1.Evaluation of the Efficacy and Safety of DW1903 in Patients with Gastritis: A Randomized, Double-Blind, Noninferiority, Multicenter, Phase 3 study
Jie-Hyun KIM ; Hwoon-Yong JUNG ; In Kyung YOO ; Seon-Young PARK ; Jae Gyu KIM ; Jae Kyu SUNG ; Jin Seok JANG ; Gab Jin CHEON ; Kyoung Oh KIM ; Tae Oh KIM ; Soo Teik LEE ; Kwang Bum CHO ; Hoon Jai CHUN ; Jong-Jae PARK ; Moo In PARK ; Jae-Young JANG ; Seong Woo JEON ; Jin Woong CHO ; Dae Hwan KANG ; Gwang Ha KIM ; Jae J. KIM ; Sang Gyun KIM ; Nayoung KIM ; Yong Chan LEE ; Su Jin HONG ; Hyun-Soo KIM ; Sora LEE ; Sang Woo LEE
Gut and Liver 2024;18(1):70-76
Background/Aims:
H2 receptor antagonists (H2RA) have been used to treat gastritis by inhibiting gastric acid. Proton pump inhibitors (PPIs) are more potent acid suppressants than H2RA.However, the efficacy and safety of low-dose PPI for treating gastritis remain unclear. The aim was to investigate the efficacy and safety of low-dose PPI for treating gastritis.
Methods:
A double-blind, noninferiority, multicenter, phase 3 clinical trial randomly assigned 476 patients with endoscopic erosive gastritis to a group using esomeprazole 10 mg (DW1903) daily and a group using famotidine 20 mg (DW1903R1) daily for 2 weeks. The full-analysis set included 319 patients (DW1903, n=159; DW1903R1, n=160) and the per-protocol set included 298 patients (DW1903, n=147; DW1903R1, n=151). The primary endpoint (erosion improvement rate) and secondary endpoint (erosion and edema cure rates, improvement rates of hemorrhage, erythema, and symptoms) were assessed after the treatment. Adverse events were compared.
Results:
According to the full-analysis set, the erosion improvement rates in the DW1903 and DW1903R1 groups were 59.8% and 58.8%, respectively. According to the per-protocol analysis, the erosion improvement rates in the DW1903 and DW1903R1 groups were 61.9% and 59.6%, respectively. Secondary endpoints were not significantly different between two groups except that the hemorrhagic improvement rate was higher in DW1903 with statistical tendency. The number of adverse events were not statistically different.
Conclusions
DW1903 of a low-dose PPI was not inferior to DW1903R1 of H2RA. Thus, lowdose PPI can be a novel option for treating gastritis (ClinicalTrials.gov Identifier: NCT05163756).
2.Efficacy and safety of intragastric balloon for obesity in Korea
Kwang Gyun LEE ; Seung-Joo NAM ; Hyuk Soon CHOI ; Hang Lak LEE ; Jai Hoon YOON ; Chan Hyuk PARK ; Kyoung Oh KIM ; Do Hoon KIM ; Jung-Wook KIM ; Won SOHN ; Sung Hoon JUNG ;
Clinical Endoscopy 2023;56(3):333-339
Background/Aims:
Intragastric balloon (IGB) is the only available endoscopic bariatric and metabolic therapy in Korea. End-ball (Endalis) has the longest history of clinical use among the IGBs available in Korea. However, little clinical data on this system have been reported. In this study, we aimed to evaluate the efficacy and safety of End-ball in Korea.
Methods:
We performed a retrospective cohort study of patients who underwent IGB insertion (End-ball) from 2013 to 2019. Demographic and anthropometric data were collected. The efficacy and safety of IGB treatment were analyzed.
Results:
In total, 80 patients were included. Mean age was 33.7 years and 83.8% were female. Initial body mass index was 34.48±4.69 kg/m2. Body mass index reduction was 3.72±2.63 kg/m2 at the time of IGB removal. Percent of total body weight loss (%TBWL) was 10.76%±6.76%. Percentage excess body weight loss was 43.67%±27.59%. Most adverse events were minor, and 71.4% of participants showed nausea, vomiting, or abdominal pain.
Conclusions
IGB treatment showed good efficacy and safety profile in Korean patients with obesity. In terms of %TBWL and percentage excess body weight loss, the efficacy was similar to that in the Western population.
