Publications by authors named "Alessandro Repici"

484 Publications

Comparative Risk of Serious Infections with Biologic Agents and Oral Small Molecules in Inflammatory Bowel Diseases: A Systematic Review and Meta-analysis.

Clin Gastroenterol Hepatol 2022 Aug 6. Epub 2022 Aug 6.

Division of Gastroenterology, UC San Diego, La Jolla, California, USA; Division of Biomedical Informatics, Department of Medicine, UC San Diego, La Jolla, California, USA. Electronic address:

Background And Aims: Safety is a key consideration when choosing advanced therapies (biologic agents and oral small molecule inhibitors/modulators) in patients with inflammatory bowel diseases (IBD). We performed a systematic review and meta-analysis comparing the risk of serious infections with advanced therapies in active comparator studies.

Methods: Through a systematic search until February 28, 2022, we included 20 head-to-head studies comparing risk of serious infections with tumor necrosis factor (TNF)-α antagonists, vedolizumab, ustekinumab, tofacitinib, filgotinib and ozanimod in patients with IBD. We performed random effects meta-analysis comparing different advanced therapies.

Results: No significant difference was observed in the risk of serious infections between vedolizumab vs. TNFα antagonists in all patients with IBD (17 cohorts: OR, 0.84 [95% CI, 0.68-1.04]), with moderate heterogeneity (I=37%); on subgroup analysis, vedolizumab was associated with lower risk of serious infections in patients with ulcerative colitis (UC) (11 cohorts: OR, 0.68 [0.56-0.83], I=0%), but not in Crohn's disease (CD) (9 cohorts: OR, 1.03 [0.78-1.35], I=42%). Age, sex, prior biologic exposure and use of biologic monotherapy did not influence this association. In patients with CD, ustekinumab was associated with lower risk of serious infections vs. TNFα antagonists (3 cohorts: OR, 0.49 [0.25-0.93], I=16%) and vs. vedolizumab (3 cohorts: OR, 0.40 [0.17-0.93], I=67%). Few studies compared other advanced therapies.

Conclusions: Vedolizumab may offer net benefit over TNFα antagonists in patients with UC, but not in CD. Ustekinumab may offer net benefit over TNFα antagonists and vedolizumab in patients with CD.
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http://dx.doi.org/10.1016/j.cgh.2022.07.032DOI Listing
August 2022

Diagnostic accuracy of endoscopic ultrasound (EUS) guided fine needle biopsy (FNB) by macroscopic on-site evaluation (MOSE): A systematic review and meta-analysis.

Gastrointest Endosc 2022 Aug 3. Epub 2022 Aug 3.

Background: Assessment of endoscopic ultrasound (EUS) guided fine needle tissue adequacy by macroscopic on-site evaluation (MOSE) is gathering attention. Studies report good diagnostic parameters with MOSE; however, the overall data is limited. We conducted this systematic review and meta-analysis to report on the pooled diagnostic assessment parameters of EUS-guided tissue acquisition by MOSE using fine needle biopsy (FNB).

Methods: Multiple databases were searched (from inception to Dec-2021) and studies that reported on the diagnostic assessment of EUS-guided tissue acquisition by MOSE were selected. Pooled diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated by standard meta-analysis methods following the random-effects model. Heterogeneity was assessed by I% statistics.

Results: A total of fourteen studies were included in the analysis. A total of 1508 lesions were biopsied in 1489 patients undergoing EUS-guided tissue acquisition. MOSE definition included a visible core of tissue with opacity, 'worm-like' features of adequate size and length (≥4mm). The pooled accuracy of FNA and/or FNB specimen in yielding a pathological diagnosis by MOSE was 91.3% (95% CI 88.6-93.3, I=66%), pooled sensitivity was 91.5% (95% CI 88.6-93.6, I=66%), pooled specificity was 98.9% (95% CI 96.6-99.7, I=80%), pooled PPV was 98.8% (95% CI 97.4-99.5, I=33%), and pooled NPV was 55.5% (95% CI 46.9-63.9, I=95%). Subgroup analyses by newer generation FNB needles demonstrated similar pooled rates, with minimal adverse events (2.5%, 1.5-3.9, I=21%).

Conclusions: Excellent pooled diagnostic accuracy parameters were demonstrated in EUS-guided tissue acquisition by FNB using the MOSE method.
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http://dx.doi.org/10.1016/j.gie.2022.07.026DOI Listing
August 2022

Critical Appraisal of Filgotinib in the Treatment of Ulcerative Colitis: Current Evidence and Place in Therapy.

Clin Exp Gastroenterol 2022 23;15:121-128. Epub 2022 Jul 23.

IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.

Background And Aims: Patients affected by moderate-to-severe Ulcerative Colitis (UC) demand a challenging management. Small molecules, administrated as oral agents, have the ambition of overcoming the limitations of the biologic agents (ie, parenteral administration, rapidity of action, primary and secondary non-responsiveness). Beyond tofacitinib, a pan-Janus kinase (JAK) inhibitor already approved for the treatment of moderate-to-severe UC, novel more selective molecules like filgotinib are being currently evaluated in randomized clinical trials. We aimed to review the current evidence on filgotinib, a JAK-1 preferential inhibitor, in the treatment of UC and its place in therapy in the current scenario.

