Publications by authors named "Andrea Anderloni"

139 Publications

A prospective study on quality in endoscopic retrograde cholangiopancreatography (ERCP): trend in Italy from the REQUEST study.

Endosc Int Open 2021 Oct 16;9(10):E1563-E1571. Epub 2021 Sep 16.

Department of Gastroenterology, Nuovo Regina Margherita Hospital, Roma, Italy.

Endoscopic retrograde cholangiopancreatography (ERCP) is a complex procedure with a relatively high rate of adverse events. Data on training of operators and fulfillment of quality indicators in Italy are scarce. The goal of this study was to assess the overall quality of ERCP in Italy compared to international standards. This was a prospective, observational study from different Italian centers performing ERCP. Operators answered a questionnaire, then recorded data on ERCPs over a 1-to 3-month period. Nineteen Italian centers participated in the study. The most common concern of operators about training was the lack of structured programs. Seven/19 centers routinely used conscious sedation for ERCP. Forty-one experienced operators and 21 trainees performed 766 ERCPs: a successful deep biliary cannulation in native-papilla patients was achieved in 95.1 % of cases; the post-ERCP pancreatitis (PEP) rate was 5.4 % in native-papilla patients; cholangitis rate was 1.0 %; bleeding and perforation occurred in 2.7 % and 0.4 % of the patients, respectively. This study revealed that, overall, ERCP is performed in the participating Italian centers meeting good quality standards, but structured training and sedation practice are still subpar. The bleeding and perforation rate slightly exceeded the American Society of Gastrointestinal Endoscopy indicator targets but they are comparable to the reported rates from other international surveys.
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http://dx.doi.org/10.1055/a-1531-4691DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8445684PMC
October 2021

ENDOSCOPIC ULTRASOUND FEATURES OF PANCREATIC FLUID COLLECTIONS AND THEIR IMPACT ON THERAPEUTIC DECISIONS: AN INTEROBSERVER AGREEMENT STUDY.

Endoscopy 2021 Sep 8. Epub 2021 Sep 8.

Digestive Endoscopy Unit, L.go A. Gemelli, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.

Background And Study Aims: A validated classification of endoscopic ultrasound (EUS) morphological characteristics and consequent therapeutic intervention(s) in pancreatic and peripancreatic fluid collections (PFCs) is lacking. We performed an interobserver agreement study among expert endosonographers assessing EUS related PFCs features and therapeutic approaches utilized.

Patients And Methods: Fifty EUS videos of PFCs were independently reviewed by 12 experts and evaluated for PFC type, percentage of solid component, presence of infection, recognition and communication of the main pancreatic duct (MPD), stent choice for drainage, and direct endoscopic necrosectomy (DEN) performance and timing. The Gwet's AC1 coefficient was used to assess interobserver agreement.

Results: A moderate agreement was found for lesion type (AC1, 0.59), presence of infection (AC1, 0.41), and need for DEN (AC1, 0.50), while fair or poor agreements were stated for percentage of solid component (AC1, 0.15) and MPD recognition (AC1, 0.31). Substantial agreement was rated for ability to assess PFC-MPD communication (AC1, 0.69), decision between placing a plastic versus lumen-apposing metal stent (AC1, 0.62), and timing of DEN (AC1, 0.75).

Conclusions: Interobserver agreement between expert endosonographers regarding morphological features of PFCs appeared suboptimal, while decisions on therapeutic approaches seemed more homogeneous. Studies to achieve standardization of the diagnostic endosonographic criteria and therapeutic approaches to PFCs are warranted.
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http://dx.doi.org/10.1055/a-1640-4365DOI Listing
September 2021

Salvage Procedure for Double Trouble in Lumen-Apposing Metal Stent Misdeployment During Endoscopic Ultrasound-Guided Gastroenterostomy: Ready to Start Again.

Am J Gastroenterol 2021 Aug 26. Epub 2021 Aug 26.

Digestive Endoscopy Unit, Department of Gastroenterology, Humanitas Clinical and Research Center, IRCCS, Milan, Italy.

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http://dx.doi.org/10.14309/ajg.0000000000001411DOI Listing
August 2021

Commentary.

Authors:
Andrea Anderloni

Endoscopy 2021 09 26;53(9):984. Epub 2021 Aug 26.

Division of Gastroenterology, Digestive Endoscopy Unit, Humanitas Clinical and Research Center-IRCCS, Rozzano, Italy.

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http://dx.doi.org/10.1055/a-1519-4925DOI Listing
September 2021

Computer-aided detection versus advanced imaging for detection of colorectal neoplasia: a systematic review and network meta-analysis.

Lancet Gastroenterol Hepatol 2021 Oct 5;6(10):793-802. Epub 2021 Aug 5.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Endoscopy Unit, IRCCS Humanitas Clinical and Research Center, Rozzano, Milan, Italy.

Background: Computer-aided detection (CADe) techniques based on artificial intelligence algorithms can assist endoscopists in detecting colorectal neoplasia. CADe has been associated with an increased adenoma detection rate, a key quality indicator, but the utility of CADe compared with existing advanced imaging techniques and distal attachment devices is unclear.

