Transoral endoscopic therapies in gastro-esophageal reflux disease (GERD) are increasingly performed in patients who do not respond to medical therapy or are not suitable for or willing to undergo long-term PPI therapy or surgery. Currently available effective techniques include reconstruction of the gastro-esophageal valve by transoral incisionless fundoplication (TIF) and tightening of the gastro-esophageal junction through scarring, obtained by mucosal resection or ablation. TIF may be accomplished by an EsophyX 2.0/Z, MUSE, or GERD-X device. An iatrogenic stricture of the cardia may be obtained using a procedure called anti-reflux mucosectomy (ARMS), which includes several technical variants, or through mucosal ablation (ARMA). TIF using EsophyX 2.0 has strong evidence of efficacy in patients with small hiatal hernias, irrespective of hernia reducibility, who experience high-volume reflux episodes and troublesome regurgitation despite PPI therapy. MUSE can be performed only in the presence of a spontaneously reducing hiatal hernia and is probably more effective than EsophyX in maintaining the reduced hernia over time. However, MUSE is no longer available in Western countries. GERD-X shows promising results but needs further confirmation of its efficacy over the long term. ARMS and ARMA are not indicated in the presence of hiatal hernias but have shown promising results in the short term and are less expensive than TIF. Appropriate patient selection and the possibility of proposing a tailored approach to different types of patients and clinical/anatomical conditions result in favorable outcomes in most GERD patients, especially considering their quality of life and independence from PPIs. In the last several years, transoral endoscopic therapies have been proposed, along with concomitant laparoscopic repair for large hiatal hernias (cTIF), for GERD occurring after esophageal peroral endoscopic myotomy (E-POEM), in obese patients before or after bariatric surgery, and in patients with Barrett’s esophagus.
This review aims to summarize the role of endoscopic therapy in the management and outcomes of recurrent acute pancreatitis (RAP). RAP is a clinical entity characterized by repeated episodes of acute pancreatitis in the setting of a normal gland or chronic pancreatitis (CP). The aetiology of RAP can be identified in about 70% of cases; for the remaining cases, the term “idiopathic” (IRAP) is used. However, advanced diagnostic techniques may reduce the percentage of IRAP to 10%. Recognized causes of RAP are gallstone disease, including microlithiasis and biliary sludge, sphincter of Oddi dysfunction (SOD), pancreatic ductal abnormalities (either congenital or acquired) interfering with pancreatic juice or bile outflow, genetic mutations, and alcohol consumption. SOD, as a clinical entity, was recently revised in the Rome IV consensus, which only recognized type 1 dysfunction as a true pathological condition, while type 2 SOD was defined as a suspected functional biliary sphincter disorder requiring the documentation of elevated basal sphincter pressure to be considered a true clinical entity and type 3 was abandoned as a diagnosis and considered functional pain. Endoscopic therapy by retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS) has been proven effective when a mechanical obstruction is found and can be removed. If an obstruction is not documented, few treatment options are available to prevent the recurrence of pancreatitis and progression toward chronic disease. In gallstone disease, endoscopic biliary sphincterotomy (EBS) is effective when a dilated common bile duct or biliary sludge/microlithiasis is documented. In type 1 SOD, biliary or dual sphincterotomy is generally successful, while in type 2 SOD, endotherapy should be reserved for patients with documented sphincter dysfunction. However, in recent years, doubts have been expressed about the real efficacy of sphincterotomy in this setting. When sphincter dysfunction is not confirmed, endotherapy should be discouraged. In pancreas divisum (PD), minor papilla sphincterotomy is effective when there is a dilated dorsal duct, and the success rate is the highest in RAP patients. In the presence of obstructive conditions of the main pancreatic duct, pancreatic endotherapy is generally successful if RAP depends on intraductal hypertension. However, despite the efficacy of endotherapy, progression toward CP has been shown in some of these patients, mainly in the presence of PD, very likely depending on underlying genetic mutations. In patients with IRAP, the real utility of endotherapy still remains unclear; this is because several unknown factors may play a role in the disease, and data on outcomes are few, frequently contradictory or uncontrolled, and, in general, limited to a short period of time.
