Impact of the coronavirus disease 2019 (COVID-19) pandemic on the operational efficiency of emergency medical services and its association with out-of-hospital cardiac arrest survival rates: A population-based cohort study in Kobe, Japan.

Aim: To identify whether the coronavirus disease 2019 (COVID-19) pandemic affects the operational efficiency of emergency medical services (EMS) and the survival rate of out-of-hospital cardiac arrest (OHCA) in prehospital settings. Methods: We conducted a population-based cohort study in Kobe, Japan, between March 1, 2020, and September 31, 2022. In study 1, the operational efficiency of EMS, such as the total out-of-service time for ambulances, the daily occupancy rate of EMS, and response time, was compared between the pandemic and nonpandemic periods. In study 2, the impacts of the changes in EMS operational efficiency were investigated among patients with OHCA, with 1-month survival as the primary outcome and return of spontaneous circulation, 24-h survival, 1-week survival, and favorable neurological outcomes as the secondary outcomes. Logistic regression analysis was conducted to identify the factors associated with survival among patients with OHCA. Results: The total out-of-service time, occupancy rate, and response time significantly increased during the pandemic period (p < 0.001). The response time during the pandemic period increased significantly per pandemic wave. Regarding OHCA outcomes, 1-month survival rates during the pandemic period significantly decreased compared with those during the nonpandemic period (pandemic 3.7% vs. nonpandemic 5.7%; p < 0.01). Similarly, 24-h survival (9.9% vs. 12.8%), and favorable neurological outcomes significantly decreased during the pandemic period. In the logistic regression analysis, response time was associated with lower OHCA survival in all outcomes (p < 0.05). Conclusion: The COVID-19 pandemic has been associated with reduced operational efficiency of EMS and decreased OHCA survival rates. Further research is required to improve the efficiency of EMS and OHCA survival rates.

Gastrointestinal symptoms in 609 Japanese patients with COVID-19: a single-center retrospective study.

BACKGROUND: GI symptoms are common in acute COVID-19 patients. This study aimed to characterize the GI symptoms occurring in Japanese COVID-19 patients. METHODS: This retrospective single-center cohort study included 751 hospitalized acute COVID-19 patients. The primary outcomes were the frequency and severity of GI symptoms. The secondary outcomes included the association between COVID-19 severity and GI symptoms and the timing of GI symptom onset. RESULTS: After exclusion, the data of 609 patients were analyzed. The median age was 62 years, and 55% were male. The median time from initial symptom onset to admission was five days. On admission, 92% of the patients had fever, 35.1% had fatigue, 75% had respiratory symptoms, and 75% had pneumonia. The sample included patients with mild (19%), moderate (59%), and severe COVID-19 (22%). A total of 218 patients (36%) had GI symptoms, of which 93% were classified as grade 1/2; 170 patients had both respiratory and GI symptoms. Diarrhea was the most frequent GI symptom, occurring in 170 patients, followed by anorexia in 73 patients and nausea/vomiting in 36 patients, and abdominal pain in 8 patients. There was no significant relationship between COVID-19 severity and GI symptoms. Among COVID-19 patients with both GI and respiratory symptoms, 48% had respiratory symptoms preceding GI symptoms, 25% had GI symptoms preceding respiratory symptoms and 27% had a simultaneous onset of respiratory and GI symptoms. CONCLUSION: Thirty-six percent of the Japanese COVID-19 patients had GI symptoms; diarrhea was the most frequent GI symptom but did not predict severe COVID-19.

Stratification Based on Risk Factors at Diagnosis Could Predict Progression in Patients with Pancreatic Cysts.

BACKGROUND: Predicting the risk of malignant transformation in pancreatic cyst patients is challenging. AIM: We retrospectively investigated the risk factors for malignant transformation in pancreatic cyst patients. METHODS: Patients with pancreatic cysts diagnosed using imaging tests were followed from November 2008 to December 2021. A significant change was defined as the additional development of high-risk stigmata (HRS), worrisome features (WFs), or pancreatic cancer during monitoring. RESULTS: In total, 479 patients were analyzed, with a median observation period of 50 months. Forty-four patients (9.2%) showed significant changes, and eight (1.7%) developed pancreatic cancer. The univariate analysis showed that the cyst diameter at diagnosis (≥ 14 mm), main pancreatic duct (MPD) diameter at diagnosis (≥ 3 mm), presence of multilocular cysts, and an inconsistent MPD caliber were significant predictive factors for a significant change. One point was assigned for each significant factor. We grouped the patients into three groups: the low-risk group (total score 0), medium-risk group (score 1-2), and high-risk group (score 3-4). The high-risk group had a higher risk of a significant change than the medium- and low-risk groups (age-adjusted HRs for the medium-risk and high-risk groups were 3.0 and 5.2 compared with the low-risk group). CONCLUSION: Stratification based on risk factors may help predict the development of significant changes in pancreatic cyst patients.

