Two-year outcomes of anti-reflux mucosectomy in treating gastroesophageal reflux disease: A Chinese prospective cohort study.

OBJECTIVES: Anti-reflux mucosectomy (ARMS) is an emerging and promising endoscopic treatment for gastroesophageal reflux disease (GERD). In the current study we aimed to evaluate the safety and efficacy of ARMS in treating Chinese GERD patients. METHODS: This was a single-center prospective cohort study. ARMS was performed in GERD patients by an experienced endoscopist. The patients were required to undergo symptom assessment as well as endoscopic examination, high-resolution manometry (HRM), and impedance-pH monitoring before and after ARMS. RESULTS: Twelve patients were enrolled. Follow-up was completed by all patients at 3 and 6 months, 11 patients at 1 year, and 8 patients at 2 years after ARMS, respectively. Symptom improvement was achieved in 66.7%, 75.0%, 72.7%, and 50.0% of the patients at 3 months, 6 months, 1 year, and 2 years after ARMS, respectively. Postoperative dysphagia was reported by 25.0%, 25.0%, 27.3%, and 25.0% of patients at 3 months, 6 months, 1 year, and 2 years after surgery, none of whom required additional invasive treatment. All patients with preoperative esophagitis healed after ARMS. For impedance-pH monitoring parameters, number of acidic reflux episodes and the proportion of patients with acid exposure time (AET) >4.0% decreased significantly after ARMS. CONCLUSIONS: ARMS was safe and effective in Chinese GERD patients. The efficacy of ARMS was not short-term and remained evident throughout the 2-year follow-up. Further multicenter studies with larger sample sizes are needed to verify our findings.

Patients at risk for further examination with conventional gastroscopy after undergoing magnetically controlled capsule endoscopy.

OBJECTIVE: In this study we aimed to compare the need for further examination with conventional gastroscopy within 1 year after magnetically assisted capsule endoscopy (MCCE) examination between patients with gastrointestinal (GI) symptoms and asymptomatic individuals. METHODS: After propensity score matching analysis, 372 patients with GI symptoms and 372 asymptomatic individuals who had undergone MCCE at the First Affiliated Hospital of Sun Yat-sen University from January 1, 2019 to December 30, 2020 were retrospectively enrolled. Demographic and clinical characteristics of the participants and their MCCE and gastroscopic findings (performed within 1 year after MCCE) were analyzed. RESULTS: Fifty-one (6.85%) patients underwent further examination with conventional gastroscopy within 1 year after MCCE. Those with GI symptoms were more likely to undergo conventional gastroscopy than those without (9.95% vs 3.76%, P < 0.001). Polyps were the most common finding of MCCE. The rate of conventional gastroscopy in patients with focal lesions was significantly higher than that in those without focal lesions (P < 0.05). However, such rate did not differ in the different age groups (P = 0.106). CONCLUSIONS: MCCE is an optimal alternative for gastric examination, especially for large-scale screening of asymptomatic individuals. Patients with GI symptoms or focal lesions detected by MCCE are more likely to seek further examination with conventional gastroscopy for biopsy or endoscopic treatment than those without.

Efficacy and Safety of Keverprazan Compared With Lansoprazole in the Treatment of Duodenal Ulcer: A Phase III, Randomized, Double-Blind, Multicenter Trial.

INTRODUCTION: Keverprazan is a novel potassium-competitive acid blocker for the treatment of acid-related disorders requiring potent acid inhibition. This study aimed to establish the noninferiority of keverprazan to lansoprazole in the treatment of patients with duodenal ulcer (DU). METHODS: In this phase III, double-blind, multicenter study, 360 Chinese patients with endoscopically confirmed active DU were randomized 1:1 to take either keverprazan (20 mg) or lansoprazole (30 mg) treatment for up to 6 weeks. The primary end point was DU healing rate at week 6. The secondary end point was DU healing rate at week 4. Symptom improvement and safety were also assessed. RESULTS: Based on the full analysis set, the cumulative healing rates at week 6 were 94.4% (170/180) and 93.3% (166/178) for keverprazan and lansoprazole, respectively (difference: 1.2%; 95% confidence intervel: -4.0%-6.5%). At week 4, the respective healing rates were 83.9% (151/180) and 80.3% (143/178). In the per protocol set, the 6-week healing rates in keverprazan and lansoprazole groups were 98.2% (163/166) and 97.6% (163/167), respectively (difference: 0.6%; 95% confidence intervel: -3.1%-4.4%); the 4-week healing rates were respectively 86.8% (144/166) and 85.6% (143/167). Keverprazan was noninferior to lansoprazole in DU healing after the treatment for 4 and 6 weeks. The incidence of treatment-emergent adverse events was comparable among groups. DISCUSSION: Keverprazan 20 mg had a good safety profile and was noninferior to lansoprazole 30 mg once daily for DU healing.

