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Aim: For women, being underweight increases their susceptibility to osteoporosis, anemia, and other conditions and affects the weight of their infants and the well‐being of future generations. This study examined the association between low pre‐pregnancy body mass index (BMI) and low birthweight using health insurance claims data and health checkup data, including weight measurements. Methods: We used health insurance claims data and health checkup data (JMDC, Tokyo, Japan) of women and their newborns in Japan between 2006 and 2020. We used checkup data, which included more accurate weight measurements and blood test‐based diagnoses of anemia and hyperlipidemia compared to self‐reported data. Maternal pre‐pregnancy BMI was compared across three groups: underweight (BMI <18.5 kg/m2), normal weight (BMI 18.5–24.9 kg/m2), and overweight (BMI ≥25.0 kg/m2). The primary outcome was low birthweight (<2500 g), and secondary outcome was preterm childbirth. Logistic regression analyses were conducted to compare outcomes in the three groups by BMI. The underweight BMI group was considered as the reference group. A subgroup analysis was performed by maternal age. Results: In total, 16 363 mothers (underweight, 3418 [21%], normal weight, 11 493 [70%], and overweight, 1452 [8.9%]) were included. The risk of primary outcome (low birthweight) was significantly lower in the normal weight group than in the underweight group (4.6% vs. 5.7%; adjusted odds ratio 0.78 [95% confidence interval: 0.65–0.96]). In the subgroup analyses, no significant differences were noted in the incidences of low birthweight and preterm childbirth between maternal age groups. Conclusions: Pre‐pregnancy BMI was associated with an increased risk of delivering low‐birthweight infant. Awareness about the importance of women's pre‐pregnancy health and appropriate BMI may reduce the incidence of low birthweight. [ABSTRACT FROM AUTHOR]

Purpose: Very low birth weight infants (VLBWIs) have been thought as risk of bad outcomes in the patients with esophageal atresia (EA). However, detailed outcomes of EA within VLBWIs were not fully understood. We aimed to reveal short- and long-term outcomes in VLBWIs with EA. Methods: Clinical data regarding VLBWIs with EA registered in Neonatal Research Network Japan, a multicenter research database in Japan, were collected. Patients with chromosomal abnormality were excluded. Short term outcome was survival discharge from NICU and long-term outcome was neurodevelopmental impairment (NDI) at 3 years. Results: A total of 103 patients were analyzed. the overall survival discharge rate from NICU was 68.0% (70/103). The risk of death was increased as the birth weight got reduced. The presence of associated anomaly increased the risk of death. Three-year neurodevelopmental information was available in 32.9% (23/70) of patients. Of the 23 included patients for 3-year follow-up, 34.8% had NDI. The risk of NDI was increased as the birth weight reduced. Conclusions: In VLBWIs with EA, survival discharge from NICU was still not high. More immature patients and patients with an associated anomaly had worse outcomes. Among patients who survived, NDI was confirmed in a certain number of patients. [ABSTRACT FROM AUTHOR]

Aim: We evaluated the predictive ability of prolonged requirements for mechanical ventilation or tube feeding support for 18‐month composite outcomes in infants with hypoxic‐ischaemic encephalopathy treated with hypothermia. Methods: This retrospective, nationwide, observational study focused on newborn infants registered in Japan's Baby Cooling Registry between 1 January 2012 and 31 December 2016. The adverse outcomes were defined as death or survival with cerebral palsy, visual or auditory impairment or the requirement for mechanical ventilation or tube feeding at 18 months of age. Results: Adverse outcomes occurred in 165 (28%) of the 591 children in the final cohort. These were predicted by prolonged dependence on mechanical ventilation or tube feeding for more than seven and more than 14 days. The respective values were positive predictive value 0.34 (95% CI 0.33–0.34) and 0.60 (95% CI 0.56–0.62), negative predictive value 0.97 (95% CI 0.91–0.99) and 0.93 (95% CI 0.90–0.95) and area under the curve 0.59 (95% CI 0.54–0.64) and 0.81 (95% CI 0.77–0.85). Conclusion: Prolonged dependence on mechanical ventilation or tube feeding for more than 14 days may be useful in predicting 18‐month outcomes in newborn infants who have received therapeutic hypothermia. [ABSTRACT FROM AUTHOR]

The article focuses on the use of gabapentin to treat apnea in infants with trisomy 13 and 18. The study presents a case series demonstrating the effectiveness of gabapentin in managing breath-holding spells associated with apnea in these infants, highlighting its potential as a therapeutic option. Topics discussed include the characteristics of apnea treated with gabapentin, the dosage recommendations, and the positive outcomes observed in the case series.

Background and Aim: To clarify whether there were any significant differences in clinical symptoms and eating patterns between functional dyspepsia (FD) patients and FD with pancreatic enzyme abnormalities (FD‐P) patients as refractory FD, we compared these factors in multicenter studies in Singapore and Japan. Methods: One hundred ninety‐eight consecutive patients presenting with FD (n = 88), FD‐P patients (n = 81) based on Rome III classification and controlled group (n = 39) recruited from six institutions in Singapore and Japan. Clinical characteristics, clinical symptoms for dietary fat intake, and eating behaviors were estimated using questionnaires. Anxiety and health‐related quality of life were determined by STAI‐state/‐trait and SF‐8, respectively. Results: There were no significant differences in age, sex, BMI, smoking, alcohol intake, past medical history, and history of allergy in FD and FD‐P patients between Singapore and Japan. There were no significant differences in FD subtypes, gastrointestinal symptom rating scale score, severity of FD symptoms, and eating pattern in Singapore and Japan. Moreover, there were significant differences in certain eating behaviors between FD and FD‐P patients in Singapore and Japan. Interestingly, epigastric pain and early satiety following fat meals in FD‐P patients were significantly (P = 0.003 and P = 0.008, respectively) higher compared with those in FD patients in Japan. Physical component score in FD‐P patients was significantly (P = 0.019) disturbed compared with those in FD patients in Japan. Conclusions: Epigastric pain and early satiety following fat meals in FD‐P patients may be useful tools to differentiate FD‐P patients from FD patients in Japan. [ABSTRACT FROM AUTHOR]

