Comparison of different types of covered self-expandable metal stents for malignant colorectal obstruction.

BACKGROUND: Stent migration is one of the main drawbacks of covered self-expandable metal stent (SEMSs), occurring in up to 40% of malignant colorectal obstruction management cases. Various types of covered SEMSs have been developed to reduce this risk. We aimed to compare the effectiveness and complication rates of the flare-type covered SEMS (Flare) with those of the double-layered covered SEMS (ComVi). METHODS: We performed a prospective, randomized study in four tertiary referral centers between July 2016 and April 2018. Patients with malignant colorectal obstruction were eligible for the study. The primary outcome was migration rate as observed within the first month. Rates of technical success, clinical success, and complications within the first month were also assessed. RESULTS: A total of 60 patients were included (mean age, 70.5 ± 12.5 years; male, 31 [51.7%]). Flare and ComVi stents were applied in 30 patients each. The Flare and ComVi groups showed comparable technical success rates (90% [27/30] vs. 96.7% [29/30], p = 0.605) and clinical success rates (85.2% [23/27] vs. 75.9% [22/29], p = 0.589). Migration occurred in three (11.1%) and four (13.8%) cases in the Flare and ComVi groups, respectively, without significant difference (p = 0.99), and the risk of other complications, including perforation and re-obstruction, did not differ between the two groups. CONCLUSIONS: Our study indicates that both flare-shape and double-layered covered SEMSs are equally effective options for the management of malignant colorectal obstruction with low migration rates when compared with previously reported migration risk of covered SEMS.

Comparison of scoring systems for nonvariceal upper gastrointestinal bleeding: a multicenter prospective cohort study.

BACKGROUND AND AIM: The Glasgow-Blatchford score (GBS) and Rockall score (RS) are widely used to assess risk in patients with upper gastrointestinal bleeding (UGIB). We compared both scoring systems and evaluated their clinical usefulness. METHODS: Between February 2011 and December 2013, 1584 patients with nonvariceal UGIB were included in the study. A prospective study was conducted to compare the performance of the GBS, pre-RS, and full RS. We compared the performance of these scores using receiver operating characteristic curves. RESULTS: For prediction of the need for hospital-based intervention, the GBS was similar to the full RS (area under the receiver operating characteristic curves [AUROC] 0.705 vs 0.727; P = 0.282) and superior to the pre-RS (AUROC 0.705 vs 0.601; P < 0.0001). In predicting death, the full RS was superior to the GBS (AUROC 0.758 vs 0.644; P = 0.0006) and similar to the pre-RS (AUROC 0.758 vs 0.754; P = 0.869). In predicting rebleeding, the full RS was superior to both GBS (AUROC 0.642 vs 0.585; P = 0.031) and pre-RS (AUROC 0.642 vs 0.593; P = 0.0003). Of 1584 patients, 13 (0.8%) scored 0 on the GBS. Therapeutic intervention was not performed in any of these patients. CONCLUSIONS: The GBS is more useful than the pre-RS for predicting the need for hospital-based intervention. A cutoff value of 0 for low-risk patients who might be suitable for outpatient management is useful. The full RS is helpful in predicting death. None of the systems accurately predict rebleeding with a low AUROC. ( CLINICAL TRIAL: cris.nih.go.kr/KCT0000514).

Risk Factors Associated with Rebleeding in Patients with High Risk Peptic Ulcer Bleeding: Focusing on the Role of Second Look Endoscopy.

BACKGROUND: Re-bleeding after initial hemostasis in peptic ulcer bleeding can be life threatening. Identification of factors associated with re-bleeding is important. The aims of this study were to determine incidence of rebleeding in patients with high risk peptic ulcer bleeding and to evaluate factors associated with rebleeding. METHODS: Among patients diagnosed as upper gastrointestinal hemorrhage at seven hospitals in Daegu-Gyeongbuk, and one hospital in Gyeongnam, South Korea, from Feb 2011 to Dec 2013, 699 patients diagnosed as high risk peptic ulcer bleeding with Forrest classification above llb were included. The data were obtained in a prospective manner. RESULTS: Among 699 patients, re-bleeding occurred in 64 (9.2 %) patients. Second look endoscopy was significantly more performed in the non-rebleeding group than the rebleeding group (81.8 vs 62.5 %, p < 0.001). In multivariate analysis, use of non-steroidal anti-inflammatory agents, larger transfusion volume (≥5 units), and non-performance of second look endoscopy were found as risk factors for rebleeding in high risk peptic ulcer bleeding. CONCLUSION: In our study, rebleeding was observed in 9.2 % of patients with high risk peptic ulcer bleeding. Performance of second look endoscopy seems to lower the risk of rebleeding in high risk peptic ulcer bleeding patients and caution should be paid to patients receiving high volume transfusion and on medication with NSAIDs.

