Publications by authors named "Alessandro Fugazza"

80 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

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

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

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

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

A multicenter survey on endoscopic retrograde cholangiopancreatography during the COVID-19 pandemic in northern and central Italy.

Endosc Int Open 2021 Apr 15;9(4):E629-E634. Epub 2021 Apr 15.

Operative Endoscopy Unit, ASST Monza, Italy.

COVID-19 has dramatically impacted endoscopy practice because upper endoscopy procedures can be aerosol-generating. Most elective procedures have been rescheduled. Endoscopic retrograde cholangiopancreatography (ERCP) is frequently performed in emergency or urgent settings in which rescheduling is not possible. We evaluated the impact of the COVID-19 pandemic on ERCP in Italy during the SARS-CoV-2 lockdown, in areas with high incidence of COVID-19. We performed a retrospective survey of centers performing ERCP in high COVID-19 prevalence areas in Italy to collect information regarding clinical data from patients undergoing ERCP, staff, case-volume and organization of endoscopy units from March 8, 2020 to April 30, 2020. We collected data from 31 centers and 804 patients. All centers adopted a triage and/or screening protocol for SARS-CoV-2 and performed follow-up of patients 2 weeks after the procedure. ERCP case-volume was reduced by 44.1 % compared to the respective 2019 timeframe. Of the 804 patients undergoing ERCP, 22 (2.7 %) were positive for COVID-19. Adverse events occurred at a similar rate to previously published data. Of the patients, endoscopists, and nurses, 1.6 %, 11.7 %, and 4.9 %, respectively, tested positive for SARS-CoV-2 at follow up. Only 38.7 % of centers had access to a negative-pressure room for ERCP. The case-volume reduction for ERCP during lockdown was lower than for other gastrointestinal endoscopy procedures. No definitive conclusions can be drawn about the percentage of SARS-CoV-2-positive patients and healthcare workers observed after ERCP. Appropriate triage and screening of patients and adherence to society recommendations are paramount.
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http://dx.doi.org/10.1055/a-1380-3419DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8050562PMC
April 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

Endoscopic Management of Refractory Benign Esophageal Strictures.

Dysphagia 2021 Jun 12;36(3):504-516. Epub 2021 Mar 12.

Digestive Endoscopy Unit, Department of Gastroenterology, IRCCS Humanitas Research Hospital, via Manzoni 56, 20089, Rozzano, Milan, Italy.

Benign esophageal strictures are commonly encountered in clinical practice. The principal etiologies of benign esophageal strictures include long term acid reflux, caustic injuries, eosinophilic esophagitis, anastomotic strictures or endoscopic therapy. Dysphagia is most prominently present in esophageal strictures along with a variety of other symptoms which depend on the stricture etiology. Benign esophageal strictures can be categorized into two groups: simple or complex depending on their structure. Most strictures can be treated successfully with endoscopic dilation by bougies or balloons dilators. In some cases, treatment is more challenging, involving a higher risk of the patient developing recurrent or refractory strictures. To improve symptoms in these patients, other endoscopic treatments such as steroid injection, incisional therapy and stent placement should be considered. In this manuscript, we provide a comprehensive review of the main treatment options currently available to manage recurrent benign esophageal strictures.
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http://dx.doi.org/10.1007/s00455-021-10270-yDOI Listing
June 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

Upper gastrointestinal stenting during the SARS-CoV-2 outbreak: impact of mitigation measures and risk of contamination for patients and staff.

Endosc Int Open 2021 Jan 1;9(1):E76-E86. Epub 2021 Jan 1.

Gastroenterology Department, Centro Hospitalar São João, Porto, Portugal.

 The impact of COVID-19 mitigation measures on stent placement procedures has not yet been reported. The aim of this study was to assess the impact of COVID-19 mitigation measures on upper stenting during SARS-CoV-2 outbreak, as well as the use of personal protection equipment (PPE) and risk of contamination for patients and staff.  This was a multicenter, retrospective study of consecutive patients who underwent stent placement for upper gastrointestinal obstruction during the second half of SARS-CoV-2 outbreak period in comparison to same period one year before.  A total of 29 stents were placed for upper gastrointestinal obstruction during the study period, corresponding to an increase of 241 % comparing to the same period in 2019 (n = 12). No significant major differences were found between the two time periods regarding patients' baseline characteristics, post-stenting management and number of staff involved in stent placement. Fellows' involvement was significantly lower in 2020 compared to 2019 (21 % 67 %;  = 0.01). The majority of procedures were performed using FFP2 /FFP3 mask (76 %), protective eyewear (86 %), two pairs of gloves (65 %), hairnet (76 %) and full disposable gowns (90 %). One patient tested positive for SARS-CoV-2 after the procedure. None of the medical staff involved in stenting procedures developed COVID-19 14 days after procedure.  Upper gastrointestinal stenting increased during the SARS-CoV-2 outbreak period, which could be related to yearly variation on the number of procedures or reflect a change of oncologic treatment practice during COVID times.
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http://dx.doi.org/10.1055/a-1319-1201DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7775809PMC
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