INTRODUCTION:Colonoscopy is a common procedure that requires adequate bowel preparation. Polyethylene glycol (PEG) is widely used but commonly associated with patient complaints, including the split-dose administration schedule. Mannitol could be an attractive alternative as it acts quickly, requires low volumes, and is palatable. A recent Phase III international, multicenter, randomized study (SATISFACTION) compared the efficacy and safety of bowel preparation using same-day oral mannitol or a split-dose regimen of 2L PEG-ASC. This study investigated the effects of the two laxatives on the Bowel Cleansing Impact Review (BOCLIR), a questionnaire exploring the degree of satisfaction of patients undergoing preparation for a colonoscopy. METHODS:The BOCLIR measures the acceptability and tolerability of bowel cleansers on three unidimensional scales (satisfaction, symptoms, and activity limitations). The total score is the sum of the three sub-scores and ranges from 0 to 110, with higher scores representing worse patient experiences. RESULTS:This analysis included 476 patients who completed the BOCLIR questionnaire: 236 in the mannitol group and 240 in the PEG-ASC group. The difference in the least square means of the total score was -8.01 (95% CI: -10.70 to -5.31), with a highly significant difference in favor of mannitol (p < 0.0001). CONCLUSION:This analysis of the SATISFACTION study shows that bowel preparation with mannitol was far preferable to PEG-ASC in terms of acceptability and tolerability. Based on these results, mannitol may be close to an ideal preparation from the patient's point of view.
BACKGROUND:Colorectal lesions (CRLs) <10 mm found at colonoscopy tend towards "diagnose-and-leave" or "resect-and-discard" strategies based on real-time Kudo glandular pit-pattern's assessment using i-Scan. However, i-Scan has not yet been validated for Kudo's classification. We aimed to assess whether, in routine colonoscopy, i-Scan without magnification and optical enhancement (M-OE) reliably differentiates hyperplastic polyps (HPs) from other serrated lesions (SLs) and conventional adenomas (CAs), and, among SLs, HPs from sessile serrated lesions (SSLs) and traditional or unknown serrated adenomas (TSAs, USAs), in Kudo type II CRLs<10 mm, according to ASGE Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) recommended negative predictive value (NPV) threshold for adenomas. METHODS:Prospectively recorded CRLs over 12 months, classified according to Kudo pit-pattern using i-Scan, were retrospectively compared with histology. RESULTS:Overall, 898 ≤5-mm and 704 6- to 9-mm CRLs were included. Type II pit-pattern was found in 76.6% and 38.7% of HPs and SSLs-TSAs/CAs (P<0.000001), and in 84.1% and 26.6% of SLs and CAs (P<0.000001). Among SLs, it was found in 81.9% and 86.6% of HPs and SSLs-TSAs. In CRLs≤5 mm, HPs were prevalent over other SLs (P=0.00001); in CRLs 6-9 mm, CAs were prevalent (P<0.000001). About 77% of SLs in right colon were SSLs-TSAs; 82% in left colon were HPs. PIVI ≥90% NPV threshold for adenomas was reached for CRLs 6-9mm (92.1%), nearly achieved for CRLs≤5 mm (88.2%), and not reached for SLs independently on the size. CONCLUSIONS:A strategy of "diagnose-and-leave" or "resect-and-discard" cannot be recommended for SLs<10 mm with Kudo type II pit-pattern using i-Scan, especially in right colon, if M-OE unavailable.