This study investigated the 3-year clinical outcomes in relation to the severity of encephalopathy in high-survival infants who underwent therapeutic hypothermia. This retrospective observational study was conducted in level II/III neonatal intensive care units in Japan. The nationwide cohort included 474 infants registered in the Baby Cooling Registry of Japan between January 2012 and December 2016. Clinical characteristics, mortality rate and severe neurological impairment at age 3 years were evaluated. Of the infants, 48 (10.4%), 291 (63.1%) and 122 (26.5%) had mild, moderate and severe encephalopathy, respectively, upon admission. By age 3, 53 (11.2%) infants died, whereas 110 (26.1%) developed major disabilities. The mild group survived up to age 3. In the moderate group, 13 (4.5%) died and 44 (15.8%) developed major disabilities. In the severe group, 39 (32.0%) died by age 3. Adverse outcomes were observed in 100 (82.0%) infants. Mortality was relatively low in all subgroups, but the incidence of major disabilities was relatively high in the severe group. The relatively low mortality and high morbidity may be due to Japanese social and ethical norms, which rarely encourage the withdrawal of intensive life support. Cultural and ethical backgrounds may need to be considered when assessing the effect of therapeutic interventions. [ABSTRACT FROM AUTHOR]

The article focuses on the evolving threshold of viability for extremely preterm infants in high-income countries, noting improvements in survival rates. Topics discussed include the recent study on extremely low birthweight infants in Japan, indicating high survival rates at 22-24 weeks gestational age, which sets a benchmark for other countries, and the need for future studies to assess detailed data, including long-term neurodevelopmental outcomes and ethical implications.

Introduction: Despite changes in prenatal diagnostic methods and perceptions regarding the prognosis of and treatment options for patients with trisomy 18 syndrome, data on the secular changes in patient survival are limited. This study aimed to investigate the survival pattern for such patients. Methods: To investigate the general patient survival patterns, we used data from the vital statistics database of deaths in Japan from 1975 to 2016. We described demographic factors, such as sex, gestational age at delivery, and surgical history, for patients whose primary cause of death was trisomy 18 syndrome. Results: The proportions of deaths within 24 h of birth (4.0% in 1975–1980 to 21.9% in 2011–2016) and at age ≥1 year (8.9% in 1975–1980 to 17.7% in 2011–2016) increased. The median survival time was higher for females, infants born after 37 weeks of gestation, and those who received surgical intervention. The median survival time tripled among patients who received surgical intervention (61.5 days in 1995–2005 to 182.5 days in 2006–2016), and the proportion of such patients increased (from 3.8% in 1995 to 24.1% of the entire affected population in 2016). Discussion/Conclusion: In Japan, the median survival time of infants with trisomy 18 increased over time, and the proportion of death within 24 h and at ≥1 year increased. Greater acknowledgement of the possible benefits of surgical intervention likely led to the increased provision of interventions and contributed to the increased survival time. [ABSTRACT FROM AUTHOR]

Background/Aim: A sufficiently open papilla is needed to remove common bile duct stones (CBDS) but endoscopic sphincterotomy (EST) requires a high level of skill and is difficult with endoscopic papillary balloon dilation (EPBD). The main adverse event of EST is bleeding and perforation and that of EPBD is post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. To reduce these adverse events we employed minimal EST followed by papillary dilation (ESBD), and retrospectively evaluated its efficacy and safety compared with EST. Patients and Methods: CBDS patients who underwent EST (n = 114) or ESBD (n = 321) at Juntendo University Hospital from January 2009 to December 2018 were consecutively enrolled, retrospectively. The exclusion criteria were large-balloon dilation (≥ 12 mm), large CBDS (>12 mm), and previous EST/EPBD. We compared the overall stone removal rate, incidence of adverse event, procedure time, number of ERCP procedures, and rate of mechanical lithotripsy (ML) between the two groups. Results: Complete stone removal was successful in both ESBD and EST group. However, the rate of multiple ERCP sessions was significantly lower (35.1% vs. 12.8%, P < 0.001), procedure time was shorter (31.6 vs. 25.8 min, P = 0.01), and rate of ML was lower (16.7% vs. 7.8%, P = 0.01) in ESBD group. Bleeding was significantly more frequent in the EST group (9.6% vs. 1.2%, P < 0.001), particularly acute bleeding (7.9% vs. 0.9%, P < 0.001). Conclusions: ESBD is more efficient and safer in the management of CBD stones than EST. A prospective randomized study comparing ESBD with EST is needed to establish this combination technique. [ABSTRACT FROM AUTHOR]

Aim: We surveyed care practices for critically ill very preterm infants admitted to neonatal intensive care units (NICUs) in the International Network for Evaluating Outcomes in Neonates (iNeo) to identify differences relevant to outcome comparisons.Methods: We conducted an online survey on care practices for critically ill very preterm infants and infants with severe intracranial haemorrhage (ICH). The survey was distributed in 2015 to representatives of 390 NICUs in 11 countries. Survey replies were compared with network incidence of death and severe ICH for infants born between 230/7 and 286/7  weeks of gestation from January 1, 2015, to December 31, 2015.Results: Most units in Israel, Japan and Tuscany, Italy, favoured withholding care when care was considered futile, whereas most units in other networks favoured redirection of care. For infants with bilateral grade 4 ICH, redirection of care was very frequently (≥90% of cases) offered in the majority of units in Australia and New Zealand and Switzerland, but rarely in other networks. Networks where redirection of care was frequently offered for severe ICH had lower rates of survivors with severe ICH.Conclusion: We identified marked inter-network differences in care approaches that need to be considered when comparing outcomes. [ABSTRACT FROM AUTHOR]

