• Title/Summary/Keyword: multicenter

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Morbidity and Mortality After Laparoscopy-Assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy to Treat Gastric Cancer: An Interim Report: A Phase III Multicenter, Prospective, Randomized Trial (The KLASS-07 Trial)

  • Han Hong Lee;Chang Min Lee;Moon-Soo Lee ;In Ho Jeong;Myoung Won Son;Chang Hyun Kim;Moon-Won Yoo;Sung Jin Oh;Young-Gil Son;Sung Il Choi;Mi Ran Jung;Sang Hyuk Seo;Shin-Hoo Park;Seong Ho Hwang;Jae-Seok Min;Sungsoo Park
    • Journal of Gastric Cancer
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    • v.24 no.3
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    • pp.257-266
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    • 2024
  • Purpose: We conducted a randomized prospective trial (KLASS-07 trial) to compare laparoscopy-assisted distal gastrectomy (LADG) and totally laparoscopic distal gastrectomy (TLDG) for gastric cancer. In this interim report, we describe short-term results in terms of morbidity and mortality. Methods and Methods: The sample size was 442 participants. At the time of the interim analysis, 314 patients were enrolled and randomized. After excluding patients who did not undergo planned surgeries, we performed a modified per-protocol analysis of 151 and 145 patients in the LADG and TLDG groups, respectively. Results: The baseline characteristics, including comorbidity status, did not differ between the LADG and TLDG groups. Blood loss was somewhat higher in the LADG group, but statistical significance was not attained (76.76±72.63 vs. 62.91±65.68 mL; P=0.087). Neither the required transfusion level nor the operation or reconstruction time differed between the 2 groups. The mini-laparotomy incision in the LADG group was significantly longer than the extended umbilical incision required for specimen removal in the TLDG group (4.79±0.82 vs. 3.89±0.83 cm; P<0.001). There were no between-group differences in the time to solid food intake, hospital stay, pain score, or complications within 30 days postoperatively. No mortality was observed in either group. Conclusions: Short-term morbidity and mortality rates did not differ between the LADG and TLDG groups. The KLASS-07 trial is currently underway.

Prevalence of Inflammatory Bowel Disease Unclassified, as Estimated Using the Revised Porto Criteria, among Korean Pediatric Patients with Inflammatory Bowel Disease

  • Sung Hee Lee;Minsoo Shin;Seo Hee Kim;Seong Pyo Kim;Hyung-Jin Yoon;Yangsoon Park;Jaemoon Koh;Seak Hee Oh;Jae Sung Ko;Jin Soo Moon;Kyung Mo Kim
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.27 no.4
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    • pp.206-214
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    • 2024
  • Purpose: Few studies have reported the prevalence of inflammatory bowel disease unclassified (IBDU) among Korean pediatric IBD (PIBD) population. To address this gap, we used two tertiary centers and nationwide population-based healthcare administrative data to estimate the prevalence of Korean pediatric IBDU at the time of diagnosis. Methods: We identified 136 patients aged 2-17 years with newly diagnosed IBD (94 Crohn's disease [CD] and 42 ulcerative colitis [UC]) from two tertiary centers in Korea between 2005 and 2017. We reclassified these 136 patients using the revised Porto criteria. To estimate the population-based prevalence, we analyzed Korean administrative healthcare data between 2005 and 2016, which revealed 3,650 IBD patients, including 2,538 CD and 1,112 UC. By extrapolating the reclassified results to a population-based dataset, we estimated the prevalence of PIBD subtypes. Results: Among the 94 CD, the original diagnosis remained unchanged in 93 (98.9%), while the diagnosis of one (1.1%) patient was changed to IBDU. Among the 42 UC, the original diagnosis remained unchanged in 13 (31.0%), while the diagnoses in 11 (26.2%), 17 (40.5%), and one (2.4%) patient changed to atypical UC, IBDU, and CD, respectively. The estimated prevalences of CD, UC, atypical UC, and IBDU in the Korean population were 69.5%, 9.4%, 8.0%, and 13.1%, respectively. Conclusion: This study is the first in Korea to estimate the prevalence of pediatric IBDU. This prevalence (13.1%) aligns with findings from Western studies. Large-scale prospective multicenter studies on PIBDU are required to examine the clinical features and outcomes of this condition.