Objectives: We compared the efficacy and safety of transoral incisionless fundoplication (TIF) with the EsophyX2.0 and MUSE systems for treatment of gastroesophageal reflux disease (GERD). Methods: TIF outcomes from prospective protocols (Esophy2.0X: 2007-2012; MUSE: 2015-2019) were retrospectively compared regarding technical success, moderate/severe adverse events, morpho-functional findings up to 1 year, and clinical outcomes up to 3 years. Inclusion criteria were: (i) at least 6-month symptomatic GERD, full/partial response to proton pump inhibitors (PPI), esophagitis, and nonerosive reflux disease/hypersensitive esophagus (both protocols); (ii) hiatal hernia <3 cm (Esophy2.0X) and <= 2.5 cm (MUSE); and (iii) Barrett's esophagus <3 cm (MUSE). Results: In the 50 EsophyX2.0 and 46 MUSE procedures, technical success and adverse event rates were similar, but MUSE-related adverse events (4.4%) were life-threatening. At 12 months, hiatal hernia recurred more frequently after EsophyX2.0 (P = 0.008). At 6 months, significantly fewer total and acid refluxes were reported after both TIF, but not more significantly at 1 year. Symptoms improved after both TIF up to 1 year (P < 0.0001), but to a greater extent in MUSE patients up to 3 years (P < 0.0001 vs. P < 0.01 for EsophyX2.0). The rates of 3-year off-PPI therapy patients were 73.5% in the MUSE and 53.3% in the EsophyX2.0 series (P = 0.069). Conclusion: Although no conclusion could be drawn from this limited study, the MUSE technique seemed more effective in the long term in patients with hiatal hernia; however, there were more severe adverse events than with EsophyX2.0.
Background. The large number of lesions detected via high-definition (HD) imaging during colonoscopy calls for the reliable real-time histological characterization of polyps, especially diminutive and small ones, to permit tailored management based on the neoplastic risk, such as a “resect-and-discard” or a “diagnose-and-leave” strategy for low-risk adenomas and hyperplastic polyps (HPs). The Kudo classification of glandular pit pattern is currently used for predicting polyp histology. Aim. The aim in this study was to assess whether Kudo’s glandular pit pattern, assessed via HD digital chromoendoscopy (i-Scan) without magnification and optical enhancement, reliably predicts polyp histology and differentiates neoplastic lesions (NLs) from non-neoplastic lesions (non-NLs) during routine colonoscopy. Methods. Consecutive colorectal lesions recorded in a database over 12 months, with Kudo’s glandular pit pattern classification, were retrospectively compared with histology. The diagnostic accuracy and negative predictive value (NPV) for adenomatous histology of Kudo’s pit patterns were assessed separately for diminutive (≤5 mm) and small (6–9 mm) polyps, accordingly to the American Society for Gastrointestinal Endoscopy (ASGE) Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI), and in large (≥10 mm) lesions. Results. A total of 2230 lesions were recorded: 898 diminutive, 704 small, and 628 large. Kudo’s type II pit pattern was prevalent in diminutive polyps and recognized mostly in HPs (83.27%); it was also found in 38.8% of adenomas. In the right colon, Kudo’s type II pit pattern was prevalent in adenomas (70.04% vs. 20.74% in HPs); among the serrated lesions, it was evenly distributed between HPs and adenomas. Kudo’s type IIIL/IIIs/IV pit pattern was prevalent in NLs (61% vs. 8.37% of non-NLs) in diminutive polyps, evenly distributed between non-NLs and NLs in small polyps, and found only in NLs in large polyps. Kudo’s type Vi/Vn pit pattern correctly identified all but one adenocarcinoma. The NPV for adenomatous histology did not reach the recommended 90% PIVI threshold for differentiation between NLs and non-NLs in diminutive polyps showing Kudo’s type II pit pattern and in small polyps showing type IIIL/IIIs/IV pit pattern. Conclusions. Kudo’s pit pattern classification carried out with digital chromoendoscopy (i-Scan) during routine colonoscopy does not allow the reliable differentiation between non-NLs and NLs in diminutive and small polyps, so a “diagnose-and-leave” strategy for diminutive polyps may leave undetected adenomas, while a “resect-and-discard” strategy could miss lesions requiring closer follow-up.