Objective  The use of video laryngoscopy for intubating neonates in ergonomically challenging settings has not been studied well. We aimed to assess the usefulness of video laryngoscopy for experienced neonatologists to intubate neonatal manikins in incubators via side hand ports or head window. Study Design  In this randomized crossover trial at three neonatal intensive care units in Japan, 27 neonatologists were randomized into two groups, namely, those intubating neonatal simulators using video laryngoscopy and then using direct laryngoscopy, or vice versa. The intubations were performed via hand ports or head window without opening top and side walls in incubators in two manikin positions (rotated 90° or unrotated). Glottis visualization (0–100%), success rate, intubation time, and ease of laryngoscopy (from 1 [very difficult] to 10 [very easy]) were compared between video laryngoscopy and direct laryngoscopy. Generalized linear models were used for the analyses. Results  This study assessed 108 intubations performed by 27 neonatologists. The use of video laryngoscopy improved the glottis visualization by 14% (95% confidence interval, 7.4–20%; p  < 0.01) and easiness scores of laryngoscopy by 0.8 (0.2–1.4; p  < 0.01), but did not reduce the intubation time. Conclusion  Video laryngoscopy is useful for experienced neonatologists for intubating neonatal manikins in incubators without opening the top or side walls. [ABSTRACT FROM AUTHOR]

The Japan Resuscitation Council joined the International Liaison Committee on Resuscitation (ILCOR) as a member of the Resuscitation Council of Asia in 2006. In 2007, the Japan Society of Perinatal and Neonatal Medicine (JSPNM), which is a member of an affiliated body, launched the Neonatal Cardiopulmonary Resuscitation (NCPR) program as an authorized project to ensure that all staff involved in perinatal and neonatal medicine can learn and practice neonatal cardiopulmonary resuscitation based on the Consensus on Science with Treatment Recommendations developed by ILCOR. The content of courses in the NCPR program is based on the NCPR guidelines. These guidelines are revised by the Japan Resuscitation Council according to the Consensus on Science with Treatment Recommendations, which is updated by ILCOR every 5 years. The latest updated edition in Japanese was published in 2016 and we translated these Japanese guidelines to English in 2018. Here, we introduce a summary of the NCPR guidelines 2015 in Japan. The NCPR 2015 algorithm has two flows, "lifesaving flow" and "stabilization of breathing flow" at the first branching point after the initial step of resuscitation. [ABSTRACT FROM AUTHOR]

Background/Aims: We aimed to investigate incidence, characteristics, and possible risk factors of pancreatic cancer in patients under observation for hepatocellular carcinoma (HCC) because the association of hepatitis virus B infection and pancreatic cancer has been reported. Patients and Methods: We performed a retrospective cohort study in the Gastroenterology Department of a University Hospital in Japan between 2004 and 2012. A total of 1848 patients who underwent treatment for HCC were included at the initiation of treatment for HCC (mean follow-up period, 33.6 months). The patients received trimonthly radiological follow-ups. Newly developed cases of pancreatic cancer during follow-up for HCC were compared with that of an age- and sex-matched theoretical cohort from national statistics. Possible predisposing factors for pancreatic cancer related to HCC were assessed. Cumulative probabilities of developing a pancreatic cancer were compared using log-rank test. Results: About 13 of 1848 patients developed pancreatic cancer (mean follow-up period, 45.2 months). The risk ratio for all patients was 3.02 (log-rank test: P =0.01). Statistical analyses showed no effects of the following factors on the development of pancreatic cancer: age, sex, follow-up period, alcohol intake, laboratory data, presence of hepatitis virus, characteristics of HCC, type of treatment, number of radiological examinations, and cumulative effective dose. Conclusions: Increased incidence of pancreatic cancer was found in patients under observation for HCC in a relatively small cohort. HCC or other common underlying conditions might be a risk factor for development of pancreatic cancer. [ABSTRACT FROM AUTHOR]

Background and Aim: An antireflux metal stent (ARMS) for nonresectable distal malignant biliary obstruction (MBO) may prevent recurrent biliary obstruction (RBO) as a result of duodenobiliary reflux and prolong time to RBO (TRBO). Superiority of ARMS over conventional covered self‐expandable metal stents (SEMS) has not been fully examined. Methods: We conducted a multicenter randomized controlled trial to examine whether TRBO of an ARMS with a funnel‐shaped valve was longer than that of a covered SEMS in SEMS‐naïve patients. We enrolled 104 patients (52 patients per arm) at 11 hospitals in Japan. Secondary outcomes included causes of RBO, adverse events, and patient survival. Results: TRBO did not differ significantly between the ARMS and covered SEMS groups (median, 251 vs 351 days, respectively; P = 0.11). RBO as a result of biliary sludge or food impaction was observed in 13% and 9.8% of patients who received an ARMS and covered SEMS, respectively (P = 0.83). ARMS was associated with a higher rate of stent migration compared with the covered SEMS (31% vs 12%, P = 0.038). Overall rates of adverse events were 20% and 18% in the ARMS and covered SEMS groups, respectively (P = 0.97). No significant between‐group difference in patient survival was observed (P = 0.26). Conclusions: The current ARMS was not associated with longer TRBO compared with the covered SEMS. Modifications including addition of an anti‐migration system are required to use the current ARMS as first‐line palliative treatment of distal MBO (UMIN‐CTR clinical trial registration number: UMIN000014784). [ABSTRACT FROM AUTHOR]

