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1.
Korean J Gastroenterol ; 76(6): 331-336, 2020 12 25.
Article in English | MEDLINE | ID: mdl-33361709

ABSTRACT

Duodenal varices are a serious complication of portal hypertension. Bleeding from duodenal varices is rare, but when bleeding does occur, it is massive and can be fatal. Unfortunately, the optimal therapeutic modality for duodenal variceal bleeding is unclear. This paper presents a patient with duodenal variceal bleeding that was managed successfully using percutaneous trans-splenic variceal obliteration (PTVO). A 56-year-old man with a history of alcoholic cirrhosis presented with a 6-day history of melena. Emergency esophagogastroduodenoscopy revealed a large, bluish mass with a nipple sign in the second portion of the duodenum. Coil embolization of the duodenal varix was performed via a trans-splenic approach (i.e., PTVO). The patient no longer complained of melena after treatment. The duodenal varix was no longer visible at the follow-up esophagogastroduodenoscopy performed three months after PTVO. The use of PTVO might be a viable option for the treatment of duodenal variceal bleeding.


Subject(s)
Duodenal Diseases , Gastrointestinal Hemorrhage , Varicose Veins , Duodenal Diseases/diagnosis , Duodenal Diseases/etiology , Duodenal Diseases/therapy , Duodenum , Embolization, Therapeutic , Esophageal and Gastric Varices/diagnosis , Gastrointestinal Hemorrhage/diagnosis , Gastrointestinal Hemorrhage/etiology , Gastrointestinal Hemorrhage/therapy , Humans , Male , Middle Aged , Spleen , Varicose Veins/complications , Varicose Veins/diagnosis
2.
Intest Res ; 17(4): 561-564, 2019 Oct.
Article in English | MEDLINE | ID: mdl-31302994

ABSTRACT

Primary malignant melanoma (PMM) of the gastrointestinal tract is rare. Reported cases of PMM of the lower gastrointestinal tract typically describe anal and rectal involvement rather than colonic lesions. This report describes a rare case of a 50-year-old woman with PMM originating in the colon. The patient presented to Inje University Busan Paik Hospital with a 3-day history of blood-tinged stools. She underwent colonoscopy for a diagnosis of hematochezia. The colonoscopic examination revealed a large-sized semi-pedunculated sigmoid colon polyp with a reddish-colored mucosal surface. Endoscopic mucosal resection was performed, and the final histopathological findings were consistent with a diagnosis of malignant melanoma. Systemic work-up was performed for assessment of metastasis and to identify the primary tumor considering the high metastatic rate of gastrointestinal malignant melanoma; however, no other malignant lesion was detected. Thus, she was diagnosed with colonic PMM. She underwent laparoscopic low anterior resection and lymph node dissection and has been recurrence-free for > 2 years.

3.
Cancer Res Treat ; 51(4): 1568-1577, 2019 Oct.
Article in English | MEDLINE | ID: mdl-30971066

ABSTRACT

PURPOSE: The diagnostic criteria of gastric intraepithelial neoplasia (IEN) are controversial across the world. We investigated how many discrepancies occur in the pathologic diagnosis of IEN and early gastric carcinoma in endoscopic submucosal dissection (ESD) specimens, and evaluated the reasons of the discordance. MATERIALS AND METHODS: We retrospectively reviewed 1,202 ESD specimens that were originally diagnosed as gastric IEN and early carcinoma at 12 institutions. RESULTS: The final consensus diagnosis of carcinoma were 756 cases, which were originally 692 carcinomas (91.5%), 43 high-grade dysplasias (5.7%), 20 low-grade dysplasias (2.6%), and 1 others (0.1%), respectively. High- and low-grade dysplasia were finally made in 63 and 342 cases, respectively. The diagnostic concordance with the consensus diagnosis was the highest for carcinoma (91.5%), followed by low-grade dysplasia (86.3%), others (63.4%) and high-grade dysplasia (50.8%). The general kappa value was 0.83, indicating excellent concordance. The kappa values of individual institutions ranged from 0.74 to 1 and correlated with the proportion of carcinoma cases. The cases revised to a final diagnosis of carcinoma exhibited both architectural abnormalities and cytologic atypia. The main differential points between low- and high-grade dysplasias were the glandular distribution and glandular shape. Additional features such as the glandular axis, surface maturation, nuclear stratification and nuclear polarity were also important. CONCLUSION: The overall concordance of the diagnosis of gastric IEN and early carcinoma in ESD specimens was excellent. It correlated with the proportion of carcinoma cases, demonstrating that the diagnostic criteria for carcinoma are more reproducible than those for dysplasia.