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

Endoscopic ultrasound guided gastroenterostomy for efferent jeunal loop obstruction in a patient with previous pancreaticoduodenectomy and ascites.

Endosc Int Open 2020 Oct 22;8(10):E1435-E1436. Epub 2020 Sep 22.

Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center - IRCCS, Via Manzoni 56, 20089 Rozzano (Milano), Italy.

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http://dx.doi.org/10.1055/a-1221-5183DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7508657PMC
October 2020

Response.

Gastrointest Endosc 2020 10;92(4):980-981

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

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http://dx.doi.org/10.1016/j.gie.2020.06.014DOI Listing
October 2020

Chest CT in patients with a moderate or high pretest probability of COVID-19 and negative swab.

Radiol Med 2020 Dec 29;125(12):1260-1270. Epub 2020 Aug 29.

Radiology Division, Humanitas Clinical and Research Center, IRCCS, Via Alessandro Manzoni, 56, 20089, Rozzano, Milan, Italy.

Objectives: We aimed to assess the diagnostic performance of CT in patients with a negative first RT-PCR testing and to identify typical features of COVID-19 pneumonia that can guide diagnosis in this case.

Methods: Patients suspected of COVID-19 with a negative first RT-PCR testing were retrospectively revalued after undergoing CT. CT was reviewed by two radiologists and classified as suspected COVID-19 pneumonia, non-COVID-19 pneumonia or negative. The performance of both first RT-PCR result and CT was evaluated by using sensitivity (SE), specificity (SP), positive predictive value (PPV), negative predictive value (NPV) and area under the curve (AUC) and by using the second RT-PCR test as the reference standard. CT findings for confirmed COVID-19 positive or negative were compared by using the Pearson chi-squared test (P values < 0.05) RESULTS: Totally, 337 patients suspected of COVID-19 underwent CT and nasopharyngeal swabs in March 2020. Eighty-seven out of 337 patients had a negative first RT-PCR result; of these, 68 repeated RT-PCR testing and were included in the study. The first RT-PCR test showed SE 0, SP = 100%, PPV = NaN, NPV = 70%, AUC = 50%, and CT showed SE = 70% SP = 79%, PPV = 86%, NPV = 76%, AUC = 75%. The most relevant CT variables were ground glass opacity more than 50% and peripheral and/or perihilar distribution.

Discussion: Negative RT-PCR test but positive CT features should be highly suggestive of COVID-19 in a cluster or community transmission scenarios, and the second RT-PCR test should be promptly requested to confirm the final diagnosis.
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http://dx.doi.org/10.1007/s11547-020-01269-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7456362PMC
December 2020

Single-step endoscopic ultrasound-guided multiple gateway drainage of complex walled-off necrosis with lumen apposing metal stents.

Eur J Gastroenterol Hepatol 2020 10;32(10):1401-1404

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

In this study we analyzed the feasibility and safety of single-step multiple transluminal gateway drainage (MTGD) for complex walled-off necrosis (WON) using lumen-apposing metal stents (LAMSs). Six patients underwent endoscopic ultrasound (EUS)-guided MTGD using two LAMSs. Technical success was 100%. The mean procedure time was 29 min. The mean number of direct endoscopic necrosectomy sessions per patient was 2. Two of six patients developed adverse events, which was bleeding in both cases and treated endoscopically and surgically, respectively. The mean hospital stay was 52.5 days. No patients had residual necrosis or WON recurrence. Although the limited number of patients, the single-step MTGD using electrocautery-LAMSs can be considered a feasible and well-tolerated treatment option for patients with complex WON. Nevertheless, larger randomized controlled studies are needed in order to confirm our data and better define the advantages of this technique.
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http://dx.doi.org/10.1097/MEG.0000000000001793DOI Listing
October 2020

Patients with chronic autoimmune thyroiditis are not at higher risk for developing clinically overt thyroid cancer: a 10-year follow-up study.