In July 2007, the Neonatal Cardiopulmonary Resuscitation (NCPR) program in Japan was launched to ensure that all staff involved in perinatal and neonatal medicine can learn and practice NCPR based on the Consensus on Science with Treatment Recommendations developed by the International Liaison Committee on Resuscitation. In 1978 in North America, a working group on pediatric resuscitation was formed by the American Heart Association Emergency Cardiac Care Committee and concluded that the resuscitation of newborns required a different strategy than the resuscitation of adults. The original first edition of the Neonatal Resuscitation Program textbook was published in 1987. The NCPR program consists of three courses for health‐care providers and two courses for instructors. A course and B course are for newly certified health‐care providers and course S is for health‐care providers who are renewing their certification. As of 31 March 2019, 3,227 advanced instructors (I instructor) and 1,877 basic instructors (J instructor) were trained to teach A, B, and S courses to health‐care providers on the basis of their license. In total 7,075 A courses and 4,012 B courses were held; 131 651 people attended A course or B course of the NCPR program, and 77 367 were certified. A total of 1,865 S courses, which were developed in 2015, were held and 12 875 people attended this course. Here, we introduce the background, purpose, history, and content of the development of the NCPR program in Japan. [ABSTRACT FROM AUTHOR]

Background and Aim: Colorectal cancer patients often present with large bowel obstruction. Elective placement of a self‐expandable metallic stent (SEMS) can relieve obstruction, but can be challenging. Previous studies have compared cases by outcomes only, but the present study investigated successful cases only to identify factors related to prolonged and difficult SEMS placement in patients with malignant colonic obstruction. Methods: A post‐hoc analysis of a multicenter clinical trial conducted between March 2012 and October 2013 at 46 facilities across Japan (UMIN000007953) was carried out; 511 patients who required SEMS placement for acute colorectal obstruction or symptomatic stricture secondary to malignant neoplasm were enrolled. Technical success rates and procedure times were recorded. Clinical and interventional parameters were investigated for their potential effect on procedure time by univariate and multivariate analyses. Results: Technical success rate of SEMS placement was 98%. Median procedure time was 30 (range, 4–170) min. In 27% of patients, procedure time exceeded 45 min, indicating technically difficult placement. Multivariate analyses showed significant associations between technically difficult placement and a ColoRectal Obstruction Scoring System (CROSS) score of 0 before SEMS placement (odds ratio [OR], 1.6; P < 0.05), tumor site in the right colon (OR, 2.5; P < 0.0001), stricture length ≥5 cm (OR, 2.2; P < 0.001), peritoneal carcinomatosis (OR, 1.7; P < 0.05), and multiple SEMS placement (OR, 8.0; P < 0.01). Conclusion: Clinicians must anticipate technical challenges in cases with peritoneal carcinomatosis, a CROSS score of 0, or expansive strictures; such cases require experienced clinicians to carry out SEMS placement. [ABSTRACT FROM AUTHOR]

Background: Both fully covered (FC) and partially covered (PC) self-expandable metal stents (SEMSs) are now commercially available for distal malignant biliary obstruction (MBO). While FCSEMS can be easily removed at the time of re-interventions, it is theoretically prone to migration. However, few comparative data between FC and PC SEMSs have been reported.Aims: The aim of this study was to compare clinical outcomes of FCSEMS with those of PCSEMS.Methods: This was a multicenter, prospective study of FCSEMS for unresectable distal MBO with a historical control of PCSEMS, which was previously reported as the WATCH study. The primary outcome was recurrent biliary obstruction (RBO), and secondary outcomes were stent migration, stent removal, stent-related adverse events, and survival.Results: A total of 151 cases with unresectable distal MBO undergoing FCSEMS placement were enrolled and compared with a historical cohort of 141 cases undergoing PCSEMS placement. No significant differences were found in the rate of RBO (29 vs. 33%; P = 0.451), time to RBO (318 vs. 373 days; P = 0.382), and survival (229 vs. 196 days; P = 0.177) between FCSEMS and PCSEMS. The rate of stent migration also did not differ significantly between the two groups (14 vs. 8%; P = 0.113). The removal of FCSEMSs was successful in all 24 attempted cases (100%).Conclusions: FCSEMSs appeared comparable to PCSEMSs in terms of RBO without a significant increase in stent migration rate in patients with unresectable distal MBO.Clinical Trial Registration Number: UMIN000007131. [ABSTRACT FROM AUTHOR]

Background: Primary sclerosing cholangitis (PSC) is a chronic cholestatic liver disease of unknown cause that is characterized pathologically by an inflammatory and fibrotic process centered on the epithelium, leading to diffuse biliary stenosis and increased wall thickness throughout the intra- and extra-hepatic biliary trees. A nationwide survey in Japan revealed several differences in the clinical aspects of PSC between Japan and Western countries. PSC was recently designated an intractable hepatobiliary disease in Japan. The aim of this study was to establish Japanese diagnostic criteria for PSC according to the current Japanese conditions.Methods: The Intractable Hepato-Biliary Diseases Study Group in Japan of the Committee of Research on Measures for Intractable Diseases established a working group consisting of researchers specializing in PSC and proposed the 2016 Japanese diagnostic criteria for PSC.Results: The diagnostic criteria consisted of the major and minor items. Major items are directly related to bile duct changes based on biliary tract imaging and an increased alkaline phosphatase level. Minor items consist of an association with inflammatory bowel disease and liver histology.Conclusion: The diagnostic criteria for PSC are useful for general physicians in practice. [ABSTRACT FROM AUTHOR]

Purpose: Non-inferiority for overall survival (OS) following alternate-day treatment with the oral anticancer drug S-1 compared with standard daily treatment was assessed in Japanese patients with unresectable advanced pancreatic cancer in a multicenter, randomized, phase II study. This trial was registered at the UMIN Clinical Trials Registry (no. 000008604).Methods: Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned 2:1 to treatment with alternate-day (twice daily on alternate days from days 1 through 42 of a 42-day cycle) or daily (twice daily on days 1 through 28 of a 42-day cycle) treatment with S-1. The primary endpoint was OS. Secondary endpoints were progression-free survival (PFS), time to treatment failure, response rate, quality of life assessments, and safety.Results: A total of 190 patients were enrolled, of which 185 were included in the final analysis (alternate-day: 121; daily: 64). Median OS was 9.4 for the alternate-day group and 10.4 months for the daily group [hazard ratio (HR), 1.19; 95% credible interval, 0.86 to 1.64], indicating that non-inferiority of alternate-day treatment to daily treatment was not demonstrated. Median PFS was 3.0 for the alternate-day group and 4.2 months for the daily group (HR, 1.65; 95% credible interval, 1.20-2.29). The incidence of anorexia, fatigue, neutrophils, pigmentation, and pneumonitis was lower in alternate-day treatment compared with daily treatment.Conclusion: S-1 for advanced pancreatic cancer should be taken daily as recommended, based on the decreased OS and PFS and marginal improvement in safety observed in the alternate-day group. [ABSTRACT FROM AUTHOR]