Subject(s)
Carcinoma in Situ/diagnosis , Endoscopic Mucosal Resection/methods , Stomach Neoplasms/diagnosis , Carcinoma in Situ/pathology , Early Detection of Cancer , Female , Humans , Male , Observer Variation , Reproducibility of Results , Retrospective Studies , Risk Factors , Stomach Neoplasms/pathology
4.
Gut Liver ; 12(4): 402-410, 2018 07 15.
Article in English | MEDLINE | ID: mdl-29588436

ABSTRACT

Background/Aims: Endoscopic submucosal dissection (ESD) has been regarded as a curative treatment for early gastric cancer (EGC) in indicated cases. The aim of this study was to evaluate the nationwide long-term clinical outcomes of ESD for EGC in Korea. Methods: A prospective multicenter cohort study was performed to evaluate the long-term efficacy of ESD for EGC within pre-defined indications at 12 institutes in Korea. The cases that met the expanded criteria upon pathological review after ESD were followed for 5 years. The primary outcome was 5-year disease specific free survival. Results: Six hundred ninety-seven patients with 722 EGCs treated with ESD were prospectively enrolled and followed for 5 years. Complete resection was achieved in 81.3% of the cases, and curative resection was achieved in 86.1%. During the 5-year follow-up, the overall survival rate was 96.6%, and the disease specific free survival rate was 90.6%. Local recurrence developed in 0.9%, and metachronous tumor development occurred in 7.8%; both conditions were treated by endoscopic or surgical treatment. Distant metastasis developed in 0.5% during follow-up. Conclusions: ESD showed excellent long-term clinical outcomes and can be accepted as a curative treatment for patients with EGC who meet the expanded criteria in final pathology studies.


Subject(s)
Early Detection of Cancer/mortality , Endoscopic Mucosal Resection/mortality , Stomach Neoplasms/mortality , Stomach Neoplasms/surgery , Aged , Disease-Free Survival , Endoscopic Mucosal Resection/methods , Female , Follow-Up Studies , Humans , Male , Middle Aged , Neoplasm Recurrence, Local/epidemiology , Prospective Studies , Republic of Korea , Survival Rate , Time , Time Factors , Treatment Outcome
5.
Intest Res ; 16(1): 151-154, 2018 Jan.
Article in English | MEDLINE | ID: mdl-29422811

ABSTRACT

Amyloidosis is defined as the extracellular deposition of non-branching fibrils composed of a variety of serum-protein precursors. Secondary amyloidosis is associated with several chronic inflammatory conditions, such as rheumatologic or intestinal diseases, familial Mediterranean fever, or chronic infectious diseases, such as tuberculosis. Although the association of amyloidosis with inflammatory bowel disease is known, amyloidosis secondary to ulcerative colitis (UC) is rare. A 36-year-old male patient with a 15-year history of UC presented with nausea, vomiting, and abdominal pain. He had been treated with infliximab for 6 years. At the time of admission, he had been undergoing treatment with mesalazine and adalimumab since the preceding 5 months. Esophagogastroduodenoscopy showed mucosal erythema, edema, and erosions with geographic ulcers at the 2nd and 3rd portions of the duodenum. Duodenal amyloidosis was diagnosed using polarized light microscopy and Congo red stain. Monoclonal gammopathy was not detected in serum and urine tests, while the serum free light chain assay result was not specific. An increase in plasma cells in the bone marrow was not found. Secondary amyloidosis due to UC was suspected. The symptoms were resolved after glucocorticoid therapy.

6.
J Korean Med Sci ; 32(11): 1807-1813, 2017 Nov.
Article in English | MEDLINE | ID: mdl-28960033

ABSTRACT

This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was -0.4% (95% confidence interval, -9.8% to 9.1%), which was above the non-inferiority margin of -14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA-9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA-9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670).


Subject(s)
Gastritis/drug therapy , Plant Extracts/therapeutic use , Adult , Double-Blind Method , Drug Administration Schedule , Female , Gastric Mucosa/pathology , Gastrointestinal Diseases/etiology , Gastroscopy , Humans , Male , Middle Aged , Plant Extracts/adverse effects , Treatment Outcome
7.
Gut Liver ; 11(1): 87-92, 2017 Jan 15.
Article in English | MEDLINE | ID: mdl-27282267

