Comparison of endoscopic healing and durability between infliximab originator and CT-P13 in pediatric patients with inflammatory bowel disease.

Background and aims: Favourable clinical data were published on the efficacy of CT-P13, the first biosimilar of infliximab (IFX), in pediatric inflammatory bowel disease (IBD); however, few studies have compared the effect on endoscopic healing (EH) and drug retention rate between the IFX originator and CT-P13. Therefore, we aimed to compare EH and the drug retention rate between the IFX originator and CT-P13. Methods: Children with Crohn's disease (CD) and ulcerative colitis (UC)/IBD-unclassified (IBD-U) at 22 medical centers were enrolled, with a retrospective review conducted at 1-year and last follow-up. Clinical remission, EH and drug retention rate were evaluated. Results: We studied 416 pediatric patients with IBD: 77.4% had CD and 22.6% had UC/IBD-U. Among them, 255 (61.3%) received the IFX originator and 161 (38.7%) received CT-P13. No statistically significant differences were found between the IFX originator and CT-P13 in terms of corticosteroid-free remission and adverse events. At 1-year follow-up, EH rates were comparable between them (CD: P=0.902, UC: P=0.860). The estimated cumulative cessation rates were not significantly different between the two groups. In patients with CD, the drug retention rates were 66.1% in the IFX originator and 71.6% in the CT-P13 group at the maximum follow-up period (P >0.05). In patients with UC, the drug retention rates were 49.8% in the IFX originator and 56.3% in the CT-P13 group at the maximum follow-up period (P >0.05). Conclusions: The IFX originator and CT-P13 demonstrated comparable therapeutic response including EH, clinical remission, drug retention rate and safety in pediatric IBD.

Fecal Calprotectin Levels Significantly Correlate with Polyp Size in Children and Adolescents with Juvenile Colorectal Polyps.

Purpose: We aimed to investigate factors that correlate with fecal calprotectin (FC) levels in children and adolescents with colorectal polyps. Methods: Pediatric patients aged <19 years who underwent colonoscopic polypectomy for a juvenile polyps (JPs) and FC tests were simultaneously conducted in a multicenter, retrospective study. Baseline demographics, colonoscopic and histological findings, and laboratory tests, including FC levels, were investigated. Correlations between the factors were investigated, and linear regression analysis revealed factors that correlated with FC levels. FC levels measured after polypectomies were investigated and the FC levels pre- and post-polypectomies were compared. Results: A total of 33 patients were included in the study. According to Pearson correlation analysis, the polyp size was the only factor that showed a statistically significant correlation with FC levels (r=0.75, p<0.001). Furthermore, according to the multivariate linear regression analysis, polyp size was the only factor that showed a statistically significant correlation with FC levels (adjusted R2 =0.5718, ß=73.62, p<0.001). The median FC level was 400 mg/kg (interquartile range [IQR], 141.6-1,000 mg/kg), and the median polyp size was 14 mm (IQR, 9-20 mm). Nineteen patients underwent post-polypectomy FC tests. FC levels showed a significant decrease after polypectomy from a median of 445.2 mg/kg (IQR, 225-1,000) to 26.5 mg/kg (11.5-51) (p<0.001). Conclusion: FC levels significantly correlated with polyp size in children and adolescents with JPs.

Association between body mass index and fecal calprotectin levels in children and adolescents with irritable bowel syndrome.