Abstract This study tested the hypothesis that bowel preparation with mannitol should not affect the colonic concentration of H2 and CH4. Therefore, the SATISFACTION study, an international, multicenter, randomized, parallel‐group phase II–III study investigated this issue. The phase II dose‐finding part of the study evaluated H2, CH4, and O2 concentrations in 179 patients randomized to treatment with 50 g, 100 g, or 150 g mannitol. Phase III of the study compared the presence of intestinal gases in 680 patients randomized (1:1) to receive mannitol 100 g in single dose or a standard split‐dose 2 L polyethylene glycol (PEG)‐Asc preparation (2 L PEG‐Asc). Phase II results showed that mannitol did not influence the concentration of intestinal gases. During phase III, no patient in either group had H2 or CH4 concentrations above the critical thresholds. In patients with H2 and/or CH4 levels above detectable concentrations, the mean values were below the risk thresholds by at least one order of magnitude. The results also highlighted the effectiveness of standard washing and insufflation maneuvers in removing residual intestinal gases. In conclusion, bowel cleansing with mannitol was safe as the concentrations of H2 and CH4 were the same as those found in patients prepared with 2 L PEG‐Asc. In both groups, the concentrations of gases were influenced more by the degree of cleansing achieved and the insufflation and washing maneuvers performed than by the preparation used for bowel cleansing. The trial protocol was registered with ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04759885) and with EudraCT (eudract_number: 2019‐002856‐18).
PURPOSE:Clinical guidelines recommend radiofrequency ablation (RFA) for eradication of Barrett esophagus in patients with low-grade dysplasia (LGD) and high-grade dysplasia (HGD), but evidence on whether RFA provides good value for money is still sparse. This study evaluates the cost-effectiveness of RFA in Italy.METHODS:A Markov model was used to estimate lifelong costs and consequences of disease progression with different treatments. RFA was compared with esophagectomy in the HGD group or endoscopic surveillance in the LGD group. Clinical and quality-of-life parameters were derived from a review of the literature and expert opinions, whereas Italian national tariffs were used as a proxy for costs.FINDINGS:RFA dominated esophagectomy in patients with HGD with a probability of 83%. For patients with LGD, RFA was more effective and more costly than active surveillance (incremental cost-effectiveness ratio, €6276 per quality-adjusted life-year). At a cost-effectiveness threshold of €15,272, the probability of RFA being the optimal strategy in this population was close to 100%. Model results were sensitive to the cost of the interventions and utility weights used in the different disease states.IMPLICATIONS:RFA is likely to be the optimal choice for patients with LGD and HGD in Italy. Italy is discussing the implementation of a national program for the health technology assessment of medical devices, requiring more studies to prove value for money of emerging technologies.
Universita degli Studi di Milano, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Italy; Istituto Europeo di Oncologia, Italy; Centro di Riferimento Oncologico IRCCS, Italy; Fondazione Poliambulanza Istituto Ospedaliero, Italy; Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Italy; Universita Cattolica del Sacro Cuore, Italy; Ente Ospedaliero Valduce, Italy; Aziende Socio Sanitaria Territoriale Rhodense, Italy; NTC, Italy; Hopital Edouard Herriot, France; Istituto Auxologico Italiano Istituto di Ricovero e Cura a Carattere Scientifico, Italy; Ospedale Santa Chiara di Trento, Italy; Yaroslav Regional Cancer Center, Russian Federation; IRCCS Sacro Cuore Don Calabria, Italy; Ospedale Papa Giovanni XXIII, Italy; Universita degli Studi di Brescia, Italy; Irkutskij gosudarstvennyj universitet, Russian Federation; Centre Hospitalier Regional Universitaire de Montpellier, France; State Scientific Center of Coloproctology named after A.N.
Objectives Comparative trials among biological drugs for the treatment of ulcerative colitis (UC) provided conflicting results. After patent expire of infliximab originator, adalimumab, infliximab biosimilar, golimumab and vedolizumab have been approved in Italy. We compared the efficacy of these four biologics in UC according to the concept of continuous clinical remission (CCR). Methods In a retrospective, multicentre study, all UC patients treated with adalimumab, infliximab biosimilar, golimumab or vedolizumab between 2014 and 2019 were included. All drugs were compared to each other according to the 1-year CCR rate, defined as Mayo partial score ≤2, with bleeding subscore = 0, without any relapse or optimization with dose escalation, topical treatments or steroid use after first clinical remission. Results Four-hundred sixteen patients (adalimumab = 90, infliximab biosimilar = 105, golimumab = 79, vedolizumab = 142) were included. CCR was achieved in similar percentages among the groups (33%, 37%, 28%, 37%, respectively). All drugs were equivalent in biologic-naive patients, while vedolizumab was better than a second anti-TNFα in prior anti-TNFα agent failures. No differences were found according to type of adverse events or severe adverse events. Conclusions Based on a strict definition of clinical remission, all biologics appear equally effective at 1 year. Changing to vedolizumab is more effective than switching to another anti-TNFα in TNFα failures.
