1.Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, DoubleBlind, Active Control, Noninferiority, Multicenter, Phase 3 Study
Gwang Ha KIM ; Hang Lak LEE ; Moon Kyung JOO ; Hong Jun PARK ; Sung Woo JUNG ; Ok-Jae LEE ; Hyungkil KIM ; Hoon Jai CHUN ; Soo Teik LEE ; Ji Won KIM ; Han Ho JEON ; Il-Kwun CHUNG ; Hyun-Soo KIM ; Dong Ho LEE ; Kyoung-Oh KIM ; Yun Jeong LIM ; Seun-Ja PARK ; Soo-Jeong CHO ; Byung-Wook KIM ; Kwang Hyun KO ; Seong Woo JEON ; Jae Gyu KIM ; In-Kyung SUNG ; Tae Nyeun KIM ; Jae Kyu SUNG ; Jong-Jae PARK
Gut and Liver 2021;15(6):841-850
Background/Aims:
The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta Ⓡ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis.
Methods:
This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or Mucosta Ⓡ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta Ⓡ , n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta Ⓡ , n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated.
Results:
According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was −4.01% (95% confidence interval [CI], –13.09% to 5.06%) in the ITT analysis and −4.44% (95% CI, –13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 Mucosta Ⓡ -treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates.
Conclusions
The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (Mucosta Ⓡ ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.
2.Online Registry for Nationwide Database of Current Trend of Helicobacter pylori Eradication in Korea: Interim Analysis.
Beom Jin KIM ; Hyun Soo KIM ; Hyun Joo SONG ; Il Kwun CHUNG ; Gwang Ha KIM ; Byung Wook KIM ; Ki Nam SHIM ; Seong Woo JEON ; Yun Jin JUNG ; Chang Hun YANG ; Ji Hyun KIM ; Tae Ho KIM ; Sang Gyun KIM ; Woon Geon SHIN ; Sun Moon KIM ; Sok Won HAN ; Jun Haeng LEE ; Kyung Ho KIM ; Sue K PARK ; Byung Joo PARK ; Joongyub LEE ; Jae G KIM
Journal of Korean Medical Science 2016;31(8):1246-1253
Eradication of Helicobacter pylori using first-line therapy is becoming less effective. Subjects who had been treated for H. pylori infection were prospectively enrolled through an on-line database registry from October 2010 to December 2012. Demographic data, detection methods, treatment indication, regimens, durations, compliance, adverse events, and eradication results for H. pylori infection were collected. Data of 3,700 patients from 34 hospitals were analyzed. The overall eradication rate of the first-line therapy was 73.0%. Eradication failure was significantly associated with old age, concomitant medication, and comorbidity. Regional differences in eradication rates were observed. The most common first-line therapy was proton pump inhibitor-based triple therapy (standard triple therapy, STT) for 7 days (86.8%). The eradication rates varied with regimens, being 73% in STT, 81.8% in bismuth-based quadruple therapy, 100% in sequential therapy, and 90.3% in concomitant therapy. The eradication rate in treatment-naïve patients was higher than that in patients previously treated for H. pylori infection (73.8% vs. 58.5%, P < 0.001). The overall eradication rate for second-line therapy was 84.3%. There was no statistical difference in eradication rates among various regimens. H. pylori eradication rate using STT is decreasing in Korea and has become sub-optimal, suggesting the need for alternative regimens to improve the efficacy of first-line therapy for H. pylori infection.
Adult
;
Age Factors
;
Aged
;
Anti-Bacterial Agents/*therapeutic use
;
Databases, Factual
;
Drug Therapy, Combination
;
Female
;
Helicobacter Infections/*drug therapy/microbiology
;
Helicobacter pylori/isolation & purification
;
Humans
;
Internet
;
Logistic Models
;
Male
;
Middle Aged
;
Prospective Studies
;
Proton Pump Inhibitors/*therapeutic use
;
Registries
;
Republic of Korea
;
Treatment Outcome
3.Online Registry for Nationwide Database of Current Trend of Helicobacter pylori Eradication in Korea: Interim Analysis.