Irritable bowel syndrome (IBS) is a common pediatric functional gastrointestinal disorder. It is characterized by recurrent abdominal pain and changes in bowel habits and is more prevalent in obese patients. We investigated the association between obesity and IBS in pediatric patients through fecal calprotectin testing. Patients under 18 years of age with IBS who underwent fecal calprotectin testing from January 2015 through April 2020 were retrospectively investigated. The patients were divided into groups based on body mass index (BMI): group I (BMI < 85th percentile) and group II (BMI ≥ 85th percentile). Group II was divided into group IIa, overweight (85th percentile ≤ BMI < 95th percentile), and group IIb, obese (BMI ≥ 95th percentile). Among 277 included patients, 202 (72.9%) were in group I, and 75 (27.1%) were in group II (mean calprotectin levels, 75.60 ± 103.48 vs 45.89 ± 66.57 µg/g, respectively; P = .006). There were significant differences in mean calprotectin levels between groups I and IIa (75.60 ± 103.48 vs 45.45 ± 63.38 µg/g, respectively; P = .028) and groups I and IIb (75.60 ± 103.48 vs 46.22 ± 69.59 µg/g, respectively; P = .025). There was a significant difference in mean calprotectin levels between groups I and II (85.69 ± 142.13 vs 32.04 ± 28.17 µg/g, respectively; P = .029) among patients between 6 and 12 years of age but not among adolescents aged between 12 and 18 years (P = .139). Fecal calprotectin was lower when moderate-to-severe fatty livers were observed by ultrasound compared with normal livers (68.52 ± 97.22 vs 18.53 ± 18.56 µg/g, respectively; P = .017). Fecal calprotectin levels were higher in normal-weight pediatric IBS patients than in their obese counterparts, and this difference was more prominent in younger patients. In young children, IBS symptoms are thought to be influenced more by factors other than intestinal inflammation.

Clinical Characteristics and Long-term Outcomes of Pediatric Ulcerative Colitis: A Single-Center Experience in Korea.

Background/Aims: : Although pediatric ulcerative colitis (UC) has a different phenotype and clinical course than adult UC, its clinical features and outcomes are poorly defined, especially in Asian populations. This study investigated the clinical features and long-term outcomes of pediatric UC in a Korean population. Methods: We retrospectively analyzed 208 patients aged <18 years diagnosed with UC between 1987 and 2013. The patient characteristics at diagnosis according to the Paris classification and the clinical course were analyzed. Results: The male-to-female ratio was 1.3:1, and the median patient age was 15.5 years. At diagnosis, 28.8% of patients had proctitis (E1), 27.8%, left-sided colitis (E2); 5.2%, extensive colitis (E3); and 38.2%, pancolitis (E4). The cumulative probabilities of extension after 5, 10, 15, and 20 years were 32.7%, 40.4%, 52.5%, and 65.8%, respectively. Eighteen patients underwent colectomy, and three patients had colorectal cancer. The cumulative probabilities of colectomy after 5, 10, 15, and 20 years were 7.1%, 8.9%, 12.6%, and 15.6%, and those of colorectal cancer after 10, 15, and 20 years were 0%, 2.1%, and 12.0%, respectively. The disease extent, Pediatric Ulcerative Colitis Activity Index severity, and systemic corticosteroid therapy were significant risk factors for colectomy. The development of primary sclerosing cholangitis was significantly associated with colorectal cancer. Conclusions: This study provides detailed information on the disease phenotype and long-term clinical outcomes in a large cohort of Korean children with UC. They have extensive disease at diagnosis, a high rate of disease extension, and a low rate of cumulative colectomy.

Recent Improvement in Survival Outcomes and Reappraisal of Prognostic Factors in Pediatric Living Donor Liver Transplantation.

Living donor liver transplantation (LDLT) is a significant advancement for the treatment of children with end-stage liver disease given the shortage of deceased donors. The ultimate goal of pediatric LDLT is to achieve complete donor safety and zero recipient mortality. We conducted a retrospective, single-center assessment of the outcomes as well as the clinical factors that may influence graft and patient survival after primary LDLTs performed between 1994 and 2020. A Cox proportional hazards model was used for multivariate analyses. The trends for independent prognostic factors were analyzed according to the following treatment eras: 1, 1994 to 2002; 2, 2003 to 2011; and 3, 2012 to 2020. Primary LDLTs were performed on 287 children during the study period. Biliary atresia (BA; 52%), acute liver failure (ALF; 26%), and monogenic liver disease (11%) were the leading indications. There were 45 graft losses (16%) and 27 patient deaths (7%) in this population during the study period. During era 1 (n = 81), the cumulative survival rates at 1 and 5 years after LDLT were 90.1% and 81.5% for patients and 86.4% and 77.8% for grafts, respectively. During era 2 (n = 113), the corresponding rates were 92.9% and 92% for patients and 89.4% and 86.7% for grafts, respectively. During era 3 (n = 93), the corresponding rates were 100% and 98.6% for patients and 98.9% and 95.4% for grafts, respectively. In the multivariate analyses, primary diagnosis ALF, bloodstream infection, posttransplant lymphoproliferative disease, and chronic rejection were found to be negative prognostic indicators for patient survival. Based on generalized care guidelines and center-oriented experiences, comprehensive advances in appropriate donor selection, refinement of surgical techniques, and meticulous medical management may eventually realize a zero-mortality rate in pediatric LDLT.

