Small bowel lesions in patients with iron deficiency anaemia without overt bleeding: a multicentre study.

The diagnostic work-up in iron deficiency anaemia (IDA) patients can be challenging when bleedings or malabsorption are not clinically manifest. Lesions on the small bowel mucosa may cause IDA. We evaluated the prevalence of lesions on the small bowel mucosa detected at Videocapsule Endoscopy (VCE) in IDA patients following negative upper and lower endoscopies. Clinical and endoscopic data collected in 5 centres were retrieved. Lesions with a high bleeding potential (P2) were computed, and predictive factors investigated at multivariate analysis. By considering data of 230 patients, the endoscopic examination detected a total of 96 (41.7%; 95% CI: 35.4-48.1) P2 lesions on the small bowel mucosa, including 4 (1.7%) cancers. The use of non-steroidal anti-inflammatory drugs was found to be the only associated factor at both univariate (OR: 5.7, 95% CI: 2.4-13.4; P <0.001) and multivariate (OR: 2.8; 95% CI: 1.7-3.9, P <0.01) analyses. Present study showed that evaluation of small bowel mucosa with VCE allows to disclose a potential cause of IDA in near half patients. The cooperation between haematologists and gastroenterologists in the diagnostic work-up may be useful.

Gender Differences in Quality of Bowel Preparation for Colonoscopy: Post Hoc Analysis of a Randomized Controlled Trial.

OBJECTIVE: Bowel cleansing is a key element for a quality colonoscopy. Despite recent advances, not all predictors of successful cleansing are fully known. This post hoc analysis of an RCT aims to explore gender differences in bowel cleansing quality. METHODS: The "OVER" trial was a multicenter phase-4 RCT including 478 patients randomized 1:1 to receive split-dose 1L polyethylene glycol plus ascorbate (PEG+ASC) or 4L-PEG. In this post hoc analysis, multivariable logistic regression models were designed to assess predictors of cleansing success (CS) and adenoma detection rate (ADR) by gender. RESULTS: Of the 478 randomized patients, 50.2% were males and 49.8% females.Overall, CS was comparable between females and males (87.1% vs 88.4, P = 0.6), whereas CS in the right (95.7% vs 90.9, P = 0.049) and transverse colon (98.6% vs 93.9, P=0.011) was significantly higher in females.At multivariable regression analysis for CS outpatient setting (OR = 5.558) and higher withdrawal time (OR = 1.294) were independently associated with CS in females, whereas screening/surveillance indication (OR = 6.776) was independently associated with CS in males.At multivariable regression analysis for ADR, running time <5 hours (OR = 3.014) and higher withdrawal time (OR = 1.250) were independently associated with ADR in females, whereas older age (OR = 1.040) and higher withdrawal time (OR = 1.093) were independently associated with ADR in males. CONCLUSIONS: This study showed different results in bowel preparation quality and different predictors of CS and ADR by gender. These findings suggest the need for further research to explore gender-specific approaches for bowel preparation.

Diagnostic Yield of Small Bowel Videocapsule Endoscopy in Patients with Iron Deficiency Anemia. A Systematic Review and meta-analysis.

BACKGROUND AND AIM: Gastrointestinal (GI) bleeding or malabsorption represents the most frequent aetiologies of iron deficiency anemia (IDA). The cause of IDA remains undetermined in ~10% to 20% of patients undergoing upper and lower GI endoscopies. In this scenario, a small bowel examination with videocapsule endoscopy (VCE) is recommended. We performed a systematic review with meta-analysis to evaluate the diagnostic yield of VCE in patients with IDA without overt bleeding, assessing the prevalence of either any lesion or lesions at high potential of bleeding. MATERIALS AND METHODS: A computerized literature search was performed using relevant keywords to identify all the pertinent articles published until March 2023. RESULTS: Twelve studies with a total of 1703 IDA patients (Males: 47%; age range: 19-92 y) were included in this systematic review. The diagnostic yield of VCE for overall lesions in the small bowel was 61% (95% CI=44-77; 95 CI=97.2-98.1; I2=97.7%). When analyzing only small bowel lesions likely responsible of IDA, the diagnostic yield was 40% (95% CI=27-53; 95% CI=95.3-97; I2=96.3%). CONCLUSION: VCE plays a relevant role in the diagnostic work-up of patients with IDA without overt bleeding with a satisfactory diagnostic yield.

