Carrara, Silvia

ABSTRACTBackgroundPancreatic cysts are increasingly discovered on imaging studies performed for unrelated conditions. Currently, surveillance of these lesions poses a substantial burden on patients, and health care recourses. We hypothesized that individuals with small and stable cysts have a diminutive risk of progressing to high‐grade dysplasia (HGD) or pancreatic cancer (PC) that is similar to that in the general population.MethodsThis nested PACYFIC‐study is a collaboration among 44 centers in Europe and Northern‐America, and investigates the risk of HGD and PC for different cyst sizes and growth rates in participants without baseline worrisome features (WF) or high‐risk stigmata (HRS).ResultsOf the 2369 PACYFIC participants, 975 met the inclusion criteria, with a mean age of 67 years (SD 13) and 65% being female. Of these, 438 individuals (45%) had a baseline small cyst size (< 15 mm), and 885 (91%) individuals had a slow growth rate (< 2.5 mm/year). During a median follow‐up of 45 months (IQR 27), 20 individuals (2.1%) developed HGD, or PC. Individuals with small cysts had a 1.5‐fold lower risk of developing WF or HRS (hazard ratio [HR] 0.7 [0.5–1.0], p = 0.03) than those with larger cysts but a similar risk of developing HGD or PC (p > 0.05). Slow growth was protective against the development of WF or HRS (HR 0.4 [0.2–0.6], p < 0.001) and HGD or PC (HR 0.04 [95% CI 0.02–0.12], p < 0.001). Individuals with small, stable sized cysts without baseline WF or HRS did not have a higher risk of HGD or PC than the general population (standardized incidence ratio [SIR] 1.13 [95% CI 0.01–6.30]).ConclusionCyst size < 15 mm and growth rate < 2.5 mm/year appear to be “reassuring” features associated with a negligible risk of developing WF or HRS and HGD or PC. For cysts with these characteristics—and without baseline WF or HRS—less intensive surveillance (than currently recommended) or even cessation may be appropriate.

Abstract Background and study aims Use of fluoroscopy in gastrointestinal endoscopy is an essential aid in advanced endoscopic interventions. However, it also raises concerns about radiation exposure. This study aimed to develop consensus-based statements for safe and effective use of fluoroscopy in gastrointestinal endoscopy, prioritizing the safety and well-being of healthcare workers and patients. Methods A modified Delphi approach was employed to achieve consensus over three rounds of surveys. Proposed statements were generated in Round 1. In the second round, panelists rated potential statements on a 5-point scale, with consensus defined as ≥80% agreement. Statements were subsequently prioritized in Round 3, using a 1 (lowest priority) to 10 (highest priority) scale. Results Forty-six experts participated, consisting of 34 therapeutic endoscopists and 12 endoscopy nurses from six continents, with an overall 45.6% female representation (n = 21). Forty-three item statements were generated in the first round. Of these, 31 statements achieved consensus after the second round. These statements were categorized into General Considerations (n = 6), Education (n = 10), Pregnancy (n = 4), Family Planning (n = 2), Patient Safety (n = 4), and Staff Safety (n = 5). In the third round, accepted statements received mean priority scores ranging from 7.28 to 9.36, with 87.2% of statements rated as very high priority (mean score ≥ 9). Conclusions This study presents consensus-based statements for safe and effective use of fluoroscopy in gastrointestinal endoscopy, addressing the well-being of healthcare workers and patients. These consensus-based statements aim to mitigate risks associated with radiation exposure while maintaining benefits of fluoroscopy, ultimately promoting a culture of safety in healthcare settings.

AbstractBackgroundSurveillance of pancreatic cysts focuses on the detection of (mostly morphologic) features warranting surgery. European guidelines consider elevated CA19.9 as a relative indication for surgery. We aimed to evaluate the role of CA19.9 monitoring for early detection and management in a cyst surveillance population.MethodsThe PACYFIC‐registry is a prospective collaboration that investigates the yield of pancreatic cyst surveillance performed at the discretion of the treating physician. We included participants for whom at least one serum CA19.9 value was determined by a minimum follow‐up of 12 months.ResultsOf 1865 PACYFIC participants, 685 met the inclusion criteria for this study (mean age 67 years, SD 10; 61% female). During a median follow‐up of 25 months (IQR 24, 1966 visits), 29 participants developed high‐grade dysplasia (HGD) or pancreatic cancer. At baseline, CA19.9 ranged from 1 to 591 kU/L (median 10 kU/L [IQR 14]), and was elevated (≥37 kU/L) in 64 participants (9%). During 191 of 1966 visits (10%), an elevated CA19.9 was detected, and these visits more often led to an intensified follow‐up (42%) than those without an elevated CA19.9 (27%; p < 0.001). An elevated CA19.9 was the sole reason for surgery in five participants with benign disease (10%). The baseline CA19.9 value was (as continuous or dichotomous variable at the 37 kU/L threshold) not independently associated with HGD or pancreatic cancer development, whilst a CA19.9 of ≥ 133 kU/L was (HR 3.8, 95% CI 1.1–13, p = 0.03).ConclusionsIn this pancreatic cyst surveillance cohort, CA19.9 monitoring caused substantial harm by shortening surveillance intervals (and performance of unnecessary surgery). The current CA19.9 cutoff was not predictive of HGD and pancreatic cancer, whereas a higher cutoff may decrease false‐positive values. The role of CA19.9 monitoring should be critically appraised prior to implementation in surveillance programs and guidelines.

