1.Safety Profile of Biportal Endoscopic Spine Surgery Compared to Conventional Microscopic Approach: A Pooled Analysis of 2 Randomized Controlled Trials
Sang-Min PARK ; Kwang-Sup SONG ; Dae-Woong HAM ; Ho-Joong KIM ; Min-Seok KANG ; Ki-Han YOU ; Choon Keun PARK ; Dong-Keun LEE ; Jin-Sung KIM ; Hong-Jae LEE ; Hyun-Jin PARK
Neurospine 2024;21(4):1190-1198
Objective:
To compare the safety profiles of biportal endoscopic spinal surgery (BESS) and microscopic spinal surgery (MSS) for lumbar disc herniation and spinal stenosis by analyzing the associated adverse events.
Methods:
We pooled data from 2 prospective randomized controlled trials involving 220 patients (110 in each group) who underwent single-level lumbar surgery. Participants aged 20–80 years with radiating pain due to lumbar disc herniation or spinal stenosis were included in this study. Adverse events were recorded and analyzed over a 12-month follow-up period.
Results:
The overall adverse event rates were 9.1% (10 of 110) in the BESS group and 17.3% (19 of 110) in the MSS group, which were not statistically significantly different (p=0.133). Notably, wound dehiscence occurred in 8.2% of MSS cases but in none of the BESS cases. Both groups showed similarly low rates of complications, such as dural tears, epidural hematoma, and nerve root injury. The most common adverse event in the BESS group was recurrent disc herniation (2.7%), whereas that in the MSS group was wound dehiscence (8.2%).
Conclusion
BESS demonstrated a safety profile comparable to that of MSS for the treatment of lumbar disc herniation and spinal stenosis, with a trend towards fewer overall complications. BESS offers particular advantages in terms of reducing wound-related complications. These findings suggest that BESS is a safe alternative to conventional MSS and potentially offers the benefits of a minimally invasive approach without compromising patient safety.
2.Safety Profile of Biportal Endoscopic Spine Surgery Compared to Conventional Microscopic Approach: A Pooled Analysis of 2 Randomized Controlled Trials
Sang-Min PARK ; Kwang-Sup SONG ; Dae-Woong HAM ; Ho-Joong KIM ; Min-Seok KANG ; Ki-Han YOU ; Choon Keun PARK ; Dong-Keun LEE ; Jin-Sung KIM ; Hong-Jae LEE ; Hyun-Jin PARK
Neurospine 2024;21(4):1190-1198
Objective:
To compare the safety profiles of biportal endoscopic spinal surgery (BESS) and microscopic spinal surgery (MSS) for lumbar disc herniation and spinal stenosis by analyzing the associated adverse events.
Methods:
We pooled data from 2 prospective randomized controlled trials involving 220 patients (110 in each group) who underwent single-level lumbar surgery. Participants aged 20–80 years with radiating pain due to lumbar disc herniation or spinal stenosis were included in this study. Adverse events were recorded and analyzed over a 12-month follow-up period.
Results:
The overall adverse event rates were 9.1% (10 of 110) in the BESS group and 17.3% (19 of 110) in the MSS group, which were not statistically significantly different (p=0.133). Notably, wound dehiscence occurred in 8.2% of MSS cases but in none of the BESS cases. Both groups showed similarly low rates of complications, such as dural tears, epidural hematoma, and nerve root injury. The most common adverse event in the BESS group was recurrent disc herniation (2.7%), whereas that in the MSS group was wound dehiscence (8.2%).
Conclusion
BESS demonstrated a safety profile comparable to that of MSS for the treatment of lumbar disc herniation and spinal stenosis, with a trend towards fewer overall complications. BESS offers particular advantages in terms of reducing wound-related complications. These findings suggest that BESS is a safe alternative to conventional MSS and potentially offers the benefits of a minimally invasive approach without compromising patient safety.