Beom Jin KIM ; Hyun Soo KIM ; Hyun Joo SONG ; Il Kwun CHUNG ; Gwang Ha KIM ; Byung Wook KIM ; Ki Nam SHIM ; Seong Woo JEON ; Yun Jin JUNG ; Chang Hun YANG ; Ji Hyun KIM ; Tae Ho KIM ; Sang Gyun KIM ; Woon Geon SHIN ; Sun Moon KIM ; Sok Won HAN ; Jun Haeng LEE ; Kyung Ho KIM ; Sue K PARK ; Byung Joo PARK ; Joongyub LEE ; Jae G KIM
Journal of Korean Medical Science 2016;31(8):1246-1253
Eradication of Helicobacter pylori using first-line therapy is becoming less effective. Subjects who had been treated for H. pylori infection were prospectively enrolled through an on-line database registry from October 2010 to December 2012. Demographic data, detection methods, treatment indication, regimens, durations, compliance, adverse events, and eradication results for H. pylori infection were collected. Data of 3,700 patients from 34 hospitals were analyzed. The overall eradication rate of the first-line therapy was 73.0%. Eradication failure was significantly associated with old age, concomitant medication, and comorbidity. Regional differences in eradication rates were observed. The most common first-line therapy was proton pump inhibitor-based triple therapy (standard triple therapy, STT) for 7 days (86.8%). The eradication rates varied with regimens, being 73% in STT, 81.8% in bismuth-based quadruple therapy, 100% in sequential therapy, and 90.3% in concomitant therapy. The eradication rate in treatment-naïve patients was higher than that in patients previously treated for H. pylori infection (73.8% vs. 58.5%, P < 0.001). The overall eradication rate for second-line therapy was 84.3%. There was no statistical difference in eradication rates among various regimens. H. pylori eradication rate using STT is decreasing in Korea and has become sub-optimal, suggesting the need for alternative regimens to improve the efficacy of first-line therapy for H. pylori infection.
Adult
;
Age Factors
;
Aged
;
Anti-Bacterial Agents/*therapeutic use
;
Databases, Factual
;
Drug Therapy, Combination
;
Female
;
Helicobacter Infections/*drug therapy/microbiology
;
Helicobacter pylori/isolation & purification
;
Humans
;
Internet
;
Logistic Models
;
Male
;
Middle Aged
;
Prospective Studies
;
Proton Pump Inhibitors/*therapeutic use
;
Registries
;
Republic of Korea
;
Treatment Outcome
4.Endoscopic Removal of a Proximally Migrated Metal Stent during Balloon Sweeping after Stent Trimming.
Nam Jun CHO ; Tae Hoon LEE ; Sang Heum PARK ; Han Min LEE ; Kyung Hee HYUN ; Suck Ho LEE ; Il Kwun CHUNG ; Sun Joo KIM
Clinical Endoscopy 2013;46(4):418-422
Placement of a self-expanding metal stent (SEMS) is an effective method for palliation of a malignant biliary obstruction. However, metal stents can cause various complications, including stent migration. Distally migrated metal stents, particularly covered SEMS, can be removed successfully in most cases. Stent trimming using argon plasma coagulation may be helpful in difficult cases despite conventional methods. However, no serious complications related to the trimming or remnant stent removal method have been reported due to the limited number of cases. In particular, proximal migration of a remnant fragmented metal stent after stent trimming followed by balloon sweeping has not been reported. We report an unusual case of proximal migration of a remnant metal stent during balloon sweeping following stent trimming by argon plasma coagulation. The remnant metal stent was successfully removed with rotation technique using a basket and revised endoscopically.
Argon Plasma Coagulation
;
Cholangiopancreatography, Endoscopic Retrograde
;
Pancreatic Neoplasms
;
Stents
5.A Case of Delayed Fatal Hemobilia after Radiofrequency Ablation of Hepatocellular Carcinoma.
Seung Kyu CHUNG ; Baek Gyu JUN ; Sae Hwan LEE ; Suck Ho LEE ; Il Kwun CHUNG ; Hong Soo KIM ; Sang Heum PARK ; Sun Joo KIM
Soonchunhyang Medical Science 2012;18(1):52-55
Radiofrequency ablation (RFA) has been accepted as a safe and effective treatment for unresectable hepatic tumors because of the advantages of a minimally invasive procedure and the local treatment effect. Although RFA can be performed safely in most patients, early and late complications related to mechanical or thermal damage may be observed at follow-up examination. Hemobilia is a very rare complication of RFA and most hemobilia is an immediate complication. However, delayed hemobilia is an even more rare complication after RFA and is known to be a fatal complication. We present a case of delayed fatal hemobilia after RFA for hepatocellular carcinoma.
