Efficacy and safety of HIP1601 (dual delayed-release esomeprazole) 40 mg in erosive esophagitis compared to HGP1705 (delayed-release esomeprazole) 40 mg: a multicenter, randomized, double-blind, non-inferiority study.

BACKGROUND: Proton-pump inhibitors (PPIs) are the most effective drugs for treating acid-related disorders. However, once-daily dosing with conventional PPIs fail to fully control acid secretion over 24 h. This study aimed to compare the efficacy and safety of HIP1601 (dual delayed-release esomeprazole) and HGP1705 (delayed-release esomeprazole) in patients with erosive esophagitis (EE). METHODS: We enrolled 213 patients with EE randomized in a 1:1 ratio to receive 40 mg HIP1601 (n = 107) or HGP1705 (n = 106) once daily for 4 or 8 weeks. The primary endpoint was the EE healing rate, confirmed by endoscopy up to week 8. GERD-related symptoms and treatment-emergent adverse events were compared between both groups. RESULTS: By week 8, the estimated healing rates of EE were 97.8% and 96.8% in the HIP1601 and HGP1705 groups, respectively, with a 95% confidence interval of -4.7 to 7.2. After 4 or 8 weeks of treatment, the EE healing rate at week 4, complete resolution rate of symptoms, time to sustained resolution of symptoms, and number of rescue medications used were similar in both groups. The proportion of heartburn- and acid regurgitation-free nights by week 4 were higher in the HIP1601 group compared to the HGP1705 group, but the difference did not reach clinical significance (87.7% vs. 85.8%, P = 0.514, 87.5% vs. 85.8%, P = 0.774). The number of adverse events did not differ significantly between the two groups. CONCLUSIONS: The efficacy and safety of HIP1601 40 mg were comparable to those of HGP1705 40 mg for the treatment of EE and symptomatic improvement of GERD. TRIAL REGISTRATION: NCT04080726 ( https://classic. CLINICALTRIALS: gov/ct2/show/NCT04080726 ), registration date: 25/10/2018.

Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study.

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).

Clinical Characteristics and Treatment Outcomes of Cryptogenic Multifocal Ulcerous Stenosing Enteritis in Korea.

BACKGROUND: Cryptogenic multifocal ulcerous stenosing enteritis (CMUSE) is a rare disease that is characterized by multiple, recurring small intestinal ulcers with stenosis of unknown causes. The aim of this study was to investigate the clinical characteristics and the treatment outcomes of patients with CMUSE in Korea. METHODS: We performed a multicenter study to retrospectively analyze clinical data from 20 patients who suffered from CMUSE between 1984 and 2012. Their clinical characteristics and long-term disease courses were investigated. RESULTS: The most common initial symptom of CMUSE was abdominal pain (14/20, 70 %). Small bowel series (13/20, 65 %), double-balloon enteroscopy (12/20, 60 %), CT enterography (12/20, 60 %), and capsule endoscopy (10/20, 50 %) were used to diagnose CMUSE. The strictures of the patients were located in the jejunum (5/20, 25 %), ileum (7/20, 35 %), and both jejunum and ileum (6/20, 30 %). The number of patients in a state of remission, persistent disease, and relapse at the end of follow-up were 13/20 (65 %), 2/20 (10 %), and 5/20 (25 %), respectively. The median relapse-free survival was of 67.1 months. Seventy-five percent relapse-free survivals for female and male patients were 93 and 9 months, respectively (P = 0.031). CONCLUSION: CMUSE is difficult to diagnose and is an easily relapsing disease. Female patients might have a better prognosis than male patients in terms of the relapse-free time.

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.

Comparison of 22-gauge aspiration needle with 22-gauge biopsy needle in endoscopic ultrasonography-guided subepithelial tumor sampling.

