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.Reappraisal of sepsis-3 and CLIF-SOFA as predictors of mortality in patients with cirrhosis and infection presenting to the emergency department: A multicenter study
Ji Hyun KIM ; Baek Gyu JUN ; Minjong LEE ; Hye Ah LEE ; Tae Suk KIM ; Jeong Won HEO ; Da Hye MOON ; Seong Hee KANG ; Ki Tae SUK ; Moon Young KIM ; Young Don KIM ; Gab Jin CHEON ; Soon Koo BAIK ; Dong Joon KIM ; Dae Hee CHOI
Clinical and Molecular Hepatology 2022;28(3):540-552
Background/Aims:
Sepsis-3 criteria and quick Sequential Organ Failure Assessment (qSOFA) have been advocated to be used in defining sepsis in the general population. We aimed to compare the Sepsis-3 criteria and Chronic Liver Failure-SOFA (CLIF-SOFA) scores as predictors of in-hospital mortality in cirrhotic patients admitted to the emergency department (ED) for infections.
Methods:
A total of 1,622 cirrhosis patients admitted at the ED for infections were assessed retrospectively. We analyzed their demographic, laboratory, and microbiological data upon diagnosis of the infection. The primary endpoint was inhospital mortality rate. The predictive performances of baseline CLIF-SOFA, Sepsis-3, and qSOFA scores for in-hospital mortality were evaluated.
Results:
The CLIF-SOFA score proved to be significantly better in predicting in-hospital mortality (area under the receiver operating characteristic curve [AUROC], 0.80; 95% confidence interval [CI], 0.78–0.82) than the Sepsis-3 (AUROC, 0.75; 95% CI, 0.72–0.77, P<0.001) and qSOFA (AUROC, 0.67; 95% CI, 0.64–0.70; P<0.001) score. The CLIF-SOFA, CLIF-C-AD scores, Sepsis-3 criteria, septic shock, and qSOFA positivity were significantly associated with in-hospital mortality (adjusted hazard ratio [aHR], 1.24; 95% CI, 1.19–1.28; aHR, 1.13; 95% CI, 1.09–1.17; aHR, 1.19; 95% CI, 1.15–1.24; aHR, 1.88; 95% CI, 1.42–2.48; aHR, 2.06; 95% CI, 1.55–2.72; respectively; all P<0.001). For CLIF-SOFA scores ≥6, in-hospital mortality was >10%; this is the cutoff point for the definition of sepsis.
Conclusions
Among cirrhosis patients presenting with infections at the ED, CLIF-SOFA scores showed a better predictive performance for mortality than both Sepsis-3 criteria and qSOFA scores, and can be a useful tool of risk stratification in cirrhotic patients requiring timely intervention for infection.
3.Risk Factors for Local Recurrence in Patients With N1b Papillary Thyroid Carcinoma
Jung Woo LEE ; Gab-Kyun LEE ; Ji Won JANG ; Yongil CHEON ; Sung-Chan SHIN ; Jin-Choon LEE ; Bo Hyun KIM ; In Ju KIM ; Choong Rak KIM ; Byung-Joo LEE
Korean Journal of Otolaryngology - Head and Neck Surgery 2022;65(8):448-456
Background and Objectives:
Papillary thyroid carcinoma (PTC) with lateral neck lymph node metastasis is known as a major risk factor for tumor recurrence after surgical treatment. The aim of this study is to identify risk factors for loco-regional recurrence in patients with PTC with lateral neck lymph node metastasis, which has a high risk of recurrence.Subjects and Method This study involved 319 patients who underwent total thyroidectomy, central lymph node (LN) and lateral LN dissection due to PTC. The patients’ demographics and pathological factors, including lymph node metastasis were retrospectively reviewed. Univariate, multivariate and C-index with variable selection analyses were performed to identify factors associated with recurrence-free survival (RFS).
Results:
A mean follow-up of 101 months, 35 (10.9%) patients had a loco-regional recurrence. In multivariate analysis according to loco-regional recurrence, patients with a primary tumor of more than 4 cm, multifocality, vascular invasion, and bilateral lateral cervical metastasis were associated with worse RFS. In the variable selection analysis, lateral lymph node metastasis ratio was also statistically significant.
Conclusion
PTC with lateral neck lymph node metastasis included tumors larger than 4 cm. Multifocality, vascular invasion, high lateral lymph node metastasis ratio and bilateral neck lymph node metastasis are predictive factors of loco-regional recurrence, and these risk factors should be carefully followed-up after surgery.
4.Eradication Rate Using a First-line Triple Therapy for Helicobacter pylori Infection in Yeongdong, Gangwon Province, Korea
Eun Jeong GONG ; Chang Seok BANG ; Myeongsook SEO ; Hyun Il SEO ; Jong Kyu PARK ; Sang Jin LEE ; Koon Hee HAN ; Woo Jin JEONG ; Young Don KIM ; Gab Jin CHEON
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2022;22(2):139-145
Background/Aims:
The eradication success rate of Helicobacter pylori (H. pylori) infection with a first-line standard triple therapy (STT) has been decreasing in Korea. However, treatment outcomes of H. pylori infection in Yeongdong, Gangwon Province have been scarcely reported. This study aimed to investigate the treatment outcomes of H. pylori infection in a single tertiary care hospital with regional characteristics.
