Development and validation of a simple and multifaceted instrument, Chronic Constipation-Therapeutic Efficacy and Satisfaction Test (CC-TEST), for the clinical evaluation of the patients with chronic constipation.

INTRODUCTION: This study evaluated the psychometric properties of the newly developed chronic constipation therapeutic efficacy and satisfaction test (CC-TEST) among patients with chronic constipation. METHODS: Japanese patients with moderate or severe chronic constipation underwent a four-week remedy. The baseline, 2-week, and 4-week assessments included the CC-TEST, Constipation Scoring System (CSS), Medical Outcome Study Short Form-8 Health Survey (SF-8), and Hospital Anxiety and Depression Scale (HADS). The CC-TEST comprises three domains: (1) symptoms; chronic constipation symptom severity (seven items), defecation status (five items), (2) impact for daily life; dissatisfaction with daily life level (DS; four items), and (3) therapeutic response; therapeutic efficacy measured by patients and medication compliance (four items). RESULTS: Of 201 eligible patients at baseline, 110 completed the 4-week treatment and the survey responses. Cronbach's α values for the stool, defecation, and abdominal symptom subscales, as well as the total symptom score and DS subscale, showed good internal consistency reliability (0.72 - 0.80). Pearson's r for comparisons between corresponding items (CC-TEST symptoms with CSS, and CC-TEST DS with SF-8 physical and mental component summary scores) was significant. After 4 weeks, scores for symptoms, defecation status, and DS items/subscales notably decreased, with a significant effect size (P < 0.005, Cohen's d; 0.30-1.16). Statistically significant differences emerged between treatment responders and non-responders using the three responder definitions, in changes in scores for most CC-TEST symptoms, defecation status, and DS items/subscales (P < 0.05). CONCLUSION: CC-TEST demonstrates commendable reliability, convergent and known-group validity, and responsiveness to treatment effects. As a simple, comprehensive, and versatile patient-reported outcome measure, CC-TEST may be well suited for clinical trials and primary care of Japanese patients with chronic constipation.

Utility of urinary presepsin in the diagnosis of pyelonephritis: a cross-sectional study.

BACKGROUND: Presepsin is produced during the phagocytosis of bacteria by granulocytes. Presepsin increases at the site of infection; however, the significance of urinary presepsin in pyelonephritis is unknown. This study aimed to evaluate whether measuring urinary presepsin can distinguish between pyelonephritis and nonpyelonephritis. METHODS: A cross-sectional study of patients with suspected pyelonephritis was conducted. Urinary presepsin at admission was compared between the pyelonephritis and nonpyelonephritis groups using the Mann-Whitney test. The predictive accuracy of urinary presepsin for diagnosing pyelonephritis was evaluated by the area under the receiver operating characteristics (ROC) analysis curve. RESULTS: A total of 35 eligible participants were included in the pyelonephritis group and 25 in the nonpyelonephritis group. The median urinary presepsin level was 2232.0 (interquartile range [IQR], 1029.0-3907.0) pg/mL in the pyelonephritis group and 1348.0 (IQR, 614.5-2304.8) pg/mL in the nonpyelonephritis group. Urinary presepsin concentrations were significantly higher in the pyelonephritis group than in the nonpyelonephritis group (P = 0.023). ROC analysis of urinary presepsin revealed a cutoff value of 3650 pg/mL to distinguish between the pyelonephritis and nonpyelonephritis groups. Sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio for the diagnosis of pyelonephritis were 0.40 (95% confidence interval [CI], 0.24-0.58), 0.96 (95% CI, 0.79-1.00), 0.93 (95% CI, 0.68-1.00), 0.52 (95% CI, 0.37-0.68), 9.60 (95% CI, 1.35-68.23), and 0.62 (95% CI, 0.47-0.83), respectively. CONCLUSIONS: The measurement of urinary presepsin is useful in differentiating pyelonephritis from other diseases.

A comparison of the effects of anti-reflux procedures during esophagogastrostomy after proximal gastrectomy on the postoperative quality of life.