Background: In the early phase of severe acute pancreatitis, timely multidisciplinary management is required to reduce mortality. The aim of this observational study was to evaluate the impact of weekend hospital admission on outcomes using population-based data in Japan.Methods: Data on adult patients (≥20 years) with severe acute pancreatitis were extracted from a nationwide Japanese administrative database covering over 1000 hospitals. In-hospital mortality, length of stay, and total costs were compared between weekend and weekday admissions, with adjustment for disease severity according to the current Japanese severity scoring system for acute pancreatitis, and other potential risk factors.Results: In total, 8328 patients hospitalized during the study period 2010-2013 were analyzed (2242 admitted at weekends and 6086 on weekdays). In-hospital mortality rates were not significantly different: 5.9 vs. 5.4 % for weekend and weekday admissions, respectively (multivariate-adjusted odds ratio, 1.06; 95 % confidence interval, 0.83-1.35). The impact of weekend admission was not significant either for length of hospitalization (median, 18 vs. 19 days) and total costs (median, 6161 vs. 6233 US dollars) (both p > 0.19 in multivariate-adjusted linear regression). The rates of, and time to, specific treatments were also similar between patients with weekend and weekday admissions.Conclusions: A weekend effect in severe acute pancreatitis admissions was not evident. Adjustments to weekend staffing and selective hospital referral of patients admitted at weekends are not indicated for severe acute pancreatitis in current clinical practice in Japan. [ABSTRACT FROM AUTHOR]

Background: Endoscopic stenting with a self-expandable metallic stent (SEMS) is a widely accepted procedure for malignant colonic obstruction. The Colonic Stent Safe Procedure Research Group conducted the present prospective feasibility study.Methods: Our objectives were to estimate the safety and feasibility of SEMS placement as a bridge to surgery (BTS) for malignant colorectal obstruction. We conducted a prospective, observational, single-arm, multicenter clinical trial from March 2012 to October 2013. Each patient was treated with an uncovered WallFlex enteral colonic stent. Patients were followed up until discharge after surgery.Results: A total of 518 consecutive patients were enrolled in this study. The cohort intended for BTS consisted of 312 patients (61 %), and the stent could be released in 305 patients. Technical and clinical success rates were 98 and 92 %, respectively. Elective surgery was performed in 297 patients, and emergency surgery was performed in eight patients for the treatment of complications. The overall preoperative complication rate was 7.2 %. Major complications, including perforation, occurred in 1.6 %, persistent colonic obstruction occurred in 1.0 %, and stent migration occurred in 1.3 % patients. The median time from SEMS to surgery was 16 days. Silent perforations were observed in 1.3 %. Open and laparoscopic surgery was performed in 121 and 184 patients, respectively. The tumor could be resected in 297 patients. The primary anastomosis rate was 92 %. The rate of anastomotic leakage was 4 %, and the overall stoma creation rate was 10 %. The median duration of hospitalization following surgery was 12 days. Overall postoperative morbidity and mortality rates were 16 and 0.7 %, respectively.Conclusions: This largest, multicenter, prospective study demonstrates the feasibility of SEMS placement as a BTS for malignant colorectal obstruction. SEMS serves as a safe and effective BTS with acceptable stoma creation and complication rates in patients with acute malignant colonic obstruction. [ABSTRACT FROM AUTHOR]

Background: Controversy exists as to whether birthweight-for-gestational age references used to classify infants as small for gestational age (SGA) should be country specific or based on an international (common) standard. We examined whether different birthweight-for-gestational age references affected the association of SGA with adverse outcomes among very preterm neonates.Methods: Singleton infants (n = 23 788) of 24(0) -28(6) weeks' gestational age in nine high-resource countries were classified as SGA (<10th centile) using common and country-specific references based on birthweight and estimated fetal weight (EFW). For each reference, the adjusted relative risk (aRR) for the association of SGA with composite outcome of mortality or major morbidity was estimated.Results: The percentage of infants classified as SGA differed slightly for common compared with country specific for birthweight references [9.9% (95% CI 9.5, 10.2) vs. 11.1% (95% CI 10.7, 11.5)] and for EFW references [28.6% (95% CI 28.0, 29.2) vs. 24.6% (95% CI 24.1, 25.2)]. The association of SGA with the composite outcome was similar when using common or country-specific references for the total sample for birthweight [aRRs 1.47 (95% CI 1.43, 1.51) and 1.48 (95% CI 1.44, 1.53) respectively] and for EFW references [aRRs 1.35 (95% CI 1.31, 1.38) and 1.39 (95% CI 1.35, 1.43) respectively].Conclusion: Small for gestational age is associated with higher mortality and morbidity in infants born <29 weeks' gestational age. Although common and country-specific birthweight/EFW references identified slightly different proportions of SGA infants, the risk of the composite outcome was comparable. [ABSTRACT FROM AUTHOR]