Methods: For this systematic review and network meta-analysis, we did a comprehensive search of PubMed/Medline, Embase, and Scopus databases from inception to Nov 30, 2020, for randomised controlled trials investigating the effectiveness of the following endoscopic techniques in detecting colorectal neoplasia: CADe, high definition (HD) white-light endoscopy, chromoendoscopy, or add-on devices (ie, systems that increase mucosal visualisation, such as full spectrum endoscopy [FUSE] or G-EYE balloon endoscopy). We collected data on adenoma detection rates, sessile serrated lesion detection rates, the proportion of large adenomas detected per colonoscopy, and withdrawal times. A frequentist framework, random-effects network meta-analysis was done to compare artificial intelligence with chromoendoscopy, increased mucosal visualisation systems, and HD white-light endoscopy (the control group). We estimated odds ratios (ORs) for the adenoma detection rate, sessile serrated lesion detection rate, and proportion of large adenomas detected per colonoscopy, and calculated mean differences for withdrawal time, with 95% CIs. Risk of bias and certainty of evidence were assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Findings: 50 randomised controlled trials, comprising 34 445 participants, were included in our main analysis (six trials of CADe, 18 of chromoendoscopy, and 26 of increased mucosal visualisation systems). HD white-light endoscopy was the control technique in all 50 studies. Compared with the control technique, the adenoma detection rate was 7·4% higher with CADe (OR 1·78 [95% CI 1·44-2·18]), 4·4% higher with chromoendoscopy (1·22 [1·08-1·39]), and 4·1% higher with increased mucosal visualisation systems (1·16 [1·04-1·28]). CADe ranked as the superior technique for adenoma detection (with moderate confidence in hierarchical ranking); cross-comparisons of CADe with other imaging techniques showed a significant increase in the adenoma detection rate with CADe versus increased mucosal visualisation systems (OR 1·54 [95% CI 1·22-1·94]; low certainty of evidence) and with CADe versus chromoendoscopy (1·45 [1·14-1·85]; moderate certainty of evidence). When focusing on large adenomas (≥10 mm) there was a significant increase in the detection of large adenomas only with CADe (OR 1·69 [95% CI 1·10-2·60], moderate certainty of evidence) when compared to HD white-light endoscopy; CADe ranked as the superior strategy for detection of large adenomas. CADe also seemed to be the superior strategy for detection of sessile serrated lesions (with moderate confidence in hierarchical ranking), although no significant increase in the sessile serrated lesion detection rate was shown (OR 1·37 [95% CI 0·65-2·88]). No significant difference in withdrawal time was reported for CADe compared with the other techniques.

Interpretation: Based on the published literature, detection rates of colorectal neoplasia are higher with CADe than with other techniques such as chromoendoscopy or tools that increase mucosal visualisation, supporting wider incorporation of CADe strategies into community endoscopy services.

Funding: None.
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http://dx.doi.org/10.1016/S2468-1253(21)00215-6DOI Listing
October 2021

Difficult biliary cannulation in patients with distal malignant biliary obstruction: An underestimated problem?

Dig Liver Dis 2021 Aug 4. Epub 2021 Aug 4.

Digestive Endoscopy Unit, Departement of Gastroenterology, Humanitas Research Hospital-IRCCS, Rozzano, Italy.

Background: Failed biliary cannulation still poses a major challenge in patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP). To date, there is a lack of data on rates of Difficult Biliary Cannulation (DBC) in patients with distal malignant biliary obstruction (DMBO).

Materials: This was a retrospective study (09/2015 to 02/2019) of consecutive patients with DMBO that underwent ERCP in four Italian centers. The primary outcome was to evaluate the rate of DBC. Secondary outcomes were: cannulation failure, rate of adverse events (AEs), the predictive factors for DBC as well as for AEs.

Results: A total of 622 patients with DMBO, were included in the study, with 351(56,4%) matching the definition of DBC. One-hundred and two ERCP-related AEs occurred in 97 of 622 patients (15,6%). Subjects with DBC showed a higher risk for AEs (p = 0.02). The lack of pancreatitis prophylaxis (p = 0.03), diagnosis of cholangiocarcinoma (p = 0.02), the use of papillotomy (OR=1.98; 95%CI = 1.14-3.45) and the combination of two or more techniques for cannulation (OR = 2.88; 95%CI = 1.04-7.97) were associated with the occurrence of AEs.

Conclusions: According to the results of this study, patients with DMBO carries a higher rate of DBC thus requiring alternative techniques for biliary drainage. Furthermore, DBC carries a high risk for AEs. Further prospective multicentric studies are needed to confirm these data in this specific subgroup of patients.
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http://dx.doi.org/10.1016/j.dld.2021.07.010DOI Listing
August 2021

Microbiota Gut-Brain Axis in Ischemic Stroke: A Narrative Review with a Focus about the Relationship with Inflammatory Bowel Disease.

Life (Basel) 2021 Jul 19;11(7). Epub 2021 Jul 19.

Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research Hospital, 20089 Rozzano, Italy.