ABSTRACT

BACKGROUND/AIMS: Endoscopic submucosal dissection (ESD) has been an established treatment for indicated early gastric cancer (EGC) without deterioration of quality of life (QOL) compared with surgical resection. The aim of this study was to evaluate long-term QOL in patients undergoing ESD for EGC. METHODS: Patients scheduled to undergo curative ESD for EGC were prospectively enrolled from 12 institutions between May 2010 and December 2011. Assessments of QOL with Korean versions of the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaire-core (QLQ-C30) and a gastric cancer-specific questionnaire (STO22) were performed at baseline and at 7 days, 3 months, and 6 months after ESD. RESULTS: A total of 666 subjects were assessed for QLQ-C30 and QLQ-STO22. The mean QLQ-C30 score was 69.5 at baseline, 68.8 at 7 days, 73.1 at 3 months, and 73.2 at 6 months. The global health status on the EORTC QLQ-C30 was significantly improved after 3 and 6 months (p=0.0003 and p<0.0001, respectively). The QLQ-C30 and STO22 scores were not significantly different, or they only slightly deteriorated between before and immediately after ESD, but they were significantly improved after 3 and 6 months (p<0.05). CONCLUSIONS: QOL did not deteriorate immediately after ESD, and it improved more significantly at up to 6 months in patients who underwent curative ESD for EGC without significant complications.


Subject(s)
Adenocarcinoma/surgery , Endoscopic Mucosal Resection , Quality of Life , Stomach Neoplasms/surgery , Adenocarcinoma/pathology , Aged , Cohort Studies , Female , Humans , Male , Middle Aged , Neoplasm Staging , Prospective Studies , Stomach Neoplasms/pathology , Surveys and Questionnaires
8.
Gut Liver ; 10(5): 739-48, 2016 09 15.
Article in English | MEDLINE | ID: mdl-27172929

ABSTRACT

BACKGROUND/AIMS: Endoscopic submucosal dissection (ESD) is an effective treatment for early gastric cancer (EGC) that has demonstrated a minimal risk of lymph node metastasis in retrospective studies. We sought to prospectively evaluate the short-term outcomes of ESD treatment in EGCs. METHODS: A prospective multicenter cohort study of neoplasms 3 cm or less in diameter at endoscopic size evaluation was performed in 12 Korean ESD study grouprelated university hospitals and the National Cancer Center. Resected specimens were evaluated by the central pathologic review board. RESULTS: A patient cohort (n=712) with a total of 737 EGCs was analyzed. The margin-free en bloc resection rate was 97.3%, and curative resection of 640 lesions (86.8%) was achieved. Lower curative resection rates were associated with lesions 2 to 3 cm in size prior to ESD compared with lesions 2 cm or less in size (78.6% vs 88.1%, respectively, p=0.009). Significant factors associated with noncurative resection were moderately or poorly differentiated histological type, posterior wall tumor location, tumor size larger than 3 cm, ulceration, and submucosal invasion. Delayed bleeding occurred in 49 patients (6.9%), and 12 patients (1.7%) exhibited perforations. CONCLUSIONS: ESD is an effective treatment with a high curative resection rate for EGCs that meets relatively conservative pre-ESD indications. Long-term survival outcomes should be evaluated in followup studies.


Subject(s)
Endoscopic Mucosal Resection/statistics & numerical data , Gastroscopy/statistics & numerical data , Stomach Neoplasms/surgery , Adult , Aged , Early Detection of Cancer , Endoscopic Mucosal Resection/methods , Female , Gastric Mucosa/surgery , Gastroscopy/methods , Humans , Male , Margins of Excision , Middle Aged , Prospective Studies , Stomach Neoplasms/pathology , Treatment Outcome , Tumor Burden
9.
Korean J Gastroenterol ; 67(4): 183-8, 2016 Apr 25.
Article in English | MEDLINE | ID: mdl-27112244

ABSTRACT

BACKGROUND/AIMS: This study evaluated the diagnostic efficacy of fluorine-18 fluorodeoxyglucose PET/CT (F-18 FDG PET/CT) for patients with gastric mucosa-associated lymphoid tissue (MALT) lymphoma and examined the association between FDG avidity and the clinical factors affecting lesions. METHODS: Among the patients diagnosed with gastric MALT lymphoma, 16 who underwent a PET/CT for gastric MALT lymphoma were semi-quantitatively and qualitatively tested for FDG avidity of lesions in the stomach. Retrospectively collected data was analyzed to investigate the clinicoradiological factors and endoscopic findings between the patients with positive F-18 FDG PET/CT scans and those with negative scans. RESULTS: Eight of the 16 patients showed FDG avidity. When comparing the size of lesions in the stomach, the patients with FDG avidity had significantly larger lesions than those without (28.8 mm vs. 15.0 mm, p=0.03). The FDG-avid group has a significantly higher rate of positive CT scans than the non-avid group (75% vs. 13%, p=0.03). According to the endoscopic finding of the lesions, FDG avidity was pronounced with 75% of the protruding tumors, and 100% of the erosive-ulcerative types, which are a type of depressed tumors. CONCLUSIONS: When gastric MALT lymphoma is large, when lesions are found using abdominal CT scans, and the macroscopic appearance of a lesion is that of a protruding tumor or erosive-ulcerative type of depressed tumor, there is a high probability that such patients may have a positive F-18 FDG PET/CT scan.