Objective The aim of this study is to compare patent ductus arteriosus (PDA) management strategies and outcomes between the Neonatal Research Network of Japan (NRNJ) with proactive functional echocardiography and the Canadian Neonatal Network (CNN) with selective conventional echocardiography practice. Study Design Retrospective analyses examined very low-birth-weight infants admitted to the NRNJ or CNN in 2006 to 2008. Multivariable logistic regression analyses compared a composite outcome indicating a mortality or major morbidity (severe intraventricular hemorrhage, periventricular leukomalacia, severe retinopathy of prematurity, bronchopulmonary dysplasia, or necrotizing enterocolitis) between networks, according to PDA diagnosis and treatment, and tested the association between PDA treatment and the composite outcome within networks. Results PDA treatment (NRNJ:CNN) with conservative management (8%:16%), indomethacin only (77%:59%), ligation only (1%:13%), or indomethacin and ligation (14%:13%) varied significantly between networks. The composite outcome was lower in NRNJ versus CNN only among infants with PDA (odds ratio: 0.70; 95% confidence interval: 0.62-0.80). Surgical ligation was associated with higher composite outcome only in CNN (odds ratio: 1.79; 95% confidence interval: 1.40-2.28). Conclusion Lower composite mortality/morbidity outcome in Japan versus Canada only among infants with PDA, and association of surgical ligation with higher mortality/ morbidity only in Canada, suggest differential PDAmanagement and ligation processes contribute to outcome variation. [ABSTRACT FROM AUTHOR]

Background/Aims: Endoscopic papillary balloon dilation (EPBD) is a possible alternative to endoscopic sphincterotomy (EST) for common bile duct (CBD) stones. To date, 10‑ and 8‑mm EPBD have not been fully compared. Patients and Methods: Patients who underwent EPBD for CBD stones at two Japanese tertiary care centers between May 1994 and January 2014 were identified. Matched pairs with 10‑ and 8‑mm EPBD were generated. Short‑ and long‑term outcomes were compared between the two groups. Results: A total of 869 patients were identified (61 and 808 patients for 10‑ and 8‑mm EPBD, respectively), and 61 well‑balanced pairs were generated. The rate of complete stone removal within a single session was higher in the 10‑mm EPBD group than in the 8‑mm EPBD group (69% vs. 44%, P < 0.001), and use of lithotripsy was less frequent in the 10‑mm EPBD group (23% vs. 56%, P < 0.001). The rates of post‑ERCP pancreatitis were similar between the 10‑ and 8‑mm EPBD groups (11% vs. 8%). Cumulative biliary complication‑free rates were not statistically different between the two groups: 88% [95% confidence interval (CI): 79-97%] and 94% (95% CI: 88-100%) at 1 year and 69% (95% CI: 56-85%) and 80% (95% CI: 69-93%) at 2 years in the 10‑ and 8‑mm EPBD groups, respectively. In the 10‑mm EPBD group, ascending cholangitis was not observed, and pneumobilia was found in 5% of cases during the follow‑up period. Conclusions: EPBD using a 10‑mm balloon for CBD stones is safe and more effective than 8‑mm EPBD. The sphincter function is highly preserved after 10‑mm EPBD. [ABSTRACT FROM AUTHOR]

Background Our retrospective study and phase I trial of gemcitabine and candesartan combination therapy suggested the inhibition of renin-angiotensin system potentially has a role in the treatment of advanced pancreatic cancer. The aim of this multicenter phase II trial was to assess the efficacy and toxicity of gemcitabine and candesartan combination therapy for advanced pancreatic cancer. Methods Chemotherapy-naive patients with histologically or cytologically proven advanced pancreatic cancer were enrolled. Gemcitabine was administered at a dose of 1,000 mg/m over 30 min on days 1, 8, and 15 and oral candesartan at a dose of 16 mg in normotensive patients, and 8 mg initially in hypertensive patients, with dose escalation to 16 mg allowed, from days 1 to 28, repeated every 4 weeks. Results A total of 35 patients with advanced pancreatic cancer were enrolled. Overall response rate and disease control rate were 11.4 % and 62.9 %. The median PFS and OS were 4.3 and 9.1 months with 1-year survival rate of 34.2 %. The median PFS was significantly longer in patients receiving 16 mg compared with 8 mg of candesartan (4.6 vs. 3.5 months, p = 0.031). Major severe toxicities were neutropenia (23 %), leukopenia (17 %) and thrombocytopenia (11 %). Grade 2 hypotension was observed in 3 patients (9 %) and candesartan was discontinued in 2 patients due to hypotension. Conclusions In this multicenter phase 2 trial, gemcitabine and candesartan combination therapy was tolerable but failed to demonstrate activity against advanced pancreatic cancer. (UMIN CTR: UMIN000005580) [ABSTRACT FROM AUTHOR]

Background and study aims: Only a few large cohort studies have evaluated the efficacy and safety of endoscopic necrosectomy for infected walled- off pancreatic necrosis (WOPN). Therefore, a multicenter, large cohort study was conducted to evaluate the efficacy and safety of endoscopic necrosectomy and to examine the procedural details and follow-up after successful endoscopic necrosectomy. Patients and methods: A retrospective review was conducted in 16 leading Japanese institutions for patients who underwent endoscopic necrosectomy for infected WOPN between August 2005 and July 2011.The follow-up data were also reviewed to determine the long-term outcomes of the procedures. Results: Of 57 patients, 43 (75 %) experienced successful resolution after a median of 5 sessions of endoscopic necrosectomy and 21 days of treatment. Complications occurred in 19 patients (33 %) during the treatment period. Six patients died (11 %): two due to multiple organ failure and one patient each from air embolism, splenic aneurysm, hemorrhage from a Mallory-Weiss tear, and an unknown cause. Of 43 patients with successful endoscopic necrosectomy, recurrent cavity formation was observed in three patients during a median follow-up period of 27 months. Conclusions: Endoscopic necrosectomy can be an effective technique for infected WOPN and requires a relatively short treatment period. However, serious complications can arise, including death. Therefore, patients should be carefully selected, and knowledgeable, skilled, and experienced operators should perform the procedure. Further research into safer technologies is required in order to reduce the associated morbidity and mortality. [ABSTRACT FROM AUTHOR]