PURPOSE: To investigate the postoperative quality of life (QOL) in patients with proximal gastric cancer (PGC) or esophago-gastric junction cancer, a nationwide multi-institutional study (PGSAS NEXT trial) was conducted. METHODS: Patients who had undergone radical resection more than 6 months previously were enrolled from 70 Japanese institutions between July 2018 and June 2020. The Postgastrectomy Syndrome Assessment Scale (PGSAS)-45 questionnaire was distributed to eligible patients, and responses were collected by mail. The main outcome measures of the PGSAS-45 were then calculated and compared. RESULTS: Questionnaires were retrieved from 1950 participants, and data from 300 patients who had undergone a proximal gastrectomy (PG) with esophagogastrostomy for PGC were analyzed. The mean esophageal reflux subscale value was 1.9 among the 276 patients who underwent an anti-reflux procedure, which was significantly better than the mean value (2.6) for the 21 patients who did not undergo an anti-reflux procedure (p = 0.002). The esophageal reflux subscale values were also compared among 3 major anti-reflux procedures: the double-flap technique (N = 153), the pseudo-fornix and/or His angle formation (N = 67), and fundoplication (N = 44); no statistically significant differences were observed. CONCLUSION: An anti-reflux procedure during esophagogastrostomy after PG for PGC is necessary to improve postoperative esophageal reflux symptoms, regardless of the type of procedure. TRIAL REGISTRATION: The PGSAS NEXT study was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR; registration number: 000032221).

Causal effect of anxiety and depression status on the symptoms of gastroesophageal reflux disease and functional dyspepsia during proton pump inhibitor therapy.

BACKGROUND: Although anxiety and depression status is considered related to gastroesophageal reflux disease (GERD) and functional dyspepsia (FD) symptoms, ambiguity primarily arises from the difficulty in determining their cause-effect relationships. We aimed to examine the longitudinal reciprocal causation between anxiety/depression status and GERD/FD symptoms among symptomatic adult patients with GERD. METHODS: Adult (≥ 20 years) patients with GERD symptoms received PPI treatment for 4 weeks after endoscopy. GERD and FD symptom subscales (GERD-SS/FD-SS) were evaluated using the gastroesophageal reflux and dyspepsia therapeutic efficacy and satisfaction test (GERD-TEST). Anxiety and depression status were evaluated using the hospital anxiety and depression scale (HADS). A cross-lagged analysis using structural equation modeling was conducted to examine causal relationships among psychiatric bias (anxiety and depression scores) and upper gastrointestinal symptoms (GERD-SS and FD-SS scores) over time. RESULTS: A total of 182 patients with GERD (men: 120; age: 57.1 ± 12.8 years; body mass index: 24.2 ± 4.1 kg/m2; nonerosive reflux disease/erosive reflux disease: 61/121) were eligible before (T1) and after 4 weeks (T2) of PPI therapy. The cross-lagged effect model indicated that anxiety at T1 contributed to the FD-SS at T2 (ß = 0.18*) and depression at T1 contributed to the GERD-SS at T2 (ß = 0.23*) (*p < 0.05). CONCLUSION: Psychiatric bias was a risk factor for refractory GERD and FD. Anxiety and depression status reduced the therapeutic effect of PPIs on GERD and FD symptoms. Therefore, attention is required to detect the anxiety/depression status of patients with GERD/FD symptoms to treat patients appropriately and optimize therapeutic outcomes.

Effects of Proximal Gastrectomy and Various Clinical Factors on Postoperative Quality of Life for Upper-third Gastric Cancer Assessed using the Postgastrectomy Syndrome Assessment Scale-45 (PGSAS-45): A PGSAS NEXT Study.

BACKGROUND: It is important to determine the effect of clinical factors on several domains (symptoms, living status, and quality of life [QOL]) after gastrectomy to establish individualized therapeutic strategies. This study was designed to determine the factors-particularly surgical method-that influence certain domains after gastrectomy for proximal gastric cancer by using the Postgastrectomy Syndrome Assessment Scale-45 (PGSAS-45) questionnaire. METHODS: We conducted a nationwide study of PGSAS-45 questionnaire responses retrieved from 1950 (82.5%) patients from 70 institutions who had undergone gastrectomy for gastric cancer. Of these, 1,538 responses for proximal gastric cancer (1020 total gastrectomies and 518 proximal gastrectomies [PGs]) were examined. RESULTS: PG significantly and favorably affected four main outcome measures (MOMs): elderly affected 10 MOMs, male sex affected 4 MOMs, longer postoperative period affected 8 MOMs, preservation of the vagus nerve affected 1 MOM, adjuvant chemotherapy affected 1 MOM, clinical stage affected 2 MOMs, and more extensive lymph node dissection affected 2 MOMs. However, the laparoscopic approach had an adverse effect on MOMs and combined resection of other organs had no favorable effect on any MOMs. CONCLUSIONS: This PGSAS NEXT study showed that it is better to perform PG for proximal gastric cancer, even for patients with advanced cancer, to obtain favorable postoperative QOL if oncological safety is guaranteed. Because the MOMs of PGSAS-45 are positively and negatively influenced by various background factors, it also is necessary to provide personalized care for each patient to prevent deterioration and further improve symptoms, living status, and QOL postoperatively.