Concomitant and hybrid therapy for Helicobacter pylori infection: A randomized clinical trial.

BACKGROUND AND AIMS: This study aimed to validate the equivalence of first-line concomitant and hybrid regimens for Helicobacter pylori infection in an era of increasing antibiotic resistance. The study also aimed to assess regimen compliance. METHODS: H. pylori-infected patients from six hospitals in Korea were randomly assigned to either concomitant or hybrid regimens. The concomitant regimen consisted of 20 mg of esomeprazole, 1 g of amoxicillin, 500 mg of clarithromycin, and 500 mg metronidazole, twice daily for 10 days. The hybrid regimen consisted of a 5-day dual therapy (20 mg of esomeprazole and 1 g of amoxicillin, twice daily) followed by a 5-day quadruple therapy (20 mg of esomeprazole, 1 g of amoxicillin, 500 mg of clarithromycin, and 500 mg of metronidazole, twice daily). RESULTS: Eradication rates for concomitant and hybrid therapy were 78.6% (187/238) and 78.8% (190/241) in the intention-to-treat analysis, and 89.8% (176/196) and 89.6% (181/202) in the per protocol analysis. For both analyses, 95% confidence intervals fell within the ± 8% equivalence margin. Adherence was better in the hybrid group (95.0%) than in the concomitant group (90.1%), a difference that was borderline significant (P = 0.051). Adverse event rates were higher in the concomitant group than in the hybrid group for nausea (15.8% vs 8.8%; P = 0.028) and regurgitation (17.6% vs 10.7%; P = 0.040). CONCLUSION: As compared with concomitant therapy, hybrid therapy offered similar efficacy, better compliance, and fewer adverse events. Hybrid therapy could be a reasonable first-line treatment option for H. pylori in areas with high antibiotics resistance.

Non-curative endoscopic resection does not always lead to grave outcomes in submucosal invasive early gastric cancer.

BACKGROUND: Endoscopic submucosal dissection (ESD) has been widely performed for the treatment of early gastric cancer (EGC). The aim of this study is to examine the effectiveness of ESD in submucosal invasive gastric cancers (SM-GC), with a special focus on patients who underwent non-curative resection. METHODS: Data for 1,246 patients who underwent ESD for treatment of EGC at six medical centers in Daegu-Gyeongbuk, Korea, between February 2003 and May 2010 were collected. After retrospective analysis of ESD databases, 118 patients were enrolled and classified into three groups: (1) EGC with submucosal invasion less than 500 µm (SM1-GC) that met the expanded criteria (EC) (SM1 EC, n = 42); (2) SM1-GC that did not meet the EC (SM1 non-EC, n = 38); and (3) EGC with submucosal invasion greater than 500 µm (SM2-GC, n = 38). RESULTS: The en bloc and complete resection rates did not differ significantly among the three groups. However, the curative resection rate was significantly better in the SM1 EC group (69.0%) compared to that in SM1 non-EC and SM2-GC groups (0% in both cases). Out of a total of 118 patients, 89 (75.4%) underwent non-curative resection, and cancer recurrence was observed in 9 (9/89, 10.1%). We analyzed the survival rate in these non-curative patients and the overall survival and disease-free survival did not differ significantly between patients that were treated with additional surgical resection and those that were simply followed up after ESD. CONCLUSIONS: Non-curative resection in SM-GC does not always lead to cancer recurrence. Thus, if additional surgery cannot be performed because of the patient's unsuitable condition or refusal, a close follow-up with endoscopy can be considered as an alternative for carefully selected patients. Moreover, as the ESD technology continues to evolve, it might be possible to expand the criteria for curative ESD in patients with SM-GC.