OBJECTIVE. Endoscopic ultrasonography (EUS)-guided fine-needle aspiration (EUS-FNA) may facilitate tissue sampling for histopathological diagnosis of subepithelial tumors (SETs) in the gastrointestinal (GI) tract. However, immunohistochemistry is not always feasible using EUS-FNA samples due to the low quality of specimens often obtained by aspiration. This study aimed to compare the use of 22-gauge (G) EUS-guided fine-needle biopsy (EUS-FNB) with 22G EUS-FNA for core sampling used for histopathological examination, including immunohistochemistry, in patients with GI SETs. METHODS. Twenty-eight patients with GI SETs ≥2 cm in size were prospectively enrolled at five university hospitals in Korea between January and June 2013. They were randomized to undergo either EUS-FNB or EUS-FNA. RESULTS. A total of 22 patients was finally analyzed in this study: 10 and 12 patients underwent EUS-FNA and EUS-FNB, respectively. Compared to the EUS-FNA group, the EUS-FNB group had a significantly lower median number of needle passes to obtain macroscopically optimal core samples (4 vs. 2, p = 0.025); higher yield rates of macroscopically and histologically optimal core samples with three needle passes (30% vs. 92%, p = 0.006; 20% vs. 75%, p = 0.010, respectively); and a higher diagnostic sufficiency rate (20% vs. 75%, p = 0.010). No technical difficulties were encountered in either group. CONCLUSIONS. This study shows that EUS-FNB has a better ability to obtain histological core samples and a higher diagnostic sufficiency rate than EUS-FNA and that EUS-FNB is a feasible, safe, and preferable modality for adequate core sampling for histopathological diagnosis of GI SETs.

Endoscopic resection for duodenal carcinoid tumors: a multicenter, retrospective study.

BACKGROUND AND AIM: Gastrointestinal carcinoid tumors < 10 mm in diameter and limited to the submucosal layer demonstrate a low frequency of lymph node and distant metastasis, and are suitable for endoscopic treatment. The aim of this study was to assess the efficacy, safety, and long-term prognosis of endoscopic resections for the treatment of duodenal carcinoid tumors. METHODS: This study included a total of 41 duodenal carcinoid tumors in 38 patients between January 2006 and December 2011. The indications for endoscopic resection were lesions ≤ 10 mm in diameter, confined to the submucosal layer, and without lymph node or distant metastasis. Endoscopic resection was accomplished using endoscopic mucosal resection (EMR), EMR with a ligation device (EMR-L), EMR after circumferential precutting, or endoscopic submucosal dissection (ESD). RESULTS: EMR was performed in 18 tumors, EMR-L in 16, EMR after circumferential precutting in 3, and ESD in 4. En-bloc resection was performed in 39 tumors (95%), and endoscopic complete resection was achieved in 40 (98%); pathological complete resection was achieved in 17 tumors (41%). The endoscopic complete resection rate did not differ according to the resection method, but the pathological complete resection rate was higher for ESD than for EMR and EMR-L. Intraprocedural bleeding was noted in five cases, with no occurrence of perforation. Recurrence was not observed during the mean follow-up period of 17 months (range 1-53 months). CONCLUSION: Endoscopic resection appears to be a safe and effective treatment for duodenal carcinoid tumors measuring ≤ 10 mm in diameter and confined to the submucosal layer.

Portal hypertensive enteropathy diagnosed by capsule endoscopy in cirrhotic patients: a nationwide multicenter study.

BACKGROUND AND AIM: Due to the limited data on portal hypertensive enteropathy (PHE), the prevalence of and clinical factors related to PHE remain unclear. This study determined the prevalence of PHE using capsule endoscopy (CE) and PHE-related clinical factors. METHODS: This was a retrospective multicenter study using the Capsule Endoscopy Nationwide Database Registry. From 2,879 cases that underwent CE, 45 cirrhosis patients with portal hypertension (PH) were enrolled and divided into PHE (n = 18) and non-PHE (n = 27) groups. From computed tomography (CT) images, six secondary changes due to PH were scored to give a total CT score of 0-6. The main outcome variable was the prevalence of PHE and PHE-related clinical factors. RESULTS: The prevalence of PHE was 40 %. Comparing the PHE and non-PHE groups, the most common findings were angiodysplasias in 55.7 % (vs. 7.4 %, p = 0.001) and varices in 38.9 % (vs. 0 %, p = 0.001). Active bleeding was observed in 16.6 and 3.7 %, respectively, but this difference was not significant. In the univariate analysis, Child-Turcotte-Pugh class C (p = 0.002) and a high CT score (≥3 vs. <3, p = 0.004) were significantly associated with PHE. However, only a high CT score was significant in the multivariate analysis (odds ratio 11.19; 95 % confidence interval, 1.59-infinity; p = 0.040). CONCLUSIONS: The prevalence of PHE was 40 %, and it might be more prevalent in cirrhosis patients with PH who have a high CT score. CE is a useful diagnostic tool for evaluating PHE in cirrhosis patients with PH.

The Effect of Tegoprazan on the Treatment of Endoscopic Resection-Induced Artificial Ulcers: A Multicenter, Randomized, Active-Controlled Study.

