1.Efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for hepatitis C in Korea: a Phase 3b study
Jeong HEO ; Yoon Jun KIM ; Sung Wook LEE ; Youn-Jae LEE ; Ki Tae YOON ; Kwan Soo BYUN ; Yong Jin JUNG ; Won Young TAK ; Sook-Hyang JEONG ; Kyung Min KWON ; Vithika SURI ; Peiwen WU ; Byoung Kuk JANG ; Byung Seok LEE ; Ju-Yeon CHO ; Jeong Won JANG ; Soo Hyun YANG ; Seung Woon PAIK ; Hyung Joon KIM ; Jung Hyun KWON ; Neung Hwa PARK ; Ju Hyun KIM ; In Hee KIM ; Sang Hoon AHN ; Young-Suk LIM
The Korean Journal of Internal Medicine 2023;38(4):504-513
Despite the availability of direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection in Korea, need remains for pangenotypic regimens that can be used in the presence of hepatic impairment, comorbidities, or prior treatment failure. We investigated the efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for 12 weeks in HCV-infected Korean adults. Methods: This Phase 3b, multicenter, open-label study included 2 cohorts. In Cohort 1, participants with HCV genotype 1 or 2 and who were treatment-naive or treatment-experienced with interferon-based treatments, received sofosbuvir–velpatasvir 400/100 mg/day. In Cohort 2, HCV genotype 1 infected individuals who previously received an NS5A inhibitor-containing regimen ≥ 4 weeks received sofosbuvir–velpatasvir–voxilaprevir 400/100/100 mg/day. Decompensated cirrhosis was an exclusion criterion. The primary endpoint was SVR12, defined as HCV RNA < 15 IU/mL 12 weeks following treatment. Results: Of 53 participants receiving sofosbuvir–velpatasvir, 52 (98.1%) achieved SVR12. The single participant who did not achieve SVR12 experienced an asymptomatic Grade 3 ASL/ALT elevation on day 15 and discontinued treatment. The event resolved without intervention. All 33 participants (100%) treated with sofosbuvir–velpatasvir–voxilaprevir achieved SVR 12. Overall, sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir were safe and well tolerated. Three participants (5.6%) in Cohort 1 and 1 participant (3.0%) in Cohort 2 had serious adverse events, but none were considered treatment-related. No deaths or grade 4 laboratory abnormalities were reported. Conclusions: Treatment with sofosbuvir–velpatasvir or sofosbuvir–velpatasvir–voxilaprevir was safe and resulted in high SVR12 rates in Korean HCV patients.
2.Multidisciplinary and Multisociety Practice Guideline on Reprocessing Flexible Gastrointestinal Endoscopes and Endoscopic Accessories
Dae Young CHEUNG ; Byung Ik JANG ; Sang Wook KIM ; Jie-Hyun KIM ; Hyung Keun KIM ; Jeong Eun SHIN ; Won Jae YOON ; Yong Kang LEE ; Kwang Hyun CHUNG ; Soo-Jeong CHO ; Hyun Phil SHIN ; Sun Young CHO ; Woon Geon SHIN ; Kee Don CHOI ; Byung-Wook KIM ; Joong Goo KWON ; Hee Chan YANG ; Tae-Geun GWEON ; Hyun Gun KIM ; Dong-Won AHN ; Kwang Bum CHO ; Sun Hee KIM ; Kyong Hwa HWANG ; Hee Hyuk IM
Clinical Endoscopy 2020;53(3):276-285
The area of endoscopic application has been continuously expanded since its introduction in the last century and the frequency of its use also increased stiffly in the last decades. Because gastrointestinal endoscopy is naturally exposed to diseased internal organs and contact with pathogenic materials, endoscopy mediated infection or disease transmission becomes a major concern in this field. Gastrointestinal endoscopy is not for single use and the proper reprocessing process is a critical factor for safe and reliable endoscopy procedures. What needed in these circumstances is a practical guideline for reprocessing the endoscope and its accessories which is feasible in the real clinical field to guarantee acceptable prevention of pathogen transmission. This guideline contains principles and instructions of the reprocessing procedure according to the step by step. And it newly includes general information and updated knowledge about endoscopy-mediated infection and disinfection. Multiple societies and working groups participated to revise; Korean Association for the Study of the Liver, the Korean Society of Infectious Diseases, Korean College of Helicobacter and Upper Gastrointestinal Research, the Korean Society of Gastroenterology, Korean Society of Gastrointestinal Cancer, Korean Association for the Study of Intestinal Diseases, Korean Pancreatobiliary Association, the Korean Society of Gastrointestinal Endoscopy Nurses and Associates and Korean Society of Gastrointestinal Endoscopy. Through this cooperation, we enhanced communication and established a better concordance. We still need more researches in this field and fill up the unproven area. And our guidelines will be renewed accordingly.