SoUth Korean study to PrEvent cognitive impaiRment and protect BRAIN health through Multidomain interventions via facE-to-facE and video communication plaTforms in mild cognitive impairment (SUPERBRAIN-MEET): Protocol for a Multicenter Randomized Controlled Trial

  • Soo Hyun Cho;Hae Jin Kang;Yoo Kyoung Park;So Young Moon;Chang Hyung Hong;Hae Ri Na;Hong-Sun Song;Muncheong Choi;Sooin Jeong;Kyung Won Park;Hyun Sook Kim;Buong-O Chun;Jiwoo Jung;Jee Hyang Jeong;Seong Hye Choi
    • Dementia and Neurocognitive Disorders
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    • v.23 no.1
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    • pp.30-43
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    • 2024
  • Background and Purpose: The SoUth Korea study to PrEvent cognitive impaiRment and protect BRAIN health through lifestyle intervention (SUPERBRAIN) proved the feasibility of multidomain intervention for elderly people. One-quarter of the Korean population over 65 years of age has mild cognitive impairment (MCI). Digital health interventions may be cost-effective and have fewer spatial constraints. We aim to examine the efficacy of a multidomain intervention through both face-to-face interactions and video communication platforms using a tablet personal computer (PC) application in MCI. Methods: Three hundred participants aged 60-85 years, with MCI and at least one modifiable dementia risk factor, will be recruited from 17 centers and randomly assigned in a 1:1 ratio to the multidomain intervention and the waiting-list control groups. Participants will receive the 24-week intervention through the tablet PC SUPERBRAIN application, which encompasses the following five elements: managing metabolic and vascular risk factors, cognitive training, physical exercise, nutritional guidance, and boosting motivation. Participants will attend the interventions at a facility every 1-2 weeks. They will also engage in one or two self-administered cognitive training sessions utilizing the tablet PC application at home each week. They will participate in twice or thrice weekly online exercise sessions at home via the ZOOM platform. The primary outcome will be the change in the total scale index score of the Repeatable Battery for the Assessment of Neuropsychological Status from baseline to study end. Conclusions: This study will inform the effectiveness of a comprehensive multidomain intervention utilizing digital technologies in MCI.

Parenchymal-sparing anatomical hepatectomy based on portal ramification of the right anterior section: A prospective multicenter experience with short-term outcomes

  • Truong Giang Nguyen;Thanh Khiem Nguyen;Ham Hoi Nguyen;Hong Son Trinh;Tuan Hiep Luong;Minh Trong Nguyen;Van Duy Le;Hai Dang Do;Kieu Hung Nguyen;Van Minh Do;Quang Huy Tran;Cuong Thinh Nguyen
    • Annals of Hepato-Biliary-Pancreatic Surgery
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    • v.28 no.1
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    • pp.25-33
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    • 2024
  • Backgrounds/Aims: Parenchymal-sparing anatomical hepatectomy (Ps-AH) based on portal ramification of the right anterior section (RAS) is a new technique to avoid unnecessarily transecting too much liver parenchyma, especially in cases of major anatomical hepatectomy. Methods: We prospectively assessed 26 patients with primary hepatic malignancies having undergone major Ps-AH based on portal ramification of the RAS from August 2018 to August 2022 (48 months). The perioperative indications, clinical data, intra-operative index, pathological postoperative specimens, postoperative complications, and follow-up results were retrospectively evaluated. Results: Among the 26 patients analyzed, there was just one case that had intrahepatic cholangiocarcinoma The preoperative level of α-Fetoprotein was 25.2 ng/mL. All cases (100%) had Child-Pugh A liver function preoperatively. The ventral/dorsal RAS was preserved in 19 and 7 patients, respectively. The mean surgical margin was 6.2 mm. The mean surgical time was 228.5 minutes, while the mean blood loss was 255 mL. In pathology, 5 cases (19.2%) had microvascular invasion, and in the group of HCC patients, 92% of all cases had moderate or poor tumor differentiation. Six cases (23.1%) of postoperative complications were graded over III according to the Clavien-Dindo system, including in three patients resistant ascites or intra-abdominal abscess that required intervention. Conclusions: Parenchymal-sparing anatomical hepatectomy based on portal ramification of the RAS to achieve R0-resection was safe and effective, with favorable short-term outcomes. This technique can be used widely in clinical practice.