The gut microbiota is emerging as an important player in neurodevelopment and aging as well as in brain diseases including stroke, Alzheimer's disease, and Parkinson's disease. The complex interplay between gut microbiota and the brain, and vice versa, has recently become not only the focus of neuroscience, but also the starting point for research regarding many diseases such as inflammatory bowel diseases (IBD). The bi-directional interaction between gut microbiota and the brain is not completely understood. The aim of this review is to sum up the evidencesconcerningthe role of the gut-brain microbiota axis in ischemic stroke and to highlight the more recent evidences about the potential role of the gut-brain microbiota axis in the interaction between inflammatory bowel disease and ischemic stroke.
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http://dx.doi.org/10.3390/life11070715DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8305026PMC
July 2021

Classification, outcomes, and management of misdeployed stents during EUS-guided gastroenterostomy.

Gastrointest Endosc 2021 Aug 2. Epub 2021 Aug 2.

Johns Hopkins Medicine, Baltimore, MD, United States. Electronic address:

Background And Aims: Stent misdeployment (SM) has hindered the dissemination of EUS-GE for gastric outlet obstruction (GOO) management. We aimed to provide a classification system for SM during EUS-GE and study clinical outcomes and management accordingly.

Methods: This is a retrospective study involving 16 tertiary-care centers (8 United States, 8 Europe) from March 2015 to December 2020. Patients who developed SM during EUS-GE for GOO were included. We propose classifying SM into 4 types. The primary outcome was rate and severity of SM (per ASGE lexicon). Secondary outcomes included clinical outcomes and management of dislodgement according to the SM classification type, in addition to salvage management of GOO after SM.

Results: From a total of 467 EUS-GEs performed for GOO during the study period, SM occurred in 46 (9.85%) patients. The majority (73.2%) of SMs occurred during the first 13 EUS-GE cases by the performing operators. SM was graded as mild (n=28, 60.9%), moderate (n=11, 23.9%), severe (n=6, 13.0%), or fatal (n=1, 2.2%), with 5 (10.9%) patients requiring surgical intervention. Type I SM was the most common (n=29, 63.1%), followed by Type II (n=14, 30.4%), Type IV (n=2, 4.3%) and Type III (n=1, 2.2%). Type I SM was more frequently rated as mild compared with type II SM (75.9% vs 42.9%, p=0.04), despite an equivalent rate of surgical repair (10.3% vs 7.1%, p=0.7). Overall, 4 (8.7%) patients required ICU stay (median 2.5 days). The median length of stay was 4 days after SM.

Conclusions: Although SM is not infrequent during EUS-GE, the majority are Type I, mild/moderate in severity, and can be managed endoscopically with a surgical intervention rate of approximately 11%.
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http://dx.doi.org/10.1016/j.gie.2021.07.023DOI Listing
August 2021

Curriculum for ERCP and endoscopic ultrasound training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

Endoscopy 2021 Oct 26;53(10):1071-1087. Epub 2021 Jul 26.

Department of Gastroenterology and Hepatology, University Hospitals Leuven, and TARGID, KU Leuven, Leuven, Belgium.

The European Society of Gastrointestinal Endoscopy (ESGE) has recognized the need to formalize and enhance training in endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS). This manuscript represents the outcome of a formal Delphi process resulting in an official Position Statement of the ESGE and provides a framework to develop and maintain skills in ERCP and EUS. This curriculum is set out in terms of the prerequisites prior to training; recommended steps of training to a defined syllabus; the quality of training; and how competence should be defined and evidenced before independent practice. 1: Trainees should be competent in gastroscopy prior to commencing training. Formal training courses and the use of simulation in training are recommended. 2: Trainees should keep a contemporaneous logbook of their procedures, including key performance indicators and the degree of independence. Structured formative assessment is encouraged to enhance feedback. There should be a summative assessment process prior to commencing independent practice to ensure there is robust evidence of competence. This evidence should include a review of a trainee's procedure volume and current performance measures. A period of mentoring is strongly recommended in the early stages of independent practice. 3: Specifically for ERCP, all trainees should be competent up to Schutz level 2 complexity (management of distal biliary strictures and stones > 10 mm), with advanced ERCP requiring a further period of training. Prior to independent practice, ESGE recommends that a trainee can evidence a procedure volume of > 300 cases, a native papilla cannulation rate of ≥ 80 % (90 % after a period of mentored independent practice), complete stones clearance of ≥ 85 %, and successful stenting of distal biliary strictures of ≥ 90 % (90 % and 95 % respectively after a mentored period of independent practice). 4: The progression of EUS training and competence attainment should start from diagnostic EUS and then proceed to basic therapeutic EUS, and finally to advanced therapeutic EUS. Before independent practice, ESGE recommends that a trainee can evidence a procedure volume of > 250 cases (75 fine-needle aspirations/biopsies [FNA/FNBs]), satisfactory visualization of key anatomical landmarks in ≥ 90 % of cases, and an FNA/FNB accuracy rate of ≥ 85 %. ESGE recognizes the often inadequate quality of the evidence and the need for further studies pertaining to training in advanced endoscopy, particularly in relation to therapeutic EUS.
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http://dx.doi.org/10.1055/a-1537-8999DOI Listing
October 2021

Safety and efficacy of multiband mucosectomy for Barrett's esophagus: a systematic review with pooled analysis.

Ann Gastroenterol 2021 Jul-Aug;34(4):487-492. Epub 2021 Apr 2.

