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Efficacy of a Multiplex Paclitaxel Emission Stent Using a Pluronic® Mixture Membrane versus a Covered Metal Stent in Malignant Biliary Obstruction: A Prospective Randomized Comparative Study.

Sung Ill JANG ; Se Joon LEE ; Seok JEONG ; Don Haeng LEE ; Myung Hwan KIM ; Hong Jin YOON ; Dong Ki LEE

Gut and Liver.2017;11(4):567-573. doi:10.5009/gnl16428

BACKGROUND/AIMS: A drug-eluting stent for unresectable malignant biliary obstruction was developed to increase stent patency by preventing tumor ingrowth. The safety and efficacy of a new generation of metallic stents covered with a paclitaxel-incorporated membrane using a Pluronic® mixture (MSCPM-II) were compared prospectively with those of covered metal stents (CMSs) in patients with malignant biliary obstructions. METHODS: This study was initially designed as a prospective randomized trial but was closed early because of a high incidence of early occlusion. Therefore, the data were analyzed using the intent-to-treat method. A total of 72 patients with unresectable distal malignant biliary obstructions were prospectively enrolled. RESULTS: The two groups did not differ significantly in basic characteristics and mean follow-up period (MSCPM-II 194 days vs CMS 277 days, p=0.063). Stent occlusion occurred in 14 patients (35%) who received MSCPM-II and in seven patients (21.9%) who received CMSs. Stent patency and survival time did not significantly differ between the two groups (p=0.355 and p=0.570). The complications were mild and resolved by conservative management in both groups. CONCLUSIONS: There were no significant differences in stent patency or patient survival in MSCPM-II and CMS patients with malignant biliary obstructions.
Biliary Tract Neoplasms ; Drug-Eluting Stents ; Follow-Up Studies ; Humans ; Incidence ; Membranes* ; Methods ; Paclitaxel* ; Pancreatic Neoplasms ; Prospective Studies* ; Self Expandable Metallic Stents ; Stents*

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Comparison of Histologic Core Portions Acquired from a Core Biopsy Needle and a Conventional Needle in Solid Mass Lesions: A Prospective Randomized Trial.

Ban Seok LEE ; Chang Min CHO ; Min Kyu JUNG ; Jung Sik JANG ; Han Ik BAE

Gut and Liver.2017;11(4):559-566. doi:10.5009/gnl16284

BACKGROUND/AIMS: The superiority of endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) over EUS-guided fine needle aspiration (EUS-FNA) remains controversial. Given the lack of studies analyzing histologic specimens acquired from EUS-FNB or EUS-FNA, we compared the proportion of the histologic core obtained from both techniques. METHODS: A total of 58 consecutive patients with solid mass lesions were enrolled and randomly assigned to the EUS-FNA or EUS-FNB groups. The opposite needle was used after the failure of core tissue acquisition using the initial needle with up to three passes. Using computerized analyses of the scanned histologic slide, the overall area and the area of the histologic core portion in specimens obtained by the two techniques were compared. RESULTS: No significant differences were identified between the two groups with respect to demographic and clinical characteristics. Fewer needle passes were required to obtain core specimens in the FNB group (p<0.001). There were no differences in the proportion of histologic core (11.8%±19.5% vs 8.0%±11.1%, p=0.376) or in the diagnostic accuracy (80.6% vs 81.5%, p=0.935) between two groups. CONCLUSIONS: The proportion of histologic core and the diagnostic accuracy were comparable between the FNB and FNA groups. However, fewer needle passes were required to establish an accurate diagnosis in EUS-FNB.
Biopsy* ; Biopsy, Fine-Needle ; Diagnosis ; Endoscopic Ultrasound-Guided Fine Needle Aspiration ; Endosonography ; Humans ; Needles* ; Prospective Studies*

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Simeprevir-Based Triple Therapy with Reduced Doses of Pegylated Interferon α-2a Plus Ribavirin for Interferon Ineligible Patients with Genotype 1b Hepatitis C Virus.