Methods: PubMed and EMBASE were searched to identify relevant studies: those investigating the efficacy and safety of filgotinib in the treatment of UC patients were included in this narrative review.

Results: The current preliminary data have shown that filgotinib is safe and effective in inducing clinical end endoscopic response in both biologic-naïve and biologic-experienced patients with moderate-to-severe UC, also with high inflammatory burden at baseline. In the SELECTION trial, one case of pulmonary embolism occurred with filgotinib 200 mg induction, and three venous thrombosis cases were observed in the placebo maintenance/LTE; the incidence of herpes zoster was ≤1% in all UC treated patients. Filgotinib represents an appealing treatment option for its high selectiveness, route of administration and rapidity of action; cost-effectiveness studies and head-to-head trials are needed to better define its place in therapy.
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http://dx.doi.org/10.2147/CEG.S350193DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9329679PMC
July 2022

Sphingosine 1-Phosphate Modulation in Inflammatory Bowel Diseases: Keeping Lymphocytes Out of the Intestine.

Biomedicines 2022 Jul 19;10(7). Epub 2022 Jul 19.

IBD Center, Department of Gastroenterology, IRCCS Humanitas Research Hospital, 20089 Rozzano, Milan, Italy.

Inflammatory bowel diseases (IBDs) are chronic and disabling conditions that, uncontrolled, lead to irreversible bowel damage and associated comorbidities. Despite the new era of biological therapies, IBDs remain not curative. The treatment purpose is to induce endoscopic remission, reduce the progression of the disease and improve the quality of life. Optimal and early treatment could enable the prevention of their complications. Small molecules, administrated as oral agents, have the capacity of overcoming the limitations of biologic agents (i.e., parenteral administration, rapidity of action and primary and secondary non-responsiveness). Of special interest are results from the use of oral sphingosine 1-phosphate (S1P) receptor modulators (ozanimod, etrasimod, fingolimod and laquinimod), based on S1P activities to target lymphocyte recirculation in the mucosa, acting as immunosuppressive agents. Most S1P modulators are reported to be safe and effective in the treatment of both UC and CD. High and satisfactory rates of clinical remission as well as endoscopic improvement and remission can be achieved with these molecules. Safety alarms remain rather low, although the S1P binding to two of its G protein-coupled receptors, 2 and 3 (S1PR2 and S1PR3), may be associated with cardiovascular risks. Cost-effectiveness studies and head-to-head trials are needed to better define their place in therapy. This review summarizes these emerging data published by PubMed and EMBASE databases and from ongoing clinical trials on the safety and efficacy of selectivity of S1P modulators in the treatment of IBD.
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http://dx.doi.org/10.3390/biomedicines10071735DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9313037PMC
July 2022

EUS-guided biliary drainage with a novel electrocautery-enhanced lumen apposing metal stent as first approach for distal malignant biliary obstruction: a prospective study.

Endosc Int Open 2022 Jul 15;10(7):E998-E1003. Epub 2022 Jul 15.

Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy.

 Endoscopic retrograde cholangiopancreatography (ERCP) represents the gold standard for jaundice palliation in malignant biliary obstruction (MBO) patients. Biliary drainage using electrocautery lumen apposing metal stent (EC-LAMS) is currently a well-established procedure when ERCP fails. We aimed to assess the technical and clinical success of a new EC-LAMS as the first approach to the palliation of malignant jaundice due to MBO in patients unfit for surgery.  Twenty-five consecutive patients undergoing endoscopic-guided biliary drainage with the new EC-LAMS were prospectively enrolled. Clinical success was defined as bilirubin level decrease > 15 % 24 hours after EC-LAMS placement.  Mean age was 76.6 ± 11.56 years, and male patients were 10 (40 %). EC-LAMS placement was technically feasible in 24 patients (96 %) and clinical success rate was 100 %. Only one patient (4 %) experienced a misplacement rescued by an immediate second EC-LAMS placement. The mean duration of hospital stay was 4.66 ± 4.22 days. The median overall survival was 7 months (95 % CI 1-7).  In this preliminary study, the new EC-LAMS seems to allow a single-step palliative endoscopic therapy in patients affected by jaundice due to MBO, with high technical and clinical success and low adverse events. Further large prospective studies are warranted to validate these results.
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http://dx.doi.org/10.1055/a-1838-2683DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9286767PMC
July 2022

Ileal Pouch-Anal Anastomosis and Pouchitis: The Role of the Microbiota in the Pathogenesis and Therapy.

Nutrients 2022 Jun 24;14(13). Epub 2022 Jun 24.

IBD Center, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089 Rozzano, Milan, Italy.

Inflammatory bowel diseases, Crohn's disease and ulcerative colitis, are life-long disorders characterized by the chronic relapsing inflammation of the gastrointestinal tract with the intermittent need for escalation treatment and, eventually, even surgery. The total proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the surgical intervention of choice in subjects affected by ulcerative colitis (UC). Although IPAA provides satisfactory functional outcomes, it can be susceptible to some complications, including pouchitis as the most common. Furthermore, 10-20% of the pouchitis may develop into chronic pouchitis. The etiology of pouchitis is mostly unclear. However, the efficacy of antibiotics in pouchitis suggests that the dysbiosis of the IPAA microbiota plays an important role in its pathogenesis. We aimed to review the role of the microbiota in the pathogenesis and as a target therapy in subjects who develop pouchitis after undergoing the surgical intervention of total proctocolectomy with IPAA reconstruction.
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http://dx.doi.org/10.3390/nu14132610DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9268595PMC
June 2022

Long-Term Outcomes of Per-Oral Endoscopic Myotomy (POEM) for Achalasia: a Systematic Review and Meta-analysis.