Background/Aims: : Tegoprazan is a novel potassium-competitive acid blocker that has beneficial effects on acid-related disorders such as gastroesophageal reflux and peptic ulcer diseases. This study aimed to validate the effect of tegoprazan on endoscopic submucosal dissection (ESD)-induced artificial ulcers. Methods: : Patients from 16 centers in Korea who underwent ESD for gastric neoplasia were enrolled. After ESD, pantoprazole was administered intravenously for 48 hours. The patients were randomly allocated to either the tegoprazan or esomeprazole group. Tegoprazan 50 mg or esomeprazole 40 mg were administered for 4 weeks, after which gastroscopic evaluation was performed. If the artificial ulcer had not healed, the same dose of tegoprazan or esomeprazole was administered for an additional 4 weeks, and a gastroscopic evaluation was performed. Results: : One hundred sixty patients were enrolled in this study. The healing rates of artificial ulcers at 4 weeks were 30.3% (23/76) and 22.1% (15/68) in the tegoprazan and esomeprazole groups, respectively (p=0.006). At 8 weeks after ESD, the cumulative ulcer healing rates were 73.7% (56/76) and 77.9% (53/68) in the tegoprazan and esomeprazole groups, respectively (p=0.210). Delayed bleeding occurred in two patients in the tegoprazan group (2.6%) and in one patient in the esomeprazole group (1.5%). Other adverse events were negligible in both groups. Conclusions: : Tegoprazan showed similar effects on post-ESD artificial ulcer healing in comparison with esomeprazole.

Randomised clinical trial: comparison of tegoprazan and lansoprazole as maintenance therapy for healed mild erosive oesophagitis.

BACKGROUND: Tegoprazan is a novel potassium-competitive acid blocker used to treat acid-related disorders. AIM: To compare tegoprazan 25 mg with lansoprazole 15 mg as maintenance therapy in healed erosive oesophagitis (EE) METHODS: In this phase 3, double-blind, multi-centre study, patients with endoscopically confirmed healed EE were randomised 1:1 to receive tegoprazan 25 mg or lansoprazole 15 mg once daily for up to 24 weeks. The primary efficacy endpoint was the endoscopic remission rate after 24 weeks. The secondary efficacy endpoint was the endoscopic remission rate after 12 weeks. Safety endpoints included adverse events, clinical laboratory results and serum gastrin and pepsinogen I/II levels. RESULTS: We randomised patients to tegoprazan 25 mg (n = 174) or lansoprazole 15 mg (n = 177). Most had mild EE (Los Angeles (LA) grade A: 57.3%, LA grade B: 37.3%). The endoscopic remission rate after 24 weeks was 90.6% with tegoprazan and 89.5% with lansoprazole. Tegoprazan was not inferior to lansoprazole for maintaining endoscopic remission at 24 weeks and 12 weeks. In subgroup analysis, tegoprazan 25 mg showed no significant difference in maintenance rate according to LA grade (p = 0.47). The maintenance effect of tegoprazan was consistent in CYP2C19 extensive metabolisers (p = 0.76). Increases in serum gastrin were not higher in tegoprazan-treated than lansoprazole-treated patients. CONCLUSIONS: Tegoprazan 25 mg was non-inferior to lansoprazole 15 mg in maintenance of healing of mild EE. In this study, tegoprazan had a similar safety profile to lansoprazole.

Outcome of Endoscopic Ultrasound-Guided Sampling of Mediastinal Lymphadenopathy.

Methods: From May 2006 to January 2017, patients with mediastinal lymphadenopathy, who received an EUS-guided trucut biopsy or an FNA biopsy, were retrospectively reviewed. Demographic data, endosonographic characteristics of LNs including size, shape, border, echotexture, and echogenicity, diagnostic yield, and adverse events between the trucut needle group and aspiration needle group were compared. Results: A total of 69 patients (trucut group, n = 33 vs. aspiration group, n = 36) were identified. There were no significant differences in demographic data, indication for an EUS-guided biopsy, location of LNs, number of needle passes, and endosonographic features of LNs between the two groups. The sizes of LNs were larger in the trucut group than in the aspiration group (28.9 ± 14.0 mm vs. 21.1 ± 8.8 mm, P = 0.007). However, there was no significant difference in the ratio of LNs that were ≥10 mm in both groups. The overall accuracy of the EUS-guided biopsy for the diagnosis of malignant lesions was 79.7% (55/69). There were no significant differences in the histological diagnostic yield of malignant LNs between the two groups. There were no significant procedure-related adverse events in both groups. Conclusion: The EUS-guided biopsy can be a useful method for histologic evaluation of mediastinal nodal lesions.

