds diagnostic and therapeutic potential for small-bowel investigations. This systematic review and meta-analysis aims to evaluate the performance of this modality in diagnosing and treating small-bowel lesions. METHODS: A systematic search of MEDLINE, Cochrane, and ClinicalTrials.gov databases were performed through September 2022. The primary outcome was diagnostic success, defined as the identification of a lesion relative to the indication. Secondary outcomes were successful therapeutic manipulation, total enteroscopy rate (examination from the duodenojejunal flexion to the cecum), technical success (passage from the ligament of Treitz or ileocecal valve for anterograde and retrograde approach, respectively), and adverse event rates. We performed meta-analyses using a random-effects model, and the results are reported as percentages with 95% confidence intervals (CIs). RESULTS: From 2016 to 2022, 9 studies (959 patients; 42% women; mean age >45 years; 474 patients [49.4%] investigated for mid-GI bleeding/anemia) were considered eligible and included in analysis. The diagnostic success rate of mSE was 78% (95% CI, 72-84; I2 = 78.3%). Considering secondary outcomes, total enteroscopy was attempted in 460 cases and completed with a rate of 51% (95% CI, 30-72; I2 = 96.2%), whereas therapeutic interventions were successful in 98% of cases (95% CI, 96-100; I2 = 79.8%) where attempted. Technical success rates were 96% (95% CI, 94-97; I2 = 1.5%) for anterograde and 97% (95% CI, 94-100; I2 = 38.6%) for retrograde approaches, respectively. Finally, the incidence of adverse events was 17% (95% CI, 13-21; I2 = 65.1%), albeit most were minor adverse events (16%; 95% CI, 11-20; I2 = 67.2%) versus major adverse events (1%; 95% CI, 0-1; I2 = 0%). CONCLUSIONS: mSE provides high rates of diagnostic and therapeutic success with a low prevalence of severe adverse events.

Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial.

BACKGROUND & AIMS: Benign biliary strictures (BBS) are complications of chronic pancreatitis (CP). Endotherapy using multiple plastic stents (MPS) or a fully covered self-expanding metal stent (FCSEMS) are acceptable treatment options for biliary obstructive symptoms in these patients. METHODS: Patients with symptomatic CP-associated BBS enrolled in a multicenter randomized noninferiority trial comparing 12-month treatment with MPS vs FCSEMS. Primary outcome was stricture resolution status at 24 months, defined as absence of restenting and 24-month serum alkaline phosphatase not exceeding twice the level at stenting completion. Secondary outcomes included crossover rate, numbers of endoscopic retrograde cholangiopancreatography (ERCPs) and stents, and stent- or procedure-related serious adverse events. RESULTS: Eighty-four patients were randomized to MPS and 80 to FCSEMS. Baseline technical success was 97.6% for MPS and 98.6% for FCSEMS. Eleven patients crossed over from MPS to FCSEMS, and 10 from FCSEMS to MPS. For MPS vs FCSEMS, respectively, stricture resolution status at 24 months was 77.1% (54/70) vs 75.8% (47/62) (P = .008 for noninferiority intention-to-treat analysis), mean number of ERCPs was 3.9 ± 1.3 vs 2.6 ± 1.3 (P < .001, intention-to-treat), and mean number of stents placed was 7.0 ± 4.4 vs 1.3 ± .6 (P < .001, as-treated). Serious adverse events occurred in 16 (19.0%) MPS and 19 (23.8%) FCSEMS patients (P = .568), including cholangitis/fever/jaundice (9 vs 7 patients respectively), abdominal pain (5 vs 5), cholecystitis (1 vs 3) and post-ERCP pancreatitis (0 vs 2). No stent- or procedure-related deaths occurred. CONCLUSIONS: Endotherapy of CP-associated BBS has similar efficacy and safety for 12-month treatment using MPS compared with a single FCSEMS, with FCSEMS requiring fewer ERCPs over 2 years. (ClinicalTrials.gov, Number: NCT01543256.).