Incidence and outcome of congenital anomalies of the kidney and urinary tract detected by prenatal ultrasonography: a single center study (산전 초음파로 발견된 선천성 신 요로 기형의 발생률과 임상 결과: 단일 기관 연구)

  • Lim, Gina;Lee, Joo Hoon;Park, Young Seo;Kim, Kun Seok;Won, Hye-Sung
    • Clinical and Experimental Pediatrics
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    • v.52 no.4
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    • pp.464-470
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    • 2009
  • Purpose : This study assessed the incidence and outcome of congenital anomalies of the kidney and urinary tract (CAKUT) detected by prenatal ultrasonography Methods : There were 906 cases of CAKUT detected by prenatal ultrasonography and postnatally confirmed at the Asan Medical Center from October 1989 to October 2007. We investigated the incidence and outcome of these cases by reviewing medical records retrospectively. Results : The order of incidence was hydronephrosis, multicystic dysplastic kidney (MCDK), duplex kidney, vesico-ureteral reflux (VUR), single kidney, hydroureteronephrosis, ectopic kidney, polycystic kidney, ureterocele, and posterior urethral valve (PUV). There were 520 cases (57.4%) of hydronephrosis, and 20% of these needed an operation due to significant obstruction. MCDK was associated with other CAKUT in 25.4% of all cases. Approximately 57.9% of duplex kidney cases needed surgical treatment due to ureterocele and VUR. VUR had a male: female ratio of 10:1. Two out of seven cases of autosomal recessive polycystic kidney had progressed to chronic renal failure. Patients with PUV were relatively uncommon, and one out of nine cases progressed to end-stage renal disease. Conclusion : CAKUTs detected by prenatal ultrasonography were composed of various anomalies, and almost all of them had a good outcome without any intervention. However, in some cases, recurrent urinary tract infection or renal failure occurred, especially in bilateral cases. For further management, a long-term multicenter study is needed to investigate the precise incidence and outcome of each anomaly in the general population.

Association between Kawasaki disease and acute respiratory viral infections (가와사끼병과 급성 호흡기 바이러스 감염증의 연관성에 관한 연구)

  • Cho, Eun Young;Eun, Byung Wook;Kim, Nam Hee;Lee, Jina;Choi, Eun Hwa;Lee, Hoan Jong;Choi, Jung Yun
    • Clinical and Experimental Pediatrics
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    • v.52 no.11
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    • pp.1241-1248
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    • 2009
  • Purpose:The etiology of Kawasaki disease (KD) is still unknown. Recently, an association between human coronavirus NL63 (HCoV-NL63) and KD was implicated. Hence, we attempted to determine the association between KD and acute respiratory viral infections. Methods:Nasopharyngeal aspirate samples were obtained from 54 patients diagnosed with KD at the Seoul National University (SNU) Children's Hospital and SNU-Bundang Hospital between October 2003 and September 2006. Viral diagnoses of 11 respiratory viruses were made using multiplex reverse transcriptase-polymerase chain reaction (RT-PCR): respiratory syncytial virus (RSV), adenovirus, rhinovirus (RV), parainfluenza viruses (PIVs) 1 and 3, influenza viruses (IFVs) A and B, human metapneumovirus (HMPV), human bocavirus (HBoV), HCoV OC43/229E, and HCoV-NL63. Clinical data were reviewed retrospectively. Results:The median age was 32 months (6 months-10.4 years). Respiratory symptoms were observed in 37 patients (69%). The following respiratory viruses were identified in 12 patients (22%): RV (n=4), PIV-3 (n=2), HBoV (n=2), and adenovirus, RSV, PIV-1, IFV-A, and HCoV-NL63 (n=1). Co-infection with PIV-3 and RV was observed in one patient. Respiratory symptoms were observed in 7 (58.3%) and 30 (71.4%) patients of the virus-positive and virus-negative groups (P>0.05). Response rate to intravenous immunoglobulin administration was 67% (n=8) and 86% (n=36) in the virus- positive and virus-negative groups (P>0.05). Conclusion:Respiratory symptoms were commonly observed in KD patients but the association between respiratory viruses and KD were not found. Large multicenter-based investigations are required to confirm the association between acute respiratory viral infections and KD.

A RETROSPECTIVE MULTICENTER CLINICAL STUDY OF INSTALLED US II / SS II IMPLANTS AFTER MAXILLARY SINUS FLOOR ELEVATION (상악동저 거상술 후 Osstem Implant (US II / SS II)의 다기관 후향적 임상연구)

