Novel gastric endoscopic submucosal dissection training model enhances the endoscopic submucosal dissection skills of trainees: a multicenter comparative study.

BACKGROUND: Endoscopic submucosal dissection (ESD) requires high endoscopic technical skills, and trainees should develop effective training methods. In collaboration with KOTOBUKI Medical, we developed the G-Master, which is a non-animal training model that can simulate various parts of gastric ESD. We aimed to clarify the usefulness of the G-Master for inexperienced ESD trainees. METHODS: We collected data from the first 5 gastric ESD cases conducted by 15 inexperienced ESD trainees at 5 participating centers between 2018 and 2022. The participants were divided into two groups: the G-Master training and non-G-Master training groups. Outcome measurements, such as procedural speed, perforation rate, self-completion rate, and en bloc resection rate, were compared between the two groups retrospectively. RESULTS: A total of 75 gastric ESD cases were included in this study. The G-Master training group included 25 cases performed by 5 trainees, whereas the non-G-Master training group included 50 cases performed by 10 trainees. The median procedural speed for all cases was significantly faster in the G-Master training group than in the non-G-Master training group. Moreover, the procedural speed was linearly improved from the initial to the last cases in the lower location in the G-Master training group compared with the non-G-Master training group. In addition, although there was no significant difference, the G-Master training group showed lower rates of perforation and a lesser need to transition to expert operators than the non-G-Master training group. CONCLUSION: The G-Master could improve the ESD skills of inexperienced ESD trainees.

[Indications and Outcomes of Laparoscopic Endoscopic Cooperative Surgery(LECS)for Gastric Gastrointestinal Stromal Tumor].

Laparoscopic and endoscopic cooperative surgery(LECS)for gastric gastrointestinal stromal tumor(GIST)has become a popular surgery with both curability and functional preservation. In this study, we examined the outcomes of 14 patients who underwent classical LECS or CLEAN-NET in our hospital. Until March 2022, classical LECS was performed in patients with intraluminal growth tumors or tumors close to the gastroesophageal junction. After April 2022, classical LECS was performed in patients with intraluminal growth tumors without ulceration, and CLEAN-NET was performed in patients with ulceration or intramural growth tumors. There were 10 males and 4 females with a median age of 80.5 years. Intraluminal growth tumor were 8 patients, close to the gastroesophageal junction tumor were 3, and intramural growth tumor were 4, respectively. Five of these patients had tumors with ulceration. Classical LECS was performed in 10 patients and CLEAN-NET in 4 patients, and the median operative time was 165.5 minutes. All patients underwent R0 resection, and no postoperative complications or recurrences were observed. LECS was performed safely, and it is important to select the surgical procedure according to the tumor site and growth type.

Safety and efficacy of atezolizumab plus bevacizumab in patients with unresectable hepatocellular carcinoma in early clinical practice: A multicenter analysis.

PURPOSE: To assess the impact of clinical factors on the safety and efficacy of atezolizumab plus bevacizumab (ATZ + BV) treatment in patients with unresectable hepatocellular carcinoma (u-HCC). METHOD: Ninety-four u-HCC patients who were treated with ATZ + BV at multiple centers were enrolled. We defined Child-Pugh (CP)-A patients who received ATZ + BV treatment as a first line therapy as the 'meets the broad sense of the IMbrave150 criteria' group (B-IMbrave150-in, n = 46), and patients who received ATZ + BV treatment as a later line therapy or CP-B patients (regardless of whether ATZ + BV was a first line or later line therapy) as the B-IMbrave150-out group (n = 48). Patients were retrospectively analyzed for adverse events (AEs) and treatment outcomes according to their clinical characteristics, including neutrophil lymphocyte ratio (NLR) at baseline. RESULTS: The overall incidence of AEs was 87.2% (82/94 patients). The frequency of interruption of ATZ + BV treatment due to fatigue was higher in CP-B than CP-A patients (p = 0.030). Objective response (OR) rates of the B-IMbrave150-in group (28.3%, 39.1%) were significantly higher than those of the B-IMbrave150-out group (8.3%, 18.8%; p = 0.0157, 0.0401) using Response Evaluation Criteria in Solid Tumors (RECIST) and modified RECIST, respectively. In multivariate analysis, NLR (hazard ratio (HR), 4.591; p = 0.0160) and B-IMbrave150 criteria (HR, 4.108; p = 0.0261) were independent factors associated with the OR of ATZ + BV treatment using RECIST. CONCLUSION: In real-world practice, ATZ + BV treatment might offer significant benefits in patients who meet B-IMbrave150 criteria or have low NLR.