Prevalence and Natural History of Segmental Colitis Associated With Diverticulosis.

INTRODUCTION: We assessed the prevalence and clinical outcomes of segmental colitis associated with diverticulosis (SCAD) in patients with newly diagnosed diverticulosis. METHODS: A 3-year international, multicenter, prospective cohort study was conducted involving 2,215 patients. RESULTS: SCAD diagnosis was posed in 44 patients (30 male patients; median age: 64.5 years; prevalence of 1.99%, 95% confidence interval, 1.45%-2.66%). Patients with SCAD types D and B showed worse symptoms, higher fecal calprotectin values, needed more steroids, and reached less likely complete remission. DISCUSSION: Although SCAD generally had a benign outcome, types B and D were associated with more severe symptoms and worse clinical course.

Improved Survival for Patients With Acute Upper Gastrointestinal Bleeding While on Antithrombotic Therapy: A Multicenter Prospective Cohort Study.

GOALS: Aim of the study was to determine if patients with acute upper gastrointestinal bleeding (AUGIB) while on antithrombotic agents (ATs) are at higher risk for worse outcomes. BACKGROUND: ATs are risk factors of AUGIB, but their impact on clinical outcomes is uncertain. STUDY: Patients with AUGIB (nonvariceal, NV-AUGIB or variceal, V-AUGIB) in 50 Italian hospitals were prospectively enrolled from January 1, 2014 to December 31, 2015. Clinical data, laboratory tests, comorbidities, prognostic scores, received therapies, and outcomes (death, rebleeding, surgery/radiology, transfusions, length of hospitalization) were analyzed. RESULTS: A total of 3324 patients (2764 NV-AUGIB, 83.2% and 560 V-AUGIB, 16.8%) were enrolled, 1399 (42.1%) on ATs. Patients taking ATs were older (75.4 vs. 62.8 y, P <0.001), had higher American Society of Anesthesiologists (ASA), Rockall and Glasgow-Blatchford scores ( P <0.001). At multivariate analysis considering comorbidities, ATs use resulted an independent protective factor against death [odds ratio (OR): 0.63, 95% confidence interval (CI): 0.45-0.87, P =0.006]. Rebleeding (5.5% vs. 5.8%, P =0.71) and need for salvage surgery/radiology (4.2% vs. 4.8%, P =0.41) were similar in the 2 groups. Considering specific ATs, low-dose aspirin was the most powerful factor lowering the death risk (OR: 0.51, 95% CI: 0.33-0.81, P =0.004). While the generic use of AT therapy did not emerge as a statistically significant independent protective factor considering separately NV-AUGIB (OR: 0.80, 95% CI: 0.56-1.13, P =0.21) and V-AUGIB (OR: 0.40, 95% CI: 0.15-1.07, P =0.068), the protective effect of low-dose aspirin was confirmed for NV-AUGIB (OR: 0.62, 95% CI: 0.41-0.94, P =0.025). CONCLUSIONS: ATs use is an independent protective factor against death in AUGIB. The protective effect is mainly derived from low-dose aspirin.

Prognostic performance of the 'DICA' endoscopic classification and the 'CODA' score in predicting clinical outcomes of diverticular disease: an international, multicentre, prospective cohort study.

