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 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).
3.Clinical Practice Guidelines for the Endoscopic Management of Peripancreatic Fluid Collections
Chi Hyuk OH ; Tae Jun SONG ; Jun Kyu LEE ; Jin-Seok PARK ; Jae Min LEE ; Jun Hyuk SON ; Dong Kee JANG ; Miyoung CHOI ; Jeong-Sik BYEON ; In Seok LEE ; Soo Teik LEE ; Ho Soon CHOI ; Ho Gak KIM ; Hoon Jai CHUN ; Chan Guk PARK ; Joo Young CHO
Korean Journal of Pancreas and Biliary Tract 2022;27(2):61-80
Endoscopic ultrasonography-guided intervention has gradually become a standard treatment for peripancreatic fluid collections (PFCs). However, it is difficult to popularize the procedure in Korea because of restrictions on insurance claims regarding the use of endoscopic accessories, as well as the lack of standardized Korean clinical practice guidelines. The Korean Society of Gastrointestinal Endoscopy (appointed a Task Force to develope medical guidelines by referring to the manual for clinical practice guidelines development prepared by the National Evidence-Based Healthcare Collaborating Agency. Previous studies on PFCs were searched, and certain studies were selected with the help of experts. Then, a set of key questions was selected, and treatment guidelines were systematically reviewed. Answers to these questions and recommendations were selected via peer review. This guideline discusses endoscopic management of PFCs and makes recommendations on indication for the procedure, pre-procedural preparations, optimal approach for drainage, procedural considerations (e.g., types of stent, advantages and disadvantages of plastic and metal stents, and accessories), adverse events of endoscopic intervention, and procedural quality issues. This guideline was reviewed by external experts and suggests best practices recommended based on the evidence available at the time of preparation. This will be revised as necessary to address advances and changes in technology and evidence obtained in clinical practice and future studies.
4.Clinical Practice Guidelines for the Endoscopic Management of Peripancreatic Fluid Collections
Chi Hyuk OH ; Jun Kyu LEE ; Tae Jun SONG ; Jin-Seok PARK ; Jae Min LEE ; Jun Hyuk SON ; Dong Kee JANG ; Miyoung CHOI ; Jeong-Sik BYEON ; In Seok LEE ; Soo Teik LEE ; Ho Soon CHOI ; Ho Gak KIM ; Hoon Jai CHUN ; Chan Guk PARK ; Joo Young CHO
Clinical Endoscopy 2021;54(4):505-521
Endoscopic ultrasonography-guided intervention has gradually become a standard treatment for peripancreatic fluid collections (PFCs). However, it is difficult to popularize the procedure in Korea because of restrictions on insurance claims regarding the use of endoscopic accessories, as well as the lack of standardized Korean clinical practice guidelines. The Korean Society of Gastrointestinal Endoscopy (KSGE) appointed a Task Force to develope medical guidelines by referring to the manual for clinical practice guidelines development prepared by the National Evidence-Based Healthcare Collaborating Agency. Previous studies on PFCs were searched, and certain studies were selected with the help of experts. Then, a set of key questions was selected, and treatment guidelines were systematically reviewed. Answers to these questions and recommendations were selected via peer review. This guideline discusses endoscopic management of PFCs and makes recommendations on Indications for the procedure, pre-procedural preparations, optimal approach for drainage, procedural considerations (e.g., types of stent, advantages and disadvantages of plastic and metal stents, and accessories), adverse events of endoscopic intervention, and procedural quality issues. This guideline was reviewed by external experts and suggests best practices recommended based on the evidence available at the time of preparation. This will be revised as necessary to address advances and changes in technology and evidence obtained in clinical practice and future studies.
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
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.
6.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.
7.Clinical Practice Guidelines for the Endoscopic Management of Peripancreatic Fluid Collections
Chi Hyuk OH ; Tae Jun SONG ; Jun Kyu LEE ; Jin-Seok PARK ; Jae Min LEE ; Jun Hyuk SON ; Dong Kee JANG ; Miyoung CHOI ; Jeong-Sik BYEON ; In Seok LEE ; Soo Teik LEE ; Ho Soon CHOI ; Ho Gak KIM ; Hoon Jai CHUN ; Chan Guk PARK ; Joo Young CHO
Gut and Liver 2021;15(5):677-693
Endoscopic ultrasonography-guided intervention has gradually become a standard treatment for peripancreatic fluid collections (PFCs). However, it is difficult to popularize the procedure in Korea because of restrictions on insurance claims regarding the use of endoscopic accessories, as well as the lack of standardized Korean clinical practice guidelines. The Korean Society of Gastrointestinal Endoscopy appointed a Task Force to develop medical guidelines by referring to the manual for clinical practice guidelines development prepared by the National Evidence-Based Healthcare Collaborating Agency. Previous studies on PFCs were searched, and certain studies were selected with the help of experts. Then, a set of key questions was selected, and treatment guidelines were systematically reviewed. Answers to these questions and recommendations were selected via peer review. This guideline discusses endoscopic management of PFCs and makes recommendations on Indications for the procedure, pre-procedural preparations, optimal approach for drainage, procedural considerations (e.g., types of stent, advantages and disadvantages of plastic and metal stents, and accessories), adverse events of endoscopic intervention, and procedural quality issues. This guideline was reviewed by external experts and suggests best practices recommended based on the evidence available at the time of preparation. This will be revised as necessary to address advances and changes in technology and evidence obtained in clinical practice and future studies.
8.Clinical practice guideline for endoscopic resection of early gastrointestinal cancer
Chan Hyuk PARK ; Dong-Hoon YANG ; Jong Wook KIM ; Jie-Hyun KIM ; Ji Hyun KIM ; Yang Won MIN ; Si Hyung LEE ; Jung Ho BAE ; Hyunsoo CHUNG ; Kee Don CHOI ; Jun Chul PARK ; Hyuk LEE ; Min-Seob KWAK ; Bun KIM ; Hyun Jung LEE ; Hye Seung LEE ; Miyoung CHOI ; Dong-Ah PARK ; Jong Yeul LEE ; Jeong-Sik BYEON ; Chan Guk PARK ; Joo Young CHO ; Soo Teik LEE ; Hoon Jai CHUN
Intestinal Research 2021;19(2):127-157
Although surgery was the standard treatment for early gastrointestinal cancers, endoscopic resection is now a standard treatment for early gastrointestinal cancers without regional lymph node metastasis. High-definition white light endoscopy, chromoendoscopy, and image-enhanced endoscopy such as narrow band imaging are performed to assess the edge and depth of early gastrointestinal cancers for delineation of resection boundaries and prediction of the possibility of lymph node metastasis before the decision of endoscopic resection. Endoscopic mucosal resection and/or endoscopic submucosal dissection can be performed to remove early gastrointestinal cancers completely by en bloc fashion. Histopathological evaluation should be carefully made to investigate the presence of risk factors for lymph node metastasis such as depth of cancer invasion and lymphovascular invasion. Additional treatment such as radical surgery with regional lymphadenectomy should be considered if the endoscopically resected specimen shows risk factors for lymph node metastasis. This is the first Korean clinical practice guideline for endoscopic resection of early gastrointestinal cancer. This guideline was developed by using mainly de novo methods and encompasses endoscopic management of superficial esophageal squamous cell carcinoma, early gastric cancer, and early colorectal cancer. This guideline will be revised as new data on early gastrointestinal cancer are collected.
9.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.
10.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

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