Carcinoma, Hepatocellular
;
Follow-Up Studies
;
Hemobilia
;
Humans
6.A Case of Synchronous Colorectal Adenocarcinoma with Anal Squamous Cell Carcinoma.
Bo Yong JUNG ; Suck Ho LEE ; Chang Kyun LEE ; Eun Seo PARK ; Il Kwun CHUNG ; Sun Joo KIM ; Moo Jun BAEK ; Ji Hye LEE
Korean Journal of Gastrointestinal Endoscopy 2011;42(1):28-32
Synchronous anal squamous cell carcinoma with colorectal adenocarcinoma is a very rare and interesting disease entity because these neoplasms are essentially different from each other in terms of their anatomical locations, clinical behaviors, histopathological characteristics and treatment. To date, there have been very few case reports regarding the concurrent occurrence of these two distinct neoplasms. Nonetheless, it is recommended that patients with squamous cell carcinoma of the anus and who are older than 50 years should undergo colonoscopy in order to rule out a synchronous colorectal neoplasm. We recently encountered a 72-year-old woman who presented with synchronous squamous cell carcinoma of the anal canal and adenocarcinoma of the rectosigmoid junction. The patient underwent curative surgical resection for the colorectal adenocarcinoma and chemoradiotherapy for the concurrent anal squamous cell carcinoma. We describe here our clinical experience with this unusual case and we also conduct a short review of relevant literature.
Adenocarcinoma
;
Aged
;
Anal Canal
;
Anus Neoplasms
;
Carcinoma, Squamous Cell
;
Chemoradiotherapy
;
Colonic Neoplasms
;
Colonoscopy
;
Colorectal Neoplasms
;
Female
;
Humans
7.A Case of Primary Duodenal Cancer on Afferent Loop Presenting with Chronic Anemia and Recurrent Melena.
Baek Gyu JUN ; Tae Hoon LEE ; Hyun Wook CHO ; Sae Hwan LEE ; Suck Ho LEE ; Il Kwun CHUNG ; Hong Soo KIM ; Sang Heum PARK ; Sun Joo KIM ; Hyun Deuk CHO
Soonchunhyang Medical Science 2011;17(1):49-52
Obscure gastrointestinal bleeding accounts for approximately 5% of all gastrointestinal bleeding. Angioectasia of the small bowel is the most common form of obscure gastrointestinal bleeding, while small bowel tumors are the second. Among small bowel tumors, primary duodenal cancer is uncommon and represents 0.3% of gastrointestinal tumors. However, primary duodenal cancer at the duodenal stump following Billroth II gastrectomy for stomach cancer is extremely rare, and have not been reported yet in Korea. We report the first case of a 74-year-old man with chronic anemia and recurrent melena, which was diagnosed as a primary duodenal adenocarcinoma developed in afferent loop. The primary lesion was successfully accessed under cap-fitted endoscopy, however final diagnosis was delayed due to the unusual anatomical site.
Adenocarcinoma
;
Afferent Loop Syndrome
;
Aged
;
Anemia
;
Duodenal Neoplasms
;
Endoscopy
;
Gastrectomy
;
Gastroenterostomy
;
Hemorrhage
;
Humans
;
Korea
;
Melena
;
Stomach Neoplasms
8.A Case of Multiple Liver Metastasis of True Gastric Leiomyosarcoma after Complete Surgical Resection.
Se Yoon PARK ; Chang Kyun LEE ; Jun Seok PARK ; Byung Kyu AHN ; Se Hun KIM ; Suck Ho LEE ; Il Kwun CHUNG ; Sun Joo KIM ; Chang Jin KIM
Soonchunhyang Medical Science 2011;17(2):138-142
Primary leiomyosarcomas of the stomach are very rare tumors originating from mesenchymal tissues and account for only 1% of all malignant gastric neoplasm. We present here a case of primary gastric leiomyosarcoma in a 79-year-old man who presented with a 10 day history of epigastric pain and gastric subepithelial tumor. Endoscopic examination showed a 5 cm in diameter, subepithelial tumor located in the body of the stomach. Radiological investigations showed nonspecific findings except for the primary gastric lesion. Complete histological evaluation including immnuohistochemical staining after complete surgical resection revealed a true leiomyosarcoma of the stomach. One year later, the patient presented with dyspepsia. Endoscopic and radiological evaluation showed a recurrent leiomyosarcoma with multiple liver metastases. Our experience suggests that a careful clinical follow-up after surgical resection should be recommended in patients with gastric leiomyosarcomas because of their aggressive clinical behavior.