3.Safety Profile of Biportal Endoscopic Spine Surgery Compared to Conventional Microscopic Approach: A Pooled Analysis of 2 Randomized Controlled Trials
Sang-Min PARK ; Kwang-Sup SONG ; Dae-Woong HAM ; Ho-Joong KIM ; Min-Seok KANG ; Ki-Han YOU ; Choon Keun PARK ; Dong-Keun LEE ; Jin-Sung KIM ; Hong-Jae LEE ; Hyun-Jin PARK
Neurospine 2024;21(4):1190-1198
Objective:
To compare the safety profiles of biportal endoscopic spinal surgery (BESS) and microscopic spinal surgery (MSS) for lumbar disc herniation and spinal stenosis by analyzing the associated adverse events.
Methods:
We pooled data from 2 prospective randomized controlled trials involving 220 patients (110 in each group) who underwent single-level lumbar surgery. Participants aged 20–80 years with radiating pain due to lumbar disc herniation or spinal stenosis were included in this study. Adverse events were recorded and analyzed over a 12-month follow-up period.
Results:
The overall adverse event rates were 9.1% (10 of 110) in the BESS group and 17.3% (19 of 110) in the MSS group, which were not statistically significantly different (p=0.133). Notably, wound dehiscence occurred in 8.2% of MSS cases but in none of the BESS cases. Both groups showed similarly low rates of complications, such as dural tears, epidural hematoma, and nerve root injury. The most common adverse event in the BESS group was recurrent disc herniation (2.7%), whereas that in the MSS group was wound dehiscence (8.2%).
Conclusion
BESS demonstrated a safety profile comparable to that of MSS for the treatment of lumbar disc herniation and spinal stenosis, with a trend towards fewer overall complications. BESS offers particular advantages in terms of reducing wound-related complications. These findings suggest that BESS is a safe alternative to conventional MSS and potentially offers the benefits of a minimally invasive approach without compromising patient safety.
4.Safety Profile of Biportal Endoscopic Spine Surgery Compared to Conventional Microscopic Approach: A Pooled Analysis of 2 Randomized Controlled Trials
Sang-Min PARK ; Kwang-Sup SONG ; Dae-Woong HAM ; Ho-Joong KIM ; Min-Seok KANG ; Ki-Han YOU ; Choon Keun PARK ; Dong-Keun LEE ; Jin-Sung KIM ; Hong-Jae LEE ; Hyun-Jin PARK
Neurospine 2024;21(4):1190-1198
Objective:
To compare the safety profiles of biportal endoscopic spinal surgery (BESS) and microscopic spinal surgery (MSS) for lumbar disc herniation and spinal stenosis by analyzing the associated adverse events.
Methods:
We pooled data from 2 prospective randomized controlled trials involving 220 patients (110 in each group) who underwent single-level lumbar surgery. Participants aged 20–80 years with radiating pain due to lumbar disc herniation or spinal stenosis were included in this study. Adverse events were recorded and analyzed over a 12-month follow-up period.
Results:
The overall adverse event rates were 9.1% (10 of 110) in the BESS group and 17.3% (19 of 110) in the MSS group, which were not statistically significantly different (p=0.133). Notably, wound dehiscence occurred in 8.2% of MSS cases but in none of the BESS cases. Both groups showed similarly low rates of complications, such as dural tears, epidural hematoma, and nerve root injury. The most common adverse event in the BESS group was recurrent disc herniation (2.7%), whereas that in the MSS group was wound dehiscence (8.2%).
Conclusion
BESS demonstrated a safety profile comparable to that of MSS for the treatment of lumbar disc herniation and spinal stenosis, with a trend towards fewer overall complications. BESS offers particular advantages in terms of reducing wound-related complications. These findings suggest that BESS is a safe alternative to conventional MSS and potentially offers the benefits of a minimally invasive approach without compromising patient safety.
5.Safety Profile of Biportal Endoscopic Spine Surgery Compared to Conventional Microscopic Approach: A Pooled Analysis of 2 Randomized Controlled Trials
Sang-Min PARK ; Kwang-Sup SONG ; Dae-Woong HAM ; Ho-Joong KIM ; Min-Seok KANG ; Ki-Han YOU ; Choon Keun PARK ; Dong-Keun LEE ; Jin-Sung KIM ; Hong-Jae LEE ; Hyun-Jin PARK
Neurospine 2024;21(4):1190-1198
Objective:
To compare the safety profiles of biportal endoscopic spinal surgery (BESS) and microscopic spinal surgery (MSS) for lumbar disc herniation and spinal stenosis by analyzing the associated adverse events.
