Introduction

The V Spanish Consensus Conference on H. pylori recommends as first-line treatment either a non-bismuth quadruple concomitant regimen (PPI, clarithromycin, amoxicillin, and metronidazole) for 14 days or a bismuth-containing quadruple therapy (PPI, bismuth, tetracycline, and metronidazole in a single-capsule) for 10 days. The superiority of one treatment over the other is currently not established.

Aims & Methods

To compare the effectiveness and safety of first-line empirical concomitant treatment versus bismuth quadruple therapy as single-capsule in Spain.
All treatment-naïve patients registered in AEG-REDCap in the Spanish cohort of the European H. pylori Registry (Hp-EuReg) from 2013 to 2023, treated with either concomitant therapy or the single-capsule, were evaluated. First, a set of pre-selected variables evaluated variations in prescriptions, observing significant differences in following: year of visit, geographical region, and patient age. Therefore, a propensity score analysis (SMR) was conducted and included in the multivariate logistic regression model to determine the modified intention-to-treat effectiveness (mITT) of both treatments. Additionally, a multivariate analysis with 10,000 bootstrap replicas was performed, balancing for geographical region and including associated variables.

Results

A total of 11,720 treatments were analysed: 6,293 (54%) with concomitant therapy (for 10 and 14 days) and 5,427 (46%) consisting of single-capsule (10 days). Concomitant therapy, both for 10 and 14 days, was associated with lower mITT effectiveness (88%; OR=0.53; [95% CI 0.43-0.66]; and 90%; OR=0.62; [0.53-0.73], respectively) compared to single-capsule therapy (93% mITT, P<0.001). Compliance (OR=6.81; [5.05-9.15]), presence of ulcer (OR=1.49; [1.17-1.91]), and central geographical region (OR=2.51 [1.94-3.29]) were the variables associated with greater eradication success (P<0.001). However, there was no demonstrated benefit of using high-dose (equivalent to 80 mg omeprazole twice daily) PPI compared to standard dose (equivalent to 40 mg omeprazole twice daily). Compliance was higher with single-capsule (98%) compared to 10- and 14-days concomitant therapy (both 97%). The incidence of adverse effects was lower with concomitant therapy for 10 days (25%) than for 14 days (33%); and the latter was significantly higher than with single-capsule (25%) (P<0.0001). Regarding serious adverse effects, 9 (0.1%) and 7 (0.1%) cases were reported with concomitant therapy and single-capsule therapy, respectively.

Conclusion

In Spain, bismuth-containing quadruple therapy prescribed as single-capsule is more effective and better tolerated than non-bismuth quadruple concomitant treatment.

Disclosure

Javier P. Gisbert has served as speaker, consultant, and advisory member for or has received research funding from: Mayoly, Allergan/Abbvie, Diasorin, Richen, Juvisé and Biocodex.
Olga P. Nyssen received research funding from: Mayoly, Allergan/Abbvie, Richen, Juvisé and Biocodex.

Introduction

Barrett Esophagus (BE) is a long-term complication of inadequately controlled gastroesophageal reflux (GERD) resulting in the metaplastic transformation of the esophageal epithelium. Current therapy involves proton pump inhibitors (PPIs), aiming at reducing gastric, and consequently esophageal acid exposure time (AET), thereby eliminating the main pathogenic drive to dysplasia/adenocarcinoma progression. However, current guidelines recommend a standard dose PPI therapy for BE chemoprevention, without taking into consideration the need for 24-hour pH-impedance monitoring (24h MII-pH), which is the only investigation able to objectively estimate the esophageal acid exposure time (AET) and evaluate the real effectiveness of PPI therapy.

Aims & Methods

This study included prospectively enrolled BE patients referred to our tertiary care center. We identified consecutive patients with histological diagnosis of non-dysplastic BE treated with a standard dose of PPI administered once or twice daily (either pantoprazole or esomeprazole 40mg OD or 20mg BID), according to guidelines. After at least 8 weeks of PPI therapy, all participants underwent a high-resolution manometry (HRM) and 24h MII-pH monitoring on therapy. A cohort of refractory GERD patients matched for age, sex and PPI regimen (dose and type) were used as controls. GERD symptoms were recorded in the whole population by using the standardized GERD-Q questionnaire. Results are expressed as mean±SD.