3.Medical Treatment with Somatostatin Analogues in Acromegaly: Position Statement
Sang Ouk CHIN ; Cheol Ryong KU ; Byung Joon KIM ; Sung Woon KIM ; Kyeong Hye PARK ; Kee Ho SONG ; Seungjoon OH ; Hyun Koo YOON ; Eun Jig LEE ; Jung Min LEE ; Jung Soo LIM ; Jung Hee KIM ; Kwang Joon KIM ; Heung Yong JIN ; Dae Jung KIM ; Kyung Ae LEE ; Seong Su MOON ; Dong Jun LIM ; Dong Yeob SHIN ; Se Hwa KIM ; Min Jeong KWON ; Ha Young KIM ; Jin Hwa KIM ; Dong Sun KIM ; Chong Hwa KIM
Korean Journal of Medicine 2019;94(6):485-494
Acromegaly is a chronic disorder caused by excessive growth hormone (GH) secretion. In most cases, the excess GH originates from GH-producing pituitary adenomas. Surgery is the preferred first-line treatment for patients with acromegaly, but medical management is considered when the disease persists after surgery or in cases where patients refuse surgery or are poor candidates for surgery. Somatostatin analogues are commonly used to treat acromegaly. The Korean Endocrine Society and the Korean Neuroendocrine Study Group have developed a position statement for the use of somatostatin analogues in the medical treatment of acromegaly. This position statement is based on evidence from the current literature and expert opinions. In the case of discrepancies among expert opinions, the experts voted to determine the recommended approach.
Acromegaly
;
Expert Testimony
;
Growth Hormone
;
Humans
;
Octreotide
;
Pituitary Neoplasms
;
Somatostatin
4.Medical Treatment with Somatostatin Analogues in Acromegaly: Position Statement
Sang Ouk CHIN ; Cheol Ryong KU ; Byung Joon KIM ; Sung Woon KIM ; Kyeong Hye PARK ; Kee Ho SONG ; Seungjoon OH ; Hyun Koo YOON ; Eun Jig LEE ; Jung Min LEE ; Jung Soo LIM ; Jung Hee KIM ; Kwang Joon KIM ; Heung Yong JIN ; Dae Jung KIM ; Kyung Ae LEE ; Seong Su MOON ; Dong Jun LIM ; Dong Yeob SHIN ; Se Hwa KIM ; Min Jeong KWON ; Ha Young KIM ; Jin Hwa KIM ; Dong Sun KIM ; Chong Hwa KIM
Endocrinology and Metabolism 2019;34(1):53-62
The Korean Endocrine Society (KES) published clinical practice guidelines for the treatment of acromegaly in 2011. Since then, the number of acromegaly cases, publications on studies addressing medical treatment of acromegaly, and demands for improvements in insurance coverage have been dramatically increasing. In 2017, the KES Committee of Health Insurance decided to publish a position statement regarding the use of somatostatin analogues in acromegaly. Accordingly, consensus opinions for the position statement were collected after intensive review of the relevant literature and discussions among experts affiliated with the KES, and the Korean Neuroendocrine Study Group. This position statement includes the characteristics, indications, dose, interval (including extended dose interval in case of lanreotide autogel), switching and preoperative use of somatostatin analogues in medical treatment of acromegaly. The recommended approach is based on the expert opinions in case of insufficient clinical evidence, and where discrepancies among the expert opinions were found, the experts voted to determine the recommended approach.