Endoscopy 2022 Jul 7. Epub 2022 Jul 7.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.

Background: The long-term outcomes of esophageal peroral endoscopic myotomy (POEM) are still unknown.

Methods: We searched electronic databases (Medline/Pubmed, EMBASE, Scopus) for studies assessing outcomes after POEM for esophageal achalasia, with a minimum median follow-up duration of 36 months. Pooled rates of clinical success and post-operative reflux were calculated and compared with the same values at 12/24/36 months when available. Sub-group analyses were also performed to explore the inter-study heterogeneity.

Results: From 1528 initial records, 11 studies (2017-2021) satisfied all the eligibility criteria for inclusion. A total of 2342 (48.1 ± 6.8 years; 50.1% males) patients were analyzed with a median follow-up of 48 (IQR, 45-60) months. Pooled clinical success rate was 87.3% (95% CI, 86.3%-91.0%; I2= 73.1%). Symptomatic reflux pooled rate was 22.0% (95% CI, 14.4%-29.5%, I2= 92.7%). Three cases of peptic strictures and one Barrett's esophagus were reported. Pooled rate of severe adverse events was 1.5% (95% CI, 0.5%-2.5%, I2= 52.8%).

Conclusions: Long-term clinical efficacy of POEM persists in nearly 87% of patients with achalasia. Post-POEM symptomatic reflux seems to remain stable over time. Risk for Barrett's esophagus and peptic strictures appears minimal.
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http://dx.doi.org/10.1055/a-1894-0147DOI Listing
July 2022

Determinants of symptom burden related to bowel preparation for colonoscopy.

Dig Liver Dis 2022 Jun 28. Epub 2022 Jun 28.

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy; Stony Brook Cancer Center, Stony Brook University, Stony Brook, NY, USA.

Background: Symptoms developing during bowel preparation are major concerns among subjects who refuse the procedure.

Aims: We aimed to explore the determinants of symptoms occurring during preparation among patients undergoing elective colonoscopy.

Methods: This is a prospective multicenter study conducted in 10 Italian hospitals. A multidimensional approach collecting socio-demographic, clinical, psychological and occupational information before colonoscopy through validated instruments was used. Outcome was a four-category cumulative score based on symptoms occurring during preparation, according to the Mayo Clinic Bowel Prep Tolerability Questionnaire, weighted by intensity. Missing values were addressed through multiple imputation. Odds ratios (OR) and 95% confidence intervals (CI) were estimated through multivariate logistic regression models.

Results: 1137 subjects were enrolled. Severe symptoms were associated with female sex (OR=3.64, 95%CI 1.94-6.83), heavier working hours (OR=1.13, 95% CI=1.01-1.25), previous gastrointestinal symptoms (OR=7.81, 95% CI 2.36-25.8 for high score), somatic symptoms (OR=2.19, 95% CI=1.06-4.49 for multiple symptoms), day-before regimen (OR=2.71, 95%CI 1.28-5.73). On the other hand, age ≥60 years (OR=0.10, 95% CI 0.02-0.44) and good mood (p=0.042) were protective factors. A high-risk profile was identified, including women with low mood and somatic symptoms (OR=15.5, 95%CI 4.56-52.7).

Conclusions: We identified previously unreported determinants of symptoms burdening bowel preparation and identified a particularly vulnerable phenotype. Symptoms during preparation especially impact heavier working activity.
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http://dx.doi.org/10.1016/j.dld.2022.06.005DOI Listing
June 2022

EUS-guided gastro-enteral anastomosis for the treatment of gastric outlet obstruction: is the end of the enteral stent?

Expert Rev Gastroenterol Hepatol 2022 07 3;16(7):587-589. Epub 2022 Jul 3.

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

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http://dx.doi.org/10.1080/17474124.2022.2097071DOI Listing
July 2022

Endoscopic mucosal resection combined with hybrid argon plasma coagulation to prevent recurrence of large nonpedunculated colorectal polyps.

Gastrointest Endosc 2022 Jun 17. Epub 2022 Jun 17.

Montreal University Medical Research Center (CRCHUM), Montreal, Canada; Division of Gastroenterology, Montreal University Medical Center (CHUM), Montreal, Canada. Electronic address:

Background And Aims: Endoscopic mucosal resection (EMR) is the mainstay of therapy for large colorectal polyps. Local recurrence after EMR is common and can be reduced using margin ablation. Our aim was to evaluate recurrence rates when using hybrid argon plasma coagulation - HybridAPC® (h-APC) -ablation after EMR.

Methods: Adult patients (18-89 years) undergoing EMR of nonpedunculated colorectal polyps ≥20 mm were enrolled in a prospective multicenter study. H-APC was used to ablate all defect margins and in selected cases also the resection surface. Primary study outcome was the recurrence rates found during the first follow-up colonoscopy. Secondary outcomes included technical success and complication rates.