Aim This retrospective study estimated the efficacy and safety of the WallFlex duodenal stent for malignant gastric outlet obstruction ( GOO) in Japan. Methods Forty-two consecutive patients with symptomatic malignant GOO were treated using WallFlex duodenal stents between January 2010 and October 2010. Results The technical and clinical success rates were 100% and 83.3%, respectively.The median gastric outlet obstruction scoring system increased significantly, from 0 to 2, after stent placement ( P < 0.01).The median survival time was 3.3 months (95% confidence interval ( CI), 1.8-6.0 months), and the median eating period was 3.0 months (95% CI, 1.1-4.3 months). Re-intervention was required in 11 patients (26.2%). The complication rate was 26.2%. The major complication was stent occlusion (23.8%) by tumor ingrowth, which occurred in nine (21.4%) patients, and tumor overgrowth, which occurred in one (2.4%) patient. Stentmigration, perforation, and food impaction without stent occlusion were not observed.The median survival time of the patients with stent occlusion was 11.7 months (95% CI, 2.2 months - not reached), and the median stent patency of these patients was 4.0 months (95% CI, 0.8-4.7 months).These patients were successfully treated with additional stent insertion using a stent-in-stent procedure. Conclusion Duodenal stent placement using a WallFlex duodenal stent was safe and effective for managing malignant GOO.This stent is an uncovered metallic stent, and the major problem was stent occlusion due to tumor ingrowth. However, the occluded stent could be corrected by inserting an additional duodenal stent. [ABSTRACT FROM AUTHOR]

Introduction: It is important to have a venous line in cardiopulmonary arrest (CPA) patients as an emergency treatment measure in prehospital settings, but establishment of a peripheral venous line is difficult in such patients. This study aimed to investigate the current status of intravenous infusion (IVI) in CPA patients by Emergency Life-Saving Technicians (ELSTs) in Japan. We also considered alternative measures in case IVI was difficult or impossible. Methods: We investigated a nationwide database between 1 January 2005 and 31 December 2008. From a total of 431,968 CPA cases, we calculated the IVI success rate and related parameters. The Bone Injection Gun (BIG) and simulator legs (adult, pediatric, and infant) were used by 100 ELSTs selected for the study to measure the time required and the success rate for intraosseous infusion (IOI). Results: The number of CPA patients, IVI, adrenaline administration, and the IVI success rate in adult CPA patients increased every year. However, the IVI success rate in pediatric CPA patients did not increase. Although adrenaline administration elevated the ROSC rate, there was no improvement in the 1-month survival rate. The time required for IOI with BIG was not different among the leg models. The success rates of IOI with BIG were 93%, 94%, and 84% ( p < 0.05 vs. adult and pediatric) in adult, pediatric, and infant models, respectively. Conclusions: The rate of success of IVI in adult CPA patients has been increased yearly in Japan. However, as establishing a peripheral venous line in pediatric patients (1-7 years old) by ELSTs is extremely difficult in prehospital settings, there was no increase in the IVI success rate in such patients. As the study findings indicated IOI with BIG was easy and rapid, it may be necessary to consider IOI with BIG as an alternative option in case IVI is difficult or impossible in adult and pediatric patients. [ABSTRACT FROM AUTHOR]

Background and aims Intraductal papillary mucinous neoplasms (IPMNs) of the pancreas have been reported to be associated with extrapancreatic malignancies, but there have been no prospective studies evaluating the incidence of extrapancreatic cancers in patients with IPMNs. In this study, the frequency of patients with IPMNs developing extrapancreatic cancers during follow-up was examined. Methods 642 patients with IPMNs were prospectively followed up for 4.8 years on average. They underwent clinical examination at least twice a year. The incidence of the observed extrapancreatic malignancies was compared with the expected incidence of the age- and gender-matched general Japanese population based on the Vital Statistics of Japan. Results 40 extrapancreatic cancers developed in 39 patients during follow-up (1.3% per year). The most common malignancies were hepatocellular (n=7), colorectal (n=6), gastric (n=6), lung (n=5) and prostate cancers (n=4). The calculated standardised incidence rate of each of the malignancies was not significant, as follows: hepatocellular 2.17 (95% CI 0.87 to 4.47), colorectal 1.02 (0.37 to 2.21), gastric 0.76 (0.28 to 1.66), lung 0.75 (0.24 to 1.76) and prostate 1.00 (0.71 to 1.29). Pancreatic cancer was observed in 17 patients during the same period, with a standardised incidence rate of 10.7 (6.2 to 17.1). Conclusions The incidence of extrapancreatic malignancies in patients with IPMNs was similar to that in the general population, whereas the incidence of pancreatic cancers was significantly high. Intraductal papillary mucinous neoplasms are not associated with systemic carcinogenesis except for pancreatic cancer. [ABSTRACT FROM AUTHOR]

(1) Background: Endoscopic colorectal stenting with high technical success and safety is essential in discussing the oncological outcomes for the management of malignant colorectal obstruction. Mechanical properties of self-expandable metal stents are usually considered to affect clinical outcomes. (2) Methods: A multicenter, prospective study was conducted in Japan. A self-expandable metal stent with low axial force was inserted endoscopically. The primary endpoint was clinical success, defined as the resolution of symptoms and radiological findings within 24 h. Secondary endpoints were technical success and adverse events. Short-term outcomes of 7 days were evaluated in this study. (3) Results: Two hundred and five consecutive patients were enrolled. Three patients were excluded, and the remaining 202 patients were evaluated. The technical and clinical success rates were 97.5% and 96.0%, respectively. Major stent-related adverse events included stent migration (1.0%), insufficient stent expansion (0.5%), and stent occlusion (0.5%). No colonic perforation was observed. There were two fatal cases (1%) which were not related to stent placement. (4) Conclusions: The placement of self-expandable metal stents with low axial force is safe with no perforation and showed high technical and clinical success rates in short-term outcomes for the management of malignant colorectal obstruction. [ABSTRACT FROM AUTHOR]