3.Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis
Gwang Ha KIM ; Myung-Gyu CHOI ; Jin Il KIM ; Soo Teik LEE ; Hoon Jai CHUN ; Kook Lae LEE ; Suk Chei CHOI ; Jae-Young JANG ; Yong Chan LEE ; Jae Gyu KIM ; Ki Bae KIM ; Ki-Nam SHIM ; Chong Il SOHN ; Sung Kook KIM ; Sang Gyun KIM ; Jin Seok JANG ; Nayoung KIM ; Hwoon-Yong JUNG ; Hyojin PARK ; Kyu Chan HUH ; Kwang Jae LEE ; Su Jin HONG ; Song BAEK ; Jin Joo HAN ; Oh Young LEE
Gut and Liver 2023;17(6):884-893
Background/Aims:
Fexuprazan is a novel potassium-competitive acid blocker that could be of benefit to patients with gastric mucosal injury. The aim of this study was to assess the 2-week efficacy and safety of fexuprazan in patients with acute or chronic gastritis.
Methods:
In this study, 327 patients with acute or chronic gastritis who had one or more gastric erosions on endoscopy and subjective symptoms were randomized into three groups receiving fexuprazan 20 mg once a day (q.d.), fexuprazan 10 mg twice a day (b.i.d.), or placebo for 2 weeks. The posttreatment assessments were the primary endpoint (erosion improvement rate), secondary endpoints (cure rates of erosion and edema and improvement rates of redness, hemorrhage, and subjective symptoms), and drug-related adverse events.
Results:
Among the patients, 57.8% (59/102), 65.7% (67/102), and 40.6% (39/96) showed erosion improvement 2 weeks after receiving fexuprazan 20 mg q.d., fexuprazan 10 mg b.i.d., and placebo, respectively. Both fexuprazan 20 mg q.d. and 10 mg b.i.d. showed superior efficacy to the placebo (p=0.017 and p<0.001, respectively). Likewise, both fexuprazan 20 mg q.d. and 10 mg b.i.d. also showed higher erosion healing rates than the placebo (p=0.033 and p=0.010, respectively). No difference was noted in the edema healing rate and the improvement rates for redness, hemorrhage, and subjective symptoms between the fexuprazan and placebo groups.No significant difference was noted in the incidence of adverse drug reactions.
Conclusions
Fexuprazan 20 mg q.d. and 10 mg b.i.d. for 2 weeks showed therapeutic efficacy superior to that of placebo in patients with acute or chronic gastritis (ClinicalTrials.gov identifier NCT04341454).
4.Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Helicobacter pylori Infection: A Randomized, Double-Blind, Phase III, Clinical Trial
Yoon Jin CHOI ; Yong Chan LEE ; Jung Mogg KIM ; Jin Il KIM ; Jeong Seop MOON ; Yun Jeong LIM ; Gwang Ho BAIK ; Byoung Kwan SON ; Hang Lak LEE ; Kyoung Oh KIM ; Nayoung KIM ; Kwang Hyun KO ; Hye-Kyung JUNG ; Ki-Nam SHIM ; Hoon Jai CHUN ; Byung-Wook KIM ; Hyuk LEE ; Jie-Hyun KIM ; Hyunsoo CHUNG ; Sang Gyun KIM ; Jae Young JANG
Gut and Liver 2022;16(4):535-546
Background/Aims:
We examined the efficacy and safety of tegoprazan as a part of first-line triple therapy for Helicobacter pylori eradication.
Methods:
A randomized, double-blind, controlled, multicenter study was performed to evaluate whether tegoprazan (50 mg)-based triple therapy (TPZ) was noninferior to lansoprazole (30 mg)-based triple therapy (LPZ) (with amoxicillin 1 g and clarithromycin 500 mg; all administered twice daily for 7 days) for treating H. pylori. The primary endpoint was the H. pylori eradication rate. Subgroup analyses were performed according to the cytochrome P450 (CYP) 2C19 genotype, the minimum inhibitory concentration (MIC) of amoxicillin and clarithromycin, and underlying gastric diseases.
Results:
In total, 350 H. pylori-positive patients were randomly allocated to the TPZ or LPZ group. The H. pylori eradication rates in the TPZ and LPZ groups were 62.86% (110/175) and 60.57% (106/175) in an intention-to-treat analysis and 69.33% (104/150) and 67.33% (101/150) in a per-protocol analysis (non-inferiority test, p=0.009 and p=0.013), respectively. Subgroup analyses according to MICs or CYP2C19 did not show remarkable differences in eradication rate. Both first-line triple therapies were well-tolerated with no notable differences.