[Outcomes of laparoscopic surgery after preoperative metallic stent placement for obstructive colorectal cancer].

AIM: To assess the outcomes of preoperative colonic stent placement for obstructive colorectal cancer. PATIENTS AND METHODS: A total of 30 patients with colorectal cancer were treated after preoperative colonic metallic stent placement between July 2012 and March 2014. We reviewed their medical records to assess the usefulness of stent placement and the clinical course. The effects of various clinicopathological variables on post-operative complications were analyzed statistically. RESULTS: Stent insertion was effective in 93% of the 30 patients with obstructive colorectal cancer. Preoperative colonoscopy or enema for proximal colonic survey was possible in 70% of the patients after stent placement; colonic lesions requiring simultaneous resection were noted in 5 patients (24%). The mean interval between stent insertion and operation was 19 days, and 23%of the patients underwent laparoscopic surgery. Statistical analysis revealed that the occurrence of complications was associated with laparoscopic surgery and the amount of operative blood loss. CONCLUSION: Preoperative stent placement in patients with obstructive colorectal cancer is feasible and laparoscopic surgery can be selected after stent placement.

Risk factors for colonic diverticular hemorrhage: Japanese multicenter study.

BACKGROUND AND AIM: Diverticular hemorrhage is the common cause of lower gastrointestinal bleeding, and its incidence has been increasing in Japan. However, the exact cause of diverticular hemorrhage is not well understood. We investigated the risk factors for diverticular hemorrhage. METHODS: We selected 103 patients with diverticular hemorrhage as cases and patients with colonic diverticulosis without a history of bleeding were selected as control subjects, exactly matched for age and gender. We collected the data from the medical records of each of the patients, such as those related to the comorbidities, medications and findings of colonoscopy, and conducted a matched case-control study to analyze the risk factors for diverticular hemorrhage. RESULTS: Both groups were composed of 75 men and 28 women. The median age of the patients in both groups was 72.0 years (47.0-87.0). The body weight (p = 0.0065), body mass index (p = 0.006), prevalence of hypertension (p = 0.0242), prevalence of ischemic heart disease (p = 0.0015), and frequency of use of low-dose aspirin (p = 0.042) were significantly different between the two groups. The percentage of patients with bilateral diverticula, that is, diverticula on both the right and left hemicolon, was significantly higher in the diverticular hemorrhage group (p = 0.0011). Multiple regression analysis identified only the diverticular location as being significantly associated with the risk of diverticular hemorrhage (p = 0.0021). CONCLUSIONS: Only the diverticular location (bilateral) was found to be an independent risk factor for diverticular hemorrhage.

A new non-invasive modality for recording sequential images and the pH of the small bowel.

BACKGROUND/AIMS: Before the introduction of capsule endoscopy and double-balloon endoscopy, there were no effective modalities for reliable evaluation of the small bowel. Recently, the SmartPill, a wireless pH/ pressure recording capsule, has been utilized to measure the whole gut transit time. However, there are few studies on the small bowel pH. The aim of this study was to investigate the relationship between small bowel disease and the small bowel pH, we designed a new modality, the 'pH capsule', to non-invasively record sequential images and the pH. METHODOLOGY: Ten healthy male volunteers swallowed the 'pH capsule' with 50mL of water. The 'pH capsule' transmitted the acquired images and the pH to the recorder unit located outside the body for about ten hours while the subject was fasting. RESULTS: All subjects completed this study. The intragastric pH was low and the pH in the whole small intestine was 7.61, 7.55: 7.2-8.1 (mean, median: range). The pH value increased from the duodenum to the terminal ileum (p<0.0001). CONCLUSIONS: We could non-invasively monitor sequential images and the pH of the small intestine with this new modality. The 'pH capsule' is expected to become a valuable tool for clinical assessment of the small bowel.

Optimal approach for small bowel capsule endoscopy using polyethylene glycol and metoclopramide with the assistance of a real-time viewer.