Endoscopy Unit "Humanitas Research Hospital", MI, Italy (Marco Spadaccini, Roberta Maselli, Piera Alessia Galtieri, Alessandro Fugazza, Andrea Anderloni, Silvia Carrara, Gaia Pellegatta, Alessandro Repici).

Background: According to guidelines, all visible lesions in Barrett's esophagus (BE) should be endoscopically resected. Available methods of endoscopic resection include the cap-assisted technique and, more recently, multiband mucosectomy (MBM). Data on the efficacy and safety of MBM have yet to be systematically reviewed. We performed the first systematic review with pooled analysis to evaluate the outcomes of MBM in patients with BE.

Methods: Electronic databases (Medline, Scopus, EMBASE) were searched up to August 2019. Studies including patients with BE who underwent MBM were eligible. The primary outcome was the adverse events rate. Secondary outcomes were the proportions of complete resections and R0 resections. Outcomes were assessed by pooling data using a random or fixed-effect model, according to the degree of heterogeneity, to obtain a proportion with a 95% confidence interval.

Results: Fourteen studies were eligible (1334 procedures, 986 patients). The adverse event rate was 5.3%. Immediate and post-procedural bleeding, perforations and strictures occurred in 0.2%, 0.7%, 0.3% and 3.9% of procedures, respectively. Focal lesions were resected at a complete rate of 97.6% with an R0 resection rate of 94.1%.

Conclusion: MBM is a safe and effective technique for treating visible lesions in BE.
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http://dx.doi.org/10.20524/aog.2021.0620DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8276358PMC
April 2021

Cap-Assisted Endoscopic Septotomy of Zenker's Diverticulum: Early and Long-Term Outcomes.

Am J Gastroenterol 2021 09;116(9):1853-1858

Endoscopy Unit, Humanitas Clinical and Research Center, RCCS, Milano, Italy.

Introduction: Multiple therapeutic modalities including surgery and rigid and flexible endoscopy have been adopted to manage Zenker's diverticulum (ZD). Minimally invasive flexible endoscopic septotomy (FES) techniques have been increasingly favored over the past 20 years; however, long-term data are still scanty. The aim of this study is to evaluate early and long-term outcomes of FES for naive ZD in a single-center setting.

Methods: From 2010 to 2017, ZD patients treated with FES were included in a prospectively maintained database (NCT03948438). Those who had already been treated surgically or endoscopically were excluded from the analysis. The Dakkak and Bennett dysphagia scale was used to rate the dysphagia. Persistent complete or near-complete resolution of symptoms (Dakkak and Bennett 0 or 1) was defined as clinical success. Postprocedural adverse events were reported according to ASGE lexicon.

Results: Overall, 256 consecutive patients were treated. Mean pouch size was 29.8 ± 11.3 mm. The procedure was successfully completed in all scheduled patients, with an early clinical success of 96.1%. Adverse events occurred in 3.5% (9/256) of patients. Eight of them were mild/moderate with no fatal events, whereas one patient required surgery. Recurrences occurred in 31.3% (80/256) of treated patients after a mean time of 9 ± 3 months and 95% of recurrences were treated by a second FES. At an average follow-up of 5.5 years, 95.3% of patients were asymptomatic after a mean number of 1.3 procedures.

Discussion: FES is a safe and effective treatment modality for patients with ZD. Recurrence rate is significant; however, endoscopic reintervention is associated with long-term relief of dysphagia.
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http://dx.doi.org/10.14309/ajg.0000000000001356DOI Listing
September 2021

Diagnostic accuracy and interobserver agreement of digital single-operator cholangioscopy for indeterminate biliary strictures.

Gastrointest Endosc 2021 Jun 30. Epub 2021 Jun 30.

Department of Gastroenterology, University College London Hospitals, London, United Kingdom; Sheila Sherlock Liver Centre, Royal Free Hospital, London, United Kingdom. Electronic address:

Background And Aims: Digital single-operator cholangioscopy (d-SOC) with cholangioscopic biopsy has shown promise in the evaluation of indeterminate biliary strictures. Some studies have suggested higher sensitivity for visual impression compared to biopsies, although assessors were not blinded to previous investigations. We aimed to investigate the diagnostic accuracy and interobserver agreement (IOA) of d-SOC in the visual appraisal of biliary strictures when blinded to additional information.

Methods: A multicenter, international cohort study was performed. Cholangioscopic videos in patients with a known final diagnosis were systematically scored. Pseudonymized videos were reviewed by 19 experts in 2 steps: (1) blinded for patients' history and investigations and (2) unblinded.

Results: Forty-four high-quality videos were reviewed of 19 benign and 25 malignant strictures. The sensitivity and specificity for the diagnosis of malignancy was 74.2% and 46.9% (blinded) and 72.7% and 62.5% (unblinded). Cholangioscopic certainty of a malignant diagnosis led to over-diagnosis (sensitivity 90.6%, specificity 33%), especially if no additional information was provided. The IOA for the presence of malignancy was fair for both assessments (Fleiss' kappa (κ) 0.245 (blinded) and κ 0.321 (unblinded)). For individual visual features, the IOA ranged from slight to moderate for both assessments (κ 0.059 - 0.400 versus κ 0.031 - 0.452).