Impact of anticoagulants on the clinical outcomes of colonic diverticular bleeding comparing warfarin and direct oral anticoagulants.

Recently, direct oral anticoagulants (DOACs) have been widely used as antithrombotic agents to replace warfarin, but their clinical impact in patients with gastrointestinal bleeding is unclear. We compared the effects of warfarin and DOACs on the outcomes of patients with colonic diverticular bleeding. The patients were divided into warfarin and DOAC groups. We compared the clinical outcomes and the effect of the DOAC dosing and examined any readmissions due to colonic diverticular bleeding within 1 year. A total of 95 events (warfarin group: n = 43 and DOAC group: n = 52) were included. Compared with the warfarin group, the DOAC group was significantly older, had a lower rate of concomitant antiplatelet agents, and a shorter hospital stay, but no significant differences were found in the other clinical outcomes. Thirty-seven patients (71.2%) in the DOAC group had appropriate dosing, whereas 15 patients (28.9%) had an inappropriate dose. The patients with overdose or contraindications had significantly lower minimum hemoglobin levels. In the univariate analysis, prior hospitalization for colonic diverticular bleeding was a significant predictor of readmission. Compared with warfarin, patients with colonic diverticular bleeding treated with DOACs were older and had shorter hospital stays, and the inappropriate use of DOACs may worsen outcomes.

Efficacy and Safety of a Strategy for Reviewing Intravenous Antibiotics for Hospitalized Japanese Patients with Uncomplicated Diverticulitis: A Single-center Observational Study.

Objective Treatment for uncomplicated diverticulitis (UD) is not well established. We evaluated the strategy of reviewing intravenous antibiotics for hospitalized Japanese patients with UD. Methods Treatment was based on the physician's choice until August 2018; the indications for hospitalization and treatment have been standardized since September 2018. In this study, we monitored the use of intravenous antibiotics administered to patients hospitalized for UD and then reviewed the need for them on hospital day 3. We compared patients' length of antibiotic use, hospital stay, health care cost, and complications via the review strategy from September 2018 to December 2020 and via the previous physicians' choice strategy from January 2016 to August 2018. Results Two hundred and forty-seven patients were admitted to our hospital because of acute colonic diverticulitis from January 2016 to December 2020. After excluding complicated cases, 106 individuals were enrolled during the period of physician's choice; 87 were enrolled when treatment review was employed. There were no significant differences in age, sex, inflammation site, or severity during the first hospital visit. The median duration of antibiotic use was significantly reduced from 5 to 4 days (p=0.0075), with no marked increase in rates of transfer to surgery, mortality, or readmission due to recurrence. A more significant proportion of patients completed 3-day antibiotic treatment with the review strategy than with the physician's choice strategy (6.6% vs. 25.3%, p=0.0004). However, the length of hospital stay and total medical costs did not decrease. Conclusion The strategy of reviewing treatment on day 3 after hospitalization for UD safety reduced the duration of antibiotic use, but the hospital stay and health care costs did not decrease.

Effect of abdominal visceral fat on mortality risk in patients with severe acute pancreatitis.