AIM: Capsule endoscopy is limited by the poor image quality of the distal bowel and incomplete small bowel transit. The aim of this study was to establish an optimal medication protocol for capsule endoscopy performed using a real-time viewer. METHODS: A total of 80 patients were prospectively recruited. The patients were randomized into two groups: the 'conventional group' (without any preparation) and the 'real-time group' (in which a real-time viewer was attached). At 60 min after swallowing the capsule, if the capsule had reached the small bowel, 500 ml of polyethylene glycol was administered; if the capsule was still located in the stomach, 10 mg of metoclopramide was given intramuscularly, followed by 500 ml of polyethylene glycol solution. RESULTS: The completion rate was significantly higher in the real-time group as compared with that in the conventional group (72.5 vs. 90.0%). Our protocol yielded a significantly improved image quality of the distal small bowel [image quality score = 1.6 vs. 3.0 (max 4.0)]. The detection rate of lesions in the distal small bowel was higher in the real-time group than in the conventional group. CONCLUSIONS: The present study clearly showed that our protocol yielded an improved completion rate and also improved image quality.

Influence of pretreatment with H2 receptor antagonists on the cure rates of Helicobacter pylori eradication.

BACKGROUND: Pretreatment with a proton pump inhibitor (PPI) reportedly decreases the efficacy of Helicobacter pylori (H. pylori) eradication, however, the effect of pretreatment with an H2 receptor antagonist (H2RA) on H. pylori eradication has not yet been studied. We compared the efficacy of eradication regimen (lansoprazole/amoxicillin/clarithromycin) in patients with H. pylori infection with or without H2RA pretreatment. MATERIAL/METHODS: In this retrospective study conducted at three centers, 310 patients with H. pylori infection were treated. The diagnosis of H. pylori infection was made using the rapid urease test, bacterial cultures and histological examination of endoscopic biopsy specimens. The patients were assigned to receive an eradication regimen first or following pretreatment with H2RA. Eradication was assessed using the 13C-urea breath test more than 4 weeks after the completion of therapy. RESULTS: Overall, H. pylori was eradicated in 79.7% of the cases: the eradication rate was 81.6% in the pretreatment group, and 77.6% in the eradication first group (p=0.3799, chi-square test). No significant difference in the eradication rate was observed between the two groups. CONCLUSIONS: Pretreatment with H2RA had no significant influence on the efficacy of H. pylori eradication therapy.

Risk factors for mortality in patients with Mallory-Weiss syndrome.

BACKGROUND/AIMS: Although the majority of patients with Mallory-Weiss syndrome (MWS) have a benign course, in some patients MWS results in a fatal outcome. Therefore, this study was carried out to analyze the risk factors for mortality in patients with MWS. METHODOLOGY: The medical records of patients with MWS seen between March 1994 and July 2007 were reviewed retrospectively. The demographic characteristics, clinical and laboratory parameters, and endoscopic findings of the patients were analyzed and the risk factors for mortality were evaluated. RESULTS: A total of ninety-three patients (13 female and 80 male patients; median age, 53 years) were treated. The mortality rate was 9.7% (9/93). The patients with a fatal outcome were of advanced age and had a higher frequency of shock on arrival, lower hemoglobin level, more prolonged prothrombin time, higher AST and ALT levels, higher frequency of detection of exposed vessels on endoscopy, higher frequency of rebleeding, longer hospital stay, and required a larger volume of blood transfusion than those who did not have a fatal outcome. According to the results of a multivariate analysis, the significant risk factors for mortality in the MWS patients were advanced age (OR 1.222, 95% CI 1.015-1.028), very low hemoglobin level (OR 2.137, 95% CI 1.063-4.295), elevated AST level (OR 1.007, 95% CI 1.001-1.013), and presence of the clinical symptom of tarry stool (OR 45.45, 95% CI 1.080-1000). CONCLUSIONS: Intensive care with close monitoring is required for patients of advanced age with a low hemoglobin level, an elevated AST level, and the clinical symptom of tarry stool, since these are of prognostic importance in terms of the mortality in MWS patients.

Effects of domperidone on gastric emptying: a crossover study using a continuous real-time 13C breath test (BreathID system).

BACKGROUND/AIMS: To determine the correlation between domperidone and gastric emptying using the continuous real time 13C breath-test (BreathID system), a novel non-invasive technique for measuring gastric emptying. METHODOLOGY: Six healthy male volunteers participated in this randomized, two-way crossover study. Subjects fasted overnight and were randomly assigned to receive a test meal (400kcal per 400mL) 30 minutes after intake of domperidone (10mg) with 50 mL of water or intake of 50 mL of water alone. Gastric emptying was monitored for 4h after administration of the test meal by 13C-acetic acid breath test continually performed using the BreathID system. The time taken for emptying of 50% of the labeled meals (T1/2), the analog to the scintigraphy lag time for 10% emptying of the labeled meal (T lag), the gastric emptying coefficient (GEC), and the regression-estimated constants (beta and kappa) were calculated. Differences in the parameters measured at two time-points were analyzed using the Wilcoxon's signed-rank test. RESULTS: No significant differences in calculated parameters (T lag, T1/2, GEC, beta or kappa) were observed between the treated and non-treated groups. CONCLUSIONS: This study showed that domperidone had no effect on gastric emptying. The drug ameliorates nausea and vomiting via its antagonic activity against dopamine receptor. Therefore, domperidone probably ameliorates nausea through other mechanisms.