Efficacy of keverprazan for duodenal ulcer: A phase II randomized, double-blind, parallel-controlled trial.

BACKGROUND AND AIM: Considering the limitation of varying acid suppression of proton pump inhibitors, this study was aimed to assess the efficacy, safety, and dose-effect relationship of keverprazan, a novel potassium-competitive acid blocker, in the treatment of duodenal ulcer (DU) compared with lansoprazole. METHODS: A randomized, double-blind, double-dummy, multicenter, low-dose, high-dose, and positive-drug parallel-controlled study was conducted to verify the non-inferiority of keverprazan (20 or 30 mg) to lansoprazole of 30 mg once daily for 4 to 6 weeks and dose-effect relationship of keverprazan in the treatment of patients with active DU confirmed by endoscopy. RESULTS: Of the 180 subjects randomized, including 55 cases in the keverprazan_20 mg group, 61 cases in the keverprazan_30 mg group, and 64 cases in the lansoprazole_30 mg group, 168 subjects (93.33%) completed the study. The proportions of healed DU subjects in the keverprazan_20 mg, keverprazan_30 mg, and lansoprazole_30 mg groups were respectively 87.27%, 90.16%, and 79.69% at week 4 (P = 0.4595) and were respectively 96.36%, 98.36%, and 92.19% at week 6 (P = 0.2577). The incidence of adverse events in the keverprazan_20 mg group was lower than that in the lansoprazole_30 mg (P = 0.0285) and keverprazan_30 mg groups (P = 0.0398). CONCLUSIONS: Keverprazan was effective and non-inferior to lansoprazole in healing DU. Based on the comparable efficacy and safety data, keverprazan of 20 mg once daily is recommended for the follow-up study of acid-related disorders. (Trial registration number: ChiCTR2100043455.).

Patient- and physician-reported satisfaction with gastroesophageal reflux disease (GERD) treatment in Chinese clinical practice.

OBJECTIVE: The aim of this study was to assess the level of satisfaction with currently prescribed medications for gastroesophageal reflux disease (GERD) in patients and physicians in China. METHODS: Physicians across China were invited to complete physician surveys concerning factors affecting the prescription of medication for GERD and their satisfaction through an online questionnaire. The enrolled physicians invited the first five GERD patients who visited them on the same day to complete online patient surveys concerning the satisfaction with medications for GERD and its influencing factors. RESULTS: In total, 334 physician surveys (response rate 36.82%) and 1409 patient surveys (86.07%) were analyzed. Over half (62.57%) the physicians recommended taking a proton pump inhibitor (PPI) twice daily and the majority (88.02%) recommended taking a PPI for 1 week to 3 months. Factors affecting the prescription were how much it could improve quality of life (84.73%), followed by safety, medication compliance, and efficacy. Approximately 30% of patients reported taking a PPI twice daily and 47.20% reported taking a PPI for 1 week to 3 months. Factor affecting patients' adherence to medications was safety (64.30%), followed by medical insurance, efficacy and convenience. Approximately one-third of physicians and patients did not report "satisfied" or "very satisfied" with medications for GERD, including 10.51% of patients and 12.87% of physicians reporting "dissatisfied" or "very dissatisfied." CONCLUSION: One-third of GERD patients and physicians were not satisfied or very satisfied with medications for GERD. Novel medications may help optimize the management of GERD.

Ineffective esophageal motility in Chicago Classification version 4.0 better predicts abnormal acid exposure.

BACKGROUND: The updated Chicago Classification version 4.0 (CCv4.0) establishes a more stringent criteria to diagnose ineffective esophageal motility (IEM). This study aims to investigate the clinical significance of IEM in CCv4.0 in the context of gastroesophageal reflux disease (GERD). METHODS: A retrospective study was conducted among suspected GERD patients who had heartburn and/or regurgitation as their chief complaints and completed esophageal function tests in our center from 2017 to 2019. Patients were further grouped as "CCv3.0 IEM" and normal motility according to Chicago Classification version 3.0 (CCv3.0), and as "CCv4.0 IEM" and normal motility according to CCv4.0. The clinical characteristics, high-resolution manometry, esophageal reflux monitoring, and proton pump inhibitor (PPI) efficacy were compared between different groups. Multivariate analyses were performed to identify esophageal motility parameters associated with reflux burden and symptom outcome. RESULTS: Of 172 subjects included, 93 patients were identified as CCv3.0 IEM, 69 as CCv4.0 IEM. IEM in either version was concomitant with elevated acid burden and impaired esophageal clearance as compared to normal motility in corresponding diagnostic criteria, while the only presence of IEM in CCv4.0 was predictive to abnormal acid exposure (AET > 6%: OR = 2.66, 95% CI [1.27-5.56], p < 0.01). The presence of "CCv3.0 IEM" and low EGJ-CI (EGJ-CI < 39.1 mmHg·cm) had no added value in predicting increased reflux burden. No interaction effect was found between the presence of IEM and a weakened EGJ. None of the manometric variables was capable of predicting PPI response. CONCLUSIONS: Stringent criteria of IEM in CCv4.0 can better predict abnormal acid exposure as compared to CCv3.0.