Materials and Methods:
From July 2018 to June 2019, a total of 592 patients who underwent STT consisting of a proton pump inhibitor, amoxicillin, and clarithromycin for 7 to 14 days as a first-line H. pylori eradication therapy were included. Demographic data and treatment outcomes were retrospectively reviewed using medical records.
Results:
The median age of 592 patients was 58 years (range 23 to 86) and 329 patients (55.6%) were men. The indication for eradication therapy included chronic atrophic gastritis (57.9%), peptic ulcer disease (19.6%), and gastric neoplasm after endoscopic resection (5.9%). Most patients (92.2%) received a 7-day course of STT. Eradication rate of STT was 64.0% (379/592). Rescue therapy was performed in 146 patients, and the final eradication rate reached 85.6% (507/592).
Conclusions
Eradication rate of STT in Yeongdong area of Gangwon Province was unsatisfactory, warranting the consideration of a first-line eradication regimen other than STT.
5.Comparison on the Efficacy and Safety of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycholic Acid in Patients with Abnormal Alanine Aminotransferase: Multicenter, Double-blinded, Randomized, Active-controlled Clinical Trial
Sae Hwan LEE ; Gab Jin CHEON ; Hong Soo KIM ; Young Don KIM ; Sang Gyune KIM ; Young Seok KIM ; Soung Won JEONG ; Jae Young JANG ; Boo Sung KIM
The Korean Journal of Gastroenterology 2022;79(1):52-53
6.Change in Portal Pressure and Clinical Outcome in Cirrhotic Patients with Gastric Varices after Plug-Assisted Retrograde Transvenous Obliteration
Jae Woo PARK ; Jeong-Ju YOO ; Sang Gyune KIM ; Soung Won JEONG ; Jae Young JANG ; Sae Hwan LEE ; Hong Soo KIM ; Jae Myung LEE ; Jong Joon SHIM ; Young Don KIM ; Gab Jin CHEON ; Baek Gyu JUN ; Young Seok KIM
Gut and Liver 2020;14(6):783-791
Background/Aims:
Plug-assisted retrograde transvenous obliteration (PARTO) is widely used to manage gastric varices with a portosystemic shunt. It is not clear whether portal pressure and the incidence of complications increase after PARTO. The aim of this study was to determine the changes in portal pressure and the associated changes in liver func-tion, ascites, hepatic encephalopathy, and especially esopha-geal varix (EV) after PARTO.
Methods:
From March 2012 to February 2018, 54 patients who underwent PARTO were analyzed retrospectively. The parameters collected included liver function and episodes of cirrhotic complications before and at 1 and 6 months after PARTO.
Results:
The analysis of 54 patients showed improvement in liver function during the 6-month follow-up period (Model for End-Stage Liver Disease score: change from 11.46±4.35 to 10.33±2.96, p=0.021).Among these 54 patients, 25 patients were evaluated for their hepatic venous pressure gradient (HVPG) before and after PARTO (change from 12.52±3.83 to 14.68±5.03 mm Hg; p<0.001). Twenty-five patients with portal pressure mea-sured before and after PARTO were evaluated for risk factors affecting liver function improvement and EV deterioration. No factor associated with portal pressure was affected by liver function improvement. Post-PARTO portal pressure was a risk factor affecting EV deterioration (HVPG-post: odds ratio, 1.341; 95% confidence interval, 1.017 to 1.767; p=0.037).
Conclusions
The artificial blockade of the portosystemic shunt evidently leads to an increase in HVPG. Liver function was improved over the 6-month follow-up period. Portal pres-sure after PARTO was a significant risk factor for EV deterioration. Portal pressure measurement is helpful for predicting the patient’s clinical outcome.
7.An Esophageal Squamous Cell Carcinoma with Lymph Node Metastasis Presenting as a Small Subepithelial Tumor
Jang Won PARK ; Eun Jeong GONG ; Myeongsook SEO ; Baek Gyu JUN ; Hyun Il SEO ; Jong Kyu PARK ; Koon Hee HAN ; Sang Jin LEE ; Young Don KIM ; Woo Jin JEONG ; Gab Jin CHEON
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2019;19(4):272-276
A subepithelial tumor-like esophageal carcinoma is rare. We report a case of an esophageal squamous cell carcinoma with lymph node metastasis presenting as a small subepithelial tumor. A 68-year-old man presented to our hospital complaining of hoarseness since last three months. Endoscopic examination revealed a 1 cm hard and fixed subepithelial tumor with surface erosion in the lower esophagus. A biopsy specimen was obtained using conventional forceps, and histopathological evaluation revealed few atypical squamous epithelial cells. Subsequent EUS demonstrated a homogeneous hypoechoic lesion in the deep mucosal layer. A CT scan of the chest showed a 3 cm mass in the right upper paratracheal area. EUS-guided fine needle biopsy of the lesion led to the diagnosis of squamous cell carcinoma with lymph node metastasis.