Efficacy of Lafutidine Versus Famotidine in Patients with Reflux Esophagitis: A Multi-Center, Randomized, Double-Blind, Non-inferiority Phase III Trial.

BACKGROUND: There has been no study on the efficacy of lafutidine for patients with reflux esophagitis in Korea. AIM: To evaluate the efficacy of a new-generation histamine-2 receptor antagonist, lafutidine, in comparison with famotidine in patients with reflux esophagitis. METHODS: This was a randomized, double-blind, non-inferiority trial enrolling patients with erosive esophagitis. The efficacy and safety of 20 mg lafutidine (treatment group) were compared with those of 40 mg famotidine (control group) and 20 mg omeprazole (reference group). The primary endpoint was the complete healing rates of reflux esophagitis on endoscopy after 8 weeks of treatment. The non-inferiority margin was assumed to be -15 %. RESULTS: The healing rates of reflux esophagitis on endoscopy after 8 weeks of treatment were 70.14 % (101/144) in the lafutidine, 63.45 % (92/145) in the famotidine, and 85.71 % (126/147) in the omeprazole group. The difference in healing rates between the lafutidine and famotidine groups was 6.69 % (95 % confidence interval = [-4.14 to 17.52]). In addition, lafutidine was superior to famotidine in clinical improvement (53.73 % vs. 39.55 %, P = 0.0200). CONCLUSIONS: Lafutidine was non-inferior to famotidine in healing of reflux esophagitis. Lafutidine, however, was superior to famotidine in terms of symptom relief of reflux esophagitis.

Inter-observer agreement in the endoscopic classification of colorectal laterally spreading tumors: a multicenter study between experts and trainees.

BACKGROUND AND AIM: The risk of cancer varies with the subtype of colorectal "laterally spreading tumors" (LSTs). However, visual interpretations vary among endoscopists. The aim of this study was to evaluate inter-observer agreement and accuracy in the endoscopic classification of LST subtypes among experts and trainees. METHODS: In total, 40 LST images were collected and reviewed independently by 14 gastroenterology experts and 10 trainees. All investigators recorded their findings as one of the following four categories: homogeneous, nodular mixed, flat-elevated, and pseudo-depressed. Agreement was assessed in terms of the kappa (κ) statistic and AC1 estimate. Accuracy is reported as percentage agreement with the gold standard, based on the gross morphology of the resected specimens. RESULTS: Of the possible 91 pair-wise κ estimates among experts, 41 (45.1%) were >0.75, indicating excellent agreement, while only 2 (4.44%) of the 45 pair-wise κ estimates among trainees were >0.75. Agreements for individual LST subtypes in the trainee group were significantly lower than those in the expert group. The κ and AC1 estimates showed similar values in individual subtypes of LSTs. The overall accuracy of LST was also significantly higher for the experts than the trainees (85.9 vs. 72.5%, P < 0.001). Notably, the flat-elevated subtype showed the lowest agreement and accuracy and was frequently misclassified as the pseudo-depressed subtype by both groups. CONCLUSIONS: Inter-observer agreement and accuracy for LST subtype classification differ significantly between experts and trainees. Implementation of an adequate training system for beginners is necessary to better identify colorectal LSTs.

Predictive risk factors of perforation in gastric endoscopic submucosal dissection for early gastric cancer: a large, multicenter study.