Results: EMR with h-APC ablation was performed in 101 polyps (84 patients; 46.4% female). EMR with h-APC ablation was technically successful in all cases (median EMR time 15 minutes; median h-APC ablation time 4 minutes). Median polyp size was 30 mm [range 20-60]. Resected polyps were either adenomas (68/101; 67.3%), sessile serrated lesions (27/101; 27%) or adenocarcinomas (6/101; 6%). Post-EMR recurrence rate was 2.2% (2/91) [95%CI 0.27-7.71%]. All 6 patients with a cancer (4 Intramucosal cancer, 2 T1sm cancer) were found to have complete eradication of the primary tumor after EMR with h-APC and none had lymph node metastasis. Four serious adverse events occurred in three patients (2 delayed bleeding [2.4%], 1 abdominal pain [1.2%], 1 micro-perforation [1.2%]. All serious adverse events resolved with either endoscopic or antibiotic treatment only.

Conclusion: EMR with h-APC showed a high technical success rate, low complication rate, and very low post-EMR recurrence rates.

Study Registration: Trial registered at Montreal University Research Center Institutional Review Board (19.119) and at ClinicalTrials.gov (NCT04015765).
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http://dx.doi.org/10.1016/j.gie.2022.06.018DOI Listing
June 2022

Comparison of focal cryoballoon ablation with 10 and 8 second dose for treatment of Barrett's esophagus related neoplasia: results from a prospective European multicenter study.

Gastrointest Endosc 2022 Jun 17. Epub 2022 Jun 17.

Dept. of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands;; Dept. of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.

Background And Aims: Focal cryoballoon ablation (FCBA) is currently investigated for the treatment of Barrett's esophagus (BE) related neoplasia in a European multicenter study (Euro-Coldplay study). After inclusion of 28/107 patients, the initial dose of 10 seconds (s) was lowered to 8s. The current study aimed to compare the efficacy and safety of a single FCBA treatment session with 10s versus 8s.

Methods: Treatments were performed at 7 European Barrett referral centers. All 28 patients treated with 10s were compared with the 28 consecutive patients treated with 8s. The gastroesophageal junction was ablated circumferentially followed by all visible BE. To assess efficacy and safety, three expert adjudicators, blinded for physician and dose, compared pre- and post-treatment images. Primary outcomes included median BE surface regression and stricture rate after single-session FCBA.

Results: We included 56 patients (10s n=28, 8s n=28) with a median BE length of C0M2. Baseline characteristics did not significantly differ between the cohorts. The median BE surface regression after a single FCBA session was comparable for 10s and 8s (80% [95% CI 75-90] and 80% [95% CI 66-90], respectively; p=0.65). Strictures requiring dilation were seen in 19% [95% CI 4-33] and 15% [95% CI 4-30] of the 10s and 8s group respectively (p=1.00). Two patients among the 10s group developed a severe stricture requiring >3 dilations.

Conclusion: In patients with limited BE, single-session FCBA with 8s showed similar BE surface regression as compared to 10s, and may theoretically result in fewer and less severe strictures. Therefore, we suggest to use 8s as the standard dose for FCBA.
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http://dx.doi.org/10.1016/j.gie.2022.06.017DOI Listing
June 2022

Percutaneous endoscopic gastrostomy and jejunostomy: Indications and techniques.

World J Gastrointest Endosc 2022 May;14(5):250-266

Division of Gastroenterology and Digestive Endoscopy, Department of Gastroenterology, Humanitas Research Hospital - IRCCS, Rozzano 20089, Milan, Italy.

Nutritional support is essential in patients who have a limited capability to maintain their body weight. Therefore, oral feeding is the main approach for such patients. When physiological nutrition is not possible, positioning of a nasogastric, nasojejunal tube, or other percutaneous devices may be feasible alternatives. Creating a percutaneous endoscopic gastrostomy (PEG) is a suitable option to be evaluated for patients that need nutritional support for more than 4 wk. Many diseases require nutritional support by PEG, with neurological, oncological, and catabolic diseases being the most common. PEG can be performed endoscopically by various techniques, radiologically or surgically, with different outcomes and related adverse events (AEs). Moreover, some patients that need a PEG placement are fragile and are unable to express their will or sign a written informed consent. These conditions highlight many ethical problems that become difficult to manage as treatment progresses. The aim of this manuscript is to review all current endoscopic techniques for percutaneous access, their indications, postprocedural follow-up, and AEs.
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http://dx.doi.org/10.4253/wjge.v14.i5.250DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9157691PMC
May 2022

Rectal band ligation as a treatment for chronic radiation proctitis: a feasibility study.

Endosc Int Open 2022 Jun 10;10(6):E787-E790. Epub 2022 Jun 10.

Gastrointestinal Endoscopy Unit - Humanitas Mater Domini, Castellanza (VA), Italy.

