Jong Pil Im

Comparison of endoscopic ultrasonography and conventional endoscopy for prediction of depth of tumor invasion in early gastric cancer

BACKGROUND AND STUDY AIMS This study aimed to compare the diagnostic accuracy of endoscopic ultrasonography (EUS) with that of conventional endoscopy for staging depth of invasion (T staging) in early gastric cancer. PATIENTS AND METHODS A total of 955 patients with suspected early gastric cancer were prospectively registered. EUS staging was carried out prospectively by a single endoscopist using either miniprobe or radial EUS depending on the endoscopic appearance of the tumor. Conventional endoscopy staging was performed retrospectively by consensus between two endoscopists who were blinded to the EUS staging. Conventional endoscopy staging was conducted on the basis of endoscopic features such as surface nodularity and fold convergence. Patients underwent either surgical (n = 586) or endoscopic resection (n = 369) with curative intent. The staging accuracy of each test was compared with the pathological staging of the resected specimen. RESULTS The presence of a T1m tumor was histologically confirmed in 644 cases (67.4 %) and that of a T1sm tumor in 311 cases (32.6 %). The overall accuracy of EUS staging was 67.4 % (644 / 955) and that of conventional endoscopy staging was 73.7 % (704 / 955) ( P < 0.001). The accuracy of miniprobe EUS was significantly higher than that of radial EUS (79.5 % vs. 59.6 %, P < 0.001), but did not differ significantly from that of conventional endoscopy (79.0 %). CONCLUSIONS EUS does not substantially impact on pretreatment T staging of patients with early gastric cancer compared with conventional endoscopy. Therefore, EUS may not be necessary routinely, and conventional endoscopy may be sufficient for determining the optimal therapeutic strategy, especially in relation to endoscopic resection for early gastric cancer.

Eradication of Helicobacter pylori After Endoscopic Resection of Gastric Tumors Does Not Reduce Incidence of Metachronous Gastric Carcinoma

BACKGROUND & AIMS It is not clear whether eradication of Helicobacter pylori infection reduces the risk for metachronous gastric carcinoma. We performed a prospective, randomized, open-label trial of the effects of H pylori eradication on the incidence of metachronous carcinoma after endoscopic resection of gastric tumors. METHODS From April 2005 through February 2011 there were 901 consecutive patients with H pylori infection who had been treated with endoscopic resection for gastric dysplasia or cancer and who were assigned randomly to groups given therapy to eradicate the infection (n = 444) or no therapy (controls, n = 457). The eradication group received 20 mg omeprazole, 1 g amoxicillin, and 500 mg clarithromycin twice daily for 1 week. Patients underwent endoscopic examination 3, 6, and 12 months after treatment, and then yearly thereafter. The primary outcome was development of metachronous gastric carcinoma. RESULTS During a median follow-up period of 3 years, 10 patients who received H pylori eradication and 17 controls developed metachronous carcinoma; this difference was not significant (P = .15). The incidence of metachronous carcinoma between the 2 groups did not differ significantly at 1, 2, 3, and 4 years after administration of the therapy. There were no significant differences in the development of metachronous carcinoma among patients who were positive (n = 16) or negative (n = 11) for H pylori infection (P = .32). CONCLUSIONS In this prospective trial, eradication of H pylori after endoscopic resection of gastric tumors did not significantly reduce the incidence of metachronous gastric carcinoma. ClinicalTrials.gov Number: NCT01510730.

Diagnostic accuracy of T and N stages with endoscopy, stomach protocol CT, and endoscopic ultrasonography in early gastric cancer

Preoperative accurate diagnosis of the T and N stages in early gastric cancer (EGC) is important in determining the application of various limited treatments. The aim of this study is to analyze the accuracy of T and N staging of EGC with esophagogastroduodenoscopy (EGD), Stomach protocol CT (S‐CT), and endoscopic ultrasonography (EUS), and the factors influencing the accuracy.

Endoscopic prediction of tumor invasion depth in early gastric cancer.