BACKGROUND AND AIM: Obesity is a well-known risk factor for the development and severity of acute pancreatitis (AP), but the relationship between the abdominal visceral fat area (VFA) and mortality is unclear. We evaluated the effect of the VFA on mortality in severe AP (SAP). METHODS: This retrospective, single-center cohort study examined 119 consecutive patients with SAP from April 2009 to March 2019. The VFA at the umbilical level was assessed using computed tomography. The primary endpoint was to evaluate whether visceral obesity affects mortality in SAP. RESULTS: The median age was 63 years, and 66% of participants were male. Nine patients (7.5%) died during their hospital stay. The median body mass index (BMI) was 22.2 kg/m2, and six obese patients had a BMI of over 30 kg/m2 (5%). The median waist circumference and VFA were 85.5 cm and 112 cm2, respectively. Sixty-eight (57.1%) patients had a VFA over 100 cm2. The prognostic factor score based on the Japanese guidelines for AP management (cutoff value [COV], 4; area under the curve [AUC] = 0.869) and age [COV, 72; AUC = 0.780]) showed moderate accuracy for predicting mortality, followed by the VFA (COV, 167 cm2; AUC = 0.679). Univariate logistic analysis, but not multivariate analysis, showed that an increased VFA was associated with a significantly higher odds ratio (OR) for predicting mortality (OR: 4.38, P = 0.0406). The survival times of SAP patients with and without an increased VFA of 167 cm2 were not significantly different. CONCLUSIONS: Visceral obesity did not have a significant impact on predicting mortality in patients with SAP.

Immunoglobulin G4-Hepatopathy with Acute Hepatitis-Like Onset and Marked Centrilobular Necrosis: Clinicopathologically Unique Pattern of Hepatic Injury Related to Immunoglobulin G4-Related Disease.

A 69-year-old man presented with jaundice and appetite loss. Blood analyses showed elevated aminotransferase levels, hyperbilirubinemia, positivity for antinuclear antibody, elevated immunoglobulin (Ig) G4 levels, and negativity for hepatitis virus markers. Additionally, computed tomography revealed a focal enlargement of the pancreatic body and enhancement of the peripheral bile ducts. Liver biopsy showed interface hepatitis, supporting a clinical diagnosis of autoimmune hepatitis (AIH). Immunohistochemistry revealed that IgG4-bearing plasma cells accounted for more than 60% of the IgG-bearing plasma cells in the portal area. Then, we started oral prednisolone therapy. After tapering, serum transaminase levels became elevated again, and we had to adjust the dose. Azathioprine maintenance therapy was necessary to prevent relapse. We herein report a case of IgG4-hepatopathy with a clinical course similar to that of AIH with acute onset.

Seroprevalence of SARS-CoV-2 antibodies among 925 staff members in an urban hospital accepting COVID-19 patients in Osaka prefecture, Japan: A cross-sectional study.

ABSTRACT: The subclinical severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection rate in hospitals during the pandemic remains unclear. To evaluate the effectiveness of our hospital's current nosocomial infection control measures, we conducted a serological survey of anti-SARS-CoV-2 antibodies (immunoglobulin [Ig] G) among the staff of our hospital, which is treating coronavirus disease 2019 (COVID-19) patients.The study design was cross-sectional. We measured anti-SARS-CoV-2 IgG in the participants using a laboratory-based quantitative test (Abbott immunoassay), which has a sensitivity and specificity of 100% and 99.6%, respectively. To investigate the factors associated with seropositivity, we also obtained some information from the participants with an anonymous questionnaire. We invited 1133 staff members in our hospital, and 925 (82%) participated. The mean age of the participants was 40.0 ±â€Š11.8 years, and most were women (80.0%). According to job title, there were 149 medical doctors or dentists (16.0%), 489 nurses (52.9%), 140 medical technologists (14.2%), 49 healthcare providers (5.3%), and 98 administrative staff (10.5%). The overall prevalence of seropositivity for anti-SARS-CoV-2 IgG was 0.43% (4/925), which was similar to the control seroprevalence of 0.54% (16/2970) in the general population in Osaka during the same period according to a government survey conducted with the same assay. Seropositive rates did not significantly differ according to job title, exposure to suspected or confirmed COVID-19 patients, or any other investigated factors.The subclinical SARS-CoV-2 infection rate in our hospital was not higher than that in the general population under our nosocomial infection control measures.

Efficacy of Ramucirumab Versus Sorafenib as Subsequent Treatment for Hepatocellular Carcinoma.