Chronic radiation proctitis (CRP) occurs in 5 % to 20 % of patients undergoing pelvic radiation therapy and frequently manifests with rectal bleeding. Endoscopic management of more severe and refractory cases can be challenging. Rectal band ligation (RBL) has been shown to be a feasible alternative to current available techniques, especially in extensive CRP. Our aim is to evaluate clinical and technical success of RBL. We enrolled all consecutive patients treated with RBL for severe or recurrent hemorrhagic CRP. Success was defined as endoscopic evidence of complete rectal healing and/or cessation of bleeding not requiring further treatment or blood transfusion. We enrolled 10 patients (7 males, mean age 75.6 years). Median length of the CRP from the anal verge was 4.5 cm and mean surface area involved was 89 %. Eight patients (80 %) were naïve to endoscopic treatment, while two had undergone argon plasma coagulation (APC). Median follow-up was 136.5 days. Success was achieved in 100 % of patients after a mean number of 1.8 RBL sessions. A mean number of 4.7 bands were released in the first session while a mean of 3.1 and 2 bands were placed in the second and third sessions, respectively. As for adverse events, only one patient reported mild tenesmus and pelvic pain after the procedure. RBL is a safe and effective therapeutic modality for the treatment of hemorrhagic CRP. It could be considered a valid first-line option in case of extensive rectal involvement as well as a viable rescue treatment after failed APC.
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http://dx.doi.org/10.1055/a-1821-0776DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9187420PMC
June 2022

Endoscopic Suturing for Gastrointestinal Applications: Initial Results from a Prospective Multicenter European Registry.

Gastrointest Endosc 2022 Jun 8. Epub 2022 Jun 8.

IRCCS Humanitas Research Hospital. Endoscopic Unit, Department of Gastroenterology, Via Manzoni 56, 20089 Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, Milan, Italy.

Background And Aims: OverStitch devices (OverStitch/OverStitch-Sx)are used for a wide range of applications. A European registry was created to prospectively collect technical/clinical data regarding both systems, to provide procedural outcomes and to find correlation between procedural characteristics and outcomes.This study shows the initial results of the first three years of the registry.

Methods: Patients who underwent to endoscopic-suturing from January 2018 to January 2021 at 9 Centers were enrolled. Data regarding the disease treated,suturing pattern and outcomes were registered. The technical feasibility(the success to reach the target area), the technical success(the success to place sutures)and the clinical success(the complete resolution of the clinical issue) were recorded and analyzed.

Results: In the study period,137 patients(57.7% male) were enrolled with 100% technical feasibility rate. Endoscopic-suturing was successfully performed in 136cases(16.7% with OverStitch-Sx),obtaining a technical success rate of 99.3%. No adverse events were recorded. Overall clinical success was 89%. Mucosal defects were sutured in 32 patients(100%clinical success). Leaks/fistulas were treated in 23 patients(64.7% clinical success). The clinical success of stent fixations(n=38) was 85%. Perforations(n=22)were repaired with a clinical success of 94.7%. No significant correlation between location,suture pattern/number and the success was found,except in case of fistulas where fistulas <1cm treated by a continuous suture were more likely to achieve clinical success in the follow-up (p<0.001).

Conclusion: Overstitch-based suturing is technically feasible regardless of site and the method of suturing, with no cases of failure. The overall technical success rate of 99.3% and the clinical outcome success rate of 89% demonstrate the Overstitch technology provides reliable suturing with clinical advantages especially with fistulas <1 cm.
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http://dx.doi.org/10.1016/j.gie.2022.06.004DOI Listing
June 2022

Risk of Cancer in Inflammatory Bowel Diseases: Umbrella Review and Reanalysis of Meta-analyses.

Gastroenterology 2022 May 26. Epub 2022 May 26.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy. Electronic address:

Background & Aims: To summarize the epidemiologic evidence and assess the validity of claimed associations of inflammatory bowel diseases (IBDs) with overall and site-specific cancer risk.

Methods: We systematically searched PubMed, Embase, and Scopus from inception to May 10, 2021, to identify and comprehensively reanalyze the data of meta-analyses on associations between IBDs (ie, Crohn's disease [CD] and ulcerative colitis [UC]) and subsequent risk of cancer. The strength of epidemiologic evidence was graded as high, moderate, or weak, by applying prespecified criteria that included the random effects estimate, its 95% confidence interval, and P value, estimates of heterogeneity, small-study effects, and robustness to unmeasured confounding.

Results: This study critically appraised 277 estimates derived from 24 published meta-analyses and our own meta-analyses. The association between pediatric-onset IBDs and overall risk of cancer showed high epidemiologic evidence. Twenty associations (15 cancer types) demonstrated moderate evidence: any cancer (pediatric-onset UC), mouth to terminal ileum (CD), small bowel (CD/UC), colon (CD), rectum (CD/UC), colon-rectum (IBDs, pediatric-onset CD/UC), bile ducts and liver (CD/UC), liver (CD), intrahepatic cholangiocarcinoma (IBDs), bile ducts (CD), skin (CD), squamous cell carcinoma of the skin (CD), nonmelanoma skin cancer (UC), kidney (CD), and thyroid cancer (IBDs). Another 40 associations (23 cancer types) showed statistical significance; however, our confidence in these effect estimates was weak. No statistical significance was found regarding further 47 associations.

Conclusions: Associations between IBDs and different types of malignancy showed varying levels of evidence and magnitude of risk. Further primary research investigating the impact of a consistent set of risk factors that are known to affect cancer risk is warranted.

Systematic Review Registration: PROSPERO CRD42021254996.
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http://dx.doi.org/10.1053/j.gastro.2022.05.038DOI Listing
May 2022

Safety of a novel 1L-polyethylene glycol-ascorbate solution for colonoscopy cleansing (REAL Study).