BACKGROUND Although conventional endoscopy is a good diagnostic tool to evaluate tumor depth (T staging) in early gastric cancer (EGC), its accuracy has not been determined and no consensus has been reached regarding standard endoscopic criteria. OBJECTIVE To evaluate the diagnostic accuracy of endoscopic T staging and to identify the characteristic endoscopic features for mucosal (T1m) and submucosal (T1sm) tumors. DESIGN Retrospective study. PATIENTS A consecutive 2105 patients with EGC who underwent either surgical (n=1624) or endoscopic (n=481) resection. INTERVENTION Endoscopic staging was performed by consensus of 2 endoscopists based on the characteristic endoscopic criteria of T1m (smooth surface protrusion or depression, slight marginal elevation, and the smooth tapering of converging folds) and T1sm (irregular surface, marked marginal elevation, and clubbing/abrupt cutting/fusion of converging folds). The endoscopic staging was compared with the pathologic staging of the resected specimen. RESULTS The overall accuracy of endoscopic staging was 78.0% (1642/2105). The sensitivity, specificity, and positive and negative predictive values of T1m endoscopic staging were 85.5%, 73.9%, 82.0%, and 78.5%, whereas those for T1sm were 72.6%, 81.9%, 71.9%, and 82.4%, respectively. LIMITATIONS Retrospective study. Endoscopic predictions for T1sm tumors were correct in only 72% of cases. CONCLUSIONS Conventional endoscopy was found to provide reliable accuracy for T staging in EGC and may be an effective method for assessing penetration depth. A detailed endoscopic evaluation regarding tumor base, margin, and converging folds may provide useful information to determine tumor depth and to select the optimal therapeutic strategy, particularly for endoscopic resection.

Effect of Probiotics on Symptoms in Korean Adults with Irritable Bowel Syndrome

Background/Aims Irritable bowel syndrome (IBS) is a troublesome disease. Some strains of probiotics reportedly exert remarkable immunomodulatory effects, and so we designed a prospective double-blind randomized placebo-controlled clinical study to assess their effects in Korean adults with IBS. Methods IBS patients who met Rome III criteria were randomly assigned to receive composite probiotics or placebo. A total of 20 billion lyophilized bacteria were administered twice daily for 8 weeks. Primary outcome variables were symptom scores consisting of abdominal pain, flatulence, defecation discomfort, and sum of symptom scores. A visual analogue scale was used to quantify the severity. Secondary outcome variables consisted of the quality of life and bowel habits including defecation frequency and stool form. Results Thirty-six and 34 patients were randomized to the probiotics and placebo groups, respectively. Intention-to-treat analysis showed significant reductions in pain after 8 weeks of treatment: -31.9 and -17.7 in the probiotics and placebo groups, respectively (p=0.045). The reductions in abdominal pain, defecation discomfort, and sum of scores were more significant in 58 patients with a score of at least 3 on the baseline stool-form scale. Conclusions Composite probiotics containing Bifidobacterium bifidum BGN4, Lactobacillus acidophilus AD031, and other species are safe and effective, especially in patients who excrete normal or loose stools.

Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea

Objective: To evaluate the safety and efficacy of CT-P13 (Remsima®) in patients with inflammatory bowel disease (IBD) in South Korea. Methods: This post-marketing study included patients with active moderate-to-severe Crohn’s disease (CD), fistulizing CD (FCD), or moderate-to-severe ulcerative colitis (UC) treated with CT-P13 and followed for 30 weeks. Assessments included treatment-emergent adverse events (TEAEs) and disease-specific clinical response and remission. Results: No unexpected TEAEs were observed in the 173 patients recruited to date. TEAEs occurred in 18.1, 16.7, and 26.9% of CD, FCD, and UC patients, respectively. Treatment-related TEAEs occurred in 10% of patients and were mostly mild-moderate in severity. There were five serious TEAEs (two infusion-related reactions, two infections, one abdominal pain) and no cases of malignancy, pneumonia, or death. Positive outcomes for response/remission were reported regardless of whether patients had received prior infliximab or not. Conclusion: CT-P13 was well tolerated and efficacious in patients with IBD.

Efficacy, safety, and predictors of response to infliximab therapy for ulcerative colitis: A Korean multicenter retrospective study

Infliximab is currently used for the treatment of moderate‐to‐severe ulcerative colitis (UC) with an inadequate response to conventional agents. The efficacy and safety of infliximab in Korean patients with UC were assessed.

Do antiplatelets increase the risk of bleeding after endoscopic submucosal dissection of gastric neoplasms