Subject(s)
Lymphoma, B-Cell, Marginal Zone/diagnosis , Aged , Female , Fluorodeoxyglucose F18/chemistry , Fluorodeoxyglucose F18/metabolism , Gastroscopy , Humans , Lymphoma, B-Cell, Marginal Zone/diagnostic imaging , Male , Middle Aged , Positron Emission Tomography Computed Tomography , Retrospective Studies , Stomach Neoplasms/diagnostic imaging , Stomach Neoplasms/metabolism
10.
Eur J Gastroenterol Hepatol ; 28(5): 546-52, 2016 May.
Article in English | MEDLINE | ID: mdl-26849462

ABSTRACT

OBJECTIVES: This multicenter prospective randomized-controlled study was conducted to examine the effectiveness of second-look endoscopy (SLE) implemented after performing endoscopic submucosal dissection (ESD) of gastric neoplasms and to also examine which clinical and endoscopic elements are risk factors for post-ESD bleeding. PATIENTS AND METHODS: Prospective randomized studies were carried out at two tertiary medical centers. Patients were divided into a group that underwent SLE (n=110) and a group that did not undergo SLE (non-SLE, n=110). The patients' clinical characteristics, endoscopic findings, and pathologic outcomes were analyzed after ESD. RESULTS: The post-ESD bleeding rate was 4.1% and no difference was observed between the SLE group and the non-SLE group. There was no difference in age, sex, drug use, comorbidities, endoscopic findings, pathological findings, or ESD procedure time between the SLE group and the non-SLE group. When the 211 patients who showed no post-ESD bleeding and nine patients who showed post-ESD bleeding were compared with each other, there was no difference in whether they underwent SLE, age, drug use, comorbidities, endoscopic findings, or pathological findings. However, the risk of occurrence of post-ESD bleeding was higher when ulcers in lesions were found (odds ratio: 12.54; P=0.03). CONCLUSION: The SLE group and the non-SLE group did not show any significant difference in post-ESD bleeding ratios among gastric neoplasm patients. It was shown that the risk of occurrence for post-ESD bleeding was higher in cases where there were ulcers in lesions than in cases where there was no ulcer in lesions.


Subject(s)
Dissection/methods , Gastric Mucosa/surgery , Gastroscopy , Second-Look Surgery/methods , Stomach Neoplasms/surgery , Aged , Dissection/adverse effects , Female , Gastric Mucosa/pathology , Gastrointestinal Hemorrhage/etiology , Gastroscopy/adverse effects , Humans , Male , Middle Aged , Odds Ratio , Postoperative Hemorrhage/etiology , Prospective Studies , Republic of Korea , Risk Factors , Second-Look Surgery/adverse effects , Stomach Neoplasms/pathology , Stomach Ulcer/pathology , Stomach Ulcer/surgery , Time Factors , Treatment Outcome
11.
Gastric Cancer ; 19(4): 1104-1113, 2016 Oct.
Article in English | MEDLINE | ID: mdl-26621523

ABSTRACT

BACKGROUND: Discrepancies in the clinicopathologic parameters pre- and post-endoscopic submucosal dissection (ESD) sometimes necessitate additional surgical resection. The aim of this study was to assess such discrepancies in clinicopathologic parameters before and after ESD in the context of reducing the risk of failure of curative ESD. METHODS: Data on 712 early gastric cancer patients were prospectively collected from 12 university hospitals nationwide. The inclusion criteria were differentiated carcinoma <3 cm in size, no ulceration, submucosal invasion <500 µm, and no metastasis. Clinicopathologic factors were compared retrospectively. RESULTS: The discrepancy rate was 20.1 % (148/737) and the most common cause of discrepancy was tumor size (64 cases, 8.7 %). Ulceration, undifferentiated histology, and SM2 invasion were found in 34 (4.6 %), 18 (2.4 %), and 51 cases (6.9 %), respectively. Lymphovascular invasion (LVI) was observed in 34 cases (4.6 %). Cases with lesions exceeding 3 cm in size showed more frequent submucosal invasion, an elevated gross morphology, and upper and middle locations (p < 0.05). In the cases with ulceration, depth of invasion (DOI) was deeper than in the cases without ulceration (p = 0.005). Differentiation was correlated with DOI and LVI (p = 0.021 and 0.007). DOI was correlated with tumor size, ulceration, differentiation, LVI, gross type, and location. There were statistically significant differences between mucosal cancer cases and submucosal cancer cases in tumor size, differentiation, ulceration, LVI, and location. CONCLUSIONS: The overall discrepancy rate was 20.1 %. To reduce this rate, it is necessary to evaluate the DOI very cautiously, because it is correlated with other parameters. In particular, careful checking for SM-invasive cancer is required due to the high incidence of LVI irrespective of the depth of submucosal invasion.