Does postprandial itopride intake affect the rate of gastric emptying? A crossover study using the continuous real time 13C breath test (BreathID system).

BACKGROUND/AIMS: The aim of this study was to determine whether oral Itopride hydrochloride (itopride) intake might have any effect on the rate of gastric emptying, using a novel non-invasive technique for measuring the rate of gastric emptying, namely, the continuous real time 13C breath test (BreathID system: Exalenz Bioscience Ltd., Israel). METHODOLOGY: Eight healthy male volunteers participated in this randomized, two-way crossover study. The subjects fasted overnight and were randomly assigned to receive 50mg itopride following a test meal (200 kcal per 200mL, containing 100mg 13C acetate), or the test meal alone. Under both conditions, gastric emptying was monitored for 4 hours after administration of the test meal by the 13C-acetic acid breath test performed continually using the BreathID system. Using Oridion Research Software (beta version), the time required for emptying of 50% of the labeled meal (T 1/2), the analog to the scintigraphy lag time for 10% emptying of the labeled meal (T lag), the gastric emptying coefficient (GEC), and the regression-estimated constants (beta and kappa) were calculated. The parameters measured under the two conditions were compared using the Wilcoxon's signed-rank test. RESULTS: No significant differences in the calculated parameters, namely, the T 1/2, T lag, GEC, beta or kappa, were observed between the two test conditions, namely, administration of a test meal+itopride and administration of the test meal alone. CONCLUSIONS: The present study revealed that postprandial itopride intake had no significant influence on the rate of gastric emptying. Recently, several studies have shown that itopride may be effective in the treatment of patients with functional dyspepsia. Our results suggest that the efficacy of itopride in patients with functional dyspepsia may be based on its effect of improving functions other than the rate of gastric emptying, such as the activities at neuronal sites, brain-gut correlation, visceral hypersensitivity, gastric accommodation and distension-induced adaptation.

Early effects of oral administration of lafutidine with peppermint oil, compared with lafutidine alone, on intragastric pH values.

BACKGROUND/AIMS: Ideally, medications for the treatment of acid-related diseases should have a rapid onset of action to promote hemostasis and the resolution of symptoms. The aim of our study was to investigate the inhibitory effects on gastric acid secretion of a single oral administration of lafutidine alone or combined with peppermint oil. METHODOLOGY: Ten Helicobacter pylori-negative male subjects participated in this randomized, two-way crossover study. Intragastric pH was monitored continuously for 4 hours after a single oral administration of lafutidine (10 mg) or the administration of lafutidine (10 mg) with peppermint oil (0.64 mL). Each administration was separated by a 7-day washout period. RESULTS: No significant difference in the average pH was observed during the 4-hour period after the combined administration of lafutidine and peppermint oil and after the administration of lafutidine alone (median gastric pH: 5.09 versus 5.29; p = 0.3122). CONCLUSIONS: In H. pylori-negative healthy male subjects, an oral dose of lafutidine combined with peppermint oil did not increase the intragastric pH faster than lafutidine alone.

Quantitative analysis of low-dose aspirin-associated small bowel injury using a capsule endoscopy scoring index.

AIM: The major limitation of capsule endoscopy (CE) has been the lack of a standardized and validated severity scale for mucosal injury. The aim of the present study was to verify the usefulness of quantifying small bowel mucosal changes associated with giving low-dose aspirin (LDA) using a CE scoring index. METHODS: The CE score for small bowel mucosal injury was investigated to evaluate the severity of mucosal injury. Healthy volunteers and patients suspected of having small bowel disease were recruited for this study. The short-term LDA group (V+S-LDA group) consisted of volunteers who took low-dose aspirin for 14days; this group was then compared with healthy volunteers who did not receive LDA treatment (V-Control group). The long-term LDA group (L-LDA group) consisted of patients with at least a 3-month history of daily LDA use; this group was compared with non-users of LDA (P-Control group). RESULTS: The CE score was significantly higher in the V+S-LDA group than in the V-Control group. In the V-Control group, almost all the subjects were categorized as exhibiting a 'normal' change. 'Mild' changes were observed significantly more frequently in the V + S-LDA group than in the V-Control group. The CE score was significantly higher in the L-LDA group than in the P-Control group. 'Mild' or 'moderate or severe' changes were observed significantly more frequently in the L-LDA group than in the P-Control group. CONCLUSION: The CE scoring system was useful for evaluating LDA-associated small bowel mucosal disease activity and for objectively scoring the small bowel inflammatory disease state.