  • Kook, Min-Suk;Park, Hong-Ju;Kim, Su-Gwan;Kim, Young-Kyun;Cho, Yong-Seok;Choi, Gab-Lim;Oh, Young-Hak;Oh, Hee-Kyun
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.34 no.3
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    • pp.341-349
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    • 2008
  • Purpose: The purpose of this study was to evaluate the $Osstem^{(R)}$ implants (US II/SS II implants) through the retrospective study for the clinical success rate during the installation of the $Osstem^{(R)}$ implants (US II/SS II implants) by using of the procedures of maxillary sinus floor elevation. Materials and methods: The current study was researched in the 6 medical institutions: Chonnam National University, Chosun University, Pusan DaeDong Hospital, Bundang Seoul National University Hospital, Ap-Seon Clinic, and All Clinic. Based on the total number of 116 patients whose treatment was the installation of the US II/SS II implants with the procedures of the maxillary sinus floor elevation, they were conferred on the dental records of the patients under the joint consultation of the 6 medical institutions. On the dental recording charts, there were included in as the following; the name of the institutions, gender, age, with or without smoking or drinking, with or without the generalized diseases, the height of the alveolar bone on the operational sites, elapsed edentulous state period, the state of the opposed or adjacent teeth, the methods of the maxillary sinus floor elevation, secondary time period for surgery, the lengths, types, and diameters of implants, with or without bone transplantation or the types of bone, postoperative current bone height, current adjacent soft tissue state of the implants, with or without the success of the installations of the implants. We have done our survey with the clinical and radiolographical examinations and dental questionaries. The success and survival rate of the implants was evaluated. Results 1. Total number of the patients with the installation of the US II implants were 62. The 252 numbers of US II implants were installed on the 89 maxillary sinuses. The patient's mean age was 54.1 years old and there were 36 men and 27 women. 2. Total number of patients with the installation of SS II implant were 57. The 165 numbers of SS II implants were planted on the 80 maxillary sinuses. Their mean age was 48.7 years old and there were 37 men and 20 women. 3. The follow-up period was 30.7 months(21-49 mon) on average. The vertical bone loss of installed implants after the procedures of the maxillary sinus elevation was 1.1 mm on average in SS II and 1.3 mm on average in US II. There existed no statistical significance on each group. The mean enlarged bone height after the maxillary sinus floor elevation was 8.2 mm. 4. For the procedures of the maxillary sinus elevation, the Lateral approach technique occupied 87.1%, which was the most used one. In addition, the most frequently used transplanted bone was autogenous bone only which was 72.7% during the maxillary sinus floor elevation. 5. The complication of maxillary sinus floor elevation were perforation of sinus membrane, disesthesia on doner site, exposure of cover screw and exposure of maxillar bone. 6. The survival rate of US II and SS II after maxillary sinus floor elevation was 99.2% and 95.8%, respectively. And the success rate of US II and SS II after maxillary sinus floor elevation was 97.6% and 89.7%, respectively. Conclusion : On the evaluation of the analysis of our study, both US II and SS II implants showed the excellent clinical results by use of the procedures of maxillary sinus floor elevation.

Clinical Course of IgA Nephropathy in Children (소아 IgA 신병증의 추적 관찰)

  • Hong In-Hee;Lee Jun-Hwa;Go Cheol-Woo;Kwak Jung-Sik;Koo Ja-Hoon
    • Childhood Kidney Diseases
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    • v.3 no.2
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    • pp.153-160
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    • 1999
  • Purpose : Present study was undertaken to find out significance of clinical presentation, initial laboratory data and renal biopsy findings on subsequent clinical course of IgA nephropathy in children. Methods : Clinical and laboratory data were analysed retrospectively from 60 children who have been admitted to the Pediatric Department of Kyungpook National University Hospital for the past 11 years and diagnosed as IgA nephropathy. Renal biopsy findings were graded according to the pathologic subclass proposed by Haas. Results : Pathologic grading according to Haas subclassification showed 10 cases in subclass I, 36 in II, 12 in IV and 2 in V and none in subclass II. Sex distribution showed male predominance (male to female ratio = 3 : 1) and mean age at onset of disease was $10.4{\pm}2.8$ years. Episodes of gross hematuria was seen in 71.7% and IgA level increased in 28.3% of children and these were not associated with pathologic grading nor clinical outcomes. With increasing subclass grading, serum protein and albumin decreased and 24 hours urinary protein excretion increased. Normalization of urinalysis (disappearance of hematuria) was seen in 14% at 1-2 years and 37.1% at 3-4 years of follow up period. In 3 cases, renal function deteriorated progressively and they belonged one each to the Haas subclass III, IV and V. Conclusion : In children with IgA nephropathy, progression to chronic renal failure appears to be quite high and pathologic grading according to Haas' subclassification seems to predict patient's outcome faily well. However, firm conclusion cannot be drawn from present study due to the small numbers of patients and short follow-up period. Therefore further multicenter study involving larger numbers of patients and longer periods of follow-up over 10 years was to be undertaken.