[Usefulness of Stool Multiplex Polymerase Chain Reaction Assays in Patients with Acute Diarrhea].

Background/Aims: There is a recent increase in the use of stool multiplex PCR assay-based diagnostic tests in patients with acute diarrhea. We used multiplex PCR assays to analyze the distribution of diarrhea-causing bacteria and viruses, as well as the clinical features of patients with acute diarrhea. Methods: We retrospectively reviewed stool specimens of inpatients complaining of acute diarrhea from October 2018 to July 2020. The stool specimens had been tested for bacteria and viruses using multiplex PCR assays. Results: A total of 414 stool specimens from 346 patients were tested, and 152 pathogens were detected in 131 stool samples (131/414, 31.6%). Co-infection was detected in 20 patients (20/346, 5.8%). The common pathogens detected as causes of acute diarrhea, including co-infection, were Clostridium perfringens (34.9%), Clostridioides difficile (19.7%), and Campylobacter spp. (18.4%). The average age of patients with multiplex PCR-positive tests was lower than those with multiplex PCR-negative tests (p=0.001). In patients with suspected C. difficile infection (CDI), the RT-PCR for toxin gene assay was performed in 370 stool samples, 35 of which were positive (9.5%). Furthermore, 16 of the 35 samples were positive on the multiplex PCR assay (45.7%). Conclusions: The multiplex PCR assay revealed that C. perfringens was the most common diarrhea-causing pathogen. In addition, in patients with suspected CDI, the multiplex PCR assay alone was insufficiently sensitive to detect pathogens and a conventional CDI test was additionally required.

Comparison of Two Types of 1-L Polyethylene Glycol-ascorbic Acid as Colonoscopic Bowel Preparation: A Prospective Randomized Study.

Background/Aims: Recently, 1-L polyethylene glycol-ascorbic acid (PEG-Asc) has been used to reduce the volume of preparation agents in colonoscopy. This clinical trial aimed to compare the efficacy and safety of two types of 1-L PEG-Asc (CleanViewAL® [Tae Joon Pharmaceutical Company, Seoul, Korea] and Plenvu® [Norgine, Harefield, United Kingdom]) in average-aged adults. Methods: This study was a prospective, randomized, non-inferiority, open-label, phase 4 clinical trial. The primary endpoint was the efficacy evaluated using the Boston bowel preparation scale (BBPS), and the secondary endpoint was clinical safety. Results: In total, 173 patients were assigned to either the CleanViewAL® (n=84) or Plenvu® (n=89) group. Overall cleansing successes of 97.6% (82/84) and 98.8% (88/89) were achieved in the CleanViewAL® group and in the Plenvu® group, respectively, showing that CleanViewAL® has similar bowel cleansing efficacy to Plenvu® (95% CI, -0.052 to 0.027; p=0.207). The total BBPS score was 8.67±1.00 and 8.70±0.76 in the CleanViewAL® group and Plenvu® group, respectively (p=0.869). The most common adverse symptom was nausea, and no adverse symptoms requiring hospitalization were reported in either group. There were no cases of critical hypernatremia and liver dysfunction exceeding the common terminology criteria for adverse events grade I. An overall satisfaction score (scale of 1 to 10) showed no difference between the two groups (p=0.289). However, the CleanViewAL® group showed a higher taste satisfaction score (scale of 1 to 5) than the Plenvu® group (CleanViewAL®: 2.90±0.91, Plenvu®: 2.60±0.86, p=0.028). Conclusions: Both types of 1-L PEG-Asc, CleanViewAL® and Plenvu®, are effective and safe bowel cleansing agents in average-aged adults. CleanViewAL® was preferred in terms of taste satisfaction.

Evaluation of nutritional status using bioelectrical impedance analysis in patients with inflammatory bowel disease.