Subject(s)
Adenocarcinoma/pathology , Endoscopic Mucosal Resection , Gastrectomy , Gastric Mucosa/pathology , Stomach Neoplasms/pathology , Adenocarcinoma/surgery , Adult , Aged , Aged, 80 and over , Early Detection of Cancer , Female , Follow-Up Studies , Gastric Mucosa/surgery , Gastroscopy , Humans , Lymph Node Excision , Male , Middle Aged , Neoplasm Invasiveness , Neoplasm Staging , Prognosis , Prospective Studies , Republic of Korea , Stomach Neoplasms/surgery
12.
Gut Liver ; 9(2): 174-80, 2015 Mar.
Article in English | MEDLINE | ID: mdl-25167804

ABSTRACT

BACKGROUND/AIMS: This study was conducted to evaluate whether medical costs can be reduced using endoscopic submucosal dissection (ESD) instead of conventional surger-ies in patients with early gastric cancer (EGC). METHODS: Pa-tients who underwent open gastrectomy (OG), laparoscopy-assisted gastrectomy (LAG), and ESD for EGC were recruited from three medical institutions in 2009. For macro-costing, the medical costs for each patient were derived from the ex-penses incurred during the patient's hospital stay and 1-year follow-up. The overall costs in micro-costing were determined by multiplying the unit cost with the resources used during the patients' hospitalization. RESULTS: A total of 194 patients were included in this study. The hospital stay for ESD was 5 to 8 days and was significantly shorter than the 12-day hospital stay for OG or the 11- to 17-day stay for LAG. Using macro-costing, the average medical costs for ESD during the hospital stay ranged from 2.1 to 3.4 million Korean Won (KRW) per patient, and the medical costs for conventional surgeries were estimated to be between 5.1 million and 8.2 million KRW. There were no significant differences in the 1-year follow-up costs between ESD and conventional surger-ies. CONCLUSIONS: ESD patients had lower medical costs than those patients who had conventional surgeries for EGC with conservative indications. (Gut Liver, 2015;9174-180).


Subject(s)
Costs and Cost Analysis , Dissection/economics , Gastrectomy/economics , Gastroscopy/economics , Stomach Neoplasms/surgery , Dissection/methods , Gastrectomy/methods , Gastric Mucosa/surgery , Gastroscopy/methods , Humans , Laparoscopy , Length of Stay/statistics & numerical data , Republic of Korea , Stomach Neoplasms/pathology
13.
Eur J Gastroenterol Hepatol ; 27(2): 170-4, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25503738

ABSTRACT

OBJECTIVE: Endoscopic resection (ER) plays a major role in the management of early gastric cancer. Less lymph node metastasis (LNM) and better survival rates were reported in early gastric signet ring cell carcinoma (SRC) than adenocarcinoma. We investigated and compared the clinicopathologic characteristics of endoscopic and surgical features in early gastric SRC and adenocarcinoma in accordance with histologic differentiation to examine the feasibility of ER in early gastric SRC. PATIENTS AND METHODS: From January 2003 to September 2011, patients diagnosed with early gastric cancer among patients who had undergone a curative gastrectomy with lymph node dissection were enrolled. Patients' age, sex, tumor size, location, macroscopic type, depth of invasion, lymphovascular invasion (LVI), and LNM were determined. RESULTS: A total of 696 patients were enrolled. SRC was more frequent in women and more common at the mid-body than differentiated adenocarcinoma. SRC was more common in patients younger than 50 years of age (P < 0.001) and the elevated type was less common in SRC than other adenocarcinomas (P < 0.001). The incidence of submucosal invasion, LVI, and LNM in SRC were similar to well-differentiated adenocarcinoma. Moderately and poorly differentiated group, tumor size greater than 20 mm, submucosal invasion, and LVI were independent risk factors predicting LNM. Intramucosal SRC less than 20 mm had no LNM. CONCLUSION: Rate of LNM and submucosal invasion in early SRC was as low as those in early well-differentiated adenocarcinoma. ER for early gastric SRC may be an alternative to surgical gastrectomy under certain conditions.