BACKGROUND It is rarely known whether antiplatelets increase the risk of bleeding after endoscopic submucosal dissection (ESD). OBJECTIVE To evaluate the effect of antiplatelets on post-ESD bleeding. DESIGN Retrospective study. SETTING Single, tertiary-care referral center. PATIENTS This study involved 1591 gastric neoplasms (815 adenomas and 776 early gastric cancers) in 1503 patients who had ESD between April 2005 and April 2010. INTERVENTION ESD. MAIN OUTCOME MEASUREMENTS Overt hematemesis/hematochezia, a drop of hemoglobin >2 g/dL from baseline, or requirement of endoscopic hemostasis, angiographic embolization, and/or transfusion. RESULTS Of 1591 subjects, 274 took antiplatelets, among whom 102 discontinued them for 7 days or more before ESD. Post-ESD bleeding occurred in 94 subjects including 20 from the continuation group, 6 from the withdrawal group, and 68 from the no-antiplatelet group. In univariate analysis, antiplatelets, early gastric cancer (EGC), comorbidity, and specimen diameter were related to post-ESD bleeding. In multivariate analysis, EGC (odds ratio [OR] 1.839; 95% confidence interval [CI], 1.168-2.896; P = .009), comorbidity (OR 2.246; 95% CI, 1.280-3.939; P = .005), and specimen diameter (OR 2.315; 95% CI, 1.282-4.180; P = .005) were independent risk factors of post-ESD bleeding, whereas antiplatelet usage was not (OR 1.596; 95% CI, 0.877-2.903; P = .126). In subgroup analysis, continuous antiplatelet usage was not found to be an independent risk factor of post-ESD bleeding in multivariate analysis (OR 2.027; P = .146). Among 102 subjects who discontinued antiplatelets, 1 developed an acute cerebral infarction (1.0%). LIMITATION A retrospective, single-center analysis. CONCLUSION In ESD for antiplatelet users, continuous administration was not found to have an independent significant association with bleeding.

Long-term outcome of capsule endoscopy in obscure gastrointestinal bleeding: A nationwide analysis

BACKGROUND AND STUDY AIMS The clinical impact of video capsule endoscopy (VCE) in patients with obscure gastrointestinal bleeding (OGIB) remains undetermined. The aim of this study was to evaluate the long-term clinical impact of VCE in patients with OGIB using a nationwide registry. PATIENTS AND METHODS Data from 305 patients who underwent VCE for OGIB from 13 hospitals in Korea between January 2006 and March 2009 were analyzed. Prospectively collected VCE registry data were reviewed, and follow-up data were collected by chart review and telephone interviews with patients. Multivariate regression analyses using hazard ratios (HR) were performed to determine risk factors for rebleeding. RESULTS Significant findings were detected in 157 patients (51.5%). After VCE, interventional treatment was performed in 36 patients (11.8%). The overall rebleeding rate was 19.0% during a mean (±SD) follow-up of 38.7±26.4 months. Rebleeding rate did not differ by positive VCE results or application of interventional treatment. Multivariate analysis revealed that angiodysplasia (HR 1.82; 95% confidence interval [CI] 1.04-3.20; P=0.037) and duration of OGIB >3 months (HR 1.64; 95%CI 1.10-2.46; P=0.016) were independent prognostic factors associated with rebleeding. In a subgroup analysis of patients taking anticoagulants, patients who discontinued drugs after VCE showed a lower rebleeding rate than those who did not discontinue this therapy (P=0.019). CONCLUSIONS VCE did not have a significant impact on the long-term outcome of patients with OGIB. Patients with angiodysplasia on VCE or OGIB>3 months need to be closely followed even after interventional treatment. In patients who are taking anticoagulants, discontinuation of drugs is necessary in order to lower the risk of rebleeding.

Efficacy of infliximab in intestinal Behçet's disease: A Korean multicenter retrospective study

Background:Although infliximab is widely accepted as a therapeutic option for inflammatory bowel disease, its therapeutic efficacy for the treatment of intestinal Behçet’s disease (BD) is unknown. We investigated the short-term and long-term response rates to infliximab in intestinal BD and predictive factors of sustained treatment response following infliximab treatment. Methods:This study was conducted using a retrospective noncontrolled review of medical records from 8 tertiary hospitals in Korea. We collected clinical, demographic, and laboratory data for patients with 28 patients with intestinal BD who received at least 1 dose of infliximab. Response rates of infliximab at 2, 4, 30, and 54 weeks for each patient and factors predictive of sustained response were investigated. Adverse events were also identified. Results:The median duration of follow-up after initial infliximab infusion was of 29.5 months. The clinical response rates at 2, 4, 30, and 54 weeks were 75%, 64.3%, 50%, and 39.1%, respectively, with clinical remission rates of 32.1%, 28.6%, 46.2%, and 39.1%, respectively. After multivariate analysis, older age at diagnosis (≥40 yr), female sex, a longer disease duration (≥5 yr), concomitant immunomodulator use, and achievement of remission at week 4 were found to be predictive factors of sustained response. There was 1 serious infection but no malignancies or deaths in this study. Conclusions:Infliximab was a well-tolerated and effective therapy for patients with moderate-to-severe intestinal BD. Moreover, we found 5 predictive factors associated with sustained response, which might assist in optimal patient selection for infliximab treatment.