Background
We evaluated the efficacy of tailored therapy based on point mutation presence identified with the dual‐priming oligonucleotide (DPO)‐based multiplex polymerase chain reaction (PCR) method ...compared with concomitant therapy.
Materials and methods
Subjects were randomly assigned concomitant therapy (amoxicillin 1 g, clarithromycin 500 mg, metronidazole 500 mg, and lansoprazole 30 mg twice/day for 14 days) or tailored therapy (amoxicillin 1 g, clarithromycin 500 mg, and lansoprazole 30 mg twice/day for 14 days in point mutation‐negative subjects; and amoxicillin 1 g, metronidazole 500 mg, and lansoprazole 30 mg twice/day for 14 days in point mutation‐positive subjects).
Results
A total of 397 and 352 subjects were included in the intention‐to‐treat (ITT) and per‐protocol (PP) analyses, respectively. Point mutations were identified in 25.9% of the subjects. The overall eradication rate was not significantly different between the groups by ITT (86.2% vs 81.6%, P = .132) and PP analyses (90.2% vs 86.5%, P = .179). There was no significant difference in the eradication rates between the groups in both the point mutation‐negative subjects (91.7% vs 87.3%, P = .154) and the point mutation‐positive subjects (71.2% vs 64.7%, P = .312). The eradication rates were significantly lower in the point mutation‐positive subjects than in the point mutation‐negative subjects in both the concomitant and tailored therapy groups.
Conclusions
Tailored therapy based on point mutation presence identified with the DPO‐based multiplex PCR method was as effective as concomitant therapy. The eradication rates of both therapy regimens were suboptimal in point mutation‐positive subjects.
Introduction
The eradication rates for Helicobacter pylori have decreased in Korea although the prevalence of this bacterium has also decreased. Antibiotic resistance is likely to be a crucial factor ...in H. pylori eradication success, and we therefore mapped these resistance patterns nationwide in Korea.
Materials and Methods
Five hundred and ninety adult subjects were prospectively enrolled from 2017 to 2018 from 15 centers across six geographic areas of Korea. A total of 580 biopsy tissues had been sampled from these patients during an upper endoscopy and were frozen at −80°C and delivered to a central laboratory. The agar dilution method was used to determine the minimum inhibitory concentration of amoxicillin, clarithromycin, metronidazole, tetracycline, ciprofloxacin, and levofloxacin for each H. pylori isolate.
Results
The culture success rate was 60.2% (349/580). Resistance rates against clarithromycin, metronidazole, amoxicillin, tetracycline, levofloxacin, and ciprofloxacin were 17.8%, 29.5%, 9.5%, 0%, 37.0%, and 37.0%, respectively. The geographic distribution of metronidazole and quinolone resistance was highly variable. Some subjects had multiple H. pylori strains in the antrum and body of the stomach and showed a heterogeneous resistance profile between these anatomic areas. The H. pylori multidrug resistance (MDR) rate was 25.2% (88/349) among amoxicillin, clarithromycin, metronidazole, tetracycline, and quinolone and 11.2% (39/349) among four of these major antibiotics except for quinolone. The Seoul and Chungcheong areas showed a relatively lower MDR rate.
Conclusion
The antibiotic resistance of H. pylori differs by drug and geographic area in Korea. Detailed nationwide antibiotic resistance mapping is needed to develop an effective H. pylori eradication strategy.
Summary
Background
Tegoprazan is a novel potassium‐competitive acid blocker that has a fast onset of action and can control gastric pH for a prolonged period, which could offer clinical benefit in ...acid‐related disorders.
Aim
To confirm the non‐inferiority of tegoprazan to esomeprazole in patients with erosive oesophagitis (EE).
Methods
In this multicentre, randomised, double‐blind, parallel‐group comparison study, 302 Korean patients with endoscopically confirmed EE (Los Angeles Classification Grades A‐D) were randomly allocated to either tegoprazan (50 or 100 mg) or esomeprazole (40 mg) treatment groups for 4 or 8 weeks. The primary endpoint was the cumulative proportion of patients with healed EE confirmed by endoscopy up to 8 weeks from treatment initiation. Symptoms, safety and tolerability were also assessed.
