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.Relationship between 15-hydroxyprostaglandin dehydrogenase and gastric adenocarcinoma.
Jae Hyun KANG ; Sang Hyun KANG ; Sang Hyuk SEO ; Jae Ho SHIN ; Min Sung AN ; Tae Kwun HA ; Ki Beom BAE ; Tae Hyun KIM ; Chang Soo CHOI ; Sang Hoon OH ; Mi Seon KANG ; Kwang Hee KIM
Annals of Surgical Treatment and Research 2014;86(6):302-308
PURPOSE: Prostaglandin E2 (PGE2) is a contributory carcinogen in gastric adenocarcinoma. 15-Hydroxyprostaglandin dehydrogenase (15-PGDH) catabolizes PGE2 by oxidizing its 15(s)-hydroxy group. The aim of this study was to investigate the expression of 15-PGDH in gastric adenocarcinoma tissue and the relationship between 15-PGDH expression and clinicopathologic features of gastric adenocarcinoma. METHODS: Ninety-nine patients who underwent surgical resection for gastric adenocarcinoma between January 2007 and December 2007 were enrolled and evaluated retrospectively. RESULTS: In 62 patients (62.6%), 15-PGDH expression was lower in gastric adenocarcinoma tissue than in nonneoplastic tissue. Regarding the relationship between 15-PGDH expression and clinicopathological features, 15-PGDH expression was significantly lower in tissues with poor differentiation (P = 0.002), advanced T stage (P = 0.0319), a higher number of lymph node metastases (P = 0.045), lymphatic invasion (P = 0.031), and vascular invasion (P = 0.036). CONCLUSION: 15-PGDH expression was associated with a subset of clinicopathologic features such as differentiation grade, T stage, lymphatic invasion, and vascular invasion.
Adenocarcinoma*
;
Dinoprostone
;
Humans
;
Lymph Nodes
;
Neoplasm Metastasis
;
Oxidoreductases*
;
Retrospective Studies
;
Stomach Neoplasms
3.Association Between a Close Distal Resection Margin and Recurrence After a Sphincter-Saving Resection for T3 Mid- or Low-Rectal Cancer Without Radiotherapy.
Jae Woong HAN ; Min Jae LEE ; Ha Kyung PARK ; Jae Ho SHIN ; Min Sung AN ; Tae Kwun HA ; Kwang Hee KIM ; Ki Beom BAE ; Tae Hyun KIM ; Chang Soo CHOI ; Sang Hoon OH ; Min Kyung OH ; Mi Seon KANG ; Kwan Hee HONG
Annals of Coloproctology 2013;29(6):231-237
PURPOSE: To maintain the patient's quality of life, surgeons strive to preserve the sphincter during rectal cancer surgery. This study evaluated the oncologic safety of a sphincter-saving resection with a distal resection margin (DRM) <1 cm without radiotherapy in T3, mid- or low-rectal cancer. METHODS: This retrospective study enrolled 327 patients who underwent a sphincter-saving resection for proven T3 rectal cancer located <10 cm from the anal verge and without radiotherapy between January 1995 and December 2011. The oncologic outcomes included the 5-year cancer-specific survival, the local recurrence, and the systemic recurrence rates. RESULTS: In groups A (DRM < or =1 cm) and B (DRM >1 cm), the 5-year cancer-specific survival rates were 81.57% and 80.03% (P = 0.8543), the 5-year local recurrence rates were 6.69% and 9.52% (P = 0.3981), and the 5-year systemic recurrence rates were 19.46% and 23.11% (P = 0.5750), respectively. CONCLUSION: This study showed that the close DRM itself should not be a contraindication for a sphincter-saving resection for T3 mid- or low-rectal cancer without radiotherapy. However, a prospective randomized controlled trial including the effect of adjuvant therapy will be needed.
Humans
;
Quality of Life
;
Radiotherapy*
;
Rectal Neoplasms
;
Recurrence*
;
Retrospective Studies
;
Survival Rate
4.Prognostic Significance of the Decreased Rate of Perioperative Serum Carcinoembryonic Antigen Level in the Patients With Colon Cancer After a Curative Resection.