Conclusions: This study shows low sensitivity and specificity for blinded and unblinded d-SOC video appraisal of indeterminate biliary strictures, with considerable interobserver variation. Although reaching consensus on the optical features of biliary strictures remains important, optimizing visually directed biopsies may be the most important role of cholangioscopy in biliary stricture assessment.
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http://dx.doi.org/10.1016/j.gie.2021.06.027DOI Listing
June 2021

Artificial intelligence and colonoscopy experience: lessons from two randomised trials.

Gut 2021 Jun 29. Epub 2021 Jun 29.

Gastroenterology and Digestive Endoscopy Unit, Ospedale Nuovo Regina Margherita, Roma, Italy.

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.
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http://dx.doi.org/10.1136/gutjnl-2021-324471DOI Listing
June 2021

What gastroenterologists should know about SARS-CoV 2 vaccine: World Endoscopy Organization perspective.

United European Gastroenterol J 2021 Jun 8. Epub 2021 Jun 8.

Department of Biomedical Sciences, Humanitas University, Rozzano, Italy.

Background: The 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.

Methods: Several 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).

Results: Since 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.

Conclusions: Thus, 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.
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http://dx.doi.org/10.1002/ueg2.12103DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8242672PMC
June 2021

Novel 1-L polyethylene glycol + ascorbate versus high-volume polyethylene glycol regimen for colonoscopy cleansing: a multicenter, randomized, phase IV study.

Gastrointest Endosc 2021 Oct 30;94(4):823-831.e9. Epub 2021 Apr 30.

Digestive Endoscopy Unit, Carpi-Mirandola Hospitals, Azienda USL Modena.

Background And Aims: Adequate bowel cleansing is critical to ensure quality and safety of a colonoscopy. A novel 1-L polyethylene glycol plus ascorbate (1L-PEG+ASC) regimen was previously validated against low-volume regimens but was never compared with high-volume regimens.

Methods: In a phase IV study, patients undergoing colonoscopy were randomized 1:1 to receive split-dose 1L PEG+ASC or a split-dose 4-L PEG-based regimen (4L-PEG) in 5 Italian centers. Preparation was assessed with the Boston Bowel Preparation Scale (BBPS) by local endoscopists and centralized reading, both blinded to the randomization arm. The primary endpoint was noninferiority of 1L-PEG+ASC in colon cleansing. Secondary endpoints were superiority of 1L-PEG+ASC, patient compliance, segmental colon cleansing, adenoma detection rate, tolerability, and safety.

Results: Three hundred eighty-eight patients (median age, 59.8 years) were randomized between January 2019 and October 2019: 195 to 1L-PEG+ASC and 193 to 4L-PEG. Noninferiority of 1L-PEG+ASC was demonstrated for cleansing in both the entire colon (BBPS ≥ 6: 97.9% vs 93%; relative risk [RR], 1.03; 95% confidence interval [CI], 1.001-1.04; P superiority = .027) and in the right-sided colon segment (98.4% vs 96.0%; RR, 1.02; 95% CI, .99-1.02; P noninferiority = .013). Compliance was higher with 1L-PEG+ASC than with 4L-PEG (178/192 [92.7%] vs 154/190 patients [81.1%]; RR, 1.10; 95% CI, 1.05-1.12), whereas no difference was found regarding safety (moderate/severe side effects: 20.8% vs 25.8%; P = .253). No difference in adenoma detection rate (38.8% vs 43.0%) was found.

Conclusions: One-liter PEG+ASC showed noninferiority compared with 4L-PEG in achieving adequate colon cleansing and provided a higher patient compliance. No differences in tolerability and safety were detected. (Clinical trial registration number: NCT03742232.).
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http://dx.doi.org/10.1016/j.gie.2021.04.020DOI Listing
October 2021

Safety issues in endoscopy ultrasound-guided interventions using lumen apposing metal stents: a review of the literature.

Minerva Gastroenterol (Torino) 2021 Apr 19. Epub 2021 Apr 19.

Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center - IRCCS, Rozzano, Milan, Italy -

Lumen-apposing metal stents (LAMS) are recently introduced devices that allow to create anastomoses. The indications for LAMS placement are increasing and currently these stents can be used in multiple clinical situations such as endoscopic drainage of pancreatic fluid collections (PFCs), endoscopic ultrasound-guided choledocho-duodenostomy (EUS-CDS), endoscopic ultrasound gallbladder drainage (EUS-GBD), endoscopic ultrasound gastrojejunostomy (EUS-GJ). Since their introduction, they have revealed to allow a higher rate of technical and clinical success, and potentially lower risk of adverse events (AEs) compared with previously available devices. Despite ongoing innovation, any advanced intervention carries risks of AEs. These AEs may occur during the deployment or can be delayed because of the consequent effects of the procedure and/or stent itself. This review represents an overview of current indications, technical and clinical results, with an extensive focus on safety issues related to placement and on long-term indwelling related ones.
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http://dx.doi.org/10.23736/S2724-5985.21.02862-XDOI Listing
April 2021

Revising the European Society of Gastrointestinal Endoscopy (ESGE) research priorities: a research progress update.

Endoscopy 2021 05 1;53(5):535-554. Epub 2021 Apr 1.

Gastroenterology Department, Portuguese Oncology Institute of Porto, Porto, Portugal.