Simple modifications of conventional esophagogastrostomy after proximal gastrectomy adequately reduces the postoperative reflux esophagitis: a retrospective analysis of posterolateral fundoplication.

PURPOSE: While proximal gastrectomy is being performed increasingly frequently for the treatment of gastric cancer, a standard reconstruction method to obtain optimal postoperative quality of life (QOL) still remains to be established. We modified the original esophagogastrostomy technique by introducing an additional posterolateral fundoplication (PLF) technique to minimize the risk of reflux esophagitis in patients undergoing proximal gastrectomy. The aim of this study was to clarify the clinical benefit of PLF. METHODS: A retrospective analysis of the database was conducted to evaluate the effects of PLF. The data were compared between 44 patients in whom PLF was performed (PLF group) and 17 patients in whom conventional esophagogastrostomy without PLF was performed (C group). A number of incidence of postoperative reflux esophagitis and symptoms were assessed by findings of endoscopic examination and the PGSAS-45 questionnaire, respectively. RESULTS: The incidence of grade B or worse esophagitis after surgery was significantly lower in the PLF group than in the C group (0% vs. 58.8%, P < 0.01). The score for the esophageal reflux subscale, as the main outcome measure of PGSAS-45, was significantly better in the PLF group (PLF: 1.5 vs C: 2.4, P < 0.01). Cohen's d value was 1.75, which suggested a rather large effect size. Postoperative benign anastomotic stricture was encountered in 10 cases (22.7%) of the PLF group and 4 cases (23.5%) of the C group, all of whom were successfully treated by brief endoscopic mechanical dilatation. CONCLUSION: PLF is an expedient procedure for reconstruction after proximal gastrectomy.

The evaluation of the postoperative quality of life in patients undergoing radical gastrectomy for esophagogastric junction cancer using the Postgastrectomy Syndrome Assessment Scale-45: a nationwide multi-institutional study.

PURPOSE: This retrospective nationwide survey investigated the quality of life (QOL) of patients with esophagogastric junction cancer after gastrectomy using the Postgastrectomy Syndrome Assessment Scale-45. METHODS: The Postgastrectomy Syndrome Assessment Scale-45 comprises 45 questions classified into symptoms, living status, and QOL domains. A total of 1950 gastrectomized patients with upper-third gastric or esophagogastric junction cancer returned the completed forms. Among them, 224 eligible patients with esophagogastric junction cancer were selected, including 86, 120, and 18 patients who underwent total gastrectomy, proximal gastrectomy (reconstruction-esophagogastrostomy: 56; double-tract method: 51), and other procedures, respectively. RESULTS: The postoperative period was significantly shorter (47 ± 30 vs. 34 ± 30 months, p = 0.002), and the rates of early-stage disease and minimally invasive approaches significantly higher (both p < 0.001) in the proximal gastrectomy group than in the total gastrectomy group. Despite advantageous background factors for proximal gastrectomy, the postoperative QOL did not differ markedly between the groups. Compared to patients who underwent reconstruction with the double-tract method, patients who underwent esophagogastrostomy had significantly larger remnant stomachs but a similar QOL. CONCLUSION: Even with total gastrectomy, a postoperative QOL comparable to that with proximal gastrectomy can be maintained. Clarifying the optimal reconstruction methods for proximal gastrectomy for esophagogastric junction cancer is warranted. TRIAL REGISTRATION: This study was registered at the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR; registration number: 000032221).

Sex differences in risk factors for future onset of reflux esophagitis.