Metal stents placement for refractory pancreatic duct stricture in children.

AIM: To evaluate the use of fully covered self-expandable metal stents (FCSEMSs) for pancreatic duct strictures in children with chronic pancreatitis. METHODS: Eight patients with refractory benign dominant stricture of the main pancreatic duct (MPD) were enrolled through chart reviews between December 2014 and June 2017 in a single center. Endoscopic retrograde cholangiopancreatography (ERCP) with placement of a 6-mm FCSEMS with dual flaps was performed. Endoscopic removal of FCSEMSs was performed with a snare or rat-tooth forceps. All procedures were performed by a pediatric gastroenterologist. For the assessment of outcomes, technical and clinical success, adverse events, and stent patency were evaluated retrospectively. RESULTS: The placement and removal of the FCSEMSs were successful in all 8 patients. Five patients were boys and 3 were girls. The median age at initial FCSEMS placement was 12 years (range, 5-18 years). The diameters of all the inserted stents were 6 mm, and the lengths were 4-7 cm. The median indwelling time was 6 mo (range, 3-10 mo). No pancreatic sepsis, pancreatitis, cholestasis, or mortality occurred. There was no proximal and distal migration. All subjects showed a patent stent. On follow-up ERCP, the mean diameter of the stricture improved from 1.1 mm to 2.8 mm (P < 0.05), whereas that of upstream dilation improved from 8.4 mm to 6.3 mm (P < 0.05). CONCLUSION: This initial experience showed that temporary FCSEMS placement is feasible and safe for the management of refractory benign MPD stricture in children.

A Multicenter Study of the Antiviral Efficacy of Entecavir Monotherapy Compared to Lamivudine Monotherapy in Children with Nucleos(t)ide-naïve Chronic Hepatitis B.

BACKGROUND: The aim of this study was to compare the long-term efficacy of entecavir (ETV) and lamivudine (LAM) therapy in children with chronic hepatitis B (CHB) who had not received nucleoside analogue treatment. METHODS: In this multicenter, retrospective study, we included pediatric CHB patients younger than 20 years who received ETV or LAM treatment for at least 12 months and had no concomitant diseases. All of the patients were followed up every 1 to 3 months. At each visit, the patients underwent clinical evaluation and biochemical testing. RESULTS: Eight (53.3%), 14 (93.3%), and 2 (15.4%) of the ETV-treated patients achieved virologic suppression, alanine aminotransferase (ALT) normalization and hepatitis B e antigen (HBeAg) seroconversion, respectively, at 1 year. In the ETV group, the cumulative rate of virologic suppression at 3 years was 91.7%, which was significantly higher than that in the LAM group (P < 0.001). The mean duration of treatment before virologic suppression was shorter in the ETV group than in the LAM group (P = 0.040). The cumulative rate of seroconversion in the ETV group at 3 years was 39.4%, which was not significantly different from that in the LAM group (P = 0.439). The ETV group showed lower cumulate rates of virologic breakthrough (33.3% at 6 years) and genotypic mutation than the LAM group (P = 0.033 and P = 0.011, respectively). CONCLUSION: ETV is superior to LAM in pediatric CHB treatment because of its higher virologic suppression rate and lower cumulative rates of virologic breakthrough and genotypic mutation.