Eur J Endocrinol 2020 Sep;183(3):317-323

Istituti Clinici Scientifici Maugeri IRCCS, Unit of Internal Medicine and Endocrinology, Laboratory for Endocrine Disruptors, Pavia, Italy.

Objective: The association between chronic autoimmune thyroiditis (CAT) and differentiated thyroid cancer (DTC) remains controversial. The incidence of DTC increases when screening procedures are implemented, as typically occurs in CAT patients being routinely submitted to thyroid ultrasound (US). The aim of this study was to longitudinally evaluate the long-term development of DTC in patients with CAT.

Design And Methods: A retrospective longitudinal cohort study was designed. For the study, 510 patients with chronic autoimmune thyroiditis (CAT) with a 10-year follow-up were enrolled. Patients were divided in two groups according to the presence (CAT+ NOD+; n = 115) or absence (CAT+ NOD-; n = 395) of co-existent nodules at diagnosis. The main outcome measures were appearance of new thyroid-nodules and development of DTC during follow-up.

Results: During a 10-year median follow-up period, new thyroid-nodules were detected in 34/115 (29.5%) patients in the CAT+ NOD+ group and in 41/395 (10.3%) in the CAT+ NOD- group (P < 0.001). Logistic regression analysis showed that thyroid-volume at diagnosis and belonging to the CAT+ NOD+ group significantly predicted the appearance of a new thyroid nodule during follow-up, independently of baseline age and sex. Among the 75 patients experiencing the appearance of a new nodule, 27 (39%) met the criteria for fine-needle-aspiration-cytology (FNAC). A benign cytological diagnosis was rendered in all cases.

Conclusions: In our series of CAT patients, the appearance of new thyroid-nodules was frequent, but none of them were found to be malignant. The presence of CAT appears to be associated with a negligible risk of developing clinically overt DTC.
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http://dx.doi.org/10.1530/EJE-20-0350DOI Listing
September 2020

Risk of Covert Submucosal Cancer in Patients With Granular Mixed Laterally Spreading Tumors.

Clin Gastroenterol Hepatol 2021 07 17;19(7):1395-1401. Epub 2020 Jul 17.

Department of Biomedical Sciences, Humanitas University, Milan, Italy; Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center-IRCCS, Rozzano, Italy. Electronic address:

Background And Aims: Granular mixed laterally spreading tumors (GM-LSTs) have an intermediate level of risk for submucosal invasive cancer (SMICs) without clear signs of invasion (covert); the optimal resection method is uncertain. We aimed to determine the risk of covert SMIC in GM-LSTs based on clinical and endoscopic factors.

Methods: We collected data from 693 patients (50.6% male; median age, 69 years) with colorectal GM-LSTs, without signs of invasion, who underwent endoscopic resection (74.2%) or endoscopic submucosal dissection (25.2%) at 7 centers in Italy from 2016 through 2019. We performed multivariate and univariate analyses to identify demographic and endoscopic factors associated with risk of SMIC. We developed a multivariate model to calculate the number needed to treat (NNT) to detect 1 SMIC.

Results: Based on pathology analysis, 66 patients (9.5%) had covert SMIC. In multivariate analyses, increased risk of covert SMIC were independently associated with increasing lesion size (odds ratio per mm increase, 1.02, 95% CI, 1.01-1.03; P = .003) and rectal location (odds ratio, 3.08; 95% CI, 1.62-5.83; P = .004). A logistic regression model based on lesion size (with a cutoff of 40 mm) and rectal location identified patients with covert SMIC with 47.0% sensitivity, 82.6% specificity, and an area under the curve of 0.69. The NNT to identify 1 patient with a nonrectal SMIC smaller than 4 cm was 20; the NNT to identify 1 patient with a rectal SMIC of 4 cm or more was 5.

Conclusions: In an analysis of data from 693 patients, we found the risk of covert SMIC in patients with GM-LSTs to be approximately 10%. GM-LSTs of 4 cm or more and a rectal location are high risk and should be treated by en-bloc resection. ClinicalTrials.gov, Number: NCT03836131.
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http://dx.doi.org/10.1016/j.cgh.2020.07.024DOI Listing
July 2021

Side-by-side comparison of next-generation sequencing, cytology, and histology in diagnosing locally advanced pancreatic adenocarcinoma.

