Introduction

Potassium-competitive acid blockers (P-CABs) offer prolonged acid suppression and are promising agents for Helicobacter pylori eradication. Prospective studies evaluating the efficacy of tegoprazan-based triple therapy according to dosage differences have been scarce.

Aims & Methods

This study aimed to assess the efficacy and safety of tegoprazan-based versus lansoprazole-based standard triple therapy (STT). This multicenter randomized controlled study enrolled treatment-naïve adults with H. pylori infection in 18 institutions from February 2023 to April 2024. Participants were randomized 1:1:1 to receive tegoprazan 50 mg (TAC1), tegoprazan 100 mg (TAC2), or lansoprazole 30 mg (LAC) with amoxicillin 1000 mg and clarithromycin 500 mg twice daily for 14 days. The primary endpoint was the eradication rate, analyzed in the full analysis set (FAS) and per-protocol set (PPS). Secondary endpoints included eradication rates stratified by clarithromycin resistance, as determined by 23S rRNA genotyping. Non-inferiority was established if the lower bound of the 95% confidence interval (CI) for the difference in eradication rates was greater than -10%.

Results

A total of 382 patients were randomized, of whom 364 completed the study. The FAS included 372 participants after excluding those who did not receive any study medication, lacked safety data, or violated eligibility criteria. The PPS comprised 355 participants after excluding 17 protocol violators. In the FAS analysis, eradication rates were 85.95% for TAC1, 85.48% for TAC2, and 78.74% for LAC. Both TAC1 (p = 0.0002 vs. LAC) and TAC2 (p = 0.0003 vs. LAC) demonstrated non-inferiority. In the PPS analysis, eradication rates were 88.50% for TAC1, 87.39% for TAC2, and 81.30% for LAC, with TAC1 (p < 0.0001 vs. LAC) and TAC2 (p = 0.0003 vs. LAC) maintaining non-inferiority. Among 275 clarithromycin-susceptible patients in the PPS, eradication rates were 96.74% (TAC1), 98.88% (TAC2), and 94.68% (LAC). Among 80 clarithromycin-resistant patients, eradication rates were 52.38% (TAC1), 53.33% (TAC2), and 37.93% (LAC). In both subgroups, there were no significant differences between either TAC1 or TAC2 and the LAC group. Adverse event rates were comparable across groups, and no serious adverse events were reported. No significant differences in adverse event rates were observed across groups, and no serious adverse events occurred.

Conclusion

Tegoprazan-based STT demonstrated non-inferiority to lansoprazole-based STT, achieving eradication rates above 80% in the FAS population. Given its efficacy and safety profile, tegoprazan-based triple therapy may serve as an effective first-line treatment option for H. pylori eradication.

Disclosure

This study was funded in full by HK inno.N Corp., Seoul, Republic of Korea. HK inno.N Corp. contributed to the study design, data management, statistical analysis, and approval of publication in co-operation with all the authors. No other potential conflicts of interest relevant to this article were reported.

Introduction

Despite the usefulness of white light endoscopy (WLE) and nonmagnified narrow band imaging (NBI) for screening superficial esophageal squamous cell carcinoma (SESCC) and precancerous lesions, these lesions may be missed due to their subtle features and interpretation variations among endoscopists.

Aims & Methods

Our team has developed an artificial intelligence (AI) system to detect SESCC and precancerous lesions using WLE and nonmagnified NBI. This study aims to evaluate the impact of this AI system on clinical diagnosis.
A prospective tandem study was conducted to evaluate the auxiliary diagnostic performance of the AI system in a real clinical setting. Consecutive patients undergoing sedated upper gastrointestinal endoscopy at 12 hospitals in China were recruited. Patients were randomly assigned to either the AI-assisted first group or the routine first group at a 1:1 ratio. The same endoscopist at each center performed tandem upper gastrointestinal endoscopy for each eligible patient on the same day. In the AI-assisted group, the endoscopist performed the first examination with the assistance of the AI system and the second examination without it. In the routine first group, the order of examinations was reversed. The primary outcome was the miss rate of SESCC and precancerous lesions. The secondary outcome including the detection rate of SESCC and precancerous lesions.

Results

Between October 2021 and June 2022, a total of 5,856 eligible patients were included and randomly assigned to the AI-assisted first group and 5,850 were assigned to the routine first group. The per-lesion miss rate was significantly lower in the AI-assisted first group than in the routine first group (1.7% vs 6.7%; Risk ratio (RR)=0.25; p=0.08). The detection rate in the AI-assisted first group was significantly higher than that in the routine first group (1.8% vs 1.3%; RR=1.38; p=0.03).

Conclusion

The proposed AI system can reduce the miss rate and improve the detection rate of SESCC and precancerous lesions during upper gastrointestinal endoscopy under WLE and non-magnified NBI.

Introduction

The number of individuals who will be treated for and cured from HCV infection world-wide is expected to exceed 1 million per year for the next decade. In those with compensated advanced chronic liver disease (cACLD), the risks of de-novo hepatocellular carcinoma (HCC) and hepatic decompensation are decreased but not completely abolished by HCV-cure. Thus, risk stratification is key to decrease resource utilization by individualizing post-treatment management. We evaluated whether the incidences of HCC and hepatic decompensation decrease with time after HCV-cure and whether the discriminatory ability of a one-time post-treatment assessment is maintained during long-term follow-up.

Aims & Methods

We retrospectively analyzed cACLD patients with paired liver stiffness measurement (LSM) & platelet count (PLT) before and after HCV-cure by interferon-free therapies from 7 European regions. Cumulative incidence curves were used to estimate the incidence of hepatic decompensation/HCC over time in the overall group and throughout previously defined risk strata: Baveno VII criteria for clinically significant portal hypertension after HCV-cure (CSPH excluded: FU-LSM <12kPa & FU-PLT >150G/L; CSPH ruled-in: FU-LSM ≥25kPa), and Semmler et al., J Hepatol 2022 (algorithm based on age, LSM, albumin and alcohol consumption) for HCC.

Results

2347 patients (mean age 60±12 years, 60% male, 21% obese, 21% diabetes) with a median LSM of 16.3kPa (IQR: 12.1-24.5, 25% ≥25kPa) before HCV-cure were followed for a median of 6.0 years after treatment. Interestingly, the incidence of first hepatic decompensation was strictly linear with 65 patients (2.8%) developing hepatic decompensation before eventually being diagnosed with HCC (incidence rate 0.57/100 patient years, incidence at 6 years: 3.1%). Similarly, incidence of HCC was also linear with 184 patients (7.8%) developing HCC (incidence rate 1.60/100 patient years, incidence at 6 years: 8.3%). Stratifying the risks for hepatic decompensation according to Baveno VII identified patients with a distinct prognosis during long-term follow-up (incidence at 6 years: 0.3% [CSPH excluded] vs. 2.1% [Gray-zone] vs. 15.6% [CSPH ruled-in]). Similarly, cumulative HCC incidence at 6 years was 15.8% in the high-risk group vs. 5.4% in the low-risk group according to Semmler et al. Results were similar when limiting prediction to events occurring >3 years after HCV-cure.

Conclusion

In patients with cACLD, the risks of hepatic decompensation, and more importantly, HCC remain constant after HCV-cure, even in the long-term (>3 years). A one-time post-treatment risk stratification based on non-invasive criteria confers important prognostic information that is maintained during long-time follow-up, as the hazards over time remain proportional.