Reflux esophagitis is known to be more prevalent in males, and previous studies have suggested sex differences in its risk factors. However, little is known about sex differences in the time-course of risk factors before reflux esophagitis onset. Thus, we conducted a retrospective longitudinal study using health checkup records. From the records of 230,056 individuals obtained from nine institutes in Japan, we selected 1,558 male reflux esophagitis cases, 3,116 male controls, 508 female reflux esophagitis cases, and 1,016 female controls were selected. We compared time-courses of risk factors between the case and control groups and identified abdominal circumference (AC), diastolic blood pressure, alanine transaminase (ALT), and current smoking in males and body mass index (BMI) in females as sex-specific risk factors. We also found that AC and ALT in males and BMI in females were significantly different between the reflux esophagitis case and control groups during the five years before reflux esophagitis onset. Our results suggest that visceral fat-type obesity and fatty liver in males and higher BMI in females are more frequently observed in reflux esophagitis cases several years before reflux esophagitis onset, and that proactive intervention to lifestyle can help prevent reflux esophagitis in both males and females.

Effects of coexisting upper gastrointestinal symptoms on daily life and quality of life in patients with gastroesophageal reflux disease symptoms.

BACKGROUND AND AIM: Gastroesophageal reflux disease (GERD) is a common disease encountered in daily medical care and clinical problem which hampers daily life and reduces quality of life (QOL). The coexistence of GERD-related symptoms with the typical GERD symptoms, such as heartburn or acid regurgitation, and various upper abdominal symptoms is frequently observed in patients with GERD. However, the effect of these coexisting symptoms on the daily life and QOL of patients with GERD has not been clarified. Therefore, the effects of the various upper abdominal symptoms coexisting with GERD on the daily life and QOL of such patients were compared. METHODS: A total of 113 newly diagnosed patients who visited our hospital with typical GERD symptoms were assessed using the modified frequency scale for the symptoms of GERD (MFSSG), gastroesophageal reflux and dyspepsia therapeutic efficacy and satisfaction test (GERD-TEST), and short-form 8-item health survey (SF-8) questionnaires. The "gastroesophageal reflux symptom" (7 items) and "dyspepsia symptom" (7 items) groups were divided into two "typical symptoms" and two "atypical symptoms" for a total of four categories. The Pearson's correlation coefficient and multiple regression analysis were used to evaluate the correlations between each symptom category and dissatisfaction for daily life [eating, sleeping, daily activities, mood, as well as dissatisfaction for daily life-symptom subscale (SS), which is the average of the four items in the GERD-TEST, the physical component summary [PCS] and mental component summary [MCS] of the SF-8, and the influence of each symptom category on the daily life and QOL. RESULTS: The incidences of each symptom category in patients with GERD were high: typical GERD (100%), atypical GERD symptoms (67.3%), typical functional dyspepsia (FD) (71.7%), and atypical FD (75.2%). Pearson's correlation analysis demonstrated significant correlations between each symptom category and living status (dissatisfactions of eating, sleeping, daily activities, daily life-SS) and almost all items in SF-8 (PCS, MCS) (P < 0.05). Multiple regression analysis indicated the largest influences of each symptom category on living status and QOL in descending order: dissatisfaction for eating (atypical FD, typical FD), daily activities (atypical FD, typical FD, typical GERD), mood (atypical FD), daily life-SS (atypical FD, typical FD), PCS (typical FD), and MCS (atypical FD) (P < 0.05). CONCLUSION: Coexisting FD symptoms, particularly atypical FD symptoms, had a large influence on the impairments of daily life and decreases in QOL. Daily medical care of GERD requires attention to coexisting symptoms and their treatment instead of just focusing on the chief complaints by patients.

The early therapeutic response at 2 weeks is a crucial predictor of proton pump inhibitor-refractory gastroesophageal reflux disease.

BACKGROUND: In recent years, the prevalence of proton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD) has been increasing, posing a clinical obstacle to improving the management of GERD patients. The ability of known predictive factors to explain therapeutic response to PPI remains insufficient. Therefore, we examined whether the addition of early therapeutic response to PPI as an explanatory variable may increase the predictive power for PPI-refractory GERD. METHODS: The severity and therapeutic response of GERD symptoms to PPI were evaluated using the GastroEsophageal Reflux and Dyspepsia Therapeutic Efficacy and Satisfaction Test (GERD-TEST) questionnaire at baseline and at 2 and 4 weeks after treatment. The relevance of the therapeutic effect of PPI at 2 weeks compared to that at 4 weeks was examined in 301 patients with GERD. Independent predictive factors for refractory GERD at 4 weeks of PPI therapy were examined in 182 patients. The effect of various clinical factors, including the early response to PPI, was assessed using multiple regression analysis. RESULTS: The number of PPI-therapy responders increased significantly with the duration of treatment (p < 0.0001). The response to PPI therapy at 2 weeks was significantly correlated with that at 4 weeks (p < 0.0001). Multiple regression analysis revealed that the therapeutic response to PPI at 2 weeks was by far the strongest predictor of the therapeutic effect at 4 weeks among all clinical factors. CONCLUSIONS: Medication change for PPI-refractory GERD at 2 weeks may be an efficacious therapeutic strategy to improve patients' quality of life.