BACKGROUND/AIM: The present study aimed to examine the therapeutic efficacy of ramucirumab compared with that of sorafenib as subsequent systemic therapy for patients with hepatocellular carcinoma (HCC) and serum α-fetoprotein (AFP) levels ≥400 ng/ml. PATIENTS AND METHODS: In our prospectively registered, real-world cohort, 13 and 11 patients treated with ramucirumab or sorafenib, respectively, were analyzed. Progression-free survival (PFS) was primarily compared between the ramucirumab and sorafenib groups. RESULTS: The PFS was significantly longer in the ramucirumab group than in the sorafenib group (median, 2.7 vs. 0.9 months, respectively; p=0.005). There were no significant differences in the objective response rates or the disease control rates between the ramucirumab and sorafenib groups (9.1% and 54.5% vs. 0.0% and 22.2%, respectively). CONCLUSION: Subsequent systemic therapy with ramucirumab showed a better ability to control tumor progression than sorafenib in HCC patients with serum AFP levels ≥400 ng/ml.

Comparison of colonoscopy after colonic diverticulitis and positive fecal immunochemical tests for the detection of colorectal neoplasia.

Background and study aims The relationship between acute colonic diverticulitis and colorectal cancer (CRC) is unclear, but colonoscopy is recommended to exclude malignancy. We compared the detection rates for colorectal neoplasia in patients with colonic diverticulitis and asymptomatic patients who had positive fecal immunochemical tests (FITs). Patients and methods In total, 282 patients with acute colonic diverticulitis were hospitalized in our hospital from February 2011 to December 2019. Of them, 143 patients with diverticulitis and 1819 with positive FITs patients during the same period underwent colonoscopy without a prior colonoscopy within 5 years. We retrospectively compared these patients in terms of the invasive CRC rate, advanced neoplasia detection rate (ANDR), adenoma detection rate (ADR), and polyp detection rate (PDR). Results Compared to the diverticulitis group, the FIT-positive group had a significantly higher CRC rate (0 vs 2.7 %, P  = 0.0061), ANDR (5.6 vs. 14.0 %, P  = 0.0017), ADR (19.6 vs. 53.2 %, P  < .0001), and PDR (44.1 vs. 91.0 %, P  < .0001). Using 1:1 propensity score matching based on age and sex, we obtained 276 matched patients in both groups. After matching, no difference was found in the CRC rate (0 vs 0.7 %) or ANDR (5.8 vs 7.3 %) between groups, but the ADR and PDR were significantly higher in the FIT-positive group (20.3 vs 43.5 %, P  < .0001; 45.7 % vs 86.2 %, P  < .0001). Conclusion Patients with acute diverticulitis had lower ADRs and PDRs than patients with positive FITs.

Resection of a large gastrointestinal stromal tumor in the stomach after imatinib treatment in a 90-year-old patient.

A 90-year-old woman presented with a 1-month history of progressive abdominal fullness. Contrast computed tomography (CT) showed a large 17-cm mass located adjacent to the antrum of the stomach without metastatic lesions. She underwent endoscopic ultrasound-guided fine-needle aspiration for diagnosis. Aspiration specimens revealed spindle-shaped cells positive for KIT by immunohistochemistry, with exon 11 mutations of the c-kit gene according to a genetic test. We ultimately diagnosed her with gastrointestinal stromal tumor (GIST). We judged the feasibility of imatinib treatment based on physiological and comprehensive geriatric assessments. We administered imatinib to reduce the tumor size and expected an excellent response based on genetic testing. After 5 months of imatinib administration with therapeutic drug monitoring (TDM), the tumor shrank by 42%. Six months later, there was no significant uptake of 18F-fluorodeoxyglucose on positron emission tomography. We successfully performed partial gastrectomy as conversion surgery, and she was carefully observed without any medication for 10 months after surgery. Here, we report a super elderly patient aged 90 years with a large GIST harboring an exon 11 mutation who underwent surgery after imatinib treatment with appropriate dose reduction during TDM after comprehensive geriatric assessment.

Clinical course of hepatitis C virus-positive patients with decompensated liver cirrhosis in the era of direct-acting antiviral treatment.