OBJECTIVE: To investigate the predictive value of the Diverticular Inflammation and Complication Assessment (DICA) classification and to develop and validate a combined endoscopic-clinical score predicting clinical outcomes of diverticulosis, named Combined Overview on Diverticular Assessment (CODA). DESIGN: A multicentre, prospective, international cohort study. SETTING: 43 gastroenterology and endoscopy centres located in Europe and South America. PARTICIPANTS: 2215 patients (2198 completing the study) at the first diagnosis of diverticulosis/diverticular disease were enrolled. Patients were scored according to DICA classifications. INTERVENTIONS: A 3-year follow-up was performed. MAIN OUTCOME MEASURES: To predict the acute diverticulitis and the surgery according to DICA classification. Survival methods for censored observation were used to develop and validate a novel combined endoscopic-clinical score for predicting diverticulitis and surgery (CODA score). RESULTS: The 3-year cumulative probability of diverticulitis and surgery was of 3.3% (95% CI 2.5% to 4.5%) in DICA 1, 11.6% (95% CI 9.2% to 14.5%) in DICA 2 and 22.0% (95% CI 17.2% to 28.0%) in DICA 3 (p<0.001), and 0.15% (95% CI 0.04% to 0.59%) in DICA 1, 3.0% (95% CI 1.9% to 4.7%) in DICA 2 and 11.0% (95% CI 7.5% to 16.0%) in DICA 3 (p<0.001), respectively. The 3-year cumulative probability of diverticulitis and surgery was ≤4%, and ≤0.7% in CODA A; <10% and <2.5% in CODA B; >10% and >2.5% in CODA C, respectively. The CODA score showed optimal discrimination capacity in predicting the risk of surgery in the development (c-statistic: 0.829; 95% CI 0.811 to 0.846) and validation cohort (c-statistic: 0.943; 95% CI 0.905 to 0.981). CONCLUSIONS: DICA classification has a significant role in predicting the risk of diverticulitis and surgery in patients with diverticulosis, which is significantly enhanced by the CODA score. TRIAL REGISTRATION NUMBER: NCT02758860.

Artificial Intelligence Allows Leaving-In-Situ Colorectal Polyps.

BACKGROUND & AIMS: Artificial Intelligence (AI) could support cost-saving strategies for colonoscopy because of its accuracy in the optical diagnosis of colorectal polyps. However, AI must meet predefined criteria to be implemented in clinical settings. METHODS: An approved computer-aided diagnosis (CADx) module for differentiating between adenoma and nonadenoma in unmagnified white-light colonoscopy was used in a consecutive series of colonoscopies. For each polyp, CADx output and subsequent endoscopist diagnosis with advanced imaging were matched against the histology gold standard. The primary outcome was the negative predictive value (NPV) of CADx for adenomatous histology for ≤5-mm rectosigmoid lesions. We also calculated the NPV for AI-assisted endoscopist predictions, and agreement between CADx and histology-based postpolypectomy surveillance intervals according to European and American guidelines. RESULTS: Overall, 544 polyps were removed in 162 patients, of which 295 (54.2%) were ≤5-mm rectosigmoid histologically verified lesions. CADx diagnosis was feasible in 291 of 295 (98.6%), and the NPV for ≤5-mm rectosigmoid lesions was 97.6% (95% CI, 94.1%-99.1%). There were 242 of 295 (82%) lesions that were amenable for a leave-in-situ strategy. Based on CADx output, 212 of 544 (39%) would be amenable to a resect-and-discard strategy, resulting in a 95.6% (95% CI, 90.8%-98.0%) and 95.9% (95% CI, 89.8%-98.4%) agreement between CADx- and histology-based surveillance intervals according to European and American guidelines, respectively. A similar NPV (97.6%; 95% CI, 94.8%-99.1%) for ≤5-mm rectosigmoids was achieved by AI-assisted endoscopists assessing polyps with electronic chromoendoscopy, with a CADx-concordant diagnosis in 97.2% of cases. CONCLUSIONS: In this study, CADx without advanced imaging exceeded the benchmarks required for optical diagnosis of colorectal polyps. CADx could help implement cost-saving strategies in colonoscopy by reducing the burden of polypectomy and/or pathology. CLINICALTRIALS: gov registration number: NCT04884581.