Nutrition in acute pancreatitis: when, what and how.

PURPOSE OF REVIEW: This review intends to discuss recently available evidence in three topics related to nutrition in patients with acute pancreatitis, namely timing of refeeding, type of nutritional therapy and its route of administration. RECENT FINDINGS: Recent lines of research confirm that early oral feeding leads to shorter length of stay, fewer complications and lower costs in patients with acute pancreatitis. Moreover, early (<48 h) enteral nutrition led to decreased hospital mortality in patients with mild and severe acute pancreatitis; thus, in case of intolerance to oral feeding or severe disease, nutritional therapy should be offered within 24-72 h. Furthermore, enteral nutrition should be preferred against parenteral nutrition, as it is related to shorter length of stay and less complications, while initial data bring to light the potential role of the soluble dietary fibre polydextrose as an agent that could lead to faster achievement of energy goal with concomitant lower rates of feeding intolerance. Finally, enteral nutrition can be administered through gastric or jejunal feeding, depending on digestive tolerance, whereas latest data also address the safety of percutaneous gastrostomy with a jejunal extension for enteral nutrition administration. However, more data about its real benefit are warranted. SUMMARY: Accumulating evidence confirms the importance of early oral refeeding or early administration of enteral nutrition as vital parts of the armamentarium for the management of patients with acute pancreatitis.

Percutaneous endoscopic jejunostomy: when, how, and when to avoid it.

PURPOSE OF REVIEW: The current review summarizes current evidence regarding the indications, contraindications, and technical aspects of placing a direct percutaneous endoscopic jejunostomy (DPEJ), as well as procedure-related and patient-related outcomes. RECENT FINDINGS: DPEJ is indicated for patients who require long-term (>4 weeks) jejunal nutrition due to existing altered foregut anatomy (e.g., previous gastrectomy) or because the gastric route is not an option (e.g., due to high risk of aspiration, intolerance, gastroparesis). DPEJ may also offer decompression of the gastrointestinal tract in cases of small bowel obstruction (e.g., peritoneal carcinomatosis). Absolute contraindications include active peritonitis, uncorrectable coagulopathy, and ongoing bowel ischemia. Technically, the 'pull' technique using a paediatric colonoscope will be sufficient for most cases. Recent publications demonstrate high rates of technical success (>85%), while patient outcomes do not differ among patients undergoing percutaneous endoscopic gastrostomy (PEG) and those undergoing DPEJ. Obesity is a risk factor for technical failure, while age more than 80 years, diabetes mellitus, and ongoing inflammatory status may be considered risk factors for DPEJ-associated mortality. SUMMARY: DPEJ is a safe and efficacious modality for long-term jejunal nutrition with an acceptable risk of mild complications. Careful patient selection and respect of preprocedural, periprocedural, and postprocedural precautions are of the utmost importance to ensuring a favourable outcome.

Comparative diagnostic performance of end-cutting fine-needle biopsy needles for EUS tissue sampling of solid pancreatic masses: a network meta-analysis.