Comparison of Postoperative Quality of Life among Three Different Reconstruction Methods After Proximal Gastrectomy: Insights From the PGSAS Study.

BACKGROUND: Proximal gastrectomy (PG) has become an increasingly preferred procedure for early cancer in the upper third of the stomach, owing to reportedly superior quality of life (QOL) after PG when compared with total gastrectomy. However, various methods of reconstruction have currently been proposed. We compared the postoperative QOL among the three different reconstruction methods after PG using the Postgastrectomy Syndrome Assessment Scale-45 (PGSAS-45) questionnaire. METHODS: Post Gastrectomy Syndrome Assessment Study (PGSAS), a nationwide multi-institutional survey, was conducted to evaluate QOL using the PGSAS-45 among various types of gastrectomy. Of the 2,368 eligible data from the PGSAS survey, data from 193 patients who underwent PG were retrieved and used in the current study. The PGSAS-45 consists of 45 items including 22 original gastrectomy specific items in addition to the SF-8 and GSRS. These were consolidated into 19 main outcome measures pertaining postgastrectomy symptoms, amount of food ingested, quality of ingestion, work, and level of satisfaction for daily work, and the three reconstruction methods (n = 193; 115 esophago-gastrostomy [PGEG], 34 jejunal interposition [PGJI], and 44 jejunal pouch interposition [PGJPI]) were compared using PGSAS-45. RESULTS: Size of the remnant stomach was significantly larger in PGEG, and significantly smaller in PGJI and PGJPI (P < 0.05). There was no difference in other patient background factors among the groups. EGJPI tended to be superior to PGEG in several of the 19 main outcome with marginal significance (P = 0.047-0.076). CONCLUSION: PGJPI appears to be the most favorable of the three reconstruction methods after PG especially when the size of remnant stomach is rather small. TRIAL REGISTRATION NUMBER: UMIN-CTR #000002116 entitled as "A study to observe correlation between resection and reconstruction procedures employed for gastric neoplasms and development of postgastrectomy syndrome".

The prevalence and antimicrobial susceptibility of Streptococcus pneumoniae isolated from patients at Jikei University Hospitals after the implementation of the pneumococcal vaccination program in Japan.

Studies have shown that pneumococcal vaccination reduces the incidence of Streptococcus pneumoniae infections but does not change the prevalence of S. pneumoniae nasopharyngeal colonization. To comprehensively and longitudinally assess the epidemiology of S. pneumoniae after the introduction of pneumococcal vaccination, we monitored the prevalence and antimicrobial susceptibility of S. pneumoniae, irrespective of its serotypes or pathogenicity, by analyzing specimens collected from a large number of patients at Jikei University Hospitals from 2009 to 2017. A total of 5763 S. pneumoniae isolates were identified out of 375,435 specimens from various sources of patients in different age groups. The prevalence of S. pneumoniae isolated only from patients <5 years old was significantly reduced with the widespread use of pneumococcal vaccines, although this reduction differed by areas where patients resided. The incidence of pneumococcal infections, including bacteremia and otitis media, clearly decreased among patients <5 years old after the introduction of pneumococcal vaccination, while the prevalence of S. pneumoniae isolated from blood specimens of patients 15-64 years old increased, suggesting the involvement of non-vaccine serotypes in the incidence of invasive pneumococcal infections. The antimicrobial susceptibility of S. pneumoniae improved after the introduction of pneumococcal vaccination. Our results show that pneumococcal vaccination has a suppressive effect on the prevalence of S. pneumoniae and the incidence of pneumococcal infections, at least for children <5 years old, in association with an improvement in the antimicrobial susceptibility of S. pneumoniae. However, further measures will be needed to control invasive pneumococcal infections caused by non-vaccine serotypes.