Derivation and validation of Re.Co.De death score risk in patients with acute nonvariceal upper GI bleeding.

BACKGROUND AND AIMS: Scores in upper GI bleeding (UGIB) are used to stratify death risk and need for hospitalization at admission, but a tool that incorporates dynamic changes during the hospital stay is lacking. We aimed to develop a death risk score that considers changes in clinical status during hospitalization and compare its performance with existing ones. METHODS: A multicenter cohort study enrolling patients with UGIB in 50 Italian hospitals from January 2014 to December 2015 was conducted. Data were collected and used to develop a risk score using logistic regression analyses. Performance curves (area under the receiver-operating characteristic [AUROC] curves), sensitivities, specificities, positive and negative predictive values, and outcomes classified as low, intermediate, and high death risk were calculated. The score's performance was externally validated and then compared with other scores. RESULTS: We included 1852 patients with nonvariceal UGIB in the development cohort and 912 in the validation cohorts. The new score, which we named the Re.Co.De (rebleeding-comorbidities-deteriorating) score, included 10 variables depicting the changes in clinical conditions while in the hospital. The mortality AUROC curves were .93 (95% confidence interval, .91-.96) in the derivation cohort and .94 (95% confidence interval, .91-.98) in validation cohort. In a comparison of AUROC curves with other scores, the new score showed a significant performance compared with pre- and postendoscopy scores. Patients with low and high scores had 30-day mortality rates of .001% and 48.2%, respectively. CONCLUSIONS: The Re.Co.De score has a higher performance for predicting mortality in patients with UGIB compared with other scores, correctly identifying patients at low and high death risk while in the hospital through a dynamic re-evaluation of clinical status.

Efficacy of Helicobater pylori eradication in patients with diffuse large B-cell lymphoma of the stomach: A systematic review.

OBJECTIVES: The role of Helicobater pylori eradication in the treatment of high-grade diffuse large B-cell lymphoma (DLBCL) of the stomach is unclear. METHODS: We performed a systematic review and meta-analysis of currently available data. DLBCL-remission rate after eradication therapy, post-remission maintenance, and response rate in the case of additional oncological therapy were extracted. RESULTS: By considering data of seven studies, the DLBCL remission was achieved in 81 (53.3%; 95% CI = 45.3-61.2) out of 152 H. pylori eradicated patients. The regression rate did not differ between pure DLCBL and DLCBL with MALT component, between stage I and stage II disease, and between Caucasians and Asians. Disease regression was maintained in all patients after at a median of 63 months (range: 46-29) follow-up. In those non-responders, DLBLC remission after additional chemo-immunotherapy was achieved in 63 (98.4%; 95% CI = 95.4-100) out of 64 patients. CONCLUSIONS: Data this systematic review suggest considering H. pylori eradication as first-line therapy to treat infected patients with early-stage, high-grade gastric lymphoma.

Comparison of assessment tools in acute upper gastrointestinal bleeding: which one for which decision.

BACKGROUND: Upper GI bleeding (UGIB) remains a common emergency with significant mortality. Scores help triage patients, but it is still unclear which score should be used in the different decision-making moments to identify patients at high or low death risk. We aimed to compare the overall performances of the most validated scores and their cut-off performance to identify patients at low and high death risk. The secondary outcome was to compare the scores' performance for predicting therapeutic endoscopy, the need for transfusion(s), rebleeding, and surgery/interventional radiology. METHODS: We conducted a prospective multicenter cohort study, including consecutive UGIB patients admitted to 50 Italian hospitals. We collected information to calculate the Rockall, the Progetto Nazionale Endoscopia Digestiva (PNED), the AIMS65, the Glasgow-Blatchford (GBS), and the Age, Blood tests, Comorbidities (ABC) scores, together with demographic figures, clinical data, and outcomes. RESULTS: We obtained complete data of 2307 outpatients, including 1887 non-variceal and 420 variceal bleeders. Our cohort's mean age was 67.5 years, with a prevalence of male gender (69%). The GBS has the best overall performance (ROC 0.74) compared to the other scores in identifying low-risk patients (p < .001). At the cut-off 0-1, both GBS and ABC scores provide the highest PPV (100%) for low-risk patients. ABC and PNED scores are the most useful ones (for AUC >80) to assess the high-risk patients for mortality. CONCLUSIONS: At admission, GBS and ABC scores identify low-risk patients suitable for outpatient management, while PNED and ABC scores identify high-risk patients. During hospitalization, the PNED score should be used to re-assess the mortality risk if a modification of clinical status occurs.