Aged
;
Benzeneacetamides
;
Dyspepsia
;
Follow-Up Studies
;
Humans
;
Leiomyosarcoma
;
Liver
;
Neoplasm Metastasis
;
Piperidones
;
Stomach
;
Stomach Neoplasms
9.A Case of Successful Endoscopic Treatment for Acute Recurrent Pancreatitis Due to Pancreas Divisum with Santorinicele Masquerading as Drug Induced Pancreatitis.
Yun Suk SHIM ; Tae Hoon LEE ; Jun Ho CHOI ; Sang Pil KIM ; Sae Hwan LEE ; Il Kwun CHUNG ; Sang Heum PARK ; Sun Joo KIM
Korean Journal of Gastrointestinal Endoscopy 2010;40(2):139-143
There are various causes of acute pancreatitis, and accurately determining the etiology is pivotal for selecting appropriate management. Other hidden causes, such as congenital anomaly, should be considered in patients with recurrent abdominal pain or unexplained recurrent pancreatitis. A santorinicele is a focal cystic dilatation of the terminal dorsal pancreatic duct, and this is usually associated with pancreas divisum and it is a risk factor for acute pancreatitis due to the accompanying relative stenosis of the minor papilla. We present here the case of a patient who was treated for acute pancreatitis that was presumably was caused by either Rifampin or Brucellosis, and the patient recovered with conservative management. However, we eventually diagnosed pancreas divisum with santorinicele by performing MRCP and ERCP after the pancreatitis had relapsed. We report here on a case of successful endoscopic treatment for pancreas divisum with santorinicele as a cause of recurrent pancreatitis, and this was initially confused with drug or infection related pancreatitis.
Abdominal Pain
;
Brucellosis
;
Cholangiopancreatography, Endoscopic Retrograde
;
Constriction, Pathologic
;
Dilatation
;
Humans
;
Pancreas
;
Pancreatic Ducts
;
Pancreatitis
;
Rifampin
;
Risk Factors
10.A Single Institution's Experience of Ten Pediatric Patients with Endoscopic Retrograde Cholangiopancreatography.
Jin Woo PARK ; Sang Heum PARK ; Tae Hoon LEE ; Yun Suk SHIM ; Soon Oh HWANG ; Sang Pil KIM ; Jun Young LEE ; Seo Whan LEE ; Chang Kwun LEE ; Do Hyun PARK ; Suck Ho LEE ; Il Kwun CHUNG ; Hong Soo KIM ; Sun Joo KIM
Korean Journal of Gastrointestinal Endoscopy 2010;41(3):140-146
BACKGROUND/AIMS: ERCP is being used increasingly as a diagnostic and therapeutic tool for children with pancreaticobiliary disorders. Differences between thirteen pediatric ERCPs and adult ERCPs were reviewed with respect to their indications, method of anesthesia, choice of endoscope and complications. METHODS: The medical records of 13 ERCPs for 10 children (age: 23 months to 14 years) done between 2005 and 2008 were reviewed retrospectively. RESULTS: ERCP was indicated for gallstone pancreatitis (6), choledocholithiasis (3), and unexplained pain (1). The method of anesthesia was intravenous sedation with a single agent or a combination of midazolam, propofol or ketamine. The quality of sedation was satisfactory in 10 cases and unsatisfactory in three cases. These 3 cases were less than 8 years old and sedated with a combination of midazolam and propofol. Selective biliary cannulation was successful in 92.3% (12/13) of attempts. Therapeutic ERCP included sphincterotomy (4), endoscopic papillary balloon dilatation (3), and both (5). Complications occurred in 7.7% of attempts (1/13; 1 duodenal perforation) which was successfully managed by surgery. CONCLUSIONS: Pediatric ERCP is a feasible and useful technique. Special caution is needed, however, because of differences with adult ERCP in terms of the effectiveness of intravenous sedation, complications, and size of the gastrointestinal tract.
Adult
;
Anesthesia
;
Catheterization
;
Child
;
Cholangiopancreatography, Endoscopic Retrograde
;
Choledocholithiasis
;
Dilatation
;
Endoscopes
;
Gallstones
;
Gastrointestinal Tract
;
Humans
;
Ketamine
;
Medical Records
;
Midazolam
;
Pancreatitis
;
Propofol
;
Retrospective Studies

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