Background: One of the aims of the European Society of Gastrointestinal Endoscopy (ESGE) is to encourage high quality endoscopic research at a European level. In 2016, the ESGE research committee published a set of research priorities. As endoscopic research is flourishing, we aimed to review the literature and determine whether endoscopic research over the last 4 years had managed to address any of our previously published priorities.

Methods: As the previously published priorities were grouped under seven different domains, a working party with at least two European experts was created for each domain to review all the priorities under that domain. A structured review form was developed to standardize the review process. The group conducted an extensive literature search relevant to each of the priorities and then graded the priorities into three categories: (1) no longer a priority (well-designed trial, incorporated in national/international guidelines or adopted in routine clinical practice); (2) remains a priority (i. e. the above criterion was not met); (3) redefine the existing priority (i. e. the priority was too vague with the research question not clearly defined).

Results: The previous ESGE research priorities document published in 2016 had 26 research priorities under seven domains. Our review of these priorities has resulted in seven priorities being removed from the list, one priority being partially removed, another seven being redefined to make them more precise, with eleven priorities remaining unchanged. This is a reflection of a rapid surge in endoscopic research, resulting in 27 % of research questions having already been answered and another 27 % requiring redefinition.

Conclusions: Our extensive review process has led to the removal of seven research priorities from the previous (2016) list, leaving 19 research priorities that have been redefined to make them more precise and relevant for researchers and funding bodies to target.
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http://dx.doi.org/10.1055/a-1397-3005DOI Listing
May 2021

Treatment of acute cholecystitis in high-risk surgical patients. Systematic review of the literature according to the levels of evidence.

Minerva Gastroenterol (Torino) 2021 Apr 1. Epub 2021 Apr 1.

Gastroenterology Unit, Department of Medical and Surgical Sciences, Hospital of Imola, University of Bologna, Bologna, Italy.

Acute cholecystitis (AC) is the most common biliary stone disease complication. While there is consensus regarding cholecystectomy for AC, gallbladder drainage is indicated in elderly or high-risk surgical patients. We systematically reviewed available evidence in the field of EUS-guided gallbladder drainage (EUS-GBD) for AC in high-risk surgical patients. The studies were classified according to their level of evidence (LE) according to the Oxford Centre for Evidence Based Medicine classification. Literature search retrieved 175 manuscripts; most of them were expert opinions (LE V, no. 53) or caseseries (LE IV, no. 29). There was no meta-analysis of RCT (LE Ia), while two randomized controlled trials (LE Ib) demonstrated that EUS-GBD was superior to percutaneous trans-hepatic-GBD (PT-GBD) regarding longterm outcomes (adverse events, recurrent cholecystitis, and reintervention). Several meta-analyses of cohort studies (LE IIa, no. 11) were designed to compare the three available drainage strategies (endoscopic, echoendoscopic and percutaneous) and to assess the pooled risk of adverse events. Comparison between surgery and EUS-GBD was done in a single retrospective study with a propensity score analysis (LE III). The outcomes of conversion from PT-GBD to EUS-GBD were covered by few retrospective studies (LE III). Several manuscripts (no. 69) were published on EUS-GBD as a rescue strategy in case of malignant biliary obstruction. The levels of evidence of EUS-GBD in the literature have evolved from initial descriptive studies to recent randomized controlled trials and meta-analysis of cohort studies. While several articles addressed the comparison among different techniques for GBD, in our opinion some topics and questions have not been adequately investigated. are still debated.
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http://dx.doi.org/10.23736/S2724-5985.21.02854-3DOI Listing
April 2021

Micro-Biopsy Forceps in the Assessment of Peritoneal Carcinomatosis: A Possible New Indication?

Clin Endosc 2021 Jul 25;54(4):613-617. Epub 2021 Mar 25.

Gastroenterology and Digestive Endoscopy Unit, Forlì - Cesena Hospitals, AUSL Romagna, Forlì-Cesena, Italy.

Peritoneal carcinomatosis (PC) is defined as a metastatic involvement of the peritoneum by several other primary sites and it is characterized by a marked worsening of prognosis, with limited treatment opportunities. Subsequently, PC should be ruled out before any invasive treatment is administered. A new through-the-needle micro-biopsy forceps (MF) was recently introduced that permits micro-histology cores. In this case series, we evaluated the feasibility of MF in the assessment of PC to complete patient diagnostic work-ups. Five consecutive patients referred for endoscopic ultrasound staging were sampled using MF. Sampling was feasible in all patients with a technical success of 100%. No adverse events were reported in any cases. This technique was feasible and safe with a technical success rate of 100%. It permitted sampling of peritoneal irregularity, obtained high-quality tissue fragments in all cases, and enabled an additional assessment, i.e., immunohistochemical staining.
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http://dx.doi.org/10.5946/ce.2020.241DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8357587PMC
July 2021

The worst adverse event for an endoscopist after esophageal stent placement: an aortoesophageal fistula.

Endoscopy 2021 Mar 5. Epub 2021 Mar 5.

Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center - IRCCS, Rozzano, MI, Italy.

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http://dx.doi.org/10.1055/a-1368-3677DOI Listing
March 2021

Lumen-apposing metal stent through the meshes of duodenal metal stents for palliation of malignant jaundice.

Endosc Int Open 2021 Mar 18;9(3):E324-E330. Epub 2021 Feb 18.