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

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.).

Rescue Therapies for Helicobacter pylori Infection in Foreign Patients Treated in Italy.

MATERIALS AND METHODS: Consecutive foreigner patients with H. pylori infection following at least one therapy failure were enrolled. All patients underwent upper endoscopy with gastric biopsies used for both histologic examination and culture/susceptibility test. Rescue therapies administered accordingly to susceptibility testing were rifabutin-based therapy, levofloxacin-based therapy, sequential. Pylera was prescribed regardless the resistance pattern. RESULTS: A total of 103 (M/F: 27/76, mean age: 41.9 y, range: 18 to 85) were enrolled. The overall resistance rates toward clarithromycin, metronidazole, and levofloxacin were 76.7%, 66%, and 42.7%, respectively, with triple resistance present in 33.9% of bacterial isolates. Eradication rates were 71.4% on 40 patients for rifabutin-based therapy, 82.8% on 42 cases for levofloxacin-based therapy, 75% on 11 patients treated with sequential therapy, and 100% on 10 cases who received Pylera regimen. CONCLUSIONS: To our knowledge, this is the first study assessing H. pylori eradication rates in foreigner patients, who failed at least one therapeutic attempt, managed in Italy. Even by using a culture-based approach, the infection was not cured in a definite number of patients.

Clinical outcomes in cirrhotics with variceal or nonvariceal gastrointestinal bleeding: A prospective, multicenter cohort study.

BACKGROUND AND AIM: Upper gastrointestinal bleeding (UGIB) is associated with a distinct mortality in cirrhotics. We evaluated whether the rate of mortality and other outcomes differs between variceal and nonvariceal UGIB. METHODS: This was a prospective, multicenter, cohort study on UGIB cirrhotics observed in 50 hospitals. Variceal or nonvariceal UGIB were diagnosed at endoscopy. The 6-week mortality rate, need of blood transfusion, intensive care unit (ICU) admission, radiologic or surgical intervention, rebleeding rate, and length of stay in hospital were the main clinical outcomes compared. Data were analyzed at univariate and multivariate analysis, and odds ratio (OR) with their 95% confidence interval (CI) was calculated. RESULTS: The study enrolled 706 cirrhotics, including 516 (73%) variceal and 190 (27%) nonvariceal UGIB. There were 78 (11%; 95% CI = 8.7-13.4) deceases, without any difference between variceal (11.0%) and nonvariceal (11.0%) groups. Child-Pugh score C (OR: 6.99; 95% CI = 2.58-18.95), and development of either hepatorenal syndrome (OR: 16.5; 95% CI = 7.02-38.9) or hepatic encephalopathy (OR: 2.38; 95% CI = 1.25-4.5) were independent predictors of mortality. Transfusions and onset of hepatic encephalopathy were significantly more frequent in variceal, whereas ICU admission rate was higher in nonvariceal bleedings. Overall, antibiotic prophylaxis was eventually administered in only 392 (55.5%) patients. CONCLUSIONS: Data found that the overall mortality rate in cirrhotics with UGIB seems to be reducing and that the value did not differ between variceal and nonvariceal types. Prevention of both hepatorenal syndrome and hepatic encephalopathy and implementation of antibiotic prophylaxis could improve survival in these patients.

Helicobacter pylori and Upper Endoscopy in Systemic Sclerosis: A Cross-sectional Study in the Real World.