Chemotherapy for alpha-fetoprotein producing gastric cancers expressing human epidermal growth factor receptor 2.

Although, gastric cancer is one of the most common cancers worldwide, alpha-fetoprotein (AFP) producing human epidermal growth factor receptor 2 (HER2) positive gastric cancers are rare. AFP producing gastric cancer has a poor prognosis and an appropriate treatment option has not been established to date. A 75-year-old woman with AFP- producing gastric cancer was treated with S-1, an oral fluoropyrimidine derivative, chemotherapy after distal gastrectomy. Recurrence of gastric cancer was observed after 18 months and immunohistochemistry analysis showed AFP and HER2 positive gastric cancer. The patient received combination therapy containing capecitabine, cisplatin, and trastuzumab. Computed tomography scans showed regression of the lymph node metastasis. The patient's quality of life substantially improved after the treatment. Thus, the present case suggests that AFP and HER2 positive gastric cancer can be effectively treated with, capecitabine, cisplatin, and trastuzumab combination therapy.

Meal sequence and glucose excursion, gastric emptying and incretin secretion in type 2 diabetes: a randomised, controlled crossover, exploratory trial.

AIMS/HYPOTHESIS: Investigation of dietary therapy for diabetes has focused on meal size and composition; examination of the effects of meal sequence on postprandial glucose management is limited. The effects of fish or meat before rice on postprandial glucose excursion, gastric emptying and incretin secretions were investigated. METHODS: The experiment was a single centre, randomised controlled crossover, exploratory trial conducted in an outpatient ward of a private hospital in Osaka, Japan. Patients with type 2 diabetes (n = 12) and healthy volunteers (n = 10), with age 30-75 years, HbA1c 9.0% (75 mmol/mol) or less, and BMI 35 kg/m(2) or less, were randomised evenly to two groups by use of stratified randomisation, and subjected to meal sequence tests on three separate mornings; days 1 and 2, rice before fish (RF) or fish before rice (FR) in a crossover fashion; and day 3, meat before rice (MR). Pre- and postprandial levels of glucose, insulin, C-peptide and glucagon as well as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide were evaluated. Gastric emptying rate was determined by (13)C-acetate breath test involving measurement of (13)CO2 in breath samples collected before and after ingestion of rice steamed with (13)C-labelled sodium acetate. Participants, people doing measurements or examinations, and people assessing the outcomes were not blinded to group assignment. RESULTS: FR and MR in comparison with RF ameliorated postprandial glucose excursion (AUC-15-240 min-glucose: type 2 diabetes, FR 2,326.6 ± 114.7 mmol/l × min, MR 2,257.0 ± 82.3 mmol/l × min, RF 2,475.6 ± 87.2 mmol/l × min [p < 0.05 for FR vs RF and MR vs RF]; healthy, FR 1,419.8 ± 72.3 mmol/l × min, MR 1,389.7 ± 69.4 mmol/l × min, RF 1,483.9 ± 72.8 mmol/l × min) and glucose variability (SD-15-240 min-glucose: type 2 diabetes, FR 1.94 ± 0.22 mmol/l, MR 1.68 ± 0.18 mmol/l, RF 2.77 ± 0.24 mmol/l [p < 0.05 for FR vs RF and MR vs RF]; healthy, FR 0.95 ± 0.21 mmol/l, MR 0.83 ± 0.16 mmol/l, RF 1.18 ± 0.27 mmol/l). FR and MR also enhanced GLP-1 secretion, MR more strongly than FR or RF (AUC-15-240 min-GLP-1: type 2 diabetes, FR 7,123.4 ± 376.3 pmol/l × min, MR 7,743.6 ± 801.4 pmol/l × min, RF 6,189.9 ± 581.3 pmol/l × min [p < 0.05 for FR vs RF and MR vs RF]; healthy, FR 3,977.3 ± 324.6 pmol/l × min, MR 4,897.7 ± 330.7 pmol/l × min, RF 3,747.5 ± 572.6 pmol/l × min [p < 0.05 for MR vs RF and MR vs FR]). FR and MR delayed gastric emptying (Time50%: type 2 diabetes, FR 83.2 ± 7.2 min, MR 82.3 ± 6.4 min, RF 29.8 ± 3.9 min [p < 0.05 for FR vs RF and MR vs RF]; healthy, FR 66.3 ± 5.5 min, MR 74.4 ± 7.6 min, RF 32.4 ± 4.5 min [p < 0.05 for FR vs RF and MR vs RF]), which is associated with amelioration of postprandial glucose excursion (AUC-15-120 min-glucose: type 2 diabetes, r = -0.746, p < 0.05; healthy, r = -0.433, p < 0.05) and glucose variability (SD-15-240 min-glucose: type 2 diabetes, r = -0.578, p < 0.05; healthy, r = -0.526, p < 0.05), as well as with increasing GLP-1 (AUC-15-120 min-GLP-1: type 2 diabetes, r = 0.437, p < 0.05; healthy, r = 0.300, p = 0.107) and glucagon (AUC-15-120 min-glucagon: type 2 diabetes, r = 0.399, p < 0.05; healthy, r = 0.471, p < 0.05). The measured outcomes were comparable between the two randomised groups. CONCLUSIONS/INTERPRETATION: Meal sequence can play a role in postprandial glucose control through both delayed gastric emptying and enhanced incretin secretion. Our findings provide clues for medical nutrition therapy to better prevent and manage type 2 diabetes. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000017434. FUNDING: Japan Society for Promotion of Science, Japan Association for Diabetes Education and Care, and Japan Vascular Disease Research Foundation.