Humanitas University, Pieve Emanuele (MI), Italy.

Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard procedure for malignant jaundice palliation; however, it can be challenging when a duodenal self-expandable metal stent (SEMS) is already in place.  The primary aim of our study was to evaluate the technical feasibility of the placement of a lumen apposing metal stent (LAMS) through the mesh (TTM) of duodenal stents. The secondary aims were to evaluate clinical outcomes and adverse events (AEs) related to the procedures. Data from 23 patients (11 F and 12 M; mean age: 69.5 ± 11 years old) were collected. In 17 patients (73.9 %) TTM LAMS placement was performed as first intention, while in six patients (26.1 %) it was performed after a failed ERCP. Thirteen patients (56.5 %) underwent the procedure due to advanced pancreatic head neoplasia. One technical failure was experienced (4.3 %). The TTM LAMS placement led to a significant decrease in the serum levels of bilirubin, ALP, GGT, WBC and CRP. No cases of duodenal SEMS occlusion occurred and no other AEs were observed during the follow-up.  Concomitant malignant duodenal and biliary obstruction is a challenging condition. Palliation of jaundice using TTM LAMS in patients already treated with duodenal stent is associated to promising technical and clinical outcomes.
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http://dx.doi.org/10.1055/a-1333-1053DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7899809PMC
March 2021

Flexible endoscopic treatment for Zenker's diverticulum: from the lumen to the third space.

Ann Gastroenterol 2021 16;34(2):149-154. Epub 2021 Jan 16.

Endoscopy Unit, Humanitas Clinical and Research Center -IRCCS-, Rozzano, Italy (Roberta Maselli, Marco Spadaccini, Edoardo Vespa, Milena Di Leo, Alessandro Fugazza, Gaia Pellegatta, Piera Alessia Galtieri, Elisa Chiara Ferrara, Andrea Anderloni, Silvia Carrara, Alessandro Repici).

Zenker's diverticulum (ZD) is a rare outpouching of the esophageal mucosa herniating posteriorly through Killian's triangle. Treatments of ZD aim to dissect the cricopharyngeal muscle to remove the underlying dysfunctional condition. In the last decade, a septotomy performed utilizing a flexible endoscope has been reported as a safe and effective alternative to both open surgery and rigid endoscopic diverticulotomy. More recently, Li et al described a novel endoscopic technique to treat ZD, named "submucosal tunneling endoscopic septum division", inspired by the peroral endoscopic myotomy (POEM) procedure developed for achalasia. Subsequently, the term Z-POEM was introduced and has become the most frequently used acronym to define the tunneling technique for ZD. This article describes the flexible therapeutic endoscopic strategies for treating ZD, including the novel third space approach, which seems to show promising potential in terms of clinical efficacy and safety.
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http://dx.doi.org/10.20524/aog.2021.0575DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903579PMC
January 2021

Single-session EUS-guided gastroenterostomy and hepaticogastrostomy using dedicated metal stents (with videos).

Endosc Ultrasound 2021 May-Jun;10(3):214-215

Division of Gastroenterology, Digestive Endoscopy Unit, Humanitas Clinical and Research Center-IRCCS, Rozzano; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milano, Italy.

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http://dx.doi.org/10.4103/eus.eus_60_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8248308PMC
January 2021

Could Chronic Idiopatic Intestinal Pseudo-Obstruction Be Related to Viral Infections?

J Clin Med 2021 Jan 13;10(2). Epub 2021 Jan 13.

Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center (IRCCS), 20089 Rozzano, Italy.

Chronic idiopathic intestinal pseudo-obstruction (CIIPO) is a disease characterized by symptoms and signs of small bowel obstruction in the absence of displayable mechanical obstruction. Due to the known neuropathic capacity of several viruses, and their localization in the intestine, it has been hypothesized that such viruses could be involved in the pathogenesis of CIIPO. The most frequently involved viruses are John Cunningham virus, Herpesviridae, Flaviviruses, Epstein-Barr virus and Citomegalovirus. Therefore, the present narrative review aims to sum up some new perspectives in the etiology and pathophysiology of CIIPO.
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http://dx.doi.org/10.3390/jcm10020268DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7828444PMC
January 2021

Efficacy of lumen-apposing metal stents or self-expandable metal stents for endoscopic ultrasound-guided choledochoduodenostomy: a systematic review and meta-analysis.

Endoscopy 2021 Oct 27;53(10):1037-1047. Epub 2020 Nov 27.

Digestive Endoscopy Unit, Department of Gastroenterology, Humanitas Clinical and Research Center-IRCCS, Rozzano (MI), Italy.

Background:  Endoscopic ultrasound (EUS)-guided biliary drainage is becoming an option for palliation of malignant biliary obstruction. Lumen-apposing metal stents (LAMS) are replacing self-expandable metal stents (SEMS). The aim of this meta-analysis was to evaluate the efficacy and safety of LAMS and SEMS for EUS-guided choledochoduodenostomy (EUS-CDS).

Methods:  A meta-analysis was performed using PRISMA protocols. Electronic databases were searched for studies on EUS-CDS. The primary outcome was clinical success. Secondary outcomes were technical success, reintervention, and adverse events. We used the random effects model with the DerSimonian-Laird estimation, and the results were depicted using forest plots. Subgroup analyses were also performed with data stratified by selected variable.