The emergency declaration (ED) associated with the coronavirus disease-2019 (COVID-19) pandemic in Japan had a major effect on the management of gastrointestinal endoscopy. We retrospectively compared the number of pancreaticobiliary endoscopies and newly diagnosed pancreaticobiliary cancers before (1 April 2018 to 6 April 2020), during (7 April to 25 May 2020), and after the ED (26 May to 31 July). Multiple comparisons of the three groups were performed with respect to the presence or absence of symptoms and clinical disease stage. There were no significant differences among the three groups (Before/During/After the ED) in the mean number of diagnoses of pancreatic cancer and biliary cancer per month in each period (8.0/7.5/7.5 cases, p = 0.5, and 4.0/3.5/3.0 cases, p = 0.9, respectively). There were no significant differences among the three groups in the number of pancreaticobiliary endoscopies (EUS: endoscopic ultrasonography/ERCP: endoscopic retrograde cholangiopancreatography) per month (67.8/62.5/69.0 cases, p = 0.7 and 89.8/51.5/86.0 cases, p = 0.06, respectively), whereas the number of EUS cases decreased by 42.7% between before and during the ED. There were no significant differences among the three groups in the presence or absence of symptoms at diagnosis or clinical disease stage. There was no significant reduction in the newly diagnosed pancreaticobiliary cancer, even during the ED. The number of ERCP cases was not significantly reduced as a result of urgent procedures, but the number of EUS cases was significantly reduced. [ABSTRACT FROM AUTHOR]

Intraductal papillary neoplasm of the bile duct (IPNB), a pre-invasive neoplasm of the bile duct, is being established pathologically as a precursor lesion of invasive cholangiocarcinoma (CCA), and at the time of surgical resection, approximately half of IPNBs show stromal invasion (IPNB associated with invasive carcinoma). IPNB can involve any part of the biliary tree. IPNB shows grossly visible, exophytic growth in a dilated bile duct lumen, with histologically villous/papillary neoplastic epithelia with tubular components covering fine fibrovascular stalks. Interestingly, IPNB can be classified into four subtypes (intestinal, gastric, pancreatobiliary and oncocytic), similar to intraductal papillary mucinous neoplasm of the pancreas (IPMN). IPNBs are classified into low-grade and high-grade based on lining epithelial features. The new subclassification of IPNB into types 1 (low-grade dysplasia and high-grade dysplasia with regular architecture) and 2 (high-grade dysplasia with irregular architecture) proposed by the Japan–Korea pathologist group may be useful in the clinical field. The outcome of post-operative IPNBs is more favorable in type 1 than type 2. Recent genetic studies using next-generation sequencing have demonstrated the existence of several groups of mutations of genes: (i) IPNB showing mutations in KRAS, GNAS and RNF43 belonged to type 1, particularly the intestinal subtype, similar to the mutation patterns of IPMN; (ii) IPNB showing mutations in CTNNB1 and lacking mutations in KRAS, GNAS and RNF43 belonged to the pancreatobiliary subtype but differed from IPMN. IPNB showing mutation of TP53, SMAD4 and PIK3CA might reflect complicated and other features characterizing type 2. The recent recognition of IPNBs may facilitate further clinical and basic studies of CCA with respect to the pre-invasive and early invasive stages. [ABSTRACT FROM AUTHOR]

The article presents a case of a 57-year-old man with liver cirrhosis admitted to Hepato-Biliary-Pancreatic Surgery Division of the University of Tokyo Hospital in Japan. The patient undergone preoperative transarterial chemoembolization (TACE) against recurrent hepatocellular carcinoma (HCC) with biliary invasion. The findings reveal that the patient showed a rare instance of biliary tumor thrombus of HCC containing lipiodol mimicking a calcified biliary stone at the distal common bile duct.

Biliary drainage is a standard procedure for cholangitis or obstructive jaundice due to biliary obstruction. However, criterion for the selection of types of drainage tube is not established. The authors analyzed the types of drainage tube used in the University of Tokyo, Tokyo, Japan, during the month of June 2005, and they treated 63 cases. For drainage for cholangitis (31), the authors used endoscopic naso-biliary drainage (ENBD) tube in 74.1% and plastic stent in 25.9%. In contrast, for the cholestesis cases (16), the authors used ENBD tube in 37.5% and plastic stent in 63.5%. For the unresectable biliary malignancy cases (8) with improved jaundice, the authors used covered metallic stent in seven distally stricture cases and uncovered metallic stent in one proximally stricture case. The remaining eight cases received plastic stent placement. There were six cases of residual common bile duct stones and two cases of prevention of cholangitis after papillectomy. For the patients with unresectable biliary malignancies at distal portion, the authors consider that covered metallic stent is a standard endoprosthesis. For drainage for cholangitis, the authors used ENBD tube because bile juice flow is able to be checked any time. However, the authors used plastic stent rather than ENBD tube for the drainage of cholestesis. A larger study for selection of drainage tube for these aspects is needed in the future. [ABSTRACT FROM AUTHOR]

Covered metallic stent (covered MS) is useful to improve quality-of-life in patients with unresectable malignant distal biliary obstruction. We have managed 129 patients with three types of covered MS; polyurethane-covered Wallstent (hand-craft), polyurethane-covered Diamond stent (hand-craft), and silicone-covered Wallstent (commercially available). They were compared with 115 cases treated with uncovered metallic stent (uncovered MS). There was no significant difference in survival between the two groups. The cumulative stent patency was significantly higher in the covered MS group than uncovered MS group ( P = 0.0027). Stent occlusion occurred in 17 patients (13%) in the covered MS group, and in 48 patients (42%) in the uncovered MS group ( P < 0.0001). Complications of covered MS were 8 (6%) in acute cholecystitis, 10 (8%) in acute pancreatitis, and 10 (8%) in migration. We evaluated the risk factors for these complications of covered MS. [ABSTRACT FROM AUTHOR]

Respiratory care is one of the essential cares in very low birth weight (VLBW) infants. Hospital-based risk-adjusted duration of initial MV was estimated by the multiple regression analysis. There were 210 hospitals covering these patients after excluding hospitals treating <5 VLBW infants. [Extracted from the article]