Results
The cumulative healing rates at week 8 were 98.9% (91/92), 98.9% (90/91) and 98.9% (87/88) for tegoprazan 50 mg, tegoprazan 100 mg and esomeprazole 40 mg, respectively. Both doses of tegoprazan were non‐inferior to esomeprazole 40 mg. The incidence of adverse events was comparable among the groups, and tegoprazan was well‐tolerated.
Conclusion
Once daily administration of tegoprazan 50 or 100 mg showed non‐inferior efficacy in healing EE and tolerability to that of esomeprazole 40 mg.
Summary
Background
Tegoprazan is a novel, fast‐ and long‐acting potassium‐competitive acid blocker that suppresses gastric acid secretion, which could benefit patients with non‐erosive reflux disease ...(NERD), a type of gastroesophageal reflux disease.
Aim
To evaluate the efficacy and safety profiles of tegoprazan compared with those of a placebo in Korean patients with NERD.
Methods
In this phase 3, double‐blind, placebo‐controlled, multicentre study, 324 Korean patients with NERD were randomised into three treatment groups: tegoprazan 50 mg, tegoprazan 100 mg and placebo. These drugs were provided once daily for 4 weeks. The primary endpoint was the proportion of patients with complete resolution of major symptoms (both heartburn and regurgitation) for the last 7 days of the 4‐week treatment period. Other outcomes related to efficacy, safety and tolerability were also evaluated.
Results
Among all, 42.5% (45/106), 48.5% (48/99) and 24.2% (24/99) of patients showed complete resolution of major symptoms at week 4 after receiving tegoprazan 50 mg, tegoprazan 100 mg, and placebo, respectively. Both doses of tegoprazan showed superior efficacy than the placebo (P = 0.0058 and P = 0.0004, respectively). The complete resolution rates of heartburn and proportions of heartburn‐free days (as other efficacy outcomes) were significantly higher in both tegoprazan groups than in the placebo group (P < 0.05 for all). No significant difference in the incidence of treatment‐emergent adverse events were noted.
Conclusions
Tegoprazan 50 and 100 mg showed superior therapeutic efficacy compared with the placebo, as well as a favourable safety profile in patients with NERD.
Registration number: ClinicalTrials.gov identifier NCT02556021.
Tegoprazan 50 and 100 mg showed superior therapeutic efficacy compared with the placebo, as well as a favourable safety profile in patients with non‐erosive reflux disease.
Background Current guidelines for endoscopic management such as EMR and endoscopic submucosal dissection (ESD) in early gastric cancer (EGC) are in evolution, with broader indication criteria. ...Objective To determine the clinical outcomes of endoscopic treatment, based on absolute indication and extended indication criteria and endoscopic methods. Design Retrospective study. Setting Tertiary-care, academic medical center. Patients EMR or ESD was performed on 1627 cases of EGC in 1447 patients from July 1994 to January 2009. Intervention EMR and ESD. Main Outcome Measurements Clinical outcomes of EGC after EMR or ESD, based on the indication criteria. Results Although the complete resection rate was higher (95.9% vs 88.4%; P < .001), and the complication rate was lower (6.8% vs 9.8%; P = .054) in the absolute than in the extended indication group, there was no between-group difference in the local recurrence rate (0.9% vs 1.1%; P = .783) at a median follow-up period of 32 months (interquartile range 22-48 months). In the extended indication group, ESD resulted in a significantly higher complete resection rate than EMR (83.0% vs 91.1%; P = .006). Limitations Retrospective study. Conclusion ESD in the extended indication group showed acceptable clinical outcomes with a relatively high complete resection rate and a low local recurrence rate.
SUMMARY
Background
Tegoprazan is a novel potassium‐competitive acid blocker used to treat acid‐related disorders.