Acromegaly
;
Consensus
;
Expert Testimony
;
Insurance Coverage
;
Insurance, Health
;
Octreotide
;
Somatostatin
5.Medical Treatment with Somatostatin Analogues in Acromegaly: Position Statement
Sang Ouk CHIN ; Cheol Ryong KU ; Byung Joon KIM ; Sung Woon KIM ; Kyeong Hye PARK ; Kee Ho SONG ; Seungjoon OH ; Hyun Koo YOON ; Eun Jig LEE ; Jung Min LEE ; Jung Soo LIM ; Jung Hee KIM ; Kwang Joon KIM ; Heung Yong JIN ; Dae Jung KIM ; Kyung Ae LEE ; Seong Su MOON ; Dong Jun LIM ; Dong Yeob SHIN ; Se Hwa KIM ; Min Jeong KWON ; Ha Young KIM ; Jin Hwa KIM ; Dong Sun KIM ; Chong Hwa KIM
Korean Journal of Medicine 2019;94(6):485-494
Acromegaly is a chronic disorder caused by excessive growth hormone (GH) secretion. In most cases, the excess GH originates from GH-producing pituitary adenomas. Surgery is the preferred first-line treatment for patients with acromegaly, but medical management is considered when the disease persists after surgery or in cases where patients refuse surgery or are poor candidates for surgery. Somatostatin analogues are commonly used to treat acromegaly. The Korean Endocrine Society and the Korean Neuroendocrine Study Group have developed a position statement for the use of somatostatin analogues in the medical treatment of acromegaly. This position statement is based on evidence from the current literature and expert opinions. In the case of discrepancies among expert opinions, the experts voted to determine the recommended approach.
6.Transduodenal ampullectomy for ampullary tumors - single center experience of consecutive 26 patients.
Sarang HONG ; Ki Byung SONG ; Young Joo LEE ; Kwang Min PARK ; Song Cheol KIM ; Dae Wook HWANG ; Jae Hoon LEE ; Sang Hyun SHIN ; Jaewoo KWON ; Chung Hyeun MA ; Seunghyun HWANG ; Guisuk PARK ; Yejong PARK ; Seung Jae LEE ; Yong Woon KIM
Annals of Surgical Treatment and Research 2018;95(1):22-28
PURPOSE: Transduodenal ampullectomy (TDA) has been reported in a limited number of cases and in a small number of case series. The aim of this study was to analyze perioperative and long-term oncological outcomes of patients with ampullary tumors who underwent TDA in a single large-volume center. METHODS: Through a retrospective review of data from 2004 to 2016, we identified 26 patients who underwent TDA at Asan Medical Center. RESULTS: Eleven of 26 patients underwent TDA for T1 and carcinoma in situ (high-grade dysplasia) cancer; these patients are still alive without recurrence. A major in-hospital complication (3.8%) occurred in 1 case, but there was no case of 90-day mortality. In addition, none of the patients was diagnosed as having newly developed diabetes mellitus after TDA. No significant differences were found between open and laparoscopic-TDA in terms of operation time, painkiller use, and hospital stay. CONCLUSION: TDA is a feasible and effective surgical procedure for the treatment of selected patients with ampullary tumors. It is an alternative treatment option in cases of ampullary tumors not amenable to endoscopic papillectomy or pancreaticoduodenectomy.
Ampulla of Vater
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Carcinoma in Situ
;
Chungcheongnam-do
;
Diabetes Mellitus
;
Humans
;
Length of Stay
;
Mortality
;
Pancreaticoduodenectomy
;
Recurrence
;
Retrospective Studies
7.Laparoscopy Assisted versus Open Distal Gastrectomy with D2 Lymph Node Dissection for Advanced Gastric Cancer: Design and Rationale of a Phase II Randomized Controlled Multicenter Trial (COACT 1001).