AIM: The aim of the present study was to investigate the clinical course in hepatitis C virus (HCV)-positive patients with decompensated liver cirrhosis after direct-acting antivirals (DAAs) have been used for HCV infection. METHODS: This multicenter study prospectively analyzed a registered cohort composed of 73 HCV-positive patients with decompensated cirrhosis who attended our 11 institutions between January 2018 and July 2018. Prognoses, including changes in the liver reserve, hepatocellular carcinoma (HCC), decompensation events, and survival, were analyzed up to July 2020, as was the initiation of DAA treatment. RESULTS: Sixty-four (87.7%) and nine (12.3%) patients had Child-Pugh class (C-P) B and C at baseline, respectively. Within 2 years after enrollment, 17 patients (23.3%) received treatment with DAAs, and 31 patients (42.5%) developed uncontrolled HCC, switched to palliative care, or died. Patients who received DAA treatment were significantly younger and had significantly higher alanine aminotransferase levels and lower platelet counts than the patients who did not receive DAA treatment. The rates of overall survival, cumulative HCC occurrence, and cumulative hospitalization for any hepatic decompensation event at 2 years were 64.8%, 13.1%, and 65.6%, respectively. Overall survival was significantly shorter and the HCC occurrence and hospitalization rates were significantly higher in C-P C patients than in C-P B patients. CONCLUSIONS: Among HCV-positive patients with decompensated cirrhosis, approximately one-fourth received DAA treatment, but more than 40% of the patients lost the opportunity for treatment with DAAs.

Early clinical factors predicting the development of critical disease in Japanese patients with COVID-19: A single-center, retrospective, observational study.

The factors predicting the progression of coronavirus disease-2019 (COVID-19) from mild to moderate to critical are unclear. We retrospectively evaluated risk factors for disease progression in Japanese patients with COVID-19. Seventy-four patients with laboratory-confirmed COVID-19 were hospitalized in our hospital between February 20, 2020, and June 10, 2020. We excluded asymptomatic, non-Japanese, and pediatric patients. We divided patients into the stable group and the progression group (PG; requiring mechanical ventilation). We compared the clinical factors. We established the cutoff values (COVs) for significantly different factors via receiver operating characteristic curve analysis and identified risk factors by univariate regression. We enrolled 57 patients with COVID-19 (median age 52 years, 56.1% male). The median time from symptom onset to admission was 8 days. Seven patients developed critical disease (PG: 12.2%), two (3.5%) of whom died; 50 had stable disease. Univariate logistic analysis identified an elevated lactate dehydrogenase (LDH) level (COV: 309 U/l), a decreased estimated glomerular filtration rate (eGFR; COV: 68 ml/min), lymphocytopenia (COV: 980/µl), and statin use as significantly associated with disease progression. However, in the Cox proportional hazards analysis, lymphocytopenia at admission was not significant. We identified three candidate risk factors for progression to critical COVID-19 in adult Japanese patients: statin use, elevated LDH level, and decreased eGFR.

Lower Serum Sodium Levels Are Associated with the Therapeutic Effect of Sorafenib on Hepatocellular Carcinoma.

BACKGROUND AND AIM: Although the serum sodium level has been reported to be a prognostic and predictive marker for the therapeutic effects of lung cancer and renal cell carcinoma treated with molecular targeted therapy, the serum sodium level has not been investigated in hepatocellular carcinoma (HCC) patients treated with sorafenib. The aim of our analysis was to assess the prognostic role of serum sodium levels in these patients. METHODS: We retrospectively analyzed 341 HCC patients treated with sorafenib between 2009 and 2012 in our hospital and other related institutions. RESULTS: A total of 178 patients were enrolled in this study. The median age was 72 years (44-88), and 148 patients (83%) were male. The median overall survival (OS) was 12.9 months, and the median time to progression (TTP) was 3.1 months. Hyponatremia (hazard ratio (HR) 1.78, 95% confidence interval (CI) 1.26-2.52), a lower sodium level (HR 1.57, 95% CI 1.07-2.80), and a high level of α-fetoprotein (AFP) (≥ 200 ng/mL) (HR 1.78, 95% CI 1.26-2.52) were independent prognostic factors for TTP. We also categorized the patients into three groups according to serum sodium and AFP levels: Group A (n = 39) (serum sodium > 140 mEq/L, AFP < 200 ng/mL), Group C (n = 58) (serum sodium ≤ 140 mEq/L, AFP ≥ 200 ng/mL), and Group B (n = 81) (other patients). Significantly longer TTP and OS were observed in the following order: Groups A, C, and B. CONCLUSION: Serum sodium levels are associated with the effectiveness of sorafenib. The serum sodium level can predict the therapeutic effect of sorafenib in advanced HCC patients.

Time Trend of the Radiation Exposure Dose in Endoscopic Retrograde Cholangiopancreatography Over an 8-Year Period: A Single-Center Retrospective Study.