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Efficacy and Safety during the Combination Therapy of Imipramine and Desmopressin in Primary Monosymptomatic Nocturnal Enuresis (어린이의 일차성 단일 증상성 야뇨증에서 Imipramine과 Desmopressin 복합 약물치료의 효과 및 안전성)

  • Yeo Ji-Hyun;Choi Jung-Youn;Chung Hyo-Seok;Lee Kyung-Soo;Ko Cheol-Woo;Kim Kyo-Sun;Kim Kee-Hyuk;Kim Jung-Soe;NamGoong Mee-Kyung;Park Young-Seo;Pai Ki-Soo;Yoo Kee-Hwan;Park Yong-Hoon
    • Childhood Kidney Diseases
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    • v.8 no.2
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    • pp.129-137
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    • 2004
  • Purpose : Nocternal enuresis is a common disorder. Tricyclic antidepressant and desmopressin have been accepted pharmacological treatment for this disorder We conducted a cooperative study to investigate the efficacy and adverse reactions of imipramine, desmopressin and combination treatment in children with primary monosymptomatic nocturnal enuresis(PMNE). Methods: Data from a large multicenter study were analysed. In the period of 8 months in 2002, the study comprised of 168 children(78 boys and 90 girls, 5 to 15 years old) with PMNE for imipramine, desmopressin or combination treatment. Before treatment a history, physical examination and laboratory tests were performed and the children were observed for 2 weeks. Response rate, adverse reactions and enuresis episodes after stopping drug administration were evaluated after 12-weeks of imipramine, desmopressin or combination of both. Results: After 4 weeks, the frequency of bed wetting in all treated patients decreased during treatment significantly Even though a 30-50%, reduction in the number of wet nights were 68.6%, 74.4% and 86.1% during 12 weeks treatment by imipramine, desmopressin and both of them respectively, there was no significant difference between them. The most common adverse reaction was decreased appetite from imipramine administration. But no serious drug-related adverse events were reported. Conclusion: Efficacy of the combination therapy of imipramine and desmopressin in PMNE appears not to be better than either drug alone. It is necessary to pay attention on account of adverse reactions during imipramine treatment even though imipramine and desmopressin were generally well tolerated.

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A Clinicopathological Study of Rapidly Progressive Glomerulonephritis in Children (소아 급속 진행성 사구체 신염의 임상-병리학적 고찰)

  • Cho Hee-Yeon;Chung Dae-Lim;Kang Ju-Hyung;Ha Il-Soo;Choi Yong;Cheong Hae-Il
    • Childhood Kidney Diseases
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    • v.8 no.2
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    • pp.176-185
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    • 2004
  • Purpose: Rapidly progressive glomerulonephritis (RPGN) is a clinicopathologic entity characterized by extensive crescent formation and rapid deterioration of renal function within few months. For better understanding of its clinical course and designing better treatment strategies, a clinicopathological study of childhood RPGN was performed. Methods: The clinical manifestations and pathological findings were reviewed retrospectively in 12 children who were diagnosed as having RPGN by clinical manifestations and renal biopsy during a period from 1991 to 2003. Several clinicopathological parameters were analyzed as prognostic factors. Results: Among a total of 12 patients, 4 were male and 8 were female. The median onset age was 11.5 years(range 5.5-14.6 years), and the median period of follow-up was 25 months(range 7 months-6.6 years). According to the pathological classification, 10 patients (83%) were type II RPGN(immune-complex mediated glomerulonephritis), 2 patients were type III RPGN(pauci-immune glomerulonephritis), and none was type I RPGN(anti-glomerular basement membrane nephritis). All patients were treated with oral steroid in various combinations with methylprednisolone pulse therapy(10 patients, 83%), cyclophosphamide(8 patients, 67%), or plasmapheresis(4 patients, 33%). Clinical outcomes of 12 patients were complete remission in 1(8%), end-stage renal disease in 2(17%), chronic renal insufficiency with persistent proteinuria in 2(17%), and normal renal function with persistent proteinuria in 7(58%) at the last follow-up. Poor prognosis is associated with increased serum creatinine level, severe anemia and younger age at the time of diagnosis. Conclusion: Immune-complex mediated glomerulonephritis is the major cause RPGN in children and most cases showed improvement of renal function with aggressive management. For better understanding of this rare disease, a prospective multicenter study should be done.

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