BACKGROUND: Although endoscopic submucosal dissection (ESD) is standard therapy for early gastric cancer, the complication rate is unsatisfactory, with perforation as the major complication during ESD. There have been several reports regarding the complications of ESD for gastric tumor especially perforation; however, little is known about the predictors for complications in patients undergoing ESD. The purpose of this retrospective study was to determine the risk factors for perforation in patients with early gastric cancer during ESD. METHODS: Between February 2003 and May 2010, we performed ESD for 1,289 lesions in 1,246 patients at six tertiary academic hospitals in Daegu, Kyungpook, Korea. Patient-related variables (age, sex, and underlying disease), endoscopic-related variables (indication of ESD, lesion size, location, type, and mucosal ulceration), procedure-related variables (operation time, complete resection, and invasion of submucosa/vessel/lymph node), and the pathologic diagnosis were evaluated as potential risk factors. RESULTS: The mean age of the patients was 64 years. The mean size of the endoscopic lesion was 19.4 mm. The overall en bloc resection rate was 93.3 %. Perforation (microperforation and macroperforation) was seen in 35 lesions. The location of the lesion (long axis: body/short axis: greater and lesser curvature) and piecemeal resection were associated with perforation (p = 0.01/0.047 and p = 0.049). Upon multivariate analysis, the location (body vs. antrum) of the lesion (odds ratio (OR) 2.636; 95 % confidence interval (CI) 1.319-5.267; p = 0.006) and piecemeal resection (OR 2.651; 95 % CI 1.056-6.656; p = 0.038) were significant predictive factors for perforation. CONCLUSIONS: The result of this study demonstrated that the location of the lesion (body) and piecemeal resection were related to perforation during ESD.

Endoscopic submucosal dissection for early gastric cancer with undifferentiated histology: could we extend the criteria beyond?

BACKGROUND: Endoscopic submucosal desection (ESD) is an effective treatment for selected patients with early gastric cancer (EGC). The purpose of this study was to examine the short-term and long-term outcomes of ESD of undifferentiated early gastric cancer. METHODS: Data for 1,241 patients who underwent ESD for treatment of EGC between February 2003 and May 2010 were collected. We performed a retrospective analysis of the medical records of 74 patients diagnosed with undifferentiated EGC. We divided the enrolled cases into two groups: the expanded-criteria group (EC group) versus the non-EC group, according to lesion size, presence of ulceration, and pathologic review. RESULTS: Of a total of 74 lesions with undifferentiated EGC, as a result of pathologic examination the EC group included 29 cases and the non-EC group included 45 cases. The mean diameter of lesions was 19.86 ± 12.5 mm. The overall rates of en bloc resection and complete resection were 90.5% (67/74) and 73% (54/74), respectively. The curative resection rate was low at 31.1%. If limited to the pathologically diagnosed EC group, the curative resection rate was 79.3% (23/29). During median follow-up periods of 34 months (range 7-81), local recurrences were observed in 5.5% (4/74) of patients. All of these were in the non-EC group and all underwent noncurative resection. There was no mortality related to ESD for treatment of EGC during follow-up. CONCLUSIONS: ESD may be a feasible treatment for selected patients with undifferentiated EGC; this should be validated by development of new criteria for ESD for treatment of EGC.

Helicobacter pylori eradication reduces risk for recurrence of gastric hyperplastic polyp after endoscopic resection.

BACKGROUND/AIMS: Little is known about the effect of Helicobacter pylori eradication on the recurrence of gastric hyperplastic polyps after endoscopic resection. Thus, we evaluated the recurrence rate of gastric hyperplastic polyps based on H. pylori eradication following endoscopic resection. METHODS: We retrospectively reviewed the medical records of 201 patients with H. pylori infection who underwent endoscopic resection for gastric hyperplastic polyps at six medical centers. H. pylori status was assessed by histological analysis and a rapid urease test. A total of 149 patients underwent successful H. pylori eradication (eradication group), whereas 52 patients had persistent H. pylori infections (non-eradication group). The recurrence rate of gastric hyperplastic polyps and the risk factors according to H. pylori status were analyzed. RESULTS: During the mean follow-up period of 18.3 months, recurrent gastric polyps developed after endoscopic resection in 10 patients (19.2% [10/52]) in the non-eradication group and 12 patients (8.1% [12/149]) in the eradication group. The cumulative incidence of recurrent gastric hyperplastic polyps was significantly higher in the non-eradication group than in the eradication group (p = 0.041, log-rank test). In the adjusted analysis, H. pylori eradication reduced the recurrence of gastric hyperplastic polyps (hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.18 to 0.99), whereas anticoagulation therapy increased the risk of recurrence of gastric hyperplastic polyps (HR, 4.91; 95% CI, 1.39 to 17.28). CONCLUSION: Successful eradication of H. pylori may reduce the recurrence of gastric hyperplastic polyps in patients after endoscopic mucosal resection.