Assessment of postoperative quality of life following pylorus-preserving gastrectomy and Billroth-I distal gastrectomy in gastric cancer patients: results of the nationwide postgastrectomy syndrome assessment study.

BACKGROUND: Pylorus-preserving gastrectomy (PPG) is increasingly being used to treat early gastric cancer in the middle third of the stomach, with the hope of ameliorating postoperative dysfunction and improving quality of life (QOL). We evaluated symptoms of postgastrectomy syndrome (PGS) and QOL by means of a newly developed integrated questionnaire, the Postgastrectomy Syndrome Assessment Scale-45 (PGSAS-45), and compared PPG with Billroth-I distal gastrectomy (DGBI). METHODS: The PGSAS-45 consists of 45 items, including items from the SF-8 and GSRS instruments, as well as 22 newly selected items. It was designed to assess the severity of PGS and the living status and QOL of gastrectomized patients. The nationwide PGSAS surveillance study enrolled 2,368 gastric cancer patients who underwent various types of gastrectomy. In this study we analyzed 313 PPG patients and 909 DGBI patients. RESULTS: Body weight loss was -6.9% in the PPG group and -7.9% in the DGBI group (P = 0.052). The PPG group scored better on the diarrhea subscale (PPG; 1.8 vs. DGBI; 2.1, P < 0.0001), dumping subscale (1.8 vs. 2.0, P = 0.003), and frequency of additional meals (1.8 vs. 1.9, P = 0.034). Multiple regression analysis revealed that age and the preservation of the celiac branch of the vagus nerve were independent factors predicting diarrhea and dumping. CONCLUSIONS: It has been suggested that PPG is superior to DGBI for ameliorating PGS. Preservation of the celiac branch of the vagus nerve is recommended to reduce postoperative disorders regardless of the reconstruction method used.

Impaired Gastrointestinal Function Affects Symptoms and Alimentary Status in Patients After Gastrectomy.

BACKGROUND: Postgastrectomy syndrome (PGS) remains a common complication after gastrectomy that affects patients' quality of life. Although impaired gastrointestinal (GI) function by gastrectomy procedures is thought to be the cause, the precise pathophysiology of PGS is yet to be clarified. AIM: The aim of this study was to investigate relationships between GI function and various symptoms or alimentary status in patients after gastrectomy. METHODS: Fifty-one patients who underwent total or distal gastrectomy at least 1 year previously were studied. All patients replied to a questionnaire that asked presence of symptoms (esophageal reflux, nausea, abdominal pain, early satiation, diarrhea, early dumping general, early dumping abdominal, and late dumping symptoms) and alimentary status (change in body weight, food intake per meal, frequency of meals per day). They also underwent assessment of GI function consisting of gastric emptying study by 13C-acetate breath test to examine reservoir capacity and gastric emptying, and water load drink test to evaluate tolerance to volume loading (TVL). The relationships between GI function and each symptom or alimentary status were examined. RESULTS: The patients with nausea and early dumping general symptoms had significantly smaller reservoir capacity*, the patients with diarrhea and early dumping general symptoms had significantly faster gastric emptying*, and the patients with early satiation and early dumping abdominal symptoms had significantly impaired TVL*. Significant correlations were identified between TVL and body weight changes* or food intake per meal* (* p < 0.05). CONCLUSION: Impaired postoperative GI function was closely related to symptoms or worse alimentary status.