Conclusions
TPZ is as effective as proton pump inhibitor-based triple therapy and is as safe as first-line H. pylori eradication therapy but does not overcome the clarithromycin resistance of H. pylori in Korea
5.Clinical and Technical Guideline for Endoscopic Ultrasound (EUS)-Guided Tissue Acquisition of Pancreatic Solid Tumor: Korean Society of Gastrointestinal Endoscopy (KSGE)
Moon Jae CHUNG ; Se Woo PARK ; Seong-Hun KIM ; Chang Min CHO ; Jun-Ho CHOI ; Eun Kwang CHOI ; Tae Hoon LEE ; Eunae CHO ; Jun Kyu LEE ; Tae Jun SONG ; Jae Min LEE ; Jun Hyuk SON ; Jin Suk PARK ; Chi Hyuk OH ; Dong-Ah PARK ; Jeong-Sik BYEON ; Soo Teik LEE ; Ho Gak KIM ; Hoon Jai CHUN ; Ho Soon CHOI ; Chan Guk PARK ; Joo Young CHO
Gut and Liver 2021;15(3):354-374
Endoscopic ultrasound (EUS)-guided tissue acquisition of pancreatic solid tumor requires a strict recommendation for its proper use in clinical practice because of its technical difficulty and invasiveness. The Korean Society of Gastrointestinal Endoscopy (KSGE) appointed a task force to draft clinical practice guidelines for EUS-guided tissue acquisition of pancreatic solid tumor. The strength of recommendation and the level of evidence for each statement were graded according to the Minds Handbook for Clinical Practice Guideline Development 2014. The committee, comprising a development panel of 16 endosonographers and an expert on guideline development methodology, developed 12 evidence-based recommendations in eight categories intended to help physicians make evidence-based clinical judgments with regard to the diagnosis of pancreatic solid tumor. This clinical practice guideline discusses EUS-guided sampling in pancreatic solid tumor and makes recommendations on circumstances that warrant its use, technical issues related to maximizing the diagnostic yield (e.g., needle type, needle diameter, adequate number of needle passes, sample obtaining techniques, and methods of specimen processing), adverse events of EUS-guided tissue acquisition, and learning-related issues. This guideline was reviewed by external experts and suggests best practices recommended based on the evidence available at the time of preparation. This guideline may not be applicable for all clinical situations and should be interpreted in light of specific situations and the availability of resources. It will be revised as necessary to cover progress and changes in technology and evidence from clinical practice.
6.The Economic Burden of Psoriasis in Korea
Byeol HAN ; Ki-Heon JEONG ; Tae-Gyun KIM ; Kwang Joong KIM ; Dong Hyun KIM ; Byung-Soo KIM ; Kyung Duck PARK ; Chul Jong PARK ; Hai-Jin PARK ; Chul Hwan BANG ; Bong Seok SHIN ; Sang Woong YOUN ; Jai Il YOUN ; Ju Hee LEE ; Kyung Eun JUNG ; Yong Beom CHOE ; Seong-jin JO
Korean Journal of Dermatology 2021;59(5):321-331
Background:
Psoriasis is a chronic disease that can have accompanying comorbidities including arthritis, metabolic syndrome, and cardiovascular diseases. Patients with psoriasis tend to frequently visit medical institutions, and their economic burden for medical services is high.
Objective:
To investigate the economic burden of psoriasis in Korea.
Methods:
The Korean Society for Psoriasis conducted a multi-center field survey of the patients and analyzed the national insurance claim data. Also, we discussed the medical environment of psoriasis in Korea based on the results.
Results:
The economic burden of psoriasis patients is substantial and varied by the type of medical institute. Patients also paid the indirect and intangible medical costs. Biological agents, which is used in patients with severe psoriasis, led to an increase in the cost.
Conclusion
This is the first study to estimate the economic burden of psoriasis in Korea comprehensively. To improve the medical environment of psoriasis and alleviate the burden of patients, discussion on the more efficient health policy and medical insurance criteria for psoriasis would be needed.