Subject(s)
Adenocarcinoma/secondary , Carcinoma, Signet Ring Cell/secondary , Stomach Neoplasms/surgery , Adenocarcinoma/pathology , Adenocarcinoma/surgery , Adult , Aged , Carcinoma, Signet Ring Cell/pathology , Carcinoma, Signet Ring Cell/surgery , Feasibility Studies , Female , Gastrectomy , Gastric Mucosa/pathology , Gastroscopy , Humans , Lymph Node Excision , Lymphatic Metastasis , Male , Middle Aged , Neoplasm Invasiveness , Risk Factors , Stomach Neoplasms/pathology
14.
Arch Pharm Res ; 37(10): 1308-16, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24871787

ABSTRACT

Misoprostol is reported to prevent non-steroidal anti-inflammatory drug (NSAID)-associated gastroduodenal complications. There is, however, limited information regarding the efficacy of DA-9601 in this context. We performed a comparative study on the relative efficacy of DA-9601 and misoprostol for prevention of NSAID-associated complications. In this multicenter, double-blinded, active-controlled, stratified randomized, parallel group, non-inferiority trial, 520 patients who were to be treated with an NSAID (aceclofenac, 100 mg, twice daily) over a 4-week period were randomly assigned to groups for coincidental treatment with DA-9601 (60 mg, thrice daily) (236 patients for full analysis) or misoprostol (200 µg, thrice daily) (242 patients for full analysis). [corrected]. The primary endpoint was the gastric protection rate, and secondary endpoints were the duodenal protection rate and ulcer incidence rate. Endpoints were assessed by endoscopy after the 4-week treatment period. Drug-related adverse effects, including gastrointestinal (GI) symptoms, were also compared. At week 4, the gastric protection rates with DA-9601 and misoprostol were 81.4 % (192/236) and 89.3 % (216/242), respectively. The difference between the groups was -14.2 %, indicating non-inferiority of DA-9601 to misoprostol. Adverse event rates were not different between the two groups; however, the total scores for GI symptoms before and after administration were significantly lower in the DA-9601 group than in the misoprostol group (-0.2 ± 2.8 vs 1.2 ± 3.2; p < 0.0001). DA-9601 is as effective as misoprostol in preventing NSAID-associated gastroduodenal complications, and has a superior adverse GI effect profile.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Anti-Ulcer Agents/adverse effects , Misoprostol/therapeutic use , Peptic Ulcer/drug therapy , Plant Extracts/therapeutic use , Adult , Aged , Anti-Ulcer Agents/therapeutic use , Diclofenac/adverse effects , Diclofenac/analogs & derivatives , Diclofenac/therapeutic use , Double-Blind Method , Female , Humans , Middle Aged , Misoprostol/adverse effects , Peptic Ulcer/chemically induced , Plant Extracts/adverse effects , Young Adult
15.
Korean J Hepatol ; 17(3): 183-8, 2011 Sep.
Article in English | MEDLINE | ID: mdl-22102384

ABSTRACT

BACKGROUND/AIMS: The reappearance rates of hepatitis C virus (HCV) RNA after a sustained virological response (SVR) have been reported to be 1-2%. We investigated the reappearance rate of HCV RNA after SVR in chronic hepatitis C (CHC) patients treated with pegylated interferon (PEG-IFN) and ribavirin. METHODS: In total, 292 CHC patients who achieved an SVR after PEG-IFN and ribavirin treatment were included. They were treated with subcutaneous injections of either PEG-IFN-α 2a or 2b plus ribavirin orally. Liver function tests and qualitative HCV RNA assays were performed every 6 months during the follow-up period after an SVR. RESULTS: Among the 292 patients, 224 (genotype 1, 92; genotype non-1, 132) were followed up for more than 6 months after SVR. These 224 patients were aged 48.1±11.5 years (mean±SD), and 129 of them were male. The median follow-up duration was 18 months (range 6-60 months). The reappearance rate of HCV RNA during follow-up was 0%. Two patients who achieved an SVR developed hepatocellular carcinoma during the follow-up period. CONCLUSIONS: An SVR was maintained in all CHC patients treated with PEG-IFN plus ribavirin during a median follow-up of 18 months. However, a screening test for hepatocellular carcinoma is needed for patients with an SVR.


Subject(s)
Antiviral Agents/therapeutic use , Hepatitis C, Chronic/drug therapy , Interferon-alpha/therapeutic use , Polyethylene Glycols/therapeutic use , Ribavirin/therapeutic use , Adult , Drug Therapy, Combination , Female , Follow-Up Studies , Genotype , Humans , Interferon alpha-2 , Liver Function Tests , Male , Middle Aged , RNA, Viral/analysis , Recombinant Proteins/therapeutic use
16.
J Korean Med Sci ; 26(8): 1074-80, 2011 Aug.
Article in English | MEDLINE | ID: mdl-21860559