BACKGROUND/AIMS: A role for Helicobacter pylori in triggering systemic sclerosis (SSc) has been proposed, but data are conflicting. In previous studies, infection has been generally searched for by using serology. We designed this study to assess H. pylori prevalence in SSc patients with histology of gastric mucosa, considered the criterion standard for infection diagnosis. METHODS: This cross-sectional study enrolled 30 SSc patients who complained of upper gastrointestinal symptoms. All underwent upper endoscopy with gastric biopsies. Endoscopic alterations were recorded, and gastric mucosa biopsies were used for both histological examination and searching for H. pylori. The role for proton-pump inhibitor (PPI) therapy was considered. Fisher exact test was used for statistical analysis. RESULTS: Data of 28 SSc patients were available, 14 with ongoing PPI therapy. Helicobacter pylori infection at histology was detected in 14.3% patients, and it equally occurred in patients with or without PPI therapy. Erosive esophagitis/Barrett esophagus was detected in 26.6% of cases. Among patients with PPI therapy, 30% received half dose only. The prevalence of intestinal metaplasia was low (14.3%). Endoscopic esophageal alterations were significantly more frequent in those patients showing anti-Scl70 antibody positivity. CONCLUSIONS: This study showed that prevalence of H. pylori is very low in SSc patients, so that it seems not having a role in triggering SSc. Management of gastroesophageal diseases in SSc patients needs to be improved, and looking to the autoimmune profile may be of help. Thus, collaboration between rheumatologist and gastroenterologist is highly recommended.

Role of MIC levels of resistance to clarithromycin and metronidazole in Helicobacter pylori eradication.

OBJECTIVES: Antimicrobial resistance to clarithromycin and metronidazole significantly affects the cure rate of standard therapies for Helicobacter pylori infection. We tested whether different MIC levels of resistance to these antibiotics play a role in therapeutic efficacy. METHODS: This was a post hoc analysis of data from a therapeutic trial in which patients with antibiotic susceptibility testing (Etest) received first-line sequential therapy. The level of antibiotic resistance was classified according to MIC values into low (MIC from >0.5 to ≤8 for clarithromycin, and from >8 to ≤32 for metronidazole) and high (MIC from >8 to 256 mg/L for clarithromycin, and from >32 to 256 mg/L for metronidazole). RESULTS: Data from 1006 patients were included. There were 520 (51.7%) patients with susceptible strains, 136 (13.5%) with clarithromycin-resistant strains, 144 (14.3%) with metronidazole-resistant strains and 206 (20.5%) with clarithromycin-resistant and metronidazole-resistant strains. In the presence of double resistance, the cure rate was still high (38/41, 92.7%) when MIC levels were low and it was reduced (94/112, 83.9%) only when MIC levels of both antibiotics were high. The cure rates did not significantly differ between patients with single antibiotic-resistant strains, irrespective of MIC values, and those with susceptible strains. CONCLUSIONS: We found that MIC levels of resistance to either clarithromycin or metronidazole play a role in H. pylori therapy outcome and that bacterial resistance becomes relevant in vivo when clarithromycin-resistant and metronidazole-resistant strains have high MIC values for at least one of these antibiotics.

Rifabutin Triple Therapy is Effective in Patients With Multidrug-resistant Strains of Helicobacter pylori.