Results

A total of 33 BE (23M, 50±17 years) and 33 GERD patients (21M, 48±14 years) were enrolled. Typical GERD symptoms were significantly less severe in BE patients compared to controls (2.1±2.1 vs 3.1±2.3; p<0.05). Half of the population of BE patients did not achieve adequate esophageal acid suppression (AET<4%) under standard dose regimen. Despite matching PPI regimen, the risk of having a pathological 24h MII-pH was doubled in BE compared to refractory GERD patients (50% vs 25%; p<0.05). The mean AET was significantly higher in BE compared to GERD patients (6.6±10.2%vs 1.9±3%; p<0.05), particularly in the supine position (7.3±15.5% vs 2.3±5.6%; p<0.05), despite similar levels of gastric acid suppression (44.1± 25.7% vs 49.2±27%; p=NS). Although the average number of reflux events was comparable between BE and controls (49±29 vs 40±22), BE exhibited a notably prolonged reflux clearance time (mean duration of the longest reflux episode: 27.8±25.7 vs 12.7±27.3 min; p<0.05). Furthermore, Type IIIA esophagogastric junction (EGJ) morphology was more prevalent BE group compared to controls (45% vs 21%; p<0.05) as was the prevalence of ineffective esophageal motility (IEM) according to the Chicago Classification version 4.0 (42% vs 12%; p<0.05).

Conclusion

Despite the reduced severity of typical GERD symptoms, analogous therapeutic regimens and comparable gastric acid suppression, BE patients showed a significantly increased esophageal AET, especially in the supine position, compared to refractory GERD patients. Furthermore, at HRM, BE patients showed a higher prevalence of Type IIIA EGJ morphology and IEM that could justify these results. Our data show that half of the whole BE population failed to achieve an adequate esophageal acid suppression despite therapy, emphasizing the relevance of performing an HRM and a 24h MII-pH in all non-dysplastic BE patients, in order to tailor the therapeutic strategy and improve BE long-term outcomes.

Introduction

The Ki-67 labeling index is a well-established marker of cellular proliferation and has been associated with worse disease-free and overall survival in gastrointestinal stromal tumors (GISTs). Recent evidence highlights its potential role in risk stratification, particularly when Ki-67 exceeds certain thresholds. However, current assessment relies on postoperative histopathology. Radiomics, by extracting quantitative features from computer tomography (CT) images, may offer a non-invasive method to predict Ki-67 expression preoperatively. This meta-analysis aimed to evaluate the diagnostic performance of CT-based radiomics for predicting Ki-67 status in GISTs.

Aims & Methods

A systematic review and meta-analysis were conducted according to PRISMA guidelines). Four electronic databases (PubMed, Scopus, Science Direct, Cochrane Library) were searched for relevant articles up to December 2024. Eligible studies assessed CT radiomics in predicting Ki-67 in histologically confirmed GISTs. Pooled sensitivity, specificity, and area under the curve (AUC) were calculated using a random-effects model. Subgroup analyses were performed based on cohort type, CT protocol, number of features, and Ki-67 cutoff values. Study quality was assessed using the QUADAS-2 tool.

Results

Six studies comprising 1,632 patients met the inclusion criteria. Pooled sensitivity and specificity were 0.71 (95% CI: 0.63–0.79) and 0.76 (95% CI: 0.73–0.78), respectively. The pooled AUC was 0.79 (95% CI: 0.74–0.84). Subgroup analyses showed consistent performance across imaging protocols and feature counts, while Ki-67 cutoffs (8% vs. 10%) significantly impacted diagnostic accuracy. Sensitivity analysis confirmed robustness of specificity estimates. Publication bias was detected for specificity (Egger’s test p = 0.006).

Conclusion

CT radiomics demonstrates moderate accuracy for non-invasively predicting Ki-67 expression in GISTs. Given Ki-67's prognostic significance, radiomics could support preoperative risk assessment and personalized treatment planning. Further prospective validation is warranted.

Disclosure

No Conflict of Interest ​