ABSTRACT

In addition to inhibiting cyclooxygenase and prostaglandin, nonsteroidal anti-inflammatory drugs (NSAIDs) may cause gastroduodenal injuries due to reactive oxygen species produced by recruited inflammatory cells. DA-9601 is a novel antioxidant with anti-inflammatory and cyto-protective effects. This study was conducted to compare the efficacy and safety of DA-9601 with misoprostol for preventing NSAID-associated gastroduodenal injury. In this randomized, double-blind, multicenter, noninferiority trial we compared the extents of protection of gastric and duodenal mucosae by endoscopy after 4 weeks of treatment with DA-9601 60 mg or misoprostol 200 µg three times daily, in subjects with normal baseline endoscopic findings who received an NSAID twice daily for 4 weeks. A total of 266 subjects were randomized to treatment. At week 4, the gastric protection rates with DA-9601 and misoprostol were 85.1% and 95.2%, respectively; the difference between the groups was -10.1% (var = 0.001), which was shown to indicate noninferiority of DA-9601 compared to misoprostol. Adverse events were lower in the DA-9601 group, 56.4% (95% CI, 48.0%-64.8%) than in the misoprostol group, 69.2% (95% CI, 61.3%-77.0%) (P = 0.031). DA-9601 is not inferior to misoprostol for preventing NSAID-associated gastroduodenal injury, and superior to it with respect to treatment-related side effects.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Duodenal Ulcer/prevention & control , Misoprostol/adverse effects , Plant Extracts/adverse effects , Stomach Ulcer/prevention & control , Adolescent , Adult , Double-Blind Method , Duodenal Ulcer/chemically induced , Endoscopy, Gastrointestinal , Female , Gastric Mucosa/drug effects , Humans , Male , Middle Aged , Stomach Ulcer/chemically induced
17.
Korean J Gastroenterol ; 56(1): 33-8, 2010 Jul.
Article in Korean | MEDLINE | ID: mdl-20664316

ABSTRACT

BACKGROUND/AIMS: The standard treatment for chronic hepatitis C infected with hepatitis C virus (HCV) genotype 1 is a combination of pegylated interferon alfa and ribavirin over a 48 weeks period. It is unclear if 24 weeks treatment is possible for patients showing a rapid virological response (RVR) without compromising the sustained virological response (SVR) in Korea. METHODS: Between June 2005 and September 2008, among patients chronically infected with the HCV genotype 1 who were treated with pegylated interferon alfa subcutaneously once weekly plus ribavirin based on body weight, 55 patients who had low pretreatment viral load (<600,000 IU/mL) and RVR were enrolled. A total of 55 patients were divided into 24 weeks treatment group (n=29) and the standard treatment group (n=26). The HCV RNA was quantitatively assessed before treatment, and after 12 weeks of treatment, and also qualitatively assessed after 4 weeks of treatment, at end of treatment (24 weeks), and 24 weeks after end of treatment. RVR was defined as undetectable HCV RNA at the 4 weeks of treatment. RESULTS: Among the 55 patients, SVR was achieved in 100% (29/29) of the patients in 24 weeks treatment and 96.2% (25/26) of the patients in the standard treatment (p=0.473). CONCLUSIONS: HCV genotype 1 infected patients with a low baseline HCV RNA concentration who become HCV RNA negative at week 4 may be treated for 24 weeks without compromising sustained virological response. However, an additional trial will be needed to optimize the treatment duration.


Subject(s)
Antiviral Agents/administration & dosage , Hepacivirus/genetics , Hepatitis C, Chronic/drug therapy , Interferon-alpha/administration & dosage , Polyethylene Glycols/administration & dosage , Ribavirin/administration & dosage , Adult , Aged , Drug Administration Schedule , Drug Therapy, Combination , Female , Genotype , Humans , Interferon alpha-2 , Male , Middle Aged , RNA, Viral/blood , Recombinant Proteins , Viral Load , Viremia/diagnosis
18.
Korean J Hepatol ; 14(3): 318-30, 2008 Sep.
Article in Korean | MEDLINE | ID: mdl-18815455

ABSTRACT

BACKGROUND/AIMS: We assessed the efficacy and safety of pegylated interferon (peginterferon) plus ribavirin and identified the predictors of a sustained virologic response (SVR) in Korean patients with chronic hepatitis C virus infection. METHODS: A total of 192 patients with chronic hepatitis C, treated with both peginterferon (n=141) or conventional interferon (n=51) and ribavirin, were analyzed retrospectively. Peginterferon alfa-2a (180 microgram/week) or -2b (1.5 microgram/kg/week) or interferon alfa-2a (3 MIU thrice weekly) was administered in combination with ribavirin at 1,000-1,200 mg/day for 48 weeks for genotype 1 and at 800 mg/day for 24 weeks for genotypes 2 and 3. RESULTS: The overall SVR rate was 80.9% (114/141) in the peginterferon group and 52.9% (27/51) in the interferon group (P=0.0001). The SVR rate in genotype 1 was 69.5% (41/59) in the peginterferon group and 31.6% (6/19) in the interferon group (P=0.0033), whereas in genotype 2 or 3 it was 89.0% (73/82) in the peginterferon group and 65.6% (21/32) in the interferon group (P=0.0032). The predictors of SVR in the peginterferon group were genotype, absence of cirrhosis, and early virologic response (P<0.05). CONCLUSIONS: In Korean patients with chronic hepatitis C, a regimen of peginterferon and ribavirin was more effective than a regimen of conventional interferon and ribavirin. This result is comparable to those from studies on Western patients as an initial treatment for chronic hepatitis C.