7.Clinical and Technical Guideline for Endoscopic Ultrasound-Guided Tissue Acquisition of Pancreatic Solid Tumor: Korean Society of Gastrointestinal Endoscopy
Moon Jae CHUNG ; Se Woo PARK ; Seong-Hun KIM ; Chang Min CHO ; Jun-Ho CHOI ; Eun Kwang CHOI ; Tae Hoon LEE ; Eunae CHO ; Jun Kyu LEE ; Tae Jun SONG ; Jae Min LEE ; Jun Hyuk SON ; Jin Suk PARK ; Chi Hyuk OH ; Dong-Ah PARK ; Jeong-Sik BYEON ; Soo Teik LEE ; Ho Gak KIM ; Hoon Jai CHUN ; Ho Soon CHOI ; Chan Guk PARK ; Joo Young CHO
Korean Journal of Pancreas and Biliary Tract 2021;26(3):125-147
Endoscopic ultrasound (EUS)-guided tissue acquisition of pancreatic solid tumor requires a strict recommendation for its proper use in clinical practice because of its technical difficulty and invasiveness. The Korean Society of Gastrointestinal Endoscopy appointed a Task Force to draft clinical practice guidelines for EUS-guided tissue acquisition of pancreatic solid tumor. The strength of recommendation and the level of evidence for each statement were graded according to the Minds Handbook for Clinical Practice Guideline Development 2014. The committee, comprising a development panel of 16 endosonographers and an expert on guideline development methodology, developed 12 evidence-based recommendations in eight categories intended to help physicians make evidence-based clinical judgments with regard to the diagnosis of pancreatic solid tumor. This clinical practice guideline discusses EUS-guided sampling in pancreatic solid tumor and makes recommendations on circumstances that warrant its use, technical issues related to maximizing the diagnostic yield (e.g., needle type, needle diameter, adequate number of needle passes, sample obtaining techniques, and methods of specimen processing), adverse events of EUS-guided tissue acquisition, and learning-related issues. This guideline was reviewed by external experts and suggests best practices recommended based on the evidence available at the time of preparation. This guideline may not be applicable for all clinical situations and should be interpreted in light of specific situations and the availability of resources. It will be revised as necessary to cover progress and changes in technology and evidence from clinical practice.
8.Clinical and Technical Guideline for Endoscopic Ultrasound-guided Tissue Acquisition of Pancreatic Solid Tumor: Korean Society of Gastrointestinal Endoscopy
Moon Jae CHUNG ; Se Woo PARK ; Seong-Hun KIM ; Chang Min CHO ; Jun-Ho CHOI ; Eun Kwang CHOI ; Tae Hoon LEE ; Eunae CHO ; Jun Kyu LEE ; Tae Jun SONG ; Jae Min LEE ; Jun Hyuk SON ; Jin Suk PARK ; Chi Hyuk OH ; Dong-Ah PARK ; Jeong-Sik BYEON ; Soo Teik LEE ; Ho Gak KIM ; Hoon Jai CHUN ; Ho Soon CHOI ; Chan Guk PARK ; Joo Young CHO
The Korean Journal of Gastroenterology 2021;78(2):73-93
Endoscopic ultrasound (EUS)-guided tissue acquisition of pancreatic solid tumor requires a strict recommendation for its proper use in clinical practice because of its technical difficulty and invasiveness. The Korean Society of Gastrointestinal Endoscopy appointed a Task Force to draft clinical practice guidelines for EUS-guided tissue acquisition of pancreatic solid tumor. The strength of recommendation and the level of evidence for each statement were graded according to the Minds Handbook for Clinical Practice Guideline Development 2014. The committee, comprising a development panel of 16 endosonographers and an expert on guideline development methodology, developed 12 evidence-based recommendations in eight categories intended to help physicians make evidence-based clinical judgments with regard to the diagnosis of pancreatic solid tumor. This clinical practice guideline discusses EUS-guided sampling in pancreatic solid tumor and makes recommendations on circumstances that warrant its use, technical issues related to maximizing the diagnostic yield (e.g., needle type, needle diameter, adequate number of needle passes, sample obtaining techniques, and methods of specimen processing), adverse events of EUS-guided tissue acquisition, and learning-related issues.This guideline was reviewed by external experts and suggests best practices recommended based on the evidence available at the time of preparation. This guideline may not be applicable for all clinical situations and should be interpreted in light of specific situations and the availability of resources. It will be revised as necessary to cover progress and changes in technology and evidence from clinical practice
9.Outcomes after liver transplantation in Korea: Incidence and risk factors from Korean transplantation registry
Jong Man KIM ; Deok Gie KIM ; Jihyun KIM ; Keunsung LEE ; Kwang-Woong LEE ; Je Ho RYU ; Bong-Wan KIM ; Dong Lak CHOI ; Young Kyoung YOU ; Dong-Sik KIM ; Yang Won NAH ; Koo Jeong KANG ; Jai Young CHO ; Geun HONG ; Hee Chul YU ; Ju Ik MOON ; Dongho CHOI ; Shin HWANG ; Myoung Soo KIM
Clinical and Molecular Hepatology 2021;27(3):451-462
Background/Aims:
To analyze the incidence and risk factors of outcomes after liver transplantation (LT) in the Korean population.