Gastric surgery is not a risk factor for erosive esophagitis or Barrett's esophagus.

OBJECTIVE: The role of gastric acid reflux is difficult to separate from that of pancreatic-biliary reflux in the pathogenesis of erosive esophagitis (EE) and Barrett's esophagus (BE). Gastric surgery patients provide a good model for both significant pancreatic-biliary reflux and marked gastric acid inhibition. We assessed the risk of EE and BE after distal gastrectomy in a case-controlled study. MATERIAL AND METHODS: One hundred and sixty patients (121 men, 39 women; median age 68 years; range 32-86 years) with distal gastrectomies (Billroth-I) and 160 sex- and age-matched controls with intact stomachs were enrolled. The presence of EE and BE were diagnosed based on the Los Angeles Classification and the Prague C & M Criteria, respectively. A conditional logistic regression model with adjustments for potential confounding factors was used to assess the associations. RESULTS: According to the multivariate analyses, patients with distal gastrectomies tended to have inverse associations with the risks of EE and BE, and the inverse association with the risk of BE reached a significant level. CONCLUSIONS: Distal gastrectomy is not a risk factor for the development of EE and BE. This lack of a positive association between distal gastrectomy and EE and BE may suggest that pancreatic-biliary reflux with a limited amount of acid is not sufficient to damage the esophageal mucosa.

Ulcerative colitis with multidrug-resistant Pseudomonas aeruginosa infection successfully treated with bifidobacterium.

A 71-year-old man was diagnosed with ulcerative colitis (UC) complicated by bacterial infections, and his active disease proved difficult to treat with steroid therapy or antibiotics. Although the patient's UC failed to respond to several types of induction therapy, his condition finally improved when treated using Bifidobacterium. Probiotics could be one of the treatment agents for induction of remission in UC.

The histamine H2 receptor antagonist lafutidine in Japanese patients with non-erosive reflux disease.

BACKGROUND/AIMS: This study aims to investigate whether histamine H2-receptor antagonists are sufficient to treat nonerosive reflux disease in Japanese patients. The efficacy of lafutidine in Japanese nonerosive reflux disease patients was studied. METHODOLOGY: The subjects were 24 heartburn patients with two or more cases of heartburn in a week before the period of observation, QUEST score of 6 or above and diagnosed as no erosion in esophagus by upper gastrointestinal endoscopy. Following obtained informed consent, gastroesophageal 24-hour pH was monitored after the placebo period (2 weeks) and the completion of the lafitidine period (at the dose of 10 mg twice daily for 4 weeks). RESULTS: Twenty three patients completed the study. The percentage of time that the intraesophageal pH was less than 4 decreased significantly, from 3.07% to 1.17%, after the lafutidine administration. The overall percentage of time that the intragastric pH was above 3 increased significantly from 26.6% to 56.5% after the lafutidine administration, and increased from 22.7% to 51.0% (daytime period) and 34.6% to 67.2% (nighttime period), respectively. Lafutidine markedly improved heartburn and other symptoms, as recorded in patient diaries. CONCLUSIONS: Lafutidine markedly improved the intraesophageal pH and the symptoms of heartburn in Japanese patients with nonerosive reflux disease. Lafutidine also inhibited gastric acid secretion not only during the nighttime but also during the daytime.

Relationship between upper gastrointestinal symptoms and diet therapy: examination using frequency scale for the symptoms of gastroesophageal reflux disease.

BACKGROUND/AIMS: The aim of this study was to evaluate the correlation between gastrointestinal symptoms and diet therapy. METHODOLOGY: The subjects comprised of 8 patients who attended the diabetes division at Fujisawa City Hospital between April and June 2007. The subjects were diagnosed as having diabetes mellitus based on the results of a blood analysis. The body weight of the subjects was measured, and the subjects were asked to score their gastrointestinal symptoms according to the Frequency Scale for the Symptoms of GERD (FSSG) before and after diet therapy for 9 to 14 days. RESULTS: Diet therapy for diabetic subjects was effective for weight reduction. The total FSSG score was decreased, and the reduction in dysmotility-like symptoms was greater than the reduction in acid-reflux-related symptoms. CONCLUSIONS: Diet therapy for mild diabetic patients also improves gastrointestinal symptoms.