Byung Ho NAM ; Young Woo KIM ; Daniel REIM ; Bang Wool EOM ; Wan Sik YU ; Young Kyu PARK ; Keun Won RYU ; Young Joon LEE ; Hong Man YOON ; Jun Ho LEE ; Oh JEONG ; Sang Ho JEONG ; Sang Eok LEE ; Sang Ho LEE ; Ki Young YOON ; Kyung Won SEO ; Ho Young CHUNG ; Oh Kyoung KWON ; Tae Bong KIM ; Woon Ki LEE ; Seong Heum PARK ; Ji Young SUL ; Dae Hyun YANG ; Jong Seok LEE
Journal of Gastric Cancer 2013;13(3):164-171
PURPOSE: Laparoscopy-assisted distal gastrectomy for early gastric cancer has gained acceptance and popularity worldwide. However, laparoscopy-assisted distal gastrectomy for advanced gastric cancer is still controversial. Therefore, we propose this prospective randomized controlled multi-center trial in order to evaluate the safety and feasibility of laparoscopy assisted D2-gastrectomy for advanced stage gastric cancer. MATERIALS AND METHODS: Patients undergoing distal gastrectomy for advanced gastric cancer staged cT2/3/4 cN0/1/2/3a cM0 by endoscopy and computed tomography are eligible for enrollment after giving their informed consent. Patients will be randomized either to laparoscopy-assisted distal gastrectomy or open distal gastrectomy. Sample size calculation revealed that 102 patients are to be included per treatment arm. The primary endpoint is the non-compliance rate of D2 dissection; relevant secondary endpoints are three-year disease free survival, surgical and postoperative complications, hospital stay and unanimity rate of D2 dissection evaluated by reviewing the intraoperative video documentation. DISCUSSION: Oncologic safety is the major concern regarding laparoscopy-assisted distal gastrectomy for advanced gastric cancer. Therefore, the non-compliance rate of clearing the N2 area was chosen as the most important parameter for the technical feasibility of the laparoscopic procedure. Furthermore, surgical quality will be carefully reviewed, that is, three independent experts will review the video records and score with a check list. For a long-term result, disease free survival is considered a secondary endpoint for this trial. This study will offer promising evidence of the feasibility and safety of Laparoscopy-assisted distal gastrectomy for advanced gastric cancer.Trial Registration: NCT01088204 (international), NCCCTS-09-448 (Korea).
Arm
;
Disease-Free Survival
;
Endoscopy
;
Gastrectomy
;
Humans
;
Informed Consent
;
Laparoscopy
;
Length of Stay
;
Lymph Node Excision
;
Lymph Nodes
;
Postoperative Complications
;
Prospective Studies
;
Sample Size
;
Stomach Neoplasms
8.Clinical outcomes of balloon-occluded retrograde transvenous obliteration for the treatment of gastric variceal hemorrhage in Korean patients with liver cirrhosis: a retrospective multicenter study.
Se Young JANG ; Go Heun KIM ; Soo Young PARK ; Chang Min CHO ; Won Young TAK ; Jeong Han KIM ; Won Hyeok CHOE ; So Young KWON ; Jae Myeong LEE ; Sang Gyune KIM ; Dae Yong KIM ; Young Seok KIM ; Se Ok LEE ; Yang Won MIN ; Joon Hyeok LEE ; Seung Woon PAIK ; Byung Chul YOO ; Jae Wan LIM ; Hong Joo KIM ; Yong Kyun CHO ; Joo Hyun SOHN ; Jae Yoon JEONG ; Yu Hwa LEE ; Tae Yeob KIM ; Young Oh KWEON
Clinical and Molecular Hepatology 2012;18(4):368-374
BACKGROUND/AIMS: This study evaluated the clinical outcomes of balloon-occluded retrograde transvenous obliteration (BRTO) for the treatment of hemorrhage from gastric varices (GV) in Korean patients with liver cirrhosis (LC). METHODS: We retrospectively analyzed data from 183 LC patients who underwent BRTO for GV bleeding in 6 university-based hospitals between January 2001 and December 2010. RESULTS: Of the 183 enrolled patients, 49 patients had Child-Pugh (CP) class A LC, 105 had CP class B, and 30 had CP class C at the time of BRTO. BRTO was successfully performed in 177 patients (96.7%). Procedure-related complications (e.g., pulmonary thromboembolism and renal infarction) occurred in eight patients (4.4%). Among 151 patients who underwent follow-up examinations of GV, 79 patients (52.3%) achieved eradication of GV, and 110 patients (72.8%) exhibited marked shrinkage of the treated GV to grade 0 or I. Meanwhile, new-appearance or aggravation of esophageal varices (EV) occurred in 54 out of 136 patients who underwent follow-up endoscopy (41.2%). During the 36.0+/-29.2 months (mean+/-SD) of follow-up, 39 patients rebled (hemorrhage from GV in 7, EV in 18, nonvariceal origin in 4, and unknown in 10 patients). The estimated 3-year rebleeding-free rate was 74.8%, and multivariate analysis showed that CP class C was associated with rebleeding (odds ratio, 2.404; 95% confidence-interval, 1.013-5.704; P=0.047). CONCLUSIONS: BRTO can be performed safely and effectively for the treatment of GV bleeding. However, aggravation of EV or bleeding from EV is not uncommon after BRTO; thus, periodic endoscopy to follow-up of EV with or without prophylactic treatment might be necessary in LC patients undergoing BRTO.