Gastrointest Endosc 2021 03 5;93(3):597-604.e5. Epub 2020 Jul 5.

Department of Gastroenterology, Endoscopic Unit, Humanitas Clinical and Research Center-IRCCS, Rozzano, Italy; Department of Biomedical Sciences, Humanitas University, Milan, Italy.

Background And Aims: EUS-guided biopsy sampling is the method of choice for obtaining pancreatic tissue. Next-generation sequencing (NGS) has been applied to EUS-guided biopsy sampling and may classify patients based on specific molecular profiles. Our study aimed to compare side-by-side the diagnostic yield achievable by genetic identification of somatic mutations detected with NGS versus histologic and cytologic typing in locally advanced pancreatic carcinoma (LAPC) in samples acquired under EUS guidance.

Methods: We conducted a prospective comparative pilot study at Humanitas Research Hospital. The study included 33 patients referred for LAPC who underwent EUS-guided tissue acquisition using a 22-gauge Franseen needle. Material was obtained for both pathologic diagnosis and DNA extraction and targeted NGS analysis with the AmpliSeq Comprehensive Panel v3 (Illumina Inc, San Diego, Calif, USA). Twenty-one genes were prioritized for somatic mutation detection.

Results: The final diagnosis was pancreatic ductal adenocarcinoma (PDAC) in all patients (100%). A macroscopic core was obtained in 30 patients (91%). In 3 lesions no cores adequate for histologic analysis were obtained, but cytologic analysis revealed tumoral cells from PDAC. DNA was extracted from 32 of 33 samples (97%), most of which (27/32) carried at least 2 clearly pathogenic mutations in different genes. Detection of K-ras mutation allowed for molecular diagnosis of PDAC in most of the patients (30/32).

Conclusions: In our study we demonstrated that proper tissue specimens obtained under EUS guidance allowed DNA sample extraction and subsequent NGS analysis in 97% of cases. These results support the potential role of NGS as a complementary diagnostic test to be implemented in association with standard diagnostic modalities. (Clinical trial registration number: NCT03578939.).
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http://dx.doi.org/10.1016/j.gie.2020.06.069DOI Listing
March 2021

Computer-aided detection-assisted colonoscopy: classification and relevance of false positives.

Gastrointest Endosc 2020 Oct 16;92(4):900-904.e4. Epub 2020 Jun 16.

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

Background And Aims: False positive (FP) results by computer-aided detection (CADe) hamper the efficiency of colonoscopy by extending examination time. Our aim was to develop a classification of the causes and clinical relevance of CADe FPs, and to assess the relative distribution of FPs in a real-life setting.

Methods: In a post-hoc analysis of a randomized trial comparing colonoscopy with and without CADe (NCT: 04079478), we extracted 40 CADe colonoscopy videos. Using a modified Delphi process, 4 expert endoscopists identified the main domains for the reasons and clinical relevance of FPs. Then, 2 expert endoscopists manually examined each FP and classified it according to the proposed domains. The analysis was limited to the withdrawal phase.

Results: The 2 main domains for the causes of CADe FPs were identified as artifacts due to either the mucosal wall or bowel content, and clinical relevance was defined as the time spent on FPs and the FP rate per minute. The mean number of FPs per colonoscopy was 27.3 ± 13.1, of which 24 ± 12 (88%) and 3.2 ± 2.6 (12%) were due to artifacts in the bowel wall and bowel content, respectively. Of the 27.3 FPs per colonoscopy, 1.6 (5.7%) required additional exploration time of 4.8 ± 6.2 seconds per FP (ie, 0.7% of the mean withdrawal time). In detail, 15 (24.2%), 33 (53.2%), and 14 (22.6%) FPs were classified as being of mild, moderate, or severe clinical relevance. The rate of FPs per minute of withdrawal time was 2.4 ± 1.2, and was higher for FPs due to artifacts from the bowel wall than for those from bowel content (2.4 ± 0.6 vs 0.3 ± 0.2, P < .001).

Conclusions: FPs by CADe are primarily due to artifacts from the bowel wall. Despite a high frequency, FPs result in a negligible 1% increase in the total withdrawal time because most of them are immediately discarded by the endoscopist.
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http://dx.doi.org/10.1016/j.gie.2020.06.021DOI Listing
October 2020
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