BACKGROUND AND AIMS: Evidence is limited on the comparative diagnostic performance of newer end-cutting fine-needle biopsy (FNB) needles for tissue sampling of pancreatic masses. We performed a systematic review with network meta-analysis to compare the diagnostic accuracy of available FNB needles for sampling of solid pancreatic lesions. METHODS: A systematic literature review (Medline and Cochrane Database) was conducted for studies evaluating the accuracy of newer FNB needles in adults undergoing EUS-guided sampling of solid pancreatic masses. The primary outcome was diagnostic accuracy. Secondary outcomes were sample adequacy, diagnostic sensitivity, specificity, and adverse event rate. We performed pairwise and network meta-analyses and appraised the quality of evidence using Grading of Recommendations Assessment, Development and Evaluation methodology. RESULTS: Overall, 16 RCTs (1934 patients) were identified. On network meta-analysis, Franseen needles (Acquire; Boston Scientific, Marlborough, Mass, USA) significantly outperformed reverse-bevel needles (risk ratio [RR], 1.21 [95% confidence interval {CI}, 1.05-1.40] for accuracy and 1.31 [95% CI, 1.05-1.22] for adequacy) and FNA needles (RR, 1.21 [95% CI, 1.01-1.25] for accuracy and 1.07 [95% CI, 1.02-1.13] for adequacy). Likewise, the Fork-tip needle (SharkCore; Medtronic, Dublin, Ireland) was significantly superior to the reverse-bevel needle (RR, 1.17 [95% CI, 1.03-1.33] for accuracy and 1.09 [95% CI, 1.02-1.16] for adequacy) and to the FNA needle (RR, 1.09 [95% CI, 1.01-1.19] for accuracy and 1.03 [95% CI, 1.01-1.07] for adequacy). Other comparisons did not achieve statistical significance. As a consequence, Franseen (surface under the cumulative ranking score, .89 for accuracy and .94 for adequacy) and Fork-tip needles (surface under the cumulative ranking score, .76 for accuracy and .73 for adequacy) ranked as the 2 highest-performing FNB needles. When considering different needle sizes, 25-gauge Franseen and 25-gauge Fork-tip needles were not superior to 22-gauge reverse-bevel needles (RR, 1.18 [95% CI, .96-1.46] and 1.04 [95% CI, .62-1.52]). None of the tested needles was significantly superior to the other FNB devices or to FNA needles when rapid onsite cytologic evaluation was available. CONCLUSIONS: Franseen and Fork-tip needles, particularly 22-gauge size, showed the highest performance for tissue sampling of pancreatic masses, with low confidence in estimates.

Endoscopic internal drainage of complex bilomas and biliary leaks by transmural or transpapillary/transfistulary access.

BACKGROUND AND AIMS: Bilomas most frequently result from postoperative bile leaks. The endoscopic conventional treatment is sphincterotomy ± stent placement. In complex cases, such as altered anatomy or failure of conventional treatment, transpapillary/transfistulary (TP/TF) drainage or EUS-guided transmural drainage (EUS-TD) may obviate additional biliary surgery. This study reports our experience with treating biloma secondary to refractory biliary leak with TP/TF drainage or EUS-TD and evaluates the safety and outcomes associated with this approach. METHODS: This observational study focused on consecutive patients managed for biliary leakage (diagnosis based on imaging and/or bile outflow from a surgical drain) at a tertiary care hospital (2007-2017). TP/TF drainage was performed by double-pigtail stent(s) placement to drain the biloma through the leak during ERCP. For EUS-TD, plastic stent(s) were placed under EUS control. Primary outcomes were a composite of clinical success (patient free of sepsis after percutaneous drain removal and, in patients with benign disease, removal of all endoscopically placed stents, without need for reintervention) and biloma regression (<3 cm) at last follow-up. RESULTS: Thirty patients (men, 57%; median age, 55 years) were included. Most biliary leaks resulted from cholecystectomy (27%) and hepatectomy (50%). Initial EUS-TD and TP/TF drainage were performed in 14 (47%) and 16 (53%) patients, respectively. At last follow-up (median, 33.2 months), clinical success and primary outcome were achieved in 70.4% of patients (EUS-TD, 75%; TP/TF, 67%). Additional surgery was necessary in 1 patient. Rate of serious adverse events was 23% (7/30), of which 13% (4/30) were procedure related. There were 4 deaths during the course of treatment, 2 of which were related to endoscopic interventions (hemorrhage and fibrillation). CONCLUSIONS: TP/TF drainage or EUS-TD is technically feasible with high clinical success and may avoid the need for additional surgery in complex cases or in patients with altered anatomy.