INTRODUCTION: Eradicating Helicobacter pylori continues to be a challenge, and no treatment regimen is uniformly successful in all treated patients. Triple therapy with rifabutin and amoxicillin is a successful rescue therapy after consecutive treatment failures. We designed this study to test the efficacy of 12-day rifabutin-based triple therapy in patients infected with multidrug-resistant strains. METHODS: Consecutive patients with dyspeptic symptoms after at least 1 antibiotic therapy course for H. pylori infection harboring triple-resistant (clarithromycin, metronidazole, levofloxacin) strains were enrolled. They received triple therapy with esomeprazole 40 mg bid, amoxicillin 1 g bid, and rifabutin 150 mg od for 12 days. Patients who failed rifabutin therapy were treated empirically on the basis of the judgment of the treating physician. RESULTS: A total of 254 out of 756 tested patients were found to be infected with a triple-resistant H. pylori strains after at least 1 antibiotic therapy course. Overall, the infection was eradicated in 213 patients, corresponding to a cure rate of 82.9% (95% CI, 78.3-87.5) by intention-to-treat analysis and 88.7% (95% CI, 84.7-92.7) at per-protocol analysis. In multivariate analysis, no factor was identified as an independent predictor of bacterial eradication. CONCLUSIONS: There is no current standard for the growing population of patients with multidrug-resistant strains of H. pylori. The 12-day low-dose rifabutin/high-dose proton pump inhibitor regimen is a safe and reliable option for patients infected with triple-resistant strains.

Antibiotic resistance pattern of Helicobacter pylori strains isolated in Italy during 2010-2016.

PURPOSE: Bacterial resistance toward the most used antibiotics is increasing in Helicobacter pylori strains worldwide. Emergence of multidrug resistance significantly affects the efficacy of standard therapy regimens. Therefore, monitoring for primary antimicrobial resistance is essential for H. pylori management in clinical practice. METHODOLOGY: H. pylori isolates obtained from patients consecutively observed in a single center were tested for primary resistance by using E-test method. Bacterial strains showing MIC values >0.5, >8 and >1 mg/L toward clarithromycin, metronidazole and levofloxacin, respectively, were considered resistant. The trend of antibiotic prevalence, either single or combined, during 2010-2016 was assessed. RESULTS: Antibiotic susceptibility data were available in 1424 (82.3%) out of 1730 tested patients. The overall resistance for all the three antibiotics showed an increasing trend from 2010 to 2013 (clarithromycin: from 19% to 35.6%; metronidazole: from 33.6% to 45.3%; levofloxacin: from 19% to 29.7%; p < .001), when a plateau until 2016 was observed (clarithromycin: 35.9%; metronidazole: 40.2%; levofloxacin: 29.3%). A similar trend occurred for clarithromycin-metronidazole combined resistance rate (2010: 11.4%; 2013: 28.2%; 2016: 21.9%). CONCLUSION: Our data suggest that prevalence of primary resistance in H. pylori isolates toward the most frequently used antibiotics probably reached a plateau in the last years.

Rescue therapy with bismuth quadruple regimen in patients with Helicobacter pylori -resistant strains.

BACKGROUND: Bismuth quadruple therapy (BQT) is the recommended rescue therapy for Helicobacter pylori (H. pylori) infection. This study aimed to assess the efficacy and safety of a 10-day BQT regimen in patients who failed previous therapies and were infected with multiresistant H. pylori strains MATERIALS AND METHODS: Helicobacter pylori-infected patients underwent endoscopy, culture, and susceptibility test for clarithromycin, metronidazole, and levofloxacin. Treatment with three-in-one capsule (Pylera®) four times daily and esomeprazole 20 mg twice daily for 10 days was administered. Treatment-emergent adverse events (TEAEs) were registered. RESULTS: A total of 116 patients with persistent H. pylori infection following at least one eradication therapy attempt were treated. Overall, resistance toward clarithromycin was detected in 80% of strains, toward metronidazole in 70%, and levofloxacin in 47.5%, with dual or triple resistance in 72.5% of cases. An eradication rate of 81.0% (95% CI: 73.0-87.1) and 87.0% (95% CI: 79.4-92.1) at ITT and PP analyses, respectively, was achieved. The cure rate remained high until it was used as fourth-line regimen, while it dropped to low values (<67%) in those patients with more than 4 therapy failures. A total of 65.7% (95% CI: 56.4-74.0) patients complained of TEAEs. CONCLUSIONS: Our data found that bismuth-based quadruple regimen is effective as rescue therapy for curing patients infected with multiresistant H. pylori strains.