Dig Liver Dis 2022 May 22. Epub 2022 May 22.

Gastroenterology and Digestive Endoscopy Unit, AUSL Modena, Italy. Electronic address:

Background And Aim: Very low-volume bowel preparation (BP) for colonoscopy with 1-liter polyethylene glycol plus ascorbate (1L-PEG-Asc) has displayed high tolerability and quality of bowel cleansing. Concerns have been raised regarding its safety. We aimed to evaluate the incidence of adverse events (AEs) following BP with 1L-PEG-Asc or 2L-PEG-Asc.

Patients And Methods: From January 2019 to September 2020, data from all consecutive adult outpatients who underwent colonoscopy in Our Unit were collected. AEs were assessed by reviewing the clinical and laboratory data of patients who attended the Emergency Department (ED) of Modena District Hospitals in the 7 days following the colonoscopy, and were classified as "BP-related" or "BP-unrelated".

Results: During the study, 4069 (68.03%) and 1912 (31.97%) patients underwent colonoscopy after taking 2L-PEG-Asc or 1L-PEG-Asc, respectively. Regarding AEs, 77 (1.29%) patients attended ED, 53 (53/4069, 1.30%) and 24 (24/1912, 1.25%) after taking 2L-PEG-Asc and 1L-PEG-Asc. BP-related AEs were observed in 5 (5/4069, 0.12%) and 4 (4/1912, 0.21%) patients, respectively. The most frequent BP-related AEs were tachyarrhythmias (6/5981, 0.10%).

Conclusion: The incidence rate of clinically relevant BP-related AEs is extremely low. This strongly suggests that 1L-PEG-Asc colonoscopy BP is as safe as 2L-PEG-Asc BP in a real-life clinical setting of unselected patients.
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http://dx.doi.org/10.1016/j.dld.2022.04.014DOI Listing
May 2022

Gastrojejunostomy in a patient with previous choledochoduodenostomy and duodenal stent with transcholedocical approach.

Endoscopy 2022 May 25. Epub 2022 May 25.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.

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http://dx.doi.org/10.1055/a-1838-3985DOI Listing
May 2022

Nomogram for prediction of adverse events after lumen-apposing metal stent placement for drainage of pancreatic fluid collections.

Dig Endosc 2022 May 23. Epub 2022 May 23.

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

Objectives: To generate a prognostic model based on a nomogram for adverse event (AE) prediction after lumen-apposing metal stents (LAMS) placement in patients with pancreatic fluid collections (PFC).

Methods: Data from a large multicenter series of PFCs treated with LAMS placement were retrieved. AE (overall and excluding mild events) prediction was calculated through a logistic regression model and a nomogram was created and internally validated after bootstrapping. Results were expressed in terms of odds ratio (OR) and 95% confidence interval (CI). Discrimination was assessed by c-statistics and calibrated by comparing deciles of predicted and observed ORs.

Results: Overall, 516 patients were included (males 68%, mean age 61.6 ± 15.2 years). PFCs were predominantly walled-off necrosis (52.1%). Independent predictors of AE occurrence were injury of main pancreatic duct (OR in the case of leak 2.51, 95% CI 1.06-5.97, P = 0.03; OR in the case of complete disruption 2.61, 1.53-4.45, P = 0.01), abnormal vessels (OR in the case of perigastric varices 2.90, 1.31-6.42, P = 0.008; OR in the case of pseudoaneurysm 2.99, 1.75-11.93, P = 0.002), using a multigate technique (OR 3.00, 1.28-5.24; P = 0.05), and need of percutaneous drainage (OR 2.81, 1.03-7.65, P = 0.04). By nomogram, a score beyond 200 points corresponded to a 50% probability of AE occurrence. The model was confirmed even when excluding mild AEs and it showed optimal discrimination (c-index 76.8%, 95% CI 74-79), confirmed after internal validation.

Conclusion: Patients with preprocedural evidence of pancreatic duct leak/disruption, vessel alteration, requiring percutaneous drainage or a multigate technique are at higher risk for AE.
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http://dx.doi.org/10.1111/den.14354DOI Listing
May 2022

Digital single-operator cholangioscopy in diagnostic and therapeutic bilio-pancreatic diseases: A prospective, multicenter study.

Dig Liver Dis 2022 May 18. Epub 2022 May 18.

Pancreato-Biliary Endoscopy and Endosonography Division, Pancreas Translational & Clinical Research Center, Vita-Salute San Raffaele University, Milan, Italy, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Background And Aim: Digital single-operator cholangioscopy (D-SOC) is an endoscopic procedure that is increasingly used for the management of bilio-pancreatic diseases. We aimed to investigate the efficacy and safety of D-SOC for diagnostic and therapeutic indications.

Methods: This is a multicenter, prospective study(January 2016-June 2019) across eighteen tertiary centers. The primary outcome was procedural success of D-SOC. Secondary outcomes were: D-SOC visual assessment and diagnostic yield of SpyBite biopsy in cases of biliary strictures, stone clearance rate in cases of difficult biliary stones, rate of adverse events(AEs) for all indications.