Value of Fecal Calprotectin Measurement During the Initial Period of Therapeutic Anti-Tubercular Trial.

BACKGROUND/AIMS: The diagnosis of intestinal tuberculosis (ITB) is often challenging. Therapeutic anti-tubercular trial (TATT) is sometimes used for the diagnosis of ITB. We aimed to evaluate the changing pattern of fecal calprotectin (FC) levels during TATT in patients with ITB. METHODS: A retrospective review was performed on the data of 39 patients who underwent TATT between September 2015 and November 2018 in five university hospitals in Daegu, South Korea. The analysis was performed for 33 patients with serial FC measurement reports. RESULTS: The mean age of the participants was 48.8 years. The final diagnosis of ITB was confirmed in 30 patients based on complete mucosal healing on follow-up colonoscopy performed after 2 months of TATT. Before starting TATT, the mean FC level of the ITB patients was 170.2 µg/g (range, 11.5-646.5). It dropped to 25.4 µg/g (range, 11.5-75.3) and then 23.3 µg/g (range, 11.5-172.2) after one and two months of TATT, respectively. The difference in mean FC before and one month after TATT was statistically significant (p<0.001), and FC levels decreased to below 100 µg/g in all patients after one month of TATT. CONCLUSION: All ITB patients showed FC decline after only 1 month of TATT, and this finding correlated with complete mucosal healing in the follow-up colonoscopy after 2 months of TATT.

Clinical outcomes for perforations during endoscopic submucosal dissection in patients with gastric lesions.

BACKGROUND: The endoscopic submucosal dissection (ESD) technique has been gaining popularity, with continued advances in this treatment approach. However, ESD still is associated with potential complications such as severe bleeding and perforation. METHODS: This study was performed to compare the clinical outcomes for macro- and microperforations with ESD procedures and to determine the short-term prognosis after ESD. A macroperforation was defined as a gross perforation that occurred during an ESD procedure, and a microperforation was defined by free air observed on simple radiography after the procedure. Immediate closure of macroperforations was performed using endoclips. From July 2003 through May 2008, 1,711 patients underwent ESD for gastric lesions such as dysplasia, early cancer, and subepithelial lesions. RESULTS: Among 39 perforation cases (2.3%), macroperforations occurred for 26 patients (67%) and microperforations for 13 patients (33%). All the patients except one who underwent emergency surgery because of severe bleeding and perforation during ESD were managed successfully by intravenous antibiotics and no oral intake. The clinical prognosis and endoscopic characteristics of the patients with macroperforations did not differ from those of the patients with microperforations. CONCLUSIONS: Perforations associated with ESD could be managed safely and successfully by nonsurgical methods. The clinical prognoses for macro- and microperforations were favorable and comparable.

[Enhanced chemotherapeutic drug delivery to tumor tissue by high intensity focused ultrasound].

Cancer is the first leading cause of death in Korea. Systemic chemotherapy is currently the standard treatment for a wide variety of cancers; however, in the majority of cases, cure is not achieved, and the attendant side effects of the treatment are considerable. The effectiveness of chemotherapy in cancers depends on the adequate delivery of the chemotherapeutic agent to cancer cells. The achievement of uniform drug delivery of chemotherapeutic agents throughout tumors is limited by the anomalous vascularization and blood vessel permeability. Ultrasound has an ever-increasing role in the delivery of therapeutic agents including chemotherapeutic agents, proteins, and genetic materials. Ultrasound technology allows for the use of focused ultrasound energy for therapeutic purposes by delivering high-intensity focused ultrasound for applications such as tissue ablation, and enhanced drug delivery. We reviewed recent work in the emerging field of ultrasound-based therapeutics, with particular emphasis on the delivery of drugs to tumor tissue.

Corrigendum.

The original version of this article contains one mistake. The term "protein pump inhibitors (PPIs)" in the Introduction of page 219 should have been written as "proton pump inhibitors (PPIs)."

[Clinical significance of white bile (bilirubin-free bile) in malignant bile duct obstruction].