BACKGROUND:A relevant number of adenomas can be missed during colonoscopy. AIMS:Assess the current status of colonoscopy procedures in Italian centers. METHODS:A prospective observational study involving 17 hospitals (34 endoscopists) included consecutive patients undergoing standard colonoscopy. In the first phase, endoscopists performed consecutive colonoscopies. In the second phase, retraining via an online learning platform was planned, while in the third phase data were collected analogously to phase 1. RESULTS:A total of 3,504 patients were enrolled. Overall, a BBPS score ≥6 was obtained in 95.6% of cases (94.8% and 96.9% in the pre- and post-training phases, respectively). 88.4% of colonoscopies had a withdrawal time ≥6 min (88.2% and 88.7% in the pre- and post-training phases). Median adenoma detection rate (ADR) was 39.1%, with no significant differences between the pre- and post-training phases (40.1% vs 36.9%; P = 0.83). In total, 81% of endoscopists had a ADR performance above the 25% threshold. CONCLUSION:High colonoscopy quality standards are achieved by the Italian hospitals involved. Quality improvement initiatives and repeated module-based colonoscopy-training have been promoted in Italy during the last decade, which appear to have had a significant impact on quality colonoscopy metrics together with the activation of colorectal cancer screening programs.
We thank Dr. Chandnani and colleagues for their comments on the 1-year follow-up of patients with gastroesophageal reflux disease (GERD) who underwent transoral incisionless fundoplication (TIF) with the Medigus ultrasonic surgical endostapler (MUSE). They focused on four issues, the first being that TIF is still considered a challenging therapy. A meta-analysis [1] has shown significant improvements in symptoms and reflux scores, a 91% hiatal hernia reduction, and a discontinuation of proton pump inhibitor (PPI) therapy in 89% of patients, so TIF is reliable. The second was that there are no longterm studies comparing TIF with surgery. Eight studies on Esophyx and MUSE, reporting outcomes at 3, 4–6, and 10 years [3–9], showed no differences between Esophyx and MUSE. Overall, two-thirds of patients were satisfied; one-third remained off PPI therapy and, in most of those who resumed PPIs, the doses were halved; four-fifths had significant improvements in heartburn, regurgitation, and GERD-HLQR scores. Overall, these long-term outcomes are similar to those of surgical fundoplication. Thirdly, most patients who underwent TIF had Hill grade II of the gastroesophageal valve, and grade A or no esophagitis. TIF by MUSE is currently only considered for patients with proven GERD, PPI responsiveness, hiatal hernias that are < 2.5 cm and reducible, who are seeking an alternative to long-term medical or surgical treatment, rather than an alternative to surgery. Most of these patients, their number is steadily increasing, suffer from non-erosive reflux disease and are Hill grade II. Fourthly, functional studies, performed in only 13 /20 patients, reported non-significant changes after TIF. Seven patients improved and refused to repeat functional investigations, which is not a selection bias but a consequence of a good outcome. Functional findings did not show significant changes, even if a longer lower esophageal sphincter highpressure segment was found, probably because of the small numbers. However, most studies on TIF for GERD have reported discordance between the relief of symptoms and findings of pH-impedance recordings.