Methods:
We pooled data from 2 prospective randomized controlled trials involving 220 patients (110 in each group) who underwent single-level lumbar surgery. Participants aged 20–80 years with radiating pain due to lumbar disc herniation or spinal stenosis were included in this study. Adverse events were recorded and analyzed over a 12-month follow-up period.
Results:
The overall adverse event rates were 9.1% (10 of 110) in the BESS group and 17.3% (19 of 110) in the MSS group, which were not statistically significantly different (p=0.133). Notably, wound dehiscence occurred in 8.2% of MSS cases but in none of the BESS cases. Both groups showed similarly low rates of complications, such as dural tears, epidural hematoma, and nerve root injury. The most common adverse event in the BESS group was recurrent disc herniation (2.7%), whereas that in the MSS group was wound dehiscence (8.2%).
Conclusion
BESS demonstrated a safety profile comparable to that of MSS for the treatment of lumbar disc herniation and spinal stenosis, with a trend towards fewer overall complications. BESS offers particular advantages in terms of reducing wound-related complications. These findings suggest that BESS is a safe alternative to conventional MSS and potentially offers the benefits of a minimally invasive approach without compromising patient safety.
6.Rituximab plus multiagent chemotherapy for newly diagnosed CD20-positive acute lymphoblastic leukemia: a prospective phase II study
Dong Won BAEK ; Han-Seung PARK ; Sang Kyun SOHN ; Dae Young KIM ; Inho KIM ; Jae-Sook AHN ; Young Rok DO ; Se Ryeon LEE ; Hyeon-Seok EOM ; Won-Sik LEE ; Sung-Hyun KIM ; Ho Sup LEE ; Yoo Jin LEE ; Joon Ho MOON ; Je-Hwan LEE ;
The Korean Journal of Internal Medicine 2023;38(5):734-746
Background/Aims:
We performed a prospective study to determine the efficacy and safety of rituximab including chemotherapy in CD20-positive acute lymphoblastic leukemia (ALL).
Methods:
Patients with newly diagnosed ALL, aged ≥ 15 years, were eligible for the study if their leukemic blast cells in bone marrow expressed CD20 ≥ 20% at the time of diagnosis. Patients received multiagent chemotherapy with rituximab. After achieving complete remission (CR), patients received five cycles of consolidation with concomitant rituximab. Rituximab was administered monthly from day 90 of transplantation for patients who received allogeneic hematopoietic cell transplantation.
Results:
In patients with Philadelphia (Ph)-negative ALL, 39 of 41 achieved CR (95.1%), the 2- and 4-year relapse-free survival (RFS) rates were 50.4% and 35.7%, and the 2- and 4-year overall survival (OS) rates were 51.5% and 43.2%, respectively. In the group with Ph-positive ALL, all 32 patients achieved CR, the 2- and 4-year RFS rates were 60.7% and 52.1%, and the 2- and 4-year OS rates were 73.3% and 52.3%, respectively. In the Ph-negative ALL group, patients with higher CD20 positivity experienced more favorable RFS (p < 0.001) and OS (p = 0.06) than those with lower CD20 positivity. Patients who received ≥ 2 cycles of rituximab after transplantation had significantly improved RFS (hazard ratio [HR], 0.31; p = 0.049) and OS (HR, 0.29; p = 0.021) compared with those who received < 2 cycles.
Conclusions
The addition of rituximab to conventional chemotherapy for CD20-positive ALL is effective and tolerable (Clinicaltrials. gov NCT01429610).