Magnetic sphincter augmentation in treating refractory gastroesophageal reflux disease: A systematic review and meta-analysis.

OBJECTIVE: In this systematic review and meta-analysis we aimed to determine the efficacy and safety of magnetic sphincter augmentation (MSA) in the management of refractory gastroesophageal reflux disease (rGERD). METHODS: Literature search was conducted in PubMed, the Cochrane Library, EMBASE, Web of Science, OpenGrey and ClincalTrials.gov for single-arm studies evaluating the efficacy and safety of MSA in rGERD or comparative studies with proton pump inhibitor (PPI) or laparoscopic Nissen fundoplication (LNF) serving as the control published until April 2020. Primary outcome was the rate of postoperative PPI use, and secondary outcomes included postoperative GERD-health-related quality of life (GERD-HRQL), normalization of acid exposure time (AET) and incidence of procedure-related adverse events (AE). RESULTS: Ten single-arm studies, one randomized controlled trial and three cohort studies involving 1138 participants were included. Post-MSA PPI withdrawal, significant GERD-HRQL improvement and AET normalization were achieved in 87.0%, 88.0% and 75.0% of the patients, respectively. The incidence of postoperative dysphagia was 29% and endoscopic dilation was required in 7.4% of patients undergoing MSA. MSA showed a better efficacy in symptom control than PPI (PPI cessation: 91% vs 0%; GERD-HRQL improvement: 81% vs 8%) and similar effectiveness but a lower risk of gas-bloat syndrome (risk ratio [RR] 0.69, 95% confidence interval [CI] 0.51-0.93, P = 0.01) and better reserved ability to belch (RR 1.48, 95% CI 0.76-2.86, P = 0.25) compared with LNF. CONCLUSIONS: MSA was an effective and safe therapy for rGERD. Well-designed randomized trials that compare the efficacy of MSA with other therapies are needed.

White-light endoscopy is insufficient to distinguish between types of esophageal white lesions.

OBJECTIVE: Esophageal white lesions (EWL) are commonly observed under upper endoscopy, while their clinical significance remains undetermined. The aim of this study was to identify the endoscopic characteristics of EWL and distinguish between different types of EWL. METHODS: Consecutive patients with upper gastrointestinal complaints and participants admitted for health check-up who underwent esophagogastroduodenoscopy from October 2018 to August 2019 in a tertiary hospital were prospectively screened. EWL were detected under endoscopy and biopsy was performed for histological analysis. Participants' characteristics, lifestyle, esophageal motility and reflux monitoring variables were analyzed. RESULTS: Of the 3641 consecutive participants screened, 303 of them aged 56.12 ± 10.95 years were found to have EWL (detection rate of 8.3%). More than one-third of them preferred hot drinks, eating pickled or spicy food, smoking and alcohol consumption and 5.3% had current or former upper gastrointestinal or head and neck cancers. The common endoscopic appearance of the EWL (2.9 mm ± 1.2 mm in diameter) included slightly elevated plaque, translucent white in color, with a clear border, round or oval in shape, and a scaly, rough or smooth surface. Histology showed low-grade intraepithelial dysplasia in 13 cases, leukoplakia in 10 and intestinal metaplasia in one. No significant differences were found between the histological findings and endoscopic manifestations of EWL. CONCLUSIONS: EWL are not uncommon in daily endoscopic examination, with some of them being precancerous lesions. Conventional white-light endoscopy is insufficient to identify EWL, while histological assessment is important. Further studies using advanced endoscopic techniques with long-term follow-up are needed.

Impact of COVID-19 on the Healthcare of Patients With Inflammatory Bowel Disease: A Comparison Between Epicenter vs. Non-epicenter Areas.