Background Transoral incisionless fundoplication (TIF) with Medigus Ultrasonic Surgical Endostapler (MUSE) is a new intervention for treatment of gastro-esophageal reflux disease (GERD). We aimed at assessing the clinical, functional, and endoscopic effects of TIF by MUSE. Methods Forty-six patients underwent TIF. Proton pump inhibitor (PPI) consumption, GERD-health-related quality of life (HRQL) and reflux symptom index (RSI) questionnaires, upper gastrointestinal (GI) endoscopy, esophageal 24-h pH-impedance recording, and high-resolution manometry (HRM) were done before TIF and scheduled 6 and 12 months later (HRM only at 6-month). PPI consumption and symptoms were then assessed yearly. Data up to 3 years are reported in this study (PP- and ITT-analysis). Results TIF was successfully performed in 45/46 patients; in one patient esophageal intubation was impossible. Perforation occurred in two cases. One patient required surgery within 6 months. Clinical follow-up was available for 42 patients at 6 months and 1 year, 35 patients at 2 years, and 31 patients at 3 years. At 1, 2, and 3 years, PPI consumption was stopped, respectively, in 64.3%, 62.9%, and 74.2% of cases (ITT-analysis: 58.7%, 56.4%, and 65.7%). GERD-HRQL and RSI scores decreased at least 50%, respectively, in 71.5% and 76.2%, 71.4% and 68.6%, and 67.7% of cases (ITT-analysis: 65.2% and 69.6%, 64.1% and 61.5%, and 60%). A significant improvement of both scores was observed up to 3 years. 6-month and 1-year functional follow-up were possible in 31 and 20 patients. HRM showed significant increase of the median lower esophageal sphincter length and rate of peristaltic waves. Esophageal pH-impedance recording found significantly fewer acid, proximal and total refluxes, and percentage of esophageal pH < 4 total time at 6 months, but not at 1 year. Conclusion TIF by MUSE significantly improved symptoms and PPIs consumption up to 3 years. However, esophagitis still persisted in one-third of cases at 1 year and functional improvement at 6 months was not confirmed at 1 year. Severe complications requiring surgery occurred in two cases. ClinicalTrials.Gov ID: NCT03669874.
GOALS:The present survey from the Italian Society of Digestive Endoscopy (SIED-Società Italiana di Endoscopia Digestiva) was aimed at reporting infection control practice and outcomes at Digestive Endoscopy Units in a high-incidence area.BACKGROUND:Lombardy was the Italian region with the highest coronavirus disease-2019 (COVID-19) prevalence, at the end of March 2020 accounting for 20% of all worldwide deaths. Joint Gastro-Intestinal societies released recommendations for Endoscopy Units to reduce the risk of the contagion. However, there are few data from high-prevalence areas on adherence to these recommendations and on their efficacy.METHODS:A survey was designed by the Lombardy section of SIED to analyze (a) changes in activity and organization, (b) adherence to recommendations, (c) rate of health care professionals' (HCP) infection during the COVID-19 outbreak.RESULTS:In total, 35/61 invited centers (57.4%) participated; most modified activities were according to recommendations and had filtering face piece 2/filtering face piece 3 and water-repellent gowns available, but few had negative-pressure rooms or provided telephonic follow-up; 15% of HCPs called in sick and 6% had confirmed COVID-19. There was a trend (P=0.07) toward different confirmed COVID-19 rates among endoscopists (7.9%), nurses (6.6%), intermediate-care technicians (3.4%), and administrative personnel (2.2%). There was no correlation between the rate of sick HCPs and COVID-19 incidence in the provinces and personal protective equipment availability and use, whereas an inverse correlation with hospital volume was found.CONCLUSIONS:Adherence to recommendations was rather good, though a minority were able to follow all recommendations. Confirmed COVID-19 seemed higher among endoscopists and nurses, suggesting that activities in the endoscopy rooms are at considerable viral spread risk.
An 84-year-old man attended the emergency department because of jaundice, fever, and abdominal pain. Blood tests showed an increase in conjugated bilirubin and cholestasis markers. He underwent abdominal ultrasound, which revealed common bile duct dilation (12 mm in size) and the presence of several bile stones. Diagnosis of acute cholangitis was made [1] and he underwent urgent therapeutic endoscopic retrograde cholangiopancreatography (ERCP), according to guidelines [2].