Motorized spiral enteroscopy: results of an international multicenter prospective observational clinical study in patients with normal and altered gastrointestinal anatomy.

BACKGROUND : Motorized spiral enteroscopy (MSE) has been shown to be safe and effective for deep enteroscopy in studies performed at expert centers with limited numbers of patients without previous abdominal surgery. This study aimed to investigate the safety, efficacy, and learning curve associated with MSE in a real-life scenario, with the inclusion of patients after abdominal surgery and with altered anatomy. METHODS : Patients with indications for deep enteroscopy were enrolled in a prospective observational multicenter study. The primary objective was the serious adverse event (SAE) rate; secondary objectives were the diagnostic and therapeutic yield, procedural success, time, and insertion depth. Data analysis was subdivided into training and core (post-training) study phases at centers with different levels of MSE experience. RESULTS : 298 patients (120 women; median age 68, range 19-92) were enrolled. In the post-training phase, 21.5 % (n = 54) had previous abdominal surgery, 10.0 % (n = 25) had surgically altered anatomy. Overall, SAEs occurred in 2.3 % (7/298; 95 %CI 0.9 %-4.8 %). The SAE rate was 2.0 % (5/251) in the core group and 4.3 % (2/47) in the training group, and was not increased after abdominal surgery (1.9 %). Total enteroscopy was achieved in half of the patients (n = 42) undergoing planned total enteroscopy. In 295/337 procedures (87.5 %), the anatomical region of interest could be reached. CONCLUSIONS : This prospective multicenter study showed that MSE was feasible and safe in a large cohort of patients in a real-life setting, after a short learning curve. MSE was shown to be feasible in postsurgical patients, including those with altered anatomy, without an increase in the SAE rate.

Reducing the environmental footprint of gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) Position Statement.

Climate change and the destruction of ecosystems by human activities are among the greatest challenges of the 21st century and require urgent action. Health care activities significantly contribute to the emission of greenhouse gases and waste production, with gastrointestinal (GI) endoscopy being one of the largest contributors. This Position Statement aims to raise awareness of the ecological footprint of GI endoscopy and provides guidance to reduce its environmental impact. The European Society of Gastrointestinal Endoscopy (ESGE) and the European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) outline suggestions and recommendations for health care providers, patients, governments, and industry. MAIN STATEMENTS 1: GI endoscopy is a resource-intensive activity with a significant yet poorly assessed environmental impact. 2: ESGE-ESGENA recommend adopting immediate actions to reduce the environmental impact of GI endoscopy. 3: ESGE-ESGENA recommend adherence to guidelines and implementation of audit strategies on the appropriateness of GI endoscopy to avoid the environmental impact of unnecessary procedures. 4: ESGE-ESGENA recommend the embedding of reduce, reuse, and recycle programs in the GI endoscopy unit. 5: ESGE-ESGENA suggest that there is an urgent need to reassess and reduce the environmental and economic impact of single-use GI endoscopic devices. 6: ESGE-ESGENA suggest against routine use of single-use GI endoscopes. However, their use could be considered in highly selected patients on a case-by-case basis. 7: ESGE-ESGENA recommend inclusion of sustainability in the training curricula of GI endoscopy and as a quality domain. 8: ESGE-ESGENA recommend conducting high quality research to quantify and minimize the environmental impact of GI endoscopy. 9: ESGE-ESGENA recommend that GI endoscopy companies assess, disclose, and audit the environmental impact of their value chain. 10:  ESGE-ESGENA recommend that GI endoscopy should become a net-zero greenhouse gas emissions practice by 2050.

Management and follow-up of gallbladder polyps: updated joint guidelines between the ESGAR, EAES, EFISDS and ESGE.