Results: D-SOC was performed in 369 patients (201(54,5%) diagnostic and 168(45,5%)therapeutic). Overall, procedural success rate was achieved in 360(97,6%) patients. The sensitivity, specificity, PPV, NPV and accuracy in biliary strictures were: 88,5%, 77,3%, 83,3%, 84,1% and 83,6% for D-SOC visual impression; 80,2%, 92,6%, 95,1%, 72,5% and 84,7% for the SpyBite biopsy, respectively. For difficult biliary stones, complete duct clearance was obtained in 92,1% patients (82,1% in a single session). Overall, AEs occurred in 37(10%) cases.The grade of AEs was mild or moderate for all cases, except one which was fatal.

Conclusion: D-SOC is effective for diagnostic and therapeutic indications.Most of the AEs were minor and managed conservatively, even though a fatal event has happened that is not negligible and should be considered before using D-SOC.
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http://dx.doi.org/10.1016/j.dld.2022.04.019DOI Listing
May 2022

Targeting the low detector with artificial intelligence.

Endoscopy 2022 May 20. Epub 2022 May 20.

IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.

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http://dx.doi.org/10.1055/a-1819-6568DOI Listing
May 2022

The AGREE classification: A useful new tool or just a procrustean bed?

Gastrointest Endosc 2022 Jun;95(6):1280

Section of Gastroenterology, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.

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http://dx.doi.org/10.1016/j.gie.2021.12.043DOI Listing
June 2022

Dye-based chromoendoscopy for the detection of colorectal neoplasia: meta-analysis of randomized controlled trials.

Gastrointest Endosc 2022 May 16. Epub 2022 May 16.

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

Background And Aims: Dye-based chromoendoscopy (DBC) could be effective in increasing the adenoma detection rate (ADR) in patients undergoing colonoscopy, but the technique is time-consuming and its uptake is limited. We aimed to assess the effect of DBC on ADR based on available randomized controlled trials (RCTs).

Methods: Four databases were searched up to April 2022 for RCTs comparing DBC with conventional colonoscopy (CC) in terms of ADR, advanced ADR, and sessile serrated adenoma detection rate as well as the mean adenomas per patient and non-neoplastic lesions. Relative risk (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes were calculated using random-effect models. The I test was used for quantifying heterogeneity. Risk of bias was evaluated with the Cochrane tool.

Results: Overall, 10 RCTs (5334 patients) were included. Indication for colonoscopy was screening or surveillance (3 studies) and mixed (7 studies). Pooled ADR was higher in the DBC group versus the CC group (95% CI, 48.1% [41.4%-54.8%] vs 39.3% [33.5%-46.4%]; RR, 1.20 [1.11-1.29]), with low heterogeneity (I = 29%). This effect was consistent for advanced ADR (RR, 1.21 [1.03-1.42]; I = .0%), sessile serrated adenomas (6.1% vs 3.5%; RR, 1.68 [1.15-2.47]; I = 9.8%), and mean adenomas per patient (MD, .24 [.17-.31]) overall and in the right-sided colon (MD, .28 [.14-.43]). A subgroup analysis considering only trials using high-definition white-light endoscopy reduced the heterogeneity while still showing a significant increase in adenoma detection with DBC: 51.6% (95% confidence interval [CI], 47.1%-56.1%) and 59.1% (95% CI, 54.7-63.3%), RR = 1.14 (95% CI, 1.06-1.23), P = .0004, I = .0%, P = .50.

Conclusions: Meta-analysis of RCTs showed that DBC increases key quality parameters in colonoscopy, supporting its use in everyday clinical practice.
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http://dx.doi.org/10.1016/j.gie.2022.05.002DOI Listing
May 2022

Peroral endoscopic myotomy (POEM) for achalasia developing after vertical banded gastroplasty with asymptomatic gastro-gastric fistula.

VideoGIE 2022 May 14;7(5):175-177. Epub 2022 Mar 14.

Department of Gastroenterology and Hepatology, Humanitas Research Hospital IRCCS, Rozzano, Italy.

Video 1At preoperative esophagram, a typical bird's beak image is shown at the gastroesophageal junction. A gastro-gastric fistula, opening from cardia to fundus, is also shown. A scope fitted with a distal clear cap is introduced. At the cardia, we see the proximal opening of the fistula. Here, we see the gastric fundus. As we go down, the gastric pouch is regular, and further down we reach the pylorus. In the retroflexed view, we recognize the neo-pylorus and the distal opening of the fistula. After submucosal injection on the anterior wall of the esophagus, a longitudinal mucosal incision is made. Submucosal tunnelling is performed using the endoscopic submucosal dissection technique. The gastroesophageal junction is reached, as confirmed by the finding of typical spindle veins. Here, we show submucosal tunnelling across the cardia, extending 2 cm into the gastric pouch. No obstacles from past surgery are encountered. Correct extension of the tunnel down into the cardia is also confirmed by visualizing a blue cushion. Dissection of a circular layer (of the muscularis) is performed and carried into the cardia. Submucosal tunnel is smoothy performed with no issues related to past surgery. Here, we demonstrate myotomy being carried into the gastric pouch across the cardia. We can see the more complex organization of muscular fibers. Again, no obstacles from past surgery are encountered. Myotomy is then completed along the entire length of the submucosal tunnel. Clip closure of the mucosal incision is eventually performed.
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http://dx.doi.org/10.1016/j.vgie.2022.02.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9108186PMC
May 2022

Correction: Bike handlebar grip in the rectum: minimally invasive endoscopic management.