BACKGROUND/AIMS: Nutritional status influences quality of life among patients with inflammatory bowel disease (IBD), although there is no clear method to evaluate nutritional status in this setting. Therefore, this study examined whether bioelectrical impedance analysis (BIA) could be used to evaluate the nutritional status of patients with IBD. METHODS: We retrospectively analyzed data from 139 Korean patients with IBD who were treated between November 2018 and November 2019. Patients were categorized as having active or inactive IBD based on the Harvey-Bradshaw index (a score of ≥5 indicates active Crohn's disease) and the partial Mayo scoring index (a score of ≥2 indicates active ulcerative colitis). BIA results and serum nutritional markers were analyzed according to disease activity. RESULTS: The mean patient age was 45.11±17.71 years. The study included 47 patients with ulcerative colitis and 92 patients with Crohn's disease. Relative to the group with active disease (n=72), the group with inactive disease (n=67) had significantly higher values for hemoglobin (P<0.001), total protein (P<0.001), and albumin (P<0.001). Furthermore, the group with inactive disease had higher BIA values for body moisture (P=0.047), muscle mass (P=0.046), skeletal muscle mass (P=0.042), body mass index (P=0.027), and mineral content (P=0.034). Moreover, the serum nutritional markers were positively correlated with the BIA results. CONCLUSIONS: Nutritional markers evaluated using BIA were correlated with serum nutritional markers and inversely correlated with disease activity. Therefore, we suggest that BIA may be a useful tool that can help existing nutritional tests monitor the nutritional status of IBD patients.

Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Helicobacter pylori Infection: A Randomized, Double-Blind, Phase III, Clinical Trial.

Background/Aims: We examined the efficacy and safety of tegoprazan as a part of first-line triple therapy for Helicobacter pylori eradication. Methods: A randomized, double-blind, controlled, multicenter study was performed to evaluate whether tegoprazan (50 mg)-based triple therapy (TPZ) was noninferior to lansoprazole (30 mg)- based triple therapy (LPZ) (with amoxicillin 1 g and clarithromycin 500 mg; all administered twice daily for 7 days) for treating H. pylori. The primary endpoint was the H. pylori eradication rate. Subgroup analyses were performed according to the cytochrome P450 (CYP) 2C19 genotype, the minimum inhibitory concentration (MIC) of amoxicillin and clarithromycin, and underlying gastric diseases. Results: In total, 350 H. pylori-positive patients were randomly allocated to the TPZ or LPZ group. The H. pylori eradication rates in the TPZ and LPZ groups were 62.86% (110/175) and 60.57% (106/175) in an intention-to-treat analysis and 69.33% (104/150) and 67.33% (101/150) in a per-protocol analysis (non-inferiority test, p=0.009 and p=0.013), respectively. Subgroup analyses according to MICs or CYP2C19 did not show remarkable differences in eradication rate. Both first-line triple therapies were well-tolerated with no notable differences. Conclusions: TPZ is as effective as proton pump inhibitor-based triple therapy and is as safe as first-line H. pylori eradication therapy but does not overcome the clarithromycin resistance of H. pylori in Korea (ClinicalTrials.gov identifier NCT03317223).

Retreatment of Chronic Hepatitis C Failed to Daclatasvir Plus Asunaprevir by Other Direct-acting Antivirals.

The pegylated interferon plus ribavirin combination therapy has been used as the primary treatment for chronic hepatitis C (CHC) but fails to produce a sustained viral response (SVR) in many patients. In recent years, the treatment of CHC has been rapidly changing because of the introduction of direct-acting antivirals (DAAs), which have a high cure rate. However, retreatment of patients after failure of the first DAA therapy is difficult. We report two rare cases of CHC that showed acquired SVR with other DAA combinations after failure to daclatasvir and asunaprevir.

Successful Medical Treatment for Peritonitis Resulting from a Large Pyogenic Liver Abscess Rupture.

The rupture of a pyogenic liver abscess (PLA) with peritonitis is a rare occurrence but a surgical emergency with a high mortality rate in the case of gas-forming PLA. Rare cases of ruptured PLA that recovered completely with only medical treatment have been reported. This paper reports a case of a large PLA rupture with peritonitis. In this case, surgical intervention was too risky because of the patient's age and poor general condition. The patient recovered fully with appropriate antibiotic therapy and sufficient percutaneous drainage. Therefore, medical treatment may be considered an alternative option in cases of a ruptured large PLA with peritonitis if surgical intervention is too risky.

Predictive Factors for Differentiating Gastrointestinal Stromal Tumors from Leiomyomas Based on Endoscopic Ultrasonography Findings in Patients with Gastric Subepithelial Tumors: A Multicenter Retrospective Study.