Tae Doo JUNG ; Jong Han YOO ; Min Jae LEE ; Ha Kyung PARK ; Jae Ho SHIN ; Min Sung AN ; Tae Kwun HA ; Kwang Hee KIM ; Ki Beom BAE ; Tae Hyeon KIM ; Chang Soo CHOI ; Min Kyung OH ; Kwan Hee HONG
Annals of Coloproctology 2013;29(3):115-122
PURPOSE: The serum level of carcinoembryonic antigen (CEA) is a clinical prognostic factor in the follow-up evaluation of patients with colon cancer. We aimed to evaluate the prognostic significance of the rate of decrease of the perioperative serum CEA level in patients with colon cancer after a curative resection. METHODS: A total of 605 patients who underwent a curative resection for colon cancer between January 2000 and December 2007 were enrolled retrospectively. The rate of decrease was calculated using the following equation: ([preoperative CEA - postoperative CEA]/[preoperative CEA] x100). RESULTS: In the group with a preoperative serum CEA level of >5 ng/mL, the normalized group with a postoperative serum CEA level of < or =5 ng/mL showed a better overall survival (OS) rate and disease-free survival (DFS) rate than those of the non-normalized group (P < or = 0.0001). The "cutoff values" of the rate of decrease in the perioperative serum CEA that determined the OS and the DFS were 48.9% and 50.8%, respectively. In the multivariate analysis of preoperative serum CEA levels >5 ng/mL, the prognostic factors for the OS and the DFS were the cutoff value (P < 0.0001) and the pN stage (P < 0.0001). CONCLUSION: A rate of decrease of more than 50% in the perioperative serum CEA level, as well as the normalization of the postoperative serum CEA level, may be useful factors for determining a prognosis for colon cancer patients with high preoperative CEA levels.
Carcinoembryonic Antigen
;
Colon
;
Colonic Neoplasms
;
Disease-Free Survival
;
Follow-Up Studies
;
Humans
;
Multivariate Analysis
;
Prognosis
;
Retrospective Studies
5.Prognostic Significance of the Decreased Rate of Perioperative Serum Carcinoembryonic Antigen Level in the Patients With Colon Cancer After a Curative Resection.
Tae Doo JUNG ; Jong Han YOO ; Min Jae LEE ; Ha Kyung PARK ; Jae Ho SHIN ; Min Sung AN ; Tae Kwun HA ; Kwang Hee KIM ; Ki Beom BAE ; Tae Hyeon KIM ; Chang Soo CHOI ; Min Kyung OH ; Kwan Hee HONG
Annals of Coloproctology 2013;29(3):115-122
PURPOSE: The serum level of carcinoembryonic antigen (CEA) is a clinical prognostic factor in the follow-up evaluation of patients with colon cancer. We aimed to evaluate the prognostic significance of the rate of decrease of the perioperative serum CEA level in patients with colon cancer after a curative resection. METHODS: A total of 605 patients who underwent a curative resection for colon cancer between January 2000 and December 2007 were enrolled retrospectively. The rate of decrease was calculated using the following equation: ([preoperative CEA - postoperative CEA]/[preoperative CEA] x100). RESULTS: In the group with a preoperative serum CEA level of >5 ng/mL, the normalized group with a postoperative serum CEA level of < or =5 ng/mL showed a better overall survival (OS) rate and disease-free survival (DFS) rate than those of the non-normalized group (P < or = 0.0001). The "cutoff values" of the rate of decrease in the perioperative serum CEA that determined the OS and the DFS were 48.9% and 50.8%, respectively. In the multivariate analysis of preoperative serum CEA levels >5 ng/mL, the prognostic factors for the OS and the DFS were the cutoff value (P < 0.0001) and the pN stage (P < 0.0001). CONCLUSION: A rate of decrease of more than 50% in the perioperative serum CEA level, as well as the normalization of the postoperative serum CEA level, may be useful factors for determining a prognosis for colon cancer patients with high preoperative CEA levels.
Carcinoembryonic Antigen
;
Colon
;
Colonic Neoplasms
;
Disease-Free Survival
;
Follow-Up Studies
;
Humans
;
Multivariate Analysis
;
Prognosis
;
Retrospective Studies
6.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
7.Successful Removal of Common Bile Duct Stone Using Endoscopic Papillary Balloon Dilation (EPBD), in A 28-month-old Child with Down's Syndrome.
Jee Heon KANG ; Do Hyun PARK ; Jeung Hoon PARK ; Myung Ho OH ; Seung Hyo HAN ; Hyoung Su AHN ; Yong Ha LEE ; Sang Heum PARK ; Suck Ho LEE ; Il Kwun CHUNG ; Hong Soo KIM ; Sun Joo KIM
Korean Journal of Gastrointestinal Endoscopy 2006;33(2):125-129
Although cholelithiasis is an uncommon condition in infants, a recent study documented the increasing detection of this disorder. This increase may be explained by the wide use and improvement in abdominal ultrasound. Choledocholithiasis with cholestatic jaundice in infants usually requires therapeutic intervention, even though the incidence of spontaneous resolution has been reported to be higher in infants than adults. Choledocholithiasis in children has traditionally been managed surgically with open common duct exploration. Recently, endoscopic stone removal was accepted as a standard therapy in pediatric choledocholithiasis. We report a case of the successful removal of common bile duct stone using endoscopic papillary balloon dilation (EPBD), in a 28-month-old infant with Down's syndrome.
Infant
;
Child
;
Adult
;
Male
;
Female
;
Humans
;
Incidence
8.Endoscopic Unroofing Therapy for Colonic Lymphangioma: A report of two cases.