Background and Aims: The COVID-19 pandemic poses a great challenge to healthcare. We aimed to investigate the impact of COVID-19 on the healthcare of patients with inflammatory bowel disease (IBD) in epicenter and non-epicenter areas. Methods: Patients with IBD from Hubei province (the epicenter of COVID-19) and Guangdong province (a non-epicenter area), China were surveyed during the pandemic. The questionnaire included change of medications (steroids, immunomodulators, and biologics), procedures (lab tests, endoscopy, and elective surgery), and healthcare mode (standard healthcare vs. telemedicine) during 1 month before and after the outbreak of COVID-19. Results: In total, 324 IBD patients from Guangdong province (non-epicenter) and 149 from Hubei province (epicenter) completed the questionnaire with comparable demographic characteristics. Compared to patients in Guangdong province (non-epicenter), significantly more patients in Hubei (epicenter) had delayed lab tests/endoscopy procedures [61.1% (91/149) vs. 25.3% (82/324), p < 0.001], drug withdrawal [28.6% (43/149) vs. 9.3% (30/324), p < 0.001], delayed biologics infusions [60.4% (90/149) vs. 19.1% (62/324), p < 0.001], and postponed elective surgery [16.1% (24/149) vs. 3.7% (12/324), p < 0.001]. There was an increased use of telemedicine after the outbreak compared to before the outbreak in Hubei province [38.9% (58/149) vs. 15.4% (23/149), p < 0.001], while such a significant increase was not observed in Guangdong province [21.9% (71/324) vs. 18.8% (61/324), p = 0.38]. Approximately two-thirds of IBD patients from both sites agreed that telemedicine should be increasingly used in future medical care. Conclusions: Our patient-based survey study in a real-world setting showed that COVID-19 resulted in a great impact on the healthcare of patients with IBD, and such an impact was more obvious in the epicenter compared to the non-epicenter area of COVID-19. Telemedicine offers a good solution to counteract the challenges in an unprecedented situation such as COVID-19.

Esophageal symptoms versus epigastric symptoms: Relevance for diagnosis of gastroesophageal reflux disease.

OBJECTIVE: Although pathological acid reflux in patients with reflux symptoms is uncommon, it affects one-third of patients with epigastric symptoms in China. The aim of this study was to evaluate and compare the relevance of esophageal and epigastric symptoms in diagnosing gastroesophageal reflux disease (GERD) in China. METHODS: Consecutive outpatients with predominantly esophageal symptoms (heartburn, regurgitation, chest pain, dysphagia) or predominantly epigastric symptoms (epigastric pain, epigastric burning, early satiety, postprandial fullness) were enrolled. Patients underwent upper endoscopy and esophageal function tests, and took proton pump inhibitor (PPI) treatment. The prevalence of GERD and PPI efficacy was assessed and compared among patients with different dominant symptoms. RESULTS: Altogether 374 patients (244 with predominantly esophageal symptoms and 130 with predominantly epigastric symptoms) were enrolled. Patients with predominantly epigastric symptoms had a slightly lower prevalence of reflux esophagitis and pathological acid reflux but a significantly lower PPI response rate than those with predominantly esophageal symptoms. Multivariable logistic regression analysis revealed that the predominant symptom was independently associated with PPI efficacy but could not predict the objective existence of GERD. GERD was objectively found in 136 patients, 30% of whom complained of predominantly epigastric symptoms and had similar reflux profiles and symptom outcomes as patients with predominantly esophageal symptoms. CONCLUSIONS: Approximately 30% of patients with GERD complain of predominantly epigastric symptoms and have comparable reflux profiles and symptom outcomes as those with predominantly esophageal symptoms. Epigastric symptoms may be part of the diagnosis for GERD in a Chinese population. The study was registered with Clinicaltrials.gov (NCT02506634).

Steroids therapy for eosinophilic esophagitis: Systematic review and meta-analysis.

OBJECTIVE: We designed this systematic review and meta-analysis aiming to clarify the advantage of steroid therapy compared with non-steroid therapy for the treatment of eosinophilic esophagitis (EoE). METHODS: PubMed, EMBASE, Medline, ISI Web of Science and the Cochrane Database of Systematic Reviews were searched to identify relevant randomized controlled trials (RCTs) comparing steroid and non-steroid therapy, and retrospective and prospective trials on steroid therapy for EoE. RevMan 5.2 was used for the analysis. Weighted mean difference and 95% confidence interval (CI) were estimated and pooled using meta-analysis methods. RESULTS: Six RCTs including 193 participants fulfilled the inclusion criteria for meta-analysis, and another two RCTs, three prospective and five retrospective trials were included in systematic review. Meta-analysis showed that topical steroids significantly decreased the mean and peak esophageal eosinophils (EOS) count compared to non-steroid therapy (MDmean = -23.41, 95% CImean -42.08--4.73, P = 0.01 and MDpeak = -51.27, 95% CIpeak -78.62--23.92, P = 0.0002). There were 14 trials showing the efficacy of steroids on decreasing the EOS count, 10 showing the amelioration of symptoms, and five showing endoscopic improvement. Only mild adverse events were reported for topical steroids. CONCLUSIONS: Steroids are effective on decreasing the EOS count in EoE patients. Its value in ameliorating symptoms and endoscopic changes remains undetermined due to the lack of comparable criteria.