BACKGROUND/AIMS: The utility of endoscopic ultrasonography (EUS) for differentiating gastrointestinal stromal tumors (GISTs) and leiomyomas of the stomach is not well known. We aimed to evaluate the ability of EUS for differentiating gastric GISTs and leiomyomas. METHODS: We retrospectively reviewed the medical records of patients with histopathologically proven GISTs (n=274) and leiomyomas (n=87). In two consensus meetings, the inter-observer variability in the EUS image analysis was reduced. Using logistic regression analyses, we selected predictive factors and constructed a predictive model and nomogram for differentiating GISTs from leiomyomas. A receiver operating characteristic (ROC) curve analysis was performed to measure the discrimination performance in the development and internal validation sets. RESULTS: Multivariate analysis identified heterogeneity (odds ratio [OR], 9.48), non-cardia (OR, 19.11), and older age (OR, 1.06) as independent predictors of GISTs. The areas under the ROC curve of the predictive model using age, sex, and four EUS factors (homogeneity, location, anechoic spaces, and dimpling or ulcer) were 0.916 (sensitivity, 0.908; specificity, 0.793) and 0.904 (sensitivity, 0.908; specificity, 0.782) in the development and internal validation sets, respectively. CONCLUSION: The predictive model and nomogram using age, sex and homogeneity, tumor location, presence of anechoic spaces, and presence of dimpling or ulcer on EUS may facilitate differentiation between GISTs and leiomyomas.

Inter-observer agreement on the interpretation of capsule endoscopy findings based on capsule endoscopy structured terminology: a multicenter study by the Korean Gut Image Study Group.

OBJECTIVE: Capsule endoscopy (CE) is a novel investigation for the diagnosis of small-bowel disease but its interpretation is highly subjective. We studied the inter-observer agreement and accuracy of the interpretation of CE findings based on capsule endoscopy structured terminology (CEST). MATERIAL AND METHODS: Fifty-six CE video clips were collected from eight university hospitals in South Korea and were independently reviewed by 13 gastroenterology experts and 10 trainees. All investigators recorded their findings based on CEST. To determine the accuracy of individual viewers, we defined the 'gold standard' as a joint review by four experts. RESULTS: The 56 CE video clips included five normal cases, 19 cases of protruding lesions, 21 cases of depressed lesions, three cases of flat lesions, one case of abnormal mucosa, six cases with blood in the lumen, and one case of stenotic lumen. The overall mean accuracies for the experts and trainees were 74.3% +/- 22.6% and 61.7% +/- 25.4%, respectively. The overall accuracy for the trainee group was significantly lower than that for the expert group (P < 0.001), especially in normal, tumor, venous structure, and ulcer cases. The accuracies of the two groups varied with the CE findings. The accuracies were higher in cases with more prominent intraluminal changes (e.g. active small-bowel bleeding, ulcer, tumor, stenotic lumen). In contrast, subtle mucosal lesions, such as erosion, angioectasia, and diverticulum, had lower accuracies. The mean kappa values for the experts and trainees were 0.61 (range 0.39-0.97) and 0.46 (range 0.17-0.66), respectively. CONCLUSIONS: Our results showed that there was substantial agreement between experts and moderate agreement between trainees. In order to achieve higher accuracies and better inter-observer agreement, we need not only more experience with CE but also consensus regarding CEST terminology.

Capsule endoscopy in small bowel tumors: a multicenter Korean study.

BACKGROUND AND AIM: Capsule endoscopy (CE) has proven to be highly effective at detecting small bowel lesions in a variety of clinical conditions, but studies concerning the practical impact of CE on small bowel tumors are still scarce, especially in the Asian population. The aim of this study was to evaluate the diagnostic and therapeutic impact of CE in the field of small bowel tumors. METHODS: CE records consecutively pooled from the beginning of use of CE in Korea, October 2001 until April 2008, in 14 centers throughout Korea were reviewed. Clinical information and CE video images of small bowel tumors were analyzed. RESULTS: A total of 1332 cases undergoing CE were reviewed with all clinical indications. Small bowel tumors were diagnosed with CE in 57 (4.3%) of 1332 patients. The tumors were malignant in 33 cases, and included three adenocarcinomas, eight lymphomas, 20 gastrointestinal stromal tumors, and two metastatic cancers. The most frequent indications for CE in malignant tumors were obscure gastrointestinal bleeding, followed by abdominal pain and weight loss. Thirty of 57 tumors were identified exclusively by CE (diagnostic impact = 30/57), and they were smaller in size (mean, range: 14.3 mm, 2-35 mm) compared to the other tumors detected in radiological studies (48.7 mm, 10-110 mm). Seven patients underwent surgical resection (therapeutic impact = 7/57). CONCLUSION: CE effectively identifies small bowel tumors that are undetectable by conventional radiological studies (diagnostic impact = 52.6%) and can critically change the therapeutic course (therapeutic impact = 12.3%).