We read with interest the article by Soetikno et al1Soetikno R. Teoh A.Y. Kaltenbach T. et al.Considerations in performing endoscopy during the COVID-19 pandemic.Gastrointest Endosc. 2020; 92: 176-183Abstract Full Text Full Text PDF PubMed Scopus (161) Google Scholar on how to reduce the risk of COVID-19 spread among patients and healthcare workers (HCWs) during GI endoscopy. In a single-center prospective study, conducted with EC approval (Study Code GIE/COVID-19), we investigated (1) the rate of patients who experienced confirmed or probable COVID-19, according to the World Health Organization definition, after undergoing GI endoscopy and factors associated with this risk and (2) whether HCWs who took care of patients in whom COVID-19 eventually developed were at higher risk for infection. Patients were interrogated by means of a semistructured telephone questionnaire 2 weeks after the procedures; all HCWs at the endoscopy unit received serologic screening by means of a SARS-CoV-2 IgG immunoassay after a further 40 days (DiaSorin, Saluggia, Italy), and HCWs with positive results received a swab. The results are shown in Table 1. The patients' response rate was 82.9% (537/648), and 56 patients (10.4%) experienced either probable or confirmed COVID-19. Living in high-risk areas within Lombardy (odds ratio [OR] = 4.4), contact with suspected cases (OR = 10), and having undergone combined EUS + ERCP (OR = 4.8) were independent risk factors for the development of probable or confirmed COVID-19 after logistic regression analysis. Age, comorbidities, immunosuppression, being an inpatient, and week in which the procedures were performed were not associated with COVID-19.Table 1Demographics, clinical factors, and endoscopy-related factors and their association with the risk for patients of development of probable or confirmed COVID-19 after endoscopic proceduresFactorCOVID-19 (n =56)Controls (n = 481)Univariate analysis OR (95% CI); P valueMultivariate analysis OR (95% CI); P valuePatient-related variables Median age (IQR)57 (43.5-70)64 (53-74)0.97 (0.96-0.99) P = .0060.98 (0.95-1.02) P = .52 Male gender (%)25 (44.6)245 (50.9)0.77 (0.44-1.35) P = .37- Living in Lombardy (%)49 (87.5)397 (82.5)1.48 (0.64-3.38) P = .35- Living in Lombardy high-risk area∗Bergamo, Brescia, Cremona, Lodi provinces. (%)9 (16.1)31 (6.4)2.77 (1.24-6.19) P = .0124.44 (1.20-16.35) P = .024 High-risk contact after procedure (%)9 (16.1)13 (2.7)6.89 (2.79-16.97) P < .000110.09 (1.82-55.77) P = .008 Diabetes mellitus (%)10 (17.9)62 (12.9)1.46 (0.70-3.06) P = .30- Hypertension (%)18 (32.1%)172 (35.8)0.85 (0.47-1.53) P = .59- Ischemic heart disease (%)7 (12.5)61 (12.7)0.98 (0.43-2.27) P = .96- Taking immunosoppressive drugs (%)9 (16.1)43 (9.8)1.94 (0.89-4.24) P = .09- Active cancer (%)15 (26.8)137 (28.5)0.91 (0.49-1.71) P = .78-Endoscopy-related variables Deep sedation (%)26 (46.4)233 (48.4)0.92 (0.52-1.60) P = .77- EGDS (%)16 (28.6)181 (37.6)0.66 (0.35-1.21) P = .17- RSCS (%)16 (28.6)156 (32.4)0.83 (0.45-1.53) P = .54- EGDS + RSCS (%)6 (10.7)25 (5.2)2.1 (0.85-5.57) P = .12- EUS (%)11 (19.6)100 (20.8)0.92 (0.46-1.86) P = .83- EUS + ERCP (%)5 (8.9)11 (2.3)4.18 (1.39-12.5) P = .0204.86 (1.34-17.59) P =.015 ERCP (%)2 (3.6)15 (3.1)1.15 (0.25-5.16) P = .85- Week 1 (%)22 (39.3)163 (33.9)1.25 (0.71-2.22) P = .43- Week 2 (%)9 (16.1)102 (21.2)0.71 (0.34-1.51) P = .37- Week 3 (%)17 (30.4)119 (24.7)1.32 (0.72-2.42) P = .37- Week 4 (%)6 (10.7)75 (15.6)0.64 (0.26-1.56) P = .31- Week 5 (%)2 (3.6)19 (3.9)0.89 (0.20-3.96) P = .88- Hospital inpatients (%)20 (35.7)151 (31.4)1.21 (0.68-2.16) P = .51- Oncology ward (%)4/20 (20)9/151 (6)3.94 (1.08-14.27) P = .0523.70 (0.86-15.91) P = .078 Surgery ward (%)2/20 (10)30/151 (19.9)0.44 (0.09-2.03) P = .25- Emergency ward (%)8/20 (40)55/151 (36.4)1.16 (0.44-3.02) P = .75- Internal medicine ward (%)3/20 (15)6/151 (4)4.26 (0.97-18.6) P = .076- Other ward (%)6/20 (30)58/151 (38.4)0.68 (0.25-1.88) P = .45-CI, confidence interval; EGDS, esophagogastroduodenoscopy; IQR, interquartile range; OR, odds ratio; RSCS, rectosigmoidocolonoscopy.