Aged
;
Biopsy
;
Biopsy, Fine-Needle
;
Carcinoma, Squamous Cell
;
Diagnosis
;
Endosonography
;
Epithelial Cells
;
Esophageal Neoplasms
;
Esophagus
;
Hoarseness
;
Humans
;
Lymph Nodes
;
Neoplasm Metastasis
;
Surgical Instruments
;
Thorax
;
Tomography, X-Ray Computed
9.Platelet count is associated with sustained virological response rates in treatments for chronic hepatitis C
Baek Gyu JUN ; Eui Ju PARK ; Woong Cheul LEE ; Jae Young JANG ; Soung Won JEONG ; Young Don KIM ; Gab Jin CHEON ; Young Sin CHO ; Sae Hwan LEE ; Hong Soo KIM ; Yun Nah LEE ; Sang Gyune KIM ; Young Seok KIM ; Boo Sung KIM
The Korean Journal of Internal Medicine 2019;34(5):989-997
BACKGROUND/AIMS:
This study was conducted to clarify the sustained virological response (SVR) prediction ability of baseline and treatment-related factors in patients with chronic hepatitis C virus (HCV) infection.
METHODS:
This retrospective study collected data at four tertiary referral hospitals between June 2004 and July 2012. Out of 476 patients, 330 treatment-naïve patients with chronic HCV infection were recruited. Pegylated interferon α-2a/-2b plus ribavirin was administered for either 24 or 48 weeks depending on the HCV genotype. The baseline and treatment-related predictive factors of SVR were evaluated by analyzing data measured before treatment (i.e., baseline) and during treatment.
RESULTS:
SVR rates for genotypes 1 and 2 were 63% (97/154) and 79.5% (140/176), respectively (p = 0.001). Multivariate analysis for baseline factors revealed that young age (p = 0.009), genotype 2 (p = 0.001), HCV RNA level of < 800,000 IU/mL (p < 0.001), and a baseline platelet count of > 150 × 10³/µL (p < 0.001) were significant SVR predictors, regardless of the genotype. In particular, predictive accuracy for achievement of SVR was 87.3% for a baseline platelet count of > 150 × 10³/µL. In multivariate analysis for treatment-related factors, SVR was associated with achievement of a rapid virological response (RVR; p < 0.001), treatment adherence of ≥ 80/80/80 (p < 0.001).
CONCLUSIONS
Young age, genotype 2, low HCV RNA level, RVR, and treatment adherence were significantly associated with SVR. In addition, platelet count was an independent predictive factor for SVR. Therefore, platelet count could be used to develop individualized treatment regimens and to optimize treatment outcomes in patients with chronic HCV infection.
10.Clinical significance of radiation-induced liver disease after stereotactic body radiation therapy for hepatocellular carcinoma.
Baek Gyu JUN ; Young Don KIM ; Gab Jin CHEON ; Eun Seog KIM ; Eunjin JWA ; Sang Gyune KIM ; Young Seok KIM ; Boo Sung KIM ; Soung Won JEONG ; Jae Young JANG ; Sae Hwan LEE ; Hong Soo KIM
The Korean Journal of Internal Medicine 2018;33(6):1093-1102
BACKGROUND/AIMS: The aim of this study was to investigate parameters that predict radiation-induced liver disease (RILD) following stereotactic body radiotherapy (SBRT) in patients with hepatocellular carcinoma (HCC) and to identify the clinical significance of RILD. METHODS: We retrospectively reviewed the medical records of 117 HCC patients who were treated by SBRT from March 2011 to February 2015. RILD was defined as elevated liver transaminases more than five times the upper normal limit or a worsening of Child-Pugh (CP) score by 2 within 3 months after SBRT. All patients were assessed at 1 month and every 3 months after SBRT. RESULTS: Median follow-up was 22.5 months (range, 3 to 56) after SBRT. RILD was developed in 29 of the 117 patients (24.7%). On univariate analysis, significant predictive factors of RILD were pretreatment CP score (p < 0.001) and normal liver volume (p = 0.002). Multivariate analysis showed that CP score was a significant predictor of RILD (p < 0.001). The incidence of RILD increased above a CP score of 6 remarkably. The rate of recovery from RILD decreased significantly above a CP score of 8. Survival analysis showed that CP score was an independent prognostic factor of overall survival (p = 0.001). CONCLUSIONS: CP score is a significant factor to predict RILD in patients with chronic liver disease. RILD can be tolerated by patients with a CP score ≤ 7. However, careful monitoring of liver function is needed for patients with a CP score 7 after SBRT.
Carcinoma, Hepatocellular*
;
Follow-Up Studies
;
Humans
;
Incidence
;
Liver Diseases*
;
Liver*
;
Medical Records
;
Multivariate Analysis
;
Radiosurgery
;
Retrospective Studies
;
Transaminases

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