Aim
To compare tegoprazan 25 mg with lansoprazole 15 mg as maintenance therapy in ...healed erosive oesophagitis (EE)
Methods
In this phase 3, double‐blind, multi‐centre study, patients with endoscopically confirmed healed EE were randomised 1:1 to receive tegoprazan 25 mg or lansoprazole 15 mg once daily for up to 24 weeks. The primary efficacy endpoint was the endoscopic remission rate after 24 weeks. The secondary efficacy endpoint was the endoscopic remission rate after 12 weeks. Safety endpoints included adverse events, clinical laboratory results and serum gastrin and pepsinogen I/II levels.
Results
We randomised patients to tegoprazan 25 mg (n = 174) or lansoprazole 15 mg (n = 177). Most had mild EE (Los Angeles (LA) grade A: 57.3%, LA grade B: 37.3%). The endoscopic remission rate after 24 weeks was 90.6% with tegoprazan and 89.5% with lansoprazole. Tegoprazan was not inferior to lansoprazole for maintaining endoscopic remission at 24 weeks and 12 weeks. In subgroup analysis, tegoprazan 25 mg showed no significant difference in maintenance rate according to LA grade (p = 0.47). The maintenance effect of tegoprazan was consistent in CYP2C19 extensive metabolisers (p = 0.76). Increases in serum gastrin were not higher in tegoprazan‐treated than lansoprazole‐treated patients.
Conclusions
Tegoprazan 25 mg was non‐inferior to lansoprazole 15 mg in maintenance of healing of mild EE. In this study, tegoprazan had a similar safety profile to lansoprazole.
In this phase 3, double‐blind, multi‐centre study, patients with endoscopically confirmed healederosive oesophagitis were randomised 1:1 to receive tegoprazan 25 mg or lansoprazole 15 mg once daily for up to 24 weeks. The endoscopic remission rate after 24 weeks was 90.6% for the tegoprazan group and 89.5% for the lansoprazole group. Overall, tegoprazan was not inferior to lansoprazole for maintaining endoscopic remission rates at 24 weeks and 12 weeks, and was well tolerated during the maintenance period.
Previous studies have demonstrated that 50% of patients with normal high-resolution manometry (HRM) findings or ineffective esophageal motility (IEM) may have abnormal functional luminal imaging ...probe (FLIP) results. However, the specific HRM findings associated with abnormal FLIP results are unknown. Herein, we investigated the relationship between nonspecific manometry findings and abnormal FLIP results.
We retrospectively analyzed 684 patients who underwent HRM at a tertiary care center in Seoul, Korea, based on the Chicago Classification version 4.0 protocol.
Among the 684 patients, 398 had normal HRM findings or IEM. Of these 398 patients, eight showed esophageal wall thickening on endoscopic ultrasonography or computed tomography; however, no abnormalities were seen during esophagogastroduodenoscopy. Among these eight patients, seven showed repetitive simultaneous contractions (RSCs) in at least one of the two positions: 61% (±29%) in 10 swallows in the supine position and 51% (±30%) in five swallows in the upright position. Four patients who underwent FLIP had a significantly decreased esophagogastric junction distensibility index (1.0 ± 0.5
at 60 mL). Two of these patients underwent per-oral endoscopic myotomy (POEM) due to a lack of response to medication. Esophageal muscle biopsy revealed hypertrophic muscle with marginal eosinophil infiltration.
A subset of patients (2%) with normal HRM findings or IEM and RSCs experienced dysphagia associated with poor distensibility of the thickened esophageal wall. FLIP assessment or combined HRM and impedance protocols may help better define these patients who may respond well to POEM.