∗ Bergamo, Brescia, Cremona, Lodi provinces. Open table in a new tab CI, confidence interval; EGDS, esophagogastroduodenoscopy; IQR, interquartile range; OR, odds ratio; RSCS, rectosigmoidocolonoscopy. Six out of 59 (10.1%) HCWs had positive results for SARS-CoV-2 IgG, all of them with negative swab results, and no symptoms except one. Having performed procedures on patients with COVID-19 (P = .12) and number of contacts with patients in whom COVID-19 developed were not associated with seropositivity (χ2 for trend, P = .69). These findings are in keeping with recent data reporting that COVID-19 development after GI endoscopy is uncommon,2Repici A, Aragona G, Cengia G, et al. Low risk of covid-19 transmission in GI endoscopy. Gut. Epub 2020 Apr 22.Google Scholar and they suggest that it seems mainly due to environmental factors. Whether combined EUS + ERCP convey an increased risk deserves further investigation. There seemed to be no evidence of increased contagion risk among HCWs during the procedure. All authors disclosed no financial relationships. Considerations in performing endoscopy during the COVID-19 pandemicGastrointestinal EndoscopyVol. 92Issue 1PreviewBased on experiences and the literature, our objective is to provide practical suggestions for performing endoscopy in the setting of the novel coronavirus-19 (COVID-19) pandemic. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), referred to as COVID-19, has become a global pandemic. Human-to-human transmission occurs through respiratory secretions, aerosols, feces, and contaminated environmental surfaces.1,2 Transmission can occur in both symptomatic and asymptomatic individuals.3 Viable virus particles can be detected in aerosols up to 3 hours after aerosolization and up to 3 days on surfaces. Full-Text PDF
Background and study aims Few reports exist about long-term outcomes of transoral incisionless fundoplication (TIF) for treating refractory gastro-esophageal reflux disease (GERD). Methods A literature search of four major scientific databases was performed up to May 2020 for studies reporting on more than 3-year outcomes of TIF. Data on atient satisfaction, proton pump inhibitor (PPI) daily consumption, PPI use reduction, GERD health-related quality-of-life (GERD-HRQL) score, and normalization of heartburn and regurgitation scores were pooled and summarized with forest plots. Publication bias and heterogeneity were explored. Results Overall, eight studies (418 patients, 232 men; 55.5 %) with a mean follow-up of 5.3 years (range: 3–10 years) were included. The pooled proportion of patient-reported satisfaction before and after TIF was 12.3 % (95 % CI:12.3–35.1 %, I2 = 87.4 %) and 70.6 % (95 % CI:51.2–84.6, I2 = 80 %), respectively, corresponding to an odds ratio of 21.4 (95 % CI:3.27–140.5). Pooled rates of patients completely off PPIs and on occasional PPIs were 53.8 % (95 %CI: 42.0 %-65.1 %) and 75.8 % (95 %CI: 67.6–82.6), respectively. The pooled estimated mean GERD-HRQL scores off PPI before and after TIF werey 26.1 (95 %CI: 21.5–30.7; range: 20.0–35.5) and 5.9, respectively (95 %CI:0.35.1–11.4; range: 5.3–9.8; P < 0.001). The overall pooled rates of heartburn and regurgitation scores normalization were 73.0 % (95 %CI: 0.62–0.82) and 86 %, respectively (95 %CI: 75.0–91.0 %). Conclusion Our study shows that TIF appears to offer a long-term safe therapeutic option for selected patients with GERD who refuse life-long medical therapy or surgery, are intolerant to PPIs, or are at increased surgical risk.