Specific Features of Dumping Syndrome after Various Types of Gastrectomy as Assessed by a Newly Developed Integrated Questionnaire, the PGSAS-45.

AIM: Dumping syndrome is a well-known adverse outcome after gastrectomy, but the precise clinical features have not been described. The aim of this study was to examine global aspects of dumping syndrome and to explore factors affecting the intensity of dumping syndrome in a large cohort using a newly developed integrated questionnaire, the Post-Gastrectomy Syndrome Assessment Scale (PGSAS)-45. METHODS: Eligible questionnaires retrieved from 2,368 patients after 6 types of gastrectomy were analyzed. The incidence, intensity and number of symptoms of early general, early abdominal and late dumping syndrome were examined across various types of gastrectomy, and clinical factors affecting the intensity of each category of dumping syndrome were identified by multiple regression analysis. RESULTS: Dumping syndromes occurred most frequently and strongly in patients who underwent total gastrectomy with Roux-en-Y (TGRY), followed by proximal gastrectomy (PG), distal gastrectomy with Billroth-I, distal gastrectomy with Roux-en-Y, pylorus-preserving gastrectomy (PPG) and local resection (LR), in that order. Significant positive correlations among different categories of dumping syndromes were observed. TGRY, female sex, younger age, division of the celiac branch of the vagus nerve, PG and shorter postoperative period were independently related to worse dumping syndrome. CONCLUSIONS: Dumping syndromes were most common after TGRY and least common after PPG and LR among the various gastrectomy procedures. Type of gastrectomy and several clinical factors were related to the intensity of dumping syndrome. PGSAS-45 could offer a useful tool for evaluating dumping syndrome after gastrectomy.

Diminished Gastric Resection Preserves Better Quality of Life in Patients with Early Gastric Cancer.

Using the Postgastrectomy Syndrome Assessment Scale (PGSAS)-45, we compared the surgical outcomes and the quality of life (QOL) between patients undergoing limited gastrectomies and those undergoing conventional gastrectomies. In Oomoto Hospital between January 2004 and December 2013, a total of 124 patients who met the eligibility criteria were enrolled. Using the main outcome measures of PGSAS-45, we compared 4 types of limited gastrectomy procedures (1/2 distal gastrectomy [1/2DG] in 21 patients; pylorus-preserving gastrectomy [PPG] in 15 patients; segmental gastrectomy [SG] in 26 patients; and local resection [LR] in 13 patients) with conventional gastrectomy (total gastrectomy [TG] in 24 patients and 2/3 or more distal gastrectomy [WDG] in 25 patients). The TG group showed the worst QOL in almost all items of the main outcome measures. The 1/2DG, PPG, and SG groups showed better QOL than the WDG group in many of the main outcome measures, including the body weight ratio, total symptom score, ingested amount of food per meal, and the dissatisfaction for daily life subscale. The LR group showed a better intake of food than the 1/2DG, PPG, and SG groups. The body weight ratio of the LR group was better than that of the SG group. Diminished gastric resection preserved better QOL in patients with early gastric cancer.

[From Bioartificial Liver Development to Laboratory Medicine -In Vitro and In Vivo Stable Isotope-Labeled Glucose Breath Tests -].

The urea breath test was developed for the diagnosis of Helicobacter pylori infection. In this test, we measure exhaled ¹³CO2 using POCone developed in Japan, which is an infrared spectrometry photometer. Based on the urea breath test, we subsequently developed the in vitro ¹³C-glucose exhaling test. In this test, ¹³C-glucose is added in the circulation culture medium, and ¹³CO2 generated with a bioartificial liver is measured by the POCone. The quantity of discharged ¹³CO2 reflects the energy-producing ability of the bioartifi- cial liver. Therefore, we can simply and easily observe the viability of a bioartificial liver and the effect of drugs on carbohydrate metabolism in the bioartificial liver in real time. According to the results of a bioartificial liver study, we developed the fasting ¹³C-glucose breath test, which can quickly determine hepatic insu- lin resistance in humans with marked sensitivity. The bioartificial liver study unexpectedly led to the development of a new stable isotope breath test. [Review].