BACKGROUND/AIMS: White bile is colorless, translucent fluid found occasionally in malignant bile duct obstruction (MBO). Little information is available on the cause and effect of white bile. The aim of this study was to determine the frequency and clinical significance of white bile in MBO. METHODS: Bile was aspirated during endoscopic retrograde cholangiopancreatography in consecutive patients with MBO. White bile was defined as bile bilirubin <1.5 mg/dL and yellow bile was defined as bile bilirubin >or=1.5 mg/dL in the bile. Two groups were compared prospectively for the duration of jaundice, itching, cholangitis, level of obstruction, and decremental rate of bilirubin after the insertion of 7 Fr endoscopic nasobiliary drainage until the insertion of metal stent or 10 Fr plastic stent. RESULTS: Among 60 patients with MBO, 16 (26.7%) had white bile. WBC count in blood was higher (9,456/mm3 vs. 7,400/mm3, p=0.029) and cholangitis was more common (11/16 vs. 7/44, p=0.000) in white than yellow bile group. Proximal portion of MBO had no communication with GB in 9/16 patients with white bile group and 17/44 patients with yellow bile group (p>0.05). Mean survival of the inoperable 35 patients was 242 days in yellow bile and 227 days in white bile group (p>0.05). CONCLUSIONS: White bile in MBO was not rare and was associated with cholangitis. Gallbladder did not seem to play a role in the formation of white bile. Further study for the pathogenesis and prognosis of white bile in MBO will be necessary.

Factors Associated with Rebleeding in Patients with Peptic Ulcer Bleeding: Analysis of the Korean Peptic Ulcer Bleeding (K-PUB) Study.

BACKGROUND/AIMS: Rebleeding is associated with mortality in patients with peptic ulcer bleeding (PUB), and risk stratification is important for the management of these patients. The purpose of our study was to examine the risk factors associated with rebleeding in patients with PUB. METHODS: The Korean Peptic Ulcer Bleeding registry is a large prospectively collected database of patients with PUB who were hospitalized between 2014 and 2015 at 28 medical centers in Korea. We examined the basic characteristics and clinical outcomes of patients in this registry. Univariate and multivariate analyses were performed to identify the factors associated with rebleeding. RESULTS: In total, 904 patients with PUB were registered, and 897 patients were analyzed. Rebleeding occurred in 7.1% of the patients (64), and the 30-day mortality was 1.0% (nine patients). According to the multivariate analysis, the risk factors for rebleeding were the presence of co-morbidities, use of multiple drugs, albumin levels, and hematemesis/hematochezia as initial presentations. CONCLUSIONS: The presence of co-morbidities, use of multiple drugs, albumin levels, and initial presentations with hematemesis/hematochezia can be indicators of rebleeding in patients with PUB. The wide use of proton pump inhibitors and prompt endoscopic interventions may explain the low incidence of rebleeding and low mortality rates in Korea.

[A case of biliary cast syndrome after cadaveric liver transplantation].

We experienced one fatal case of biliary cast syndrome after cadaveric liver transplantation involving both intrahepatic ducts. A 58-year-old man underwent cadaveric liver transplantation because of hepatitis B virus related liver cirrhosis and concomitant hepatocellular carcinoma. Five weeks after the liver transplantation, postoperative course was complicated by development of acute cholangitis. Subsequent endoscopic retrograde cholangiography revealed diffuse intrahepatic bile duct strictures without filling defects. Percutaneous liver biopsy, which was done to exclude rejection, revealed biliary cast. Successful endoscopic removal was precluded due to its diffuse involvement. Because of the deterioration of patient's condition by refractory biliary obstruction and cholangitis, retransplantation from cadaveric donor was performed. Debridement of the biliary tree after graft removal yielded a near-complete cast of the intrahepatic ductal system. Biliary cast syndrome should be suspected when jaundice or cholangitis is associated with dilated ducts on abdominal imaging studies in cadaveric liver transplantation recipients. Initial therapeutic options include removal of biliary cast after endoscopic or percutaneous cholangiography. Although endoscopic retrieval of biliary cast by endoscopic retrograde cholangiopancreatography could be employed as a first-line management, other modalities such as endoscopic nasobiliary drainage, percutaneous transhepatic drainage, or retransplantation should be considered when complete removal is not feasible and the condition of the recipient deteriorates.

[A case of hepatic abscess caused by toxocara].