7.Outcomes in Refractory Diffuse Large B-Cell Lymphoma: Results from Two Prospective Korean Cohorts
Jun Ho YI ; Seong Hyun JEONG ; Seok Jin KIM ; Dok Hyun YOON ; Hye Jin KANG ; Youngil KOH ; Jin Seok KIM ; Won-Sik LEE ; Deok-Hwan YANG ; Young Rok DO ; Min Kyoung KIM ; Kwai Han YOO ; Yoon Seok CHOI ; Whan Jung YUN ; Yong PARK ; Jae-Cheol JO ; Hyeon-Seok EOM ; Jae-Yong KWAK ; Ho-Jin SHIN ; Byeong Bae PARK ; Seong Yoon YI ; Ji-Hyun KWON ; Sung Yong OH ; Hyo Jung KIM ; Byeong Seok SOHN ; Jong Ho WON ; Dae-Sik HONG ; Ho-Sup LEE ; Gyeong-Won LEE ; Cheolwon SUH ; Won Seog KIM
Cancer Research and Treatment 2023;55(1):325-333
Purpose:
Diffuse large B-cell lymphoma (DLBCL) is the most common hematologic malignancy worldwide. Although substantial improvement has been achieved by the frontline rituximab-based chemoimmunotherapy, up to 40%-50% of patients will eventually have relapsed or refractory disease, whose prognosis is extremely dismal.
Materials and Methods:
We have carried out two prospective cohort studies that include over 1,500 DLBCL patients treated with rituximab plus CHOP (#NCT01202448 and #NCT02474550). In the current report, we describe the outcomes of refractory DLBCL patients. Patients were defined to have refractory DLBCL if they met one of the followings, not achieving at least partial response after 4 or more cycles of R-CHOP; not achieving at least partial response after 2 or more cycles of salvage therapy; progressive disease within 12 months after autologous stem cell transplantation.
Results:
Among 1,581 patients, a total of 260 patients met the criteria for the refractory disease after a median time to progression of 9.1 months. The objective response rate of salvage treatment was 26.4%, and the complete response rate was 9.6%. The median overall survival (OS) was 7.5 months (95% confidence interval, 6.4 to 8.6), and the 2-year survival rate was 22.1%±2.8%. The median OS for each refractory category was not significantly different (p=0.529).
Conclusion
In line with the previous studies, the outcomes of refractory DLBCL patients were extremely poor, which necessitates novel approaches for this population.
8.Self-reported Non-celiac Gluten Sensitivity in the Korean Population: Demographic and Clinical Characteristics
Ra Ri CHA ; Jeong Hwan KIM ; Hoon Sup KOO ; Kee Wook JUNG ; Yang Won MIN ; Chang Hwan CHOI ; Han Seung RYU ; Yong Hwan KWON ; Dae Hyeon CHO ; Joong Goo KWON ; Kyung Sik PARK ; Hyun Jin KIM
Journal of Neurogastroenterology and Motility 2022;28(2):283-290
Background/Aims:
Non-celiac gluten sensitivity is characterized by intestinal and extra intestinal symptoms associated with the consumption of gluten-containing food. Since biomarkers for non-celiac gluten sensitivity are lacking, its prevalence is estimated based on self-reported symptoms. However, no data exist on self-reported non-celiac gluten sensitivity in the Korean population. Thus, we aim to investigate the prevalence of self-reported non-celiac gluten sensitivity in the Korean population and to determine its demographic and clinical characteristics.
Methods:
This study surveyed Korean participants aged 18-80 years who visited gastroenterology outpatient clinics at 9 tertiary hospitals in South Korea from January 2016 to February 2017. They were questioned regarding symptoms related to gluten ingestion: degree of discomfort (visual analog scale score), frequency, time of symptom onset, and duration. Abdominal discomfort caused by 11 differentkinds of gluten-containing Korean food items was investigated.
Results:
More non-celiac gluten sensitivity self-reporters were identified among those with irritable bowel syndrome (33.6%) than among controls (5.8%). Major gastrointestinal symptoms included bloating (75.0%), abdominal discomfort (71.3%), and belching (45.0%).Common extra-intestinal symptoms included fatigue (20.0%) and headache (13.7%). More than half of those who self-reported nonceliac gluten sensitivity (66.3%) developed symptoms within 1 hour of food ingestion, and symptoms were localized in the upper abdomen (37.5%) and entire abdomen (30.0%).
Conclusion
Our findings suggest that if there are gluten-related symptoms in irritable bowel syndrome, the possibility of accompanying non-celiacgluten sensitivity should be considered.