MAIN RECOMMENDATIONS: 1. Primary investigation of polypoid lesions of the gallbladder should be with abdominal ultrasound. Routine use of other imaging modalities is not recommended presently, but further research is needed. In centres with appropriate expertise and resources, alternative imaging modalities (such as contrast-enhanced and endoscopic ultrasound) may be useful to aid decision-making in difficult cases. Strong recommendation, low-moderate quality evidence. 2. Cholecystectomy is recommended in patients with polypoid lesions of the gallbladder measuring 10 mm or more, providing the patient is fit for, and accepts, surgery. Multidisciplinary discussion may be employed to assess perceived individual risk of malignancy. Strong recommendation, low-quality evidence. 3. Cholecystectomy is suggested for patients with a polypoid lesion and symptoms potentially attributable to the gallbladder if no alternative cause for the patient's symptoms is demonstrated and the patient is fit for, and accepts, surgery. The patient should be counselled regarding the benefit of cholecystectomy versus the risk of persistent symptoms. Strong recommendation, low-quality evidence. 4. If the patient has a 6-9 mm polypoid lesion of the gallbladder and one or more risk factors for malignancy, cholecystectomy is recommended if the patient is fit for, and accepts, surgery. These risk factors are as follows: age more than 60 years, history of primary sclerosing cholangitis (PSC), Asian ethnicity, sessile polypoid lesion (including focal gallbladder wall thickening > 4 mm). Strong recommendation, low-moderate quality evidence. 5. If the patient has either no risk factors for malignancy and a gallbladder polypoid lesion of 6-9 mm, or risk factors for malignancy and a gallbladder polypoid lesion 5 mm or less, follow-up ultrasound of the gallbladder is recommended at 6 months, 1 year and 2 years. Follow-up should be discontinued after 2 years in the absence of growth. Moderate strength recommendation, moderate-quality evidence. 6. If the patient has no risk factors for malignancy, and a gallbladder polypoid lesion of 5 mm or less, follow-up is not required. Strong recommendation, moderate-quality evidence. 7. If during follow-up the gallbladder polypoid lesion grows to 10 mm, then cholecystectomy is advised. If the polypoid lesion grows by 2 mm or more within the 2-year follow-up period, then the current size of the polypoid lesion should be considered along with patient risk factors. Multidisciplinary discussion may be employed to decide whether continuation of monitoring, or cholecystectomy, is necessary. Moderate strength recommendation, moderate-quality evidence. 8. If during follow-up the gallbladder polypoid lesion disappears, then monitoring can be discontinued. Strong recommendation, moderate-quality evidence. SOURCE AND SCOPE: These guidelines are an update of the 2017 recommendations developed between the European Society of Gastrointestinal and Abdominal Radiology (ESGAR), European Association for Endoscopic Surgery and other Interventional Techniques (EAES), International Society of Digestive Surgery-European Federation (EFISDS) and European Society of Gastrointestinal Endoscopy (ESGE). A targeted literature search was performed to discover recent evidence concerning the management and follow-up of gallbladder polyps. The changes within these updated guidelines were formulated after consideration of the latest evidence by a group of international experts. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was adopted to define the strength of recommendations and the quality of evidence. KEY POINT: • These recommendations update the 2017 European guidelines regarding the management and follow-up of gallbladder polyps.

Motorised spiral enteroscopy: first prospective clinical feasibility study.