INTRODUCTION: The global needs for a reduction in radiation exposure (RE) are increasing. Endoscopic retrograde cholangiopancreatography (ERCP) is a significant fluoroscopic procedure in the gastrointestinal field. However, the actual RE in ERCP and its annual trend are still unclear. Therefore, we examined the yearly trend of RE in ERCP. METHODS: This retrospective, single-center cohort study included consecutive cases of ERCP from September 2012 to June 2019. We measured the air kerma (AK, mGy), dose area product (DAP, Gycm2), and fluoroscopy time (FT, min). We also evaluated the annual trend of the RE before and after the fluoroscopy device update. RESULTS: In total, 2,174 patients receiving ERCP were enrolled. Among these, the mean age was 74.3 years, and 913 patients were women (42.0%). The median/third quartile values of AK (mGy), DAP (Gycm2), and FT (min) were 109/234 mGy, 13.3/25.8 Gycm2, and 18.2/27.7 minutes. The annual AK, DAP, and FT from 2012 to 2019 were 138, 207, 173, 177, 106, 71.0, 45.0, and 33.3 mGy; 23, 21.4, 19, 18.3, 11.9, 9.0, 6.8, and 6.4 Gycm2; and 12.5, 12.1, 9.7, 9.8, 8.2, 10.8, 9.4, and 10.3 minutes, respectively. The corresponding values before and after the update in July 2016 were 177 and 52 mGy (P < 0.0001), 19.2 and 7.6 Gycm2 (P < 0.0001), and 10.2, and 9.9 minutes (P = 0.05), respectively. DISCUSSION: The RE from ERCP tended to decrease every year, especially after fluoroscopy device updates.

Radiation exposure dose of fluoroscopy-guided gastrointestinal procedures: A single-center retrospective study.

Background and study aims Fluoroscopy-guided gastrointestinal procedures (FGPs) are increasingly common. However, the radiation exposure (RE) to patients undergoing FGPs is still unclear. We examined the actual RE of FGPs. Patients and methods This retrospective, single-center cohort study included consecutive FGPs, including endoscopic retrograde cholangiopancreatography (ERCP), interventional endoscopic ultrasound (EUS), enteral stenting, balloon-assisted enteroscopy, tube placement, endoscopic injection sclerotherapy (EIS), esophageal balloon dilatation and repositioning for sigmoid volvulus, from September 2012 to June 2019. We measured the air kerma (AK, mGy), dose area product (DAP, Gycm 2 ), and fluoroscopy time (FT, min) for each procedure. Results In total, 3831 patients were enrolled. Overall, 2778 ERCPs were performed. The median AK, DAP, and FT were as follows: ERCP: 109 mGy, 13.3 Gycm 2 and 10.0 min; self-expandable enteral stenting (SEMS): 62 mGy, 12.4 Gycm 2 and 10.4 min; tube placement: 40 mGy, 13.8 Gycm 2 and 11.1 min; balloon-assisted enteroscopy: 43 mGy, 22.4 Gycm 2 and 18.2 min; EUS cyst drainage (EUS-CD): 96 mGy, 18.3 Gycm 2 and 10.4 min; EIS: 36 mGy, 8.1 Gycm 2 and 4.4 min; esophageal balloon dilatation: 9 mGy, 2.2 Gycm 2 and 1.8 min; and repositioning for sigmoid volvulus: 7 mGy, 4.7 Gycm 2 and 1.6 min. Conclusion This large series reporting actual RE doses of various FGPs could serve as a reference for future prospective studies.

Comparison of double-layer large-diameter and conventional small-diameter plastic stents for preoperative biliary drainage in resectable distal malignant biliary obstruction.