Adult
;
Aged
;
Asian Continental Ancestry Group
;
*Balloon Occlusion/adverse effects
;
Endoscopy, Gastrointestinal
;
Esophageal and Gastric Varices/*complications
;
Female
;
Follow-Up Studies
;
Gastrointestinal Hemorrhage/etiology/prevention & control/*therapy
;
Humans
;
Liver Cirrhosis/*complications
;
Male
;
Middle Aged
;
Odds Ratio
;
Pulmonary Embolism/etiology
;
Recurrence
;
Republic of Korea
;
Retrospective Studies
;
Severity of Illness Index
;
Treatment Outcome
9.A Case of Sheehan's Syndrome with Pancytopenia.
Hyun Suk LEE ; Byung Woon KWON ; Jin Hyung HAN ; Hee Jin KIM
Endocrinology and Metabolism 2012;27(1):54-58
Sheehan's syndrome is characterized by varying degrees of anterior pituitary dysfunction due to postpartum ischemic necrosis of the pituitary gland after massive bleeding. The spectrum of clinical presentation of Sheehan's syndrome is broad, with changes from nonspecific complaints, such as weakness, fatigue, and anemia, to severe pituitary insufficiency resulting in coma and death. Normochromic anemia is commonly associated with Sheehan's syndrome, but pancytopenia is rarely observed in patients with Sheehan's syndrome. We describe a 57-year-old woman with Sheehan's syndrome who presented with pancytopenia that was treated by hormone replacement with levothyroxine and glucocorticoid.
Anemia
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Coma
;
Fatigue
;
Female
;
Glucocorticoids
;
Hemorrhage
;
Humans
;
Hypopituitarism
;
Middle Aged
;
Necrosis
;
Pancytopenia
;
Pituitary Gland
;
Postpartum Period
;
Thyroxine
10.Narrow Band Imaging and White Light Colonoscopy for Detection of Polyps.
Seok Jae HAN ; Eun Young KIM ; Jae Bum PARK ; Jong Woon CHEON ; Ka Young KIM ; Young Kook SHIN ; Jang Seok OH ; Byung Seok KIM ; Jimin HAN ; Jin Tae JUNG ; Joong Goo KWON ; Chang Hyeong LEE ; Ho Gak KIM
Korean Journal of Gastrointestinal Endoscopy 2011;42(3):152-156
BACKGROUND/AIMS: Narrow band imaging (NBI) is a new technique that is expected to improve the detection rate of colorectal polyps, but results have been inconsistent. The aim of this study was to compare the polyp miss rate and the characteristics of missed colorectal polyps using white light (WL) and NBI. METHODS: 62 patients were randomized into two groups. In the first group (NBI first, NBIF), a colonoscopic examination of each segment (cecum-ascending, transverse, descending, and rectosigmoid colons) was performed first with NBI followed by a re-examination of the same segment using WL. An opposite sequence was applied for the other group (white light first, WLF). RESULTS: 67 polyps were found in the first examination, and 31 polyps were found on the re-examination, resulting in a polyp miss rate of 31.6%. The polyp miss rate was 39% for WLF and 23% for NBIF (p>0.05). Seventy-four small polyps (<5 mm) were found, and miss rates for NBIF and WLF were 20% and 46%, respectively (p=0.01). The polyp miss rate at the rectosigmoid was 11% for NBIF and 54% for WLF (p=0.01). CONCLUSIONS: The polyp miss rate was not significantly different between NBI or WL when a colonoscopy was performed. NBI resulted in a lower polyp miss rate for small (<5 mm) and rectosigmoid polyps than WL.
Colonoscopy
;
Humans
;
Light
;
Narrow Band Imaging
;
Polyps

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