Subject(s)
Antiviral Agents/administration & dosage , Hepatitis C, Chronic/drug therapy , Interferon-alpha/administration & dosage , Polyethylene Glycols/administration & dosage , Ribavirin/administration & dosage , Adult , Data Interpretation, Statistical , Drug Therapy, Combination , Female , Genotype , Hepacivirus/drug effects , Hepacivirus/genetics , Hepatitis C, Chronic/etiology , Humans , Interferon alpha-2 , Korea , Male , Middle Aged , Odds Ratio , RNA, Viral/blood , Recombinant Proteins , Treatment Outcome
19.
Gut Liver ; 2(3): 174-9, 2008 Dec.
Article in English | MEDLINE | ID: mdl-20485643

ABSTRACT

BACKGROUND/AIMS: The aim of this study was to determine whether the margin of early to be detected gastric cancer (EGC) and gastric adenoma is easier to be detected with autofluorescence imaging (AFI) than with white-light endoscopy (WLE). METHODS: A total of 102 lesions (48 EGCs and 54 gastric adenomas) found in 98 patients were removed endoscopically or surgically. The measured length of each pathology specimen was compared with the lengths estimated using WLE, AFI, and chromoendoscopy. RESULTS: The lesions could be discriminated from surrounding mucosa by AFI in 86 cases (84.3%). The detection rates were similar for elevated lesions (85.1%) and flat/depressed lesions (82.9%, p=0.770). In terms of histology, the detection rate was slightly higher for adenomas (90.7%) than for cancer (77.1%, p=0.058). The estimated length was shorter than the pathologic length in 31.4% of cases when using WLE and 22.1% of cases when using AFI (p=0.168). The resection range was larger for EMR than for AFI in 24 of 80 cases (30.0%). CONCLUSIONS: WLE tends to underestimate the size of EGCs, whereas AFI tends to overestimate their size.

20.
Gastrointest Endosc ; 66(4): 693-700, 2007 Oct.
Article in English | MEDLINE | ID: mdl-17905010

ABSTRACT

BACKGROUND: EMR has been accepted as a treatment modality for selected cases of early gastric cancer (EGC) in Japan. However, long-term outcomes after EMR for EGC have not been fully documented. OBJECTIVES: We reviewed the experiences of EMR for EGC in Korea, with emphasis on the long-term outcome. DESIGN: Multicenter, retrospective study. METHODS: Data were collected retrospectively by use of the on-line database registry system. From January 2000 to December 2002, 514 EGCs in 506 patients were treated by EMR in 13 institutions in Korea. Median age of the patients was 60 years (range 45-83 years). The resection was regarded as incomplete if histopathologic examination revealed a positive resection margin or submucosal invasion or positive lymphovascular invasion or undifferentiated histologic diagnosis. RESULTS: The most commonly used technique was circumferential precutting followed by snare resection (EMR-P, n = 269, 52.3%). Complete resection and incomplete resection after EMR were confirmed in 399 lesions (77.6%) and 103 lesions (20.0%), respectively. For completely resected mucosal cancers (n = 399), the median duration of follow-up was 23.5 months (range 5-70 months). In this group, local recurrence was detected in 24 cases (6.0%) with a median interval between EMR and recurrence of 17.9 months (range 3.5-51.7 months). There were 3 cases with perforation and 71 cases with bleeding. No deaths were related to recurrence of gastric cancer during the overall median follow-up period of 39 months. LIMITATIONS: Multicenter retrospective design, no controls. CONCLUSIONS: EMR is an effective therapeutic modality for selected cases of EGC in Korea.


Subject(s)
Endoscopy, Gastrointestinal/methods , Gastrectomy/methods , Gastric Mucosa/surgery , Stomach Neoplasms/surgery , Aged , Aged, 80 and over , Female , Follow-Up Studies , Gastric Mucosa/pathology , Humans , Incidence , Korea/epidemiology , Male , Middle Aged , Neoplasm Recurrence, Local/epidemiology , Neoplasm Staging/methods , Retrospective Studies , Stomach Neoplasms/epidemiology , Stomach Neoplasms/pathology , Time Factors , Treatment Outcome
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