The use of a plastic stent (PS) in resectable patients with distal malignant biliary obstruction (DMBO) is uncommon due to the high failure rate of this method. This study evaluated the efficacy and safety of a double-layer, large-diameter PS as a bridge to surgery compared with a conventional PS. This was a single-center retrospective cohort study. In total, 129 consecutive patients with DMBO underwent pancreaticoduodenectomy between January 2011 and March 2018. Fifty-five patients who preoperatively underwent plastic biliary drainage were enrolled. The patients were divided into two groups based on stent diameter: a large-diameter plastic stent (LPS) group and a small-diameter plastic stent (SPS) group. The primary endpoint was the stent patency period, and the secondary endpoint was the medical cost. Thirty-six patients received SPSs; 19 patients received LPSs. The patency rate until surgery was significantly higher in the LPS group than in the SPS group (89.5% vs. 41.7%, P = 0.0006). Multivariate analysis revealed that LPS use was significantly associated with sufficient stent patency. The total cost of LPS use was significantly lower than that of SPS use. LPSs had longer patency and reduced medical costs than SPSs. LPSs may be suitable for patients with DMBO who are scheduled to undergo surgery.

Multicentre prospective observational study protocol for radiation exposure from gastrointestinal fluoroscopic procedures (REX-GI study).

INTRODUCTION: Recently, the use of various endoscopic procedures under X-ray fluoroscopic guidance, such as endoscopic retrograde cholangiopancreatography (ERCP), interventional endoscopic ultrasonography (EUS), enteral endoscopy and stenting, has been rapidly increasing because of the minimally invasive nature of these procedures compared with that of surgical intervention. With the spread of CT and fluoroscopic interventions, including endoscopic procedures under X-ray guidance, high levels of radiation exposure (RE) from medical imaging have led to major concerns throughout society. However, information about RE related to these image-guided procedures in gastrointestinal endoscopy is scarce, and the RE reference levels have not been established. The aim of this study is to prospectively collect the actual RE dose and to help establish diagnostic reference levels (DRLs) in the field of gastroenterology in Japan. METHODS AND ANALYSIS: This is a multicentre, prospective observational study that is being conducted to collect the actual RE from treatments and diagnostic procedures, including ERCP, interventional EUS, balloon-assisted enteroscopy, enteral metallic stent placement and enteral tube placement. We will measure the total fluoroscopy time (min), the total dose-area product (Gycm2) and air-kerma (mGy) of those procedures. Because we are collecting the actual RE data and identifying the influential factors through a prospective, nationwide design, this study will provide guidance regarding the DRLs of ERCP, interventional EUS, balloon-assisted enteroscopy, enteral metallic stent placement and enteral tube placement. ETHICS AND DISSEMINATION: Approval was obtained from the Institutional Review Board of Toyonaka Municipal Hospital (25 April 2019). The need for informed consent will be waived via the opt-out method of each hospital website. TRIAL REGISTRATION NUMBER: The UMIN Clinical Trials Registry, UMIN000036525.

A Triple-Drug Blister-Packaged Drug with Vonoprazan Improves First-Line Eradication of Helicobacter pylori in Elderly Patients: A Retrospective Propensity Score-Matched Cohort Study.

BACKGROUND: A blister-packaged drug might be useful to enhance the eradication of Helicobacter pylori. We investigated the effect of a blister-packaged drug for H. pylori eradication. METHODS: We treated 1,758 patients with H. pylori infections and evaluated the successful eradication rate in patients who underwent first-line eradication between January 2013 and May 2018. Treatments included a conventional proton pump inhibitor (PPI) blister-packaged drug containing lansoprazole or rabeprazole with clarithromycin (CAM) and amoxicillin (AC), vonoprazan (VPZ) with CAM and AC in a separate tablet, or a VPZ blister-packaged drug (VONOSAP) containing VPZ with CAM and AC, with all drugs given twice daily for 7 days. RESULTS: Finally, we evaluated 1,263 patients (conventional PPI: n = 644, VPZ: n = 326, and VONOSAP: n = 293). The overall successful eradication rates were 71.9% in the conventional PPI group, 90.2% in the VPZ group, and 92.2% in the VONOSAP group. There was a significantly lower eradication rate in the PPI group than in the VPZ and VONOSAP (p < 0.00001, p < 0.0001) groups, but there was no significant difference between the VPZ and VONOSAP groups (p = 0.4006). We enrolled a total of 256 age- and gender-matched patients in the VPZ and VONOSAP groups, and both groups had successful eradication rates of approximately 90% (89.8 vs. 90.4%, respectively, p = 0.7641). After analyzing the subgroup of patients older than 75 years, there was a significant treatment benefit of VONOSAP but not of VPZ in elderly patients (EPs). CONCLUSION: Triple-drug blister-packaged drugs including VPZ may improve the first-line eradication of H. pylori in EPs.