Endoscopy 2022 Feb 17;54(2):C7. Epub 2022 May 17.

Gastrointestinal Endoscopy Unit, Humanitas Mater Domini, Castellanza, Italy.

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http://dx.doi.org/10.1055/a-1842-1975DOI Listing
February 2022

Artificial intelligence-assisted optical diagnosis for the resect-and-discard strategy in clinical practice: the Artificial intelligence BLI Characterization (ABC) study.

Endoscopy 2022 05 13. Epub 2022 May 13.

Gastroenterology Unit, Valduce Hospital, Como, Italy.

Background: Optical diagnosis of colonic polyps is poorly reproducible outside of high volume referral centers. The present study aimed to assess whether real-time artificial intelligence (AI)-assisted optical diagnosis is accurate enough to implement the leave-in-situ strategy for diminutive (≤ 5 mm) rectosigmoid polyps (DRSPs).

Methods: Consecutive colonoscopy outpatients with ≥ 1 DRSP were included. DRSPs were categorized as adenomas or nonadenomas by the endoscopists, who had differing expertise in optical diagnosis, with the assistance of a real-time AI system (CAD-EYE). The primary end point was ≥ 90 % negative predictive value (NPV) for adenomatous histology in high confidence AI-assisted optical diagnosis of DRSPs (Preservation and Incorporation of Valuable endoscopic Innovations [PIVI-1] threshold), with histopathology as the reference standard. The agreement between optical- and histology-based post-polypectomy surveillance intervals (≥ 90 %; PIVI-2 threshold) was also calculated according to European Society of Gastrointestinal Endoscopy (ESGE) and United States Multi-Society Task Force (USMSTF) guidelines.

Results: Overall 596 DRSPs were retrieved for histology in 389 patients; an AI-assisted high confidence optical diagnosis was made in 92.3 %. The NPV of AI-assisted optical diagnosis for DRSPs (PIVI-1) was 91.0 % (95 %CI 87.1 %-93.9 %). The PIVI-2 threshold was met with 97.4 % (95 %CI 95.7 %-98.9 %) and 92.6 % (95 %CI 90.0 %-95.2 %) of patients according to ESGE and USMSTF, respectively. AI-assisted optical diagnosis accuracy was significantly lower for nonexperts (82.3 %, 95 %CI 76.4 %-87.3 %) than for experts (91.9 %, 95 %CI 88.5 %-94.5 %); however, nonexperts quickly approached the performance levels of experts over time.

Conclusion: AI-assisted optical diagnosis matches the required PIVI thresholds. This does not however offset the need for endoscopists' high level confidence and expertise. The AI system seems to be useful, especially for nonexperts.
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http://dx.doi.org/10.1055/a-1852-0330DOI Listing
May 2022

Underwater colonic endoscopic ultrasonography-guided fine-needle biopsy of a hypogastric neoplastic lesion.

Endoscopy 2022 May 13. Epub 2022 May 13.

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

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http://dx.doi.org/10.1055/a-1816-7521DOI Listing
May 2022

Efficacy of a computer-aided detection system in a fecal immunochemical test-based organized colorectal cancer screening program: a randomized controlled trial (AIFIT study).

Endoscopy 2022 05 11. Epub 2022 May 11.

Gastroenterology Unit, Valduce Hospital, Como, Italy.

Background: Computer-aided detection (CADe) increases adenoma detection in primary screening colonoscopy. The potential benefit of CADe in a fecal immunochemical test (FIT)-based colorectal cancer (CRC) screening program is unknown. This study assessed whether use of CADe increases the adenoma detection rate (ADR) in a FIT-based CRC screening program.

Methods: In a multicenter, randomized trial, FIT-positive individuals aged 50-74 years undergoing colonoscopy, were randomized (1:1) to receive high definition white-light (HDWL) colonoscopy, with or without a real-time deep-learning CADe by endoscopists with baseline ADR > 25 %. The primary outcome was ADR. Secondary outcomes were mean number of adenomas per colonoscopy (APC) and advanced adenoma detection rate (advanced-ADR). Subgroup analysis according to baseline endoscopists' ADR (≤ 40 %, 41 %-45 %, ≥ 46 %) was also performed.

Results: 800 individuals (median age 61.0 years [interquartile range 55-67]; 409 men) were included: 405 underwent CADe-assisted colonoscopy and 395 underwent HDWL colonoscopy alone. ADR and APC were significantly higher in the CADe group than in the HDWL arm: ADR 53.6 % (95 %CI 48.6 %-58.5 %) vs. 45.3 % (95 %CI 40.3 %-50.45 %; RR 1.18; 95 %CI 1.03-1.36); APC 1.13 (SD 1.54) vs. 0.90 (SD 1.32;  = 0.03). No significant difference in advanced-ADR was found (18.5 % [95 %CI 14.8 %-22.6 %] vs. 15.9 % [95 %CI 12.5 %-19.9 %], respectively). An increase in ADR was observed in all endoscopist groups regardless of baseline ADR.

Conclusions: Incorporating CADe significantly increased ADR and APC in the framework of a FIT-based CRC screening program. The impact of CADe appeared to be consistent regardless of endoscopist baseline ADR.
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http://dx.doi.org/10.1055/a-1849-6878DOI Listing
May 2022
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