Results:  Overall, 31 studies (820 patients) were included. The pooled rates of clinical and technical success were 93.6 % (95 % confidence interval [CI] 88.6 %-96.5 %) and 94.8 % (95 %CI 90.2 %-97.3 %) for LAMS, and 91.7 % (95 %CI 88.1 %-94.2 %) and 92.7 % (95 %CI 89.9 %-94.9 %) for SEMS, respectively. The pooled rates of adverse events were 17.1 % (95 %CI 12.5 %-22.8 %) for LAMS and 18.3 % (95 %CI 14.3 %-23.0 %) for SEMS. The pooled rates of reintervention were 10.9 % (95 %CI 7.7 %-15.3 %) for LAMS and 13.9 % (95 %CI 9.6 %-19.7 %) for SEMS. Subgroup analyses confirmed these results.

Conclusions:  This meta-analysis showed that LAMS and SEMS are comparable in terms of efficacy for EUS-CDS. Clinical and technical success, post-procedure adverse events, and reintervention rates were similar between LAMS and SEMS use; however, adverse events require further investigation.
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http://dx.doi.org/10.1055/a-1324-7919DOI Listing
October 2021

Underwater cap-assisted endoscopic retrograde cholangiopancreatography in patients with surgically altered anatomy: a pilot study.

Endoscopy 2021 09 16;53(9):927-931. Epub 2020 Nov 16.

Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center - IRCCS, Rozzano, Milan, Italy.

Introduction: Endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy (SAA) is technically challenging and associated with a significant number of failures. We examined the feasibility and efficacy of a novel technique for the management of bile duct stones (BDSs), called underwater cap-assisted ERCP (u-ERCP). METHODS : Between June 2019 and February 2020 all patients with SAA with jaundice or cholangitis secondary to BDSs who underwent u-ERCP were enrolled. The u-ERCP technique combines the underwater advancement of a pediatric colonoscope with a transparent cap fitted on the tip of the endoscope. We evaluated the technical success, clinical success, and adverse events associated with u-ERCP. RESULTS : We describe the technique itself and our initial experience in six patients. A complete and successful procedure was carried out in all patients, with the occurrence of no adverse events. None of the patients needed additional treatments for recurrence of symptoms during the follow-up period. CONCLUSIONS : u-ERCP can be considered as a promising alternative for successful endoscopic management of biliary disease in patients with SAA.
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http://dx.doi.org/10.1055/a-1311-9779DOI Listing
September 2021

Use of artificial intelligence in improving adenoma detection rate during colonoscopy: Might both endoscopists and pathologists be further helped.

World J Gastroenterol 2020 Oct;26(39):5911-5918

Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center IRCCS, Rozzano 20089, Italy.

Colonoscopy remains the standard strategy for screening for colorectal cancer around the world due to its efficacy in both detecting adenomatous or pre-cancerous lesions and the capacity to remove them intra-procedurally. Computer-aided detection and diagnosis (CAD), thanks to the brand new developed innovations of artificial intelligence, and especially deep-learning techniques, leads to a promising solution to human biases in performance by guarantying decision support during colonoscopy. The application of CAD on real-time colonoscopy helps increasing the adenoma detection rate, and therefore contributes to reduce the incidence of interval cancers improving the effectiveness of colonoscopy screening on critical outcome such as colorectal cancer related mortality. Furthermore, a significant reduction in costs is also expected. In addition, the assistance of the machine will lead to a reduction of the examination time and therefore an optimization of the endoscopic schedule. The aim of this opinion review is to analyze the clinical applications of CAD and artificial intelligence in colonoscopy, as it is reported in literature, addressing evidence, limitations, and future prospects.
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http://dx.doi.org/10.3748/wjg.v26.i39.5911DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7584058PMC
October 2020

Artificial intelligence technologies for the detection of colorectal lesions: The future is now.

World J Gastroenterol 2020 Oct;26(37):5606-5616

Department of Endoscopy, Humanitas Research Hospital, Rozzano 20089, Italy.

Several studies have shown a significant adenoma miss rate up to 35% during screening colonoscopy, especially in patients with diminutive adenomas. The use of artificial intelligence (AI) in colonoscopy has been gaining popularity by helping endoscopists in polyp detection, with the aim to increase their adenoma detection rate (ADR) and polyp detection rate (PDR) in order to reduce the incidence of interval cancers. The efficacy of deep convolutional neural network (DCNN)-based AI system for polyp detection has been trained and tested in settings such as colonoscopy still images or videos. Recent trials have evaluated the real-time efficacy of DCNN-based systems showing promising results in term of improved ADR and PDR. In this review we reported data from the preliminary experiences and summarized the results of the initial randomized controlled trials.
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http://dx.doi.org/10.3748/wjg.v26.i37.5606DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7545398PMC
October 2020

Endoscopic ultrasound-guided gastro-enteric anastomosis in the COVID era: May the pandemic emphasize the benefit?

Dig Liver Dis 2021 01 7;53(1):8-10. Epub 2020 Oct 7.

Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center - IRCCS, Rozzano, MI, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.dld.2020.09.014DOI Listing
January 2021
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