9.Development and External Validation of Survival Prediction Model for Pancreatic Cancer Using Two Nationwide Databases: Surveillance, Epidemiology and End Results (SEER) and Korea Tumor Registry System-Biliary Pancreas (KOTUS-BP)
Jae Seung KANG ; Lydia MOK ; Jin Seok HEO ; In Woong HAN ; Sang Hyun SHIN ; Yoo-Seok YOON ; Ho-Seong HAN ; Dae Wook HWANG ; Jae Hoon LEE ; Woo Jung LEE ; Sang Jae PARK ; Joon Seong PARK ; Yonghoon KIM ; Huisong LEE ; Young-Dong YU ; Jae Do YANG ; Seung Eun LEE ; Il Young PARK ; Chi-Young JEONG ; Younghoon ROH ; Seong-Ryong KIM ; Ju Ik MOON ; Sang Kuon LEE ; Hee Joon KIM ; Seungyeoun LEE ; Hongbeom KIM ; Wooil KWON ; Chang-Sup LIM ; Jin-Young JANG ; Taesung PARK
Gut and Liver 2021;15(6):912-921
Background/Aims:
Several prediction models for evaluating the prognosis of nonmetastatic resected pancreatic ductal adenocarcinoma (PDAC) have been developed, and their performances were reported to be superior to that of the 8th edition of the American Joint Committee on Cancer (AJCC) staging system. We developed a prediction model to evaluate the prognosis of resected PDAC and externally validated it with data from a nationwide Korean database.
Methods:
Data from the Surveillance, Epidemiology and End Results (SEER) database were utilized for model development, and data from the Korea Tumor Registry System-Biliary Pancreas (KOTUS-BP) database were used for external validation. Potential candidate variables for model development were age, sex, histologic differentiation, tumor location, adjuvant chemotherapy, and the AJCC 8th staging system T and N stages. For external validation, the concordance index (C-index) and time-dependent area under the receiver operating characteristic curve (AUC) were evaluated.
Results:
Between 2004 and 2016, data from 9,624 patients were utilized for model development, and data from 3,282 patients were used for external validation. In the multivariate Cox proportional hazard model, age, sex, tumor location, T and N stages, histologic differentiation, and adjuvant chemotherapy were independent prognostic factors for resected PDAC. After an exhaustive search and 10-fold cross validation, the best model was finally developed, which included all prognostic variables. The C-index, 1-year, 2-year, 3-year, and 5-year time-dependent AUCs were 0.628, 0.650, 0.665, 0.675, and 0.686, respectively.
Conclusions
The survival prediction model for resected PDAC could provide quantitative survival probabilities with reliable performance. External validation studies with other nationwide databases are needed to evaluate the performance of this model.
10.Safety of Red Blood Cell Transfusion by the Emergency Blood Transfusion Protocol
Kiwook JUNG ; Jikyo LEE ; Ji-Sang KANG ; Jae Hyeon PARK ; Yousun CHUNG ; Dae-Hyun KO ; Hyungsuk KIM ; Kyou-Sup HAN
Korean Journal of Blood Transfusion 2021;32(3):163-173
Background:
Pretransfusion testing is vital for safe transfusion. However, in situations without time to perform sufficient testing, all or part of the pretransfusion testing may be skipped to issue blood quickly. This study evaluated the safety of red blood cell (RBC) transfusion released by an emergency blood transfusion protocol through retrospective analysis at a tertiary hospital for eight years.
Methods:
All RBC transfusions following the emergency blood transfusion protocol from 2011 to 2018 at Seoul National University Hospital were included in the study. Crossmatching and unexpected antibody screening test results conducted after RBC release and the occurrence of hemolytic transfusion reactions were analyzed.
Results:
A total of 1,541 cases (5,299 RBCs issued) of emergency blood transfusion were identified. RBCs were issued after performing the immediate spin crossmatch without an unexpected antibody screening test in most cases (1,443; 93.64%), while RBCs were issued with no pretransfusion testing in 98 cases (6.36%). Antibody screening tests performed after the issue of RBCs showed that 17 (1.1%) cases were positive. Two units of RBCs from two different cases showed positive antiglobulin crossmatch test results. However, none of them were suspected to be associated with a hemolytic transfusion reaction.
Conclusion
The incidence of incompatible RBC release was very low in patients receiving RBC transfusion through the emergency blood transfusion protocol suggesting it can be used safely with minimal risk of hemolytic transfusion reactions caused by incompatible blood transfusions.

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