Early adverse events and long-term outcomes of endoscopic sphincterotomy in a pediatric population: a single-center experience.

Background and aims: The use of endoscopic sphincterotomy (EST) in the management of pancreaticobiliary disease in children is increasing. However, studies of long-term outcomes are limited in pediatric patients. Therefore, this study evaluated the early adverse events and long-term outcomes following EST in pediatric patients. Patients and methods: We retrospectively analyzed data from 198 pediatric patients who underwent ESTs at Asan Medical Center Children's Hospital between 1994 and 2013. The median age was 8.7 years (range 18 months to17 years). We evaluated the indications, success rates, early adverse events, and long-term outcomes. Results: Long-term information was available in 198 patients with a median follow-up duration of 42 months (range, 1.8 - 232.1 months). Early adverse events (< 30 days) following 294 ESTs among 198 patients included pancreatitis in 17 (5.7 %), hemorrhages in 6 (2.0 %), sepsis in 3 (1.0 %), and perforations in 2 (0.7 %). Long-term complications ( > 30 days) developed in 12 patients (6.1 %), including cholangitis with or without bile duct stone (n = 7), and minor papilla restenosis (n = 5). The cumulative incidence rates of long-term complications were 3.1 %, 6.1 %, 9.3 %, and 9.3 %, at 1, 5, 10, and 15 years. There were no procedure-related pancreaticobiliary malignancies or deaths. All adverse events and long-term complications improved with appropriate management. Conclusions: In pediatric patients with pancreaticobiliary disease, EST has a high level of technical success. In addition, pediatric EST showed low rates of early adverse events and long-term complications, which could be managed safely. Our results suggest that EST is a safe method for treating pancreaticobiliary disease, even in the pediatric population.

Cancer-related Fatigue in Patients with Advanced Cancer Treated with Autonomic Nerve Pharmacopuncture.

The purpose of this study was to observe the effects of autonomic nerve pharmacopuncture (ANP) treatment on cancer-related fatigue (CRF) in patients with advanced cancer. This observational case study was conducted at the East West Cancer Center of Daejeon University's Dunsan Korean Medical Hospital. Two patients were observed. One patient was diagnosed with left thymic cancer metastatic to the left pleura. The other patient had terminal-stage cervical cancer with iliac bone and lumbar 5 metastases. We injected mountain ginseng pharmacopuncture (MGP) into acupoints alongside the spine (Hua-Tuo-Jia-Ji-Xue, EX B2). We examined the patients for CRF using the Korean version of the Revised Piper Fatigue Scale (RPFS-K), which is a self-assessment tool. The scores on the RPFS-K for both patients tended to decrease during the treatment. Laboratory findings, including hematological changes, were also checked. Liver and renal function tests showed that the treatment was safe. Although further large-population studies are necessary, this case study suggests that ANP has a favorable effect on CRF in patients with advanced cancer.

[Optimal time interval for position change for ICU patients using foam mattress against pressure ulcer risk].

PURPOSE: This study was done to identify the time interval to pressure ulcer and to determine the optimal time interval for position change depending on pressure ulcer risk in patients using foam mattress in intensive care units. METHODS: The Braden scale score, occurrence of pressure ulcers and position change intervals were assessed with 56 patients admitted to an intensive care unit from April to November, 2011. The time to pressure ulcer occurrence by Braden scale risk group was analyzed with Kaplan-Meier survival analysis and log rank test. Then, the optimal time interval for position change was calculated with ROC curve. RESULTS: The median time to pressure ulcer occurrence was 5 hours at mild or moderate risk, 3.5 hours at high risk and 3 hours at very high risk on the Braden scale. The optimal time interval for position change was 3 hours at mild and moderate risk, 2 hours at high and very high risk of Braden scale. CONCLUSION: When foam mattresses are used a slight extension of the time interval for position change can be considered for the patients with mild or moderate pressure ulcer risk but not for patients with high or very high pressure ulcer risk by Braden scale.