Endoscopic resection of early gastric cancer is a well‐established standard therapy in Japan and Korea, and is increasingly used in other countries. Endoscopic resection should be curative for ...patients, and safe, easy and effective not only for patients, but also for endoscopists. Endoscopic submucosal dissection (ESD) is superior to standard endoscopic mucosal resection (EMR) as it is designed to provide en bloc R0 resection regardless of size and/or location. Correct pathological assessment of en bloc resected specimens is crucial for accurate diagnosis and patient stratification for the risk of metastasis. Outcome studies in Japan and Korea, countries with the highest incidence of gastric cancer, have shown that ESD is efficacious in leading to a good long‐term outcome; however, ESD requires an experienced endoscopist with a high skill level. Expanded indications for endoscopic resection have been proposed, especially after large en bloc resection have been accomplished using ESD. The use of ESD could be of huge benefit for the management of gastrointestinal superficial neoplasms. However, for ESD to become a viable therapeutic option, it requires close and supportive working relationships between endoscopists, pathologists and surgeons.
Background
Endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) meeting the expanded indication is considered investigational. We aimed to compare long-term outcomes of ESD and ...surgery for EGC in the expanded indication based on each criterion.
Methods
This study included 1823 consecutive EGC patients meeting expanded indication conditions and treated at a tertiary referral center: 916 and 907 patients underwent surgery or ESD, respectively. The expanded indication included four discrete criteria: (I) intramucosal differentiated tumor, without ulcers, size >2 cm; (II) intramucosal differentiated tumor, with ulcers, size ≤3 cm; (III) intramucosal undifferentiated tumor, without ulcers, size ≤2 cm; and (IV) submucosal invasion <500 μm (sm1), differentiated tumor, size ≤3 cm. We selected 522 patients in each group by propensity score matching and retrospectively evaluated each group. The primary outcome was overall survival (OS); the secondary outcomes were disease-specific survival (DSS), recurrence-free survival (RFS), and treatment-related complications.
Results
In all patients and subgroups meeting each criterion, OS and DSS were not significantly different between groups (OS and DSS, all patients:
p
= 0.354 and
p
= 0.930; criteria I:
p
= 0.558 and
p
= 0.688; criterion II:
p
= 1.000 and
p
= 1.000; criterion III:
p
= 0.750 and
p
= 0.799; and criterion IV:
p
= 0.599 and
p
= 0.871). RFS, in all patients and criterion I, was significantly shorter in the ESD group than in the surgery group (
p
< 0.001 and
p
< 0.003, respectively). The surgery group showed higher rates of late and severe treatment-related complications than the ESD group.
Conclusions
ESD may be an alternative treatment option to surgery for EGCs meeting expanded indications, including undifferentiated-type tumors.
Background and Aim
Although Dieulafoy's lesion (DL) is an important cause of nonvariceal upper gastrointestinal (GI) bleeding, few studies have investigated the clinico‐epidemiological outcomes due ...to its rarity. Here, we investigated clinical features of upper GI bleeding caused by peptic ulcer (PU) or DL and compared endoscopic treatment outcomes.
Methods
Patients with upper GI bleeding resulting from PU or DL who visited emergency room between January 2013 and December 2017 were eligible. Clinical features and treatment outcomes were retrospectively investigated.
Results
Overall, 728 patients with upper GI bleeding due to PU (n = 669) and DL (n = 59) were enrolled. The median age was 64 years (interquartile range IQR, 56–75 years), and 74.3% were male. Endoscopic intervention was performed in 53.7% (n = 359) and 98.3% (n = 58) of the PU and DL groups, respectively (P < 0.0001). Patients were matched by sex, age, body mass index, comorbidity, and past medical history, and 190 PU and 52 DL were finally selected. The rebleeding rates within 7 (7.37% vs 17.31%, P = 0.037) and 30 (7.37% vs 26.92%, P < 0.001) days after initial endoscopy were significantly lower in the PU than in the DL group after propensity score matching. During the median follow‐up period of 52 months (IQR, 34–70 months), there was no difference in overall survival rate (67.9% vs 82.7%, P = 0.518).
Conclusions
Although DL is a rare cause of upper GI bleeding, it requires endoscopic hemostasis more frequently and has a higher rate of rebleeding than PU even after therapeutic endoscopy. Endoscopists should pay attention and perform active endoscopic hemostasis for DL bleeding.
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