Young Soo OH ; Kwang An KWUN ; Eun Joo KIM ; Il Kwun CHUNG ; Hong Soo KIM ; Sang Heum PARK ; Moon Ho LEE ; Sun Joo KIM
Korean Journal of Gastrointestinal Endoscopy 2000;21(1):572-576
A lymphangionma is a rare benign tumor occuring in the gastrointestinal tract, which is composed of lymphatic vessels of various size. A sharply demarcated smooth, soft, cystic submucosal tumor which is easily compressible and covered with normal mucosa is a characteristic ally an endoscopic feature. This lesion is considered to be a benign lesion, which does not need to be treated, but in cases that involve risk of any complications or symptoms, the lesion needs to be removed. Servral endoscopic treatment methods for a symptomatic lymphangioma have been introduced, but accompanying risk of complications, such as bleeding or perforation were reported. As complete removal of a lymphangioma is impossible due to its broad base, a newly developed unroofing method is presented to be effective and safe for resection of a large lymphan-gioma. Recently, 2 cases were experienced involving a lymphangioma in the large intestine, which was removed successfully by colonscopic unroofing therapy.
Colon*
;
Colonoscopy
;
Gastrointestinal Tract
;
Hemorrhage
;
Intestine, Large
;
Lymphangioma*
;
Lymphatic Vessels
;
Mucous Membrane
9.Endosonographic Findings of Submucosal Tumor-like Gastric Lesion Caused by Fibrotic Ulcer Healing.
Dong Jin YOUN ; Myung Soo KIM ; Young Keun YOON ; Chan Hee HAN ; Gwang An KWUN ; Jin Oh KIM ; Joo Young CHO ; Joon Seong LEE ; Moon Sung LEE ; Chan Sup SHIM
Korean Journal of Gastrointestinal Endoscopy 2000;20(6):460-463
It is known that multiple ulcers of the gastric antrum are often accompanied by marked submucosal fibrosis during the healing process, and that this may result in a deformity of the gastric wall. Thus, benign antral ulcers may be misinterpreted as intramural tumors, or even malignant ulcers when the surrounding edema is pronounced and sharply defined. It is possible for an endoscopic ultrasonography (EUS) to detect which layer has a submucosal tumor (SMT) in the five-layer structures of the digestive tract wall. In the diagnosis of SMT of the upper digestive tract, EUS allows for the visualization of the structures underlying the gastrointestinal wall in a noninvasive manner and has a great advantage over conventional modalities such as endoscopy and X-ray examination. The EUS findings of 2 cases of submucosal tumor-like gastric lesion caused by fibrotic ulcer healing are herein reported with a brief review of relevant literature.
Congenital Abnormalities
;
Diagnosis
;
Edema
;
Endoscopy
;
Endosonography
;
Fibrosis
;
Gastrointestinal Tract
;
Pyloric Antrum
;
Stomach Ulcer
;
Ulcer*
10.Efficacy of Needle-knife Infundibulotomy in Failed Cannulation on Endoscopic Retrograde Cholangiopancreatography.
Eun Joo KIM ; Il Kwun CHUNG ; Hong Su KIM ; Moon Ho LEE ; Sun Joo KIM ; Sang Heum PARK ; Young Soo OH
Korean Journal of Gastrointestinal Endoscopy 2000;20(4):267-273
BACKGROUND/AIMS: Cannulation failure to biliary tract has been reported in 10% of patients who are performed diagnostic and therapeutic ERCP. Infundibulotomy by use of needle knife is cutting a bulbar part of protruding papilla, which has merit to avoid complete destruction of sphincter of Oddi and serious side effects than general precutting method. We want to know effectiveness and safety of infundibulotomy. METHODS: From January 1997 to December 1998, 36 patients who failed cannulation over three times trial by conventional method are included to this study. We compared the success rate of cannulation and procedure related complication according to bile duct dilatation, periampullary diverticulum and shape of ampulla of Vater. RESULTS: 1) Success rate of cannulation to bile duct is 81% (29/36). 2) All patients in group of bile duct dilatation (14) are succeed to cannulation, which is significantly high compare to other group (p=0.0288). 3) There was no statistical difference in success rate according to presence of periampullary diverticulum. 4) In groups of bulging prominent papilla are succeed in 23 among 26 patients, which is tendency of high in patients than other group (p=0.0760). 5) Total occurrence of procedure related complication was 33% (12/36). 6) The complication rate was not different in two groups according to cannulation success 7) The complication rate was tendency of high in patients without bile duct dilatation (p=0.0756). CONCLUSIONS: Infundibulotomy by use of needle knife is effeetive and safe cannulation method to patient who failed cannulation to bile duct. Success of cannulation is low and occurrence of complication is tendency of high in patient without bile duct dilation, which propose endoscopists attention in selection of indications.
Ampulla of Vater
;
Bile Ducts
;
Biliary Tract
;
Catheterization*
;
Cholangiopancreatography, Endoscopic Retrograde*
;
Dilatation
;
Diverticulum
;
Humans
;
Needles
;
Sphincter of Oddi

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