Methods:
This study analyzed data from the liver cohort of Korean Organ Transplantation Registry (KOTRY) who had LT between May 2014 and December 2017. Study measures included the incidence of post-LT outcomes in recipients of living donor LT (LDLT) and deceased donor LT (DDLT). Cox multivariate proportional hazards model was used to determine the potential risk factors predicting the outcomes.
Results:
A total of 2,563 adult recipients with LT (LDLT, n=1,956; DDLT, n=607) were included, with mean±standard deviation age of 53.9±8.9 years, and 72.2% were male. The post-LT outcomes observed in each LDLT and DDLT recipients were death (4.0% and 14.7%), graft loss (5.0% and 16.1%), rejection (7.0% and 12.0%), renal failure (2.7% and 13.8%), new onset of diabetes (12.5% and 15.4%), and hepatocellular carcinoma (HCC) recurrence (both 6.7%). In both LDLT and DDLT recipients, the most common post-LT complications were renal dysfunction (33.6% and 51.4%), infection (26.7% and 48.4%), and surgical complication (22.5% and 23.9%). Incidence of these outcomes were generally higher among recipients of DDLT than LDLT. Multivariate analysis indicated recipient age and DDLT as significant risk factors associated with death and graft loss. DDLT and ABO incompatible transplant were prognostic factors for rejection, and HCC beyond Milan criteria at pre-transplant was a strong predictor of HCC recurrence.
Conclusions
This study is a good indicator of the post-LT prognosis in the Korean population and suggests a significant burden of post-LT complications.
10.Clinical and Technical Guideline for Endoscopic Ultrasound (EUS)-Guided Tissue Acquisition of Pancreatic Solid Tumor: Korean Society of Gastrointestinal Endoscopy (KSGE)
Moon Jae CHUNG ; Se Woo PARK ; Seong-Hun KIM ; Chang Min CHO ; Jun-Ho CHOI ; Eun Kwang CHOI ; Tae Hoon LEE ; Eunae CHO ; Jun Kyu LEE ; Tae Jun SONG ; Jae Min LEE ; Jun Hyuk SON ; Jin Suk PARK ; Chi Hyuk OH ; Dong-Ah PARK ; Jeong-Sik BYEON ; Soo Teik LEE ; Ho Gak KIM ; Hoon Jai CHUN ; Ho Soon CHOI ; Chan Guk PARK ; Joo Young CHO
Clinical Endoscopy 2021;54(2):161-181
Endoscopic ultrasound (EUS)-guided tissue acquisition of pancreatic solid tumor requires a strict recommendation for its proper use in clinical practice because of its technical difficulty and invasiveness. The Korean Society of Gastrointestinal Endoscopy (KSGE) appointed a Task Force to draft clinical practice guidelines for EUS-guided tissue acquisition of pancreatic solid tumor. The strength of recommendation and the level of evidence for each statement were graded according to the Minds Handbook for Clinical Practice Guideline Development 2014. The committee, comprising a development panel of 16 endosonographers and an expert on guideline development methodology, developed 12 evidence-based recommendations in 8 categories intended to help physicians make evidence-based clinical judgments with regard to the diagnosis of pancreatic solid tumor. This clinical practice guideline discusses EUS-guided sampling in pancreatic solid tumor and makes recommendations on circumstances that warrant its use, technical issues related to maximizing the diagnostic yield (e.g., needle type, needle diameter, adequate number of needle passes, sample obtaining techniques, and methods of specimen processing), adverse events of EUS-guided tissue acquisition, and learning-related issues. This guideline was reviewed by external experts and suggests best practices recommended based on the evidence available at the time of preparation. This guideline may not be applicable for all clinical situations and should be interpreted in light of specific situations and the availability of resources. It will be revised as necessary to cover progress and changes in technology and evidence from clinical practice.

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