In the last decade, flexible endoscopic septotomy has been reported as a well-tolerated and effective treatment for Zenker’s diverticulum. More recently, novel endoscopic submucosal tunneling techniques, namely Zenker-PerOral Endoscopic Myotomy (Z-POEM) and PerOral Endoscopic Septotomy (POES) have been proposed to obtain complete muscular septum exposure and deeper myotomy. The aim of this study is to provide a systematic review with a meta-analysis of the first experiences of third space approaches for Zenker’s diverticulum. Electronic databases (Medline, Scopus, EMBASE) were searched up to October 2020. Studies including patients with symptomatic Zenker’s diverticulum who underwent endoscopic treatment by submucosal tunneling technique were eligible. Procedural, clinical and safety outcomes were assessed by pooling data with a random-effect model to obtain a proportion with a 95% confidence interval. Nine retrospective studies were eligible for inclusion (196 patients). Five studies were performed in the USA, two in Europe and two in Asia. Endoscopic treatment was feasible in 96.9% (I 2 = 0%) of patients. The mean procedure duration was 36.4 ± 14.3 minutes. Clinical success was achieved after 93.4% (I 2 = 0%) of procedures. The overall adverse events rate was 4.9% (I 2 = 0%). No differences between the two approaches (Z-POEM vs POES) have been shown in terms of both efficacy and safety. Submucosal tunneling techniques appear to be feasible for symptomatic Zenker’s diverticulum, with promising results in terms of efficacy and safety outcomes.

Background and aims Artificial intelligence has been shown to increase adenoma detection rate (ADR) as the main surrogate outcome parameter of colonoscopy quality. To which extent this effect may be related to physician experience is not known. We performed a randomised trial with colonoscopists in their qualification period (AID-2) and compared these data with a previously published randomised trial in expert endoscopists (AID-1). Methods In this prospective, randomised controlled non-inferiority trial (AID-2), 10 non-expert endoscopists (<2000 colonoscopies) performed screening/surveillance/diagnostic colonoscopies in consecutive 40–80 year-old subjects using high-definition colonoscopy with or without a real-time deep-learning computer-aided detection (CADe) (GI Genius, Medtronic). The primary outcome was ADR in both groups with histology of resected lesions as reference. In a post-hoc analysis, data from this randomised controlled trial (RCT) were compared with data from the previous AID-1 RCT involving six experienced endoscopists in an otherwise similar setting. Results In 660 patients (62.3±10 years; men/women: 330/330) with equal distribution of study parameters, overall ADR was higher in the CADe than in the control group (53.3% vs 44.5%; relative risk (RR): 1.22; 95% CI: 1.04 to 1.40; p<0.01 for non-inferiority and p=0.02 for superiority). Similar increases were seen in adenoma numbers per colonoscopy and in small and distal lesions. No differences were observed with regards to detection of non-neoplastic lesions. When pooling these data with those from the AID-1 study, use of CADe (RR 1.29; 95% CI: 1.16 to 1.42) and colonoscopy indication, but not the level of examiner experience (RR 1.02; 95% CI: 0.89 to 1.16) were associated with ADR differences in a multivariate analysis. Conclusions In less experienced examiners, CADe assistance during colonoscopy increased ADR and a number of related polyp parameters as compared with the control group. Experience appears to play a minor role as determining factor for ADR. Trial registration number NCT:04260321.

AbstractBackgroundThe novel Coronavirus (SARS‐CoV‐2) has caused almost 2 million deaths worldwide. Both Food and Drug Administration and European Medicines Agency have recently approved the first COVID‐19 vaccines, and a few more are going to be approved soon.MethodsSeveral different approaches have been used to stimulate the immune system in mounting a humoral response. As more traditional approaches are under investigation (inactivated virus vaccines, protein subunit vaccines, recombinant virus vaccines), more recent and innovative strategies have been tried (non‐replicating viral vector vaccines, RNA based vaccines, DNA based vaccines).ResultsSince vaccinations campaigns started in December 2020 in both the US and Europe, gastroenterologists will be one of the main sources of information regarding SARS‐CoV 2 vaccination for patients in their practice, including vulnerable patients such as those with Inflammatory Bowel Disease (IBD), patients with chronic liver disease, and GI cancer patients.ConclusionsThus, we must ourselves be well educated and updated in order to provide unambiguous counseling to these categories of vulnerable patients. In this commentary, we aim to provide a comprehensive review of both approved COVID‐19 vaccines and the ones still under development, and explore potential risks, benefits and prioritization of vaccination.