Toxocariasis is a helminozoonosis caused by the infection of a human host by the larva of Toxocara canis and Toxocara catis, which are common nematodes in dogs and cats, and occurs more frequently in school age children. Toxocariasis shows variable clinical manifestations including hepatomegaly, bronchial asthma, uveitis, central nervous system symptoms with peripheral eosinophilia and an increased total serum IgE level. However a hepatic abscess caused by toxocara infection in adults is rare. We experienced a case of heavy alcoholic patients with a hepatic eosinophilic abscess caused by toxocara infestation, which was confirmed by microscopic examination of liver biopsy, enzyme-linked immunosorbent assay test, abdominal CT and the ultrasonography findings.

[Change of HBV DNA level as a predictor of HBeAg loss after lamivudine treatment].

BACKGROUND AND AIMS: Lamivudine is an effective, safe therapeutic agent for the treatment of chronic hepatitis B. The aim of this study was to investigate whether early suppression of the viral load predicts HBeAg loss within 1 year during lamivudine therapy. METHODS: This prospective study encompassed 74 patients (mean age: 37.1 years, male/female: 51/23) who were positive HBeAg, their AST or ALT levels were > or =2 times the upper limit of normal and their HBV DNA was > or =10(5) copies/mL. The patients received lamivudine 100 mg for 12 months with monitoring their HBV DNA, AST, ALT, HBeAg and anti-HBe, and all these tests were performed at pretreatment and 1, 3, 6, 9 and 12 months after treatment. The serum HBV DNA was measured by HBV branched DNA assay. RESULTS: HBeAg loss was observed in 12 patients (16.2%), and 9 patients achieved anti-HBe seroconversion during up to 1 year of lamivudine therapy. The mean time to HBeAg loss was 5.6 months (range: 1-12 months). The posttreatment HBV DNA (<2,000 copies/mL) after 3 month (P=0.008) and 6 month (P=0.012)) were significant predictors of HBeAg loss after 1 year of lamivudine treatment on univariate analysis. Pretreatment HBV DNA, AST/ALT, gender, age and liver cirrhosis had no impact on HBeAg loss. The six-month posttreatment HBV DNA level <2,000 copies/mL was a significant predictor of HBeAg loss on multivariate analysis (P=0.008, odds ratio=0.108). CONCLUSION: We suggest that an HBV DNA level <2,000 copies/mL at 6 month after lamivudine therapy is the most important predictor of HBeAg loss during up to 1 year of lamivudine therapy.

A Double-blind, Randomized, Multicenter Clinical Trial Investigating the Efficacy and Safety of Esomeprazole Single Therapy Versus Mosapride and Esomeprazole Combined Therapy in Patients with Esophageal Reflux Disease.

BACKGROUND/AIMS: We aim to evaluate the efficacy and safety of combination therapy in erosive reflux disease (ERD) patients by comparing endoscopic healing rates according to the Los Angeles classification for esomeprazole alone, and esomeprazole plus mosapride. METHODS: A total of 116 ERD patients were randomized to receive esomeprazole 40 mg once daily plus mosapride 5 mg 3 times daily (E+M group), or esomeprazole plus placebo (E only group) for 8 weeks. Patients recorded gastroesophageal reflux disease (GERD) symptom questionnaire at weeks 4 and 8. The primary endpoint was the endoscopic healing rate of ERD after 8 weeks of treatment. RESULTS: Endoscopic healing rates according to the Los Angeles classification was 32 (66.7%) in the E+M group and 26 (60.5%) in the E only group, but there was no statistically significant difference between the groups. Only at 4 weeks, the total GERD symptom score changes relative to the baseline significantly improved in the E+M group than that of the E only group (-13.4 ± 14.7 vs -8.0 ± 12.3, P = 0.041), and upper abdominal pain and belching score changes showed significantly improved in the E+M group than that of the E only group (P = 0.018 and P = 0.013, respectively). CONCLUSIONS: The combination of a proton pump inhibitor with mosapride shows a tendency for upper abdominal pain, belching, and total GERD symptoms scores to improve more rapidly. This suggests that combination therapy with esomeprazole and mosapride will be useful for rapid improvement of specific GERD symptoms, such as upper abdominal pain and belching in ERD patients.