OBJECTIVE: Currently available methods for small bowel endoscopy are often time consuming; motorised PowerSpiral Enteroscopy (PSE) is a further development of spiral enteroscopy to facilitate the approach to the small bowel. The aim of this bicentric prospective trial was to study feasibility and yield of peroral PSE. DESIGN: Consecutive patients with suspected small bowel disease and indication for antegrade enteroscopy were included in two tertiary referral centres. Primary objective was diagnostic yield of antegrade PSE. Secondary objectives included technical success (defined as successful endoscope insertion at least to ligament of Treitz), depth of maximum insertion (DMI), median insertion time to DMI, rate of therapeutic procedures and adverse events. RESULTS: During a 30-month period, 140 procedures were performed on 132 patients (58 female, 74 male; median age: 68 (20-100) years) under general anaesthesia. Overall diagnostic yield of PSE was 74.2%; with 68.2% of procedures including some form of endotherapy. Technical success rate of PSE was 97%; median DMI was 450 cm (0-600) with a median insertion time to DMI of 25 min (3-122). Antegrade panenteroscopy to the cecum was achieved in 14 cases (10.6%). Overall adverse event (AE) rate was 14.4%; two major serious AEs occurred (1.5%), one delayed perforation, one bleeding from Mallory-Weiss lesion. CONCLUSION: This pilot clinical trial demonstrates that PSE is effective for diagnostic and therapeutic antegrade enteroscopy and may compare favourably with traditional methods of deep enteroscopy in ease of use and procedural duration. More comparative data are required to assess clinical application and safety of PSE. TRIAL REGISTRATION NUMBER: NCT02965209.

Nutrition in acute pancreatitis.

PURPOSE OF REVIEW: This review aims to discuss recent developments in different topics regarding nutrition and acute pancreatitis (AP), including oral refeeding, nutritional therapy, and implications of gut microbiota. RECENT FINDINGS: Obesity increases the risk for severe AP and mortality. Considering the worldwide obesity rates, this finding could have major implications in the global outcomes of patients admitted with AP. Recent research confirms that early oral feeding leads to shorter length of stay, fewer complications, and lower costs. In case of intolerance to oral feeding or severe disease, nutritional therapy should be offered within 24-72 h, whereas enteral nutrition (EN) has been shown superior to parenteral nutrition. EN can be administered through gastric or jejunal feeding, depending on digestive tolerance and the presence of ileus. Nevertheless, modalities of EN in patients undergoing endoscopic drainage of pancreatitis-related collections are still undetermined. Weight-loss after discharge occurs frequently and could reflect post-AP pancreatic exocrine failure. Finally, novel research regarding gut microbiota could open new therapeutic opportunities to prevent bacterial translocation and pancreatic necrosis' infection. SUMMARY: Despite available evidence many questions regarding nutritional management in patients with AP remain open. Modulation of gut microbiota could play an important role in further therapeutic management.

Combined use of indomethacin and hydration is the best conservative approach for post-ERCP pancreatitis prevention: A network meta-analysis.

OBJECTIVES: Post-ERCP pancreatitis (PEP) is a life-threatening complication. Given the lack of a causative treatment for pancreatitis, it is of vital importance to minimize this risk of PEP. Multi-target preventive therapy may be the best choice for PEP prevention as disease development is multifactorial. AIM: We aimed to assess the efficacy of a combination of indomethacin and hydration - type and amount - for PEP prevention via a network meta-analysis. METHODS: Through a systematic search in three databases, we searched all randomized controlled trials involving hydration and indomethacin and ranked the PEP preventive efficacy with a Bayesian network meta-analysis using the PRISMA for Network Meta-Analyses (PRISMA-NMA) guideline. The RoB2 tool was used for risk of bias assessment, surface under the cumulative ranking curve (SUCRA) for ranking and PROSPERO for the study protocol [reg. no. CRD42018112698]. We used risk ratios (RR) for dichotomous data with 95% credible intervals (95% CrI). RESULTS: The quantitative analysis included 7559 patients from 24 randomized controlled trials. Based on the SUCRA values, a combination of lactated Ringer's and indomethacin is more effective than single therapy with a 94% certainty. The percent relative risk ratios estimate preventive efficacy 70-99% higher for combinations than single therapies. Aggressive hydration with indomethacin (SUCRA 100%) is also significantly more effective than all other interventions (percent relative effect 94.3-98.1%). CONCLUSIONS: A one-hit-on-each-target therapeutic approach is recommended in PEP prevention with an easily accessible combination of indomethacin and aggressive hydration for all average and high-risk patients without contraindication.