Early complications following percutaneous endoscopic gastrostomy: results of use of a new direct technique.

BACKGROUND/AIMS: Percutaneous endoscopic gastrostomy is the standard method for enteral feeding in patients predicted to require long-term enteral nutrition because of dysphagia. A direct techinique with gastropexy is available, in which oropharyngeal passage of the internal bumper can be avoided. The aim of this study was to assess the early complications of percutaneous endoscopic gastrostomy performed using the new direct technique. METHODOLOGY: Between August 2005 and July 2009, 231 patients underwent percutaneous endoscopic gastrostomy at our hospital. We analyzed the clinical characteristics of the patients related to the development of early complications such as bleeding or local infection. Early complications were defined as complications occurring within 7 days of the percutaneous endoscopic gastrostomy. RESULTS: The study population comprised 231 patients: 157 men and 74 women (median age, 73 years; range, 28-92 years). The percutaneous endoscopic gastrostomy was performed using the pull-through technique in 134 of these patients (58%), whereas the direct technique with gastropexy was employed in the remaining 97 patients (42%). In the multiple logistic regression analyses, only the use/non-use of the direct technique was identified as a variable significantly associated with the incidence of bleeding (odds ratio 5.236, 95% confidence interval 1.040-26.316; p = 0.0447) and the incidence of local infection (odds ratio 0.283, 95% confidence interval 0.100-0.802; p = 0.0175). CONCLUSIONS: Use of the direct technique for performing percutaneous endoscopic gastrostomy was associated with the increased incidence of the early complication of bleeding, but the decreased incidence of local infection.

Does pretreatment with proton pump inhibitors influence the eradication rate of Helicobacter pylori?

BACKGROUND/AIMS: Pretreatment with a proton pump inhibitor (PPI) has been reported to decrease the efficacy of Helicobacter pylori (H. pylori) eradication. We compared the efficacy of an eradication regimen (lansoprazole/amoxicillin/clarithromycin) first or following pretreatment with a PPI. METHODOLOGY: In this retrospective study conducted at three centers, 353 patients infected with H. pylori were treated. The H. pylori status was determined using the rapid urease test, bacterial cultures, and the histological examination of endoscopic biopsy specimens, The patients were assigned to receive an eradication regimen first or following pretreatment with a PPI. Eradication was assessed using the 13C-urea breath test more than 4 weeks after the completion of therapy. RESULTS: Overall, H. pylori was eradicated in 78.8% of the cases: 79.6% in the pretreatment group, and 77.6% in the eradication first group (p = 0.6541 by chi square test). No significant difference in the eradication rates was observed between the two groups. CONCLUSIONS: This retrospective study indicated that pretreatment with a PPI does not significantly reduce the efficacy of eradication therapy in patients infected with H. pylori.

Early effects of oral administration of lafutidine with mosapride compared with lafutidine alone on intragastric pH values.

BACKGROUND: The ideal medication for treatment of acid related diseases should have a rapid onset of action to promote hemostasis and resolution of symptoms. The aim of our study was to investigate the inhibitory effects on gastric acid secretion after a single oral administrations of lafutidine, is a newly synthesized H2-receptor antagonist, with mosapride 5 mg or lafutidine alone. METHODS: Ten Helicobacter pylori negative male subjects participated in this randomized, two-way crossover study. Intragastric pH was monitored continuously for 4 hours after a single oral administration of lafutidine 10 mg or lafutidine 10 mg with mosapride 5 mg (the lafutidine being administrated one hour after the mosapride). Each administration was separated by a 7-day washout period. RESULTS: The average pH during the 4-hour period after administration of lafutidine 10 mg with mosapride 5 mg was higher than after lafutidine 10 mg alone (median: 5.25 versus 4.58, respectively; p = 0.0318). During the 3-4 hour study period, lafutidine 10 mg with mosapride 5 mg provided a higher pH, compared to lafutidine 10 mg alone (median: 7.28 versus 6.42; p = 0.0208). CONCLUSION: In H. pylori negative healthy male subjects, an oral dose of lafutidine 10 mg with mosapride 5 mg more rapidly increased intragastric pH than lafutidine 10 mg alone.