Hideyuki TAMAI ; Yoshiyuki IDA ; Akira KAWASHIMA ; Naoki SHINGAKI ; Ryo SHIMIZU ; Kosaku MORIBATA ; Tetsushi NASU ; Takao MAEKITA ; Mikitaka IGUCHI ; Jun KATO ; Taisei NAKAO ; Masayuki KITANO

Gut and Liver.2017;11(4):551-558. doi:10.5009/gnl16525

BACKGROUND/AIMS: The present study aimed to evaluate the safety and efficacy of simeprevir-based triple therapy with reduced doses of pegylated interferon (PEG-IFN) and ribavirin for interferon (IFN) ineligible patients, such as elderly and/or cirrhotic patients, and to elucidate the factors contributing to a sustained virologic response (SVR). METHODS: One hundred IFN ineligible patients infected with genotype 1b hepatitis C virus (HCV) were treated. Simeprevir (100 mg) was given orally together with reduced doses of PEG-IFN-α 2a (90 μg), and ribavirin (200 mg less than the recommended dose). RESULTS: The patients’ median age was 70 years, and 70 patients were cirrhotic. Three patients (3%) discontinued treatment due to adverse events. The SVR rate was 64%. Factors that significantly contributed to the SVR included the γ-glutamyl transferase and α-fetoprotein levels, interleukin-28B (IL28B) polymorphism status, and the level and reduction of HCV RNA at weeks 2 and 4. The multivariate analysis showed that the IL28B polymorphism status was the only independent factor that predicted the SVR, with a positive predictive value of 77%. CONCLUSIONS: Simeprevir-based triple therapy with reduced doses of PEG-IFN and ribavirin was safe and effective for IFN ineligible patients infected with genotype 1b HCV. IL28B polymorphism status was a useful predictor of the SVR.
Aged ; Genotype* ; Hepacivirus* ; Hepatitis C* ; Hepatitis* ; Humans ; Interferons* ; Multivariate Analysis ; Ribavirin* ; RNA ; Simeprevir ; Transferases

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Final Report of Unmet Needs of Interferon-Based Therapy for Chronic Hepatitis C in Korea: Basis for Moving into the Direct-Acting Antiviral Era.

Eun Sun JANG ; Young Seok KIM ; Kyung Ah KIM ; Youn Jae LEE ; Woo Jin CHUNG ; In Hee KIM ; Byung Seok LEE ; Sook Hyang JEONG

Gut and Liver.2017;11(4):543-550. doi:10.5009/gnl16530

BACKGROUND/AIMS: To evaluate the era of direct acting antivirals (DAAs), we must understand the treatment patterns and outcomes of interferon-based therapy for hepatitis C virus (HCV) infection. We aimed to elucidate the treatment rate, factors affecting treatment decisions, and efficacy of interferon-based therapy in a real-world setting. METHODS: This nationwide cohort study included 1,191 newly diagnosed patients with chronic HCV infection at seven tertiary hospitals in South Korea. Subjects were followed retrospectively until March 2015, which was just before the approval of DAA therapy. RESULTS: In total, 48.2% and 49.3% of the patients had HCV genotypes 1 and 2, respectively. Interferon-based therapy was initiated in 541 patients (45.4%). The major reasons for no treatment included ineligibility (18.9%), concern about adverse events (22.3%), cost (21.5%), and an age >75 years (19.5%). Interferon-based therapy was discontinued (18.5%) mainly due to adverse events (n=66). The intent-to-treat analysis found that the sustained virologic response (SVR) rate was 58.3% in genotype 1 patients and 74.7% in non-genotype 1 patients. CONCLUSIONS: Approximately one-third of newly diagnosed HCV patients in South Korea received interferon-based therapy and showed a suboptimal SVR rate. Diagnosis of patients at younger ages and with a less advanced liver status and reducing the DAA therapy cost may fulfill unmet needs.
Antiviral Agents ; Cohort Studies ; Diagnosis ; Genotype ; Hepacivirus ; Hepatitis C, Chronic* ; Hepatitis, Chronic* ; Humans ; Korea* ; Liver ; Retrospective Studies ; Ribavirin ; Tertiary Care Centers

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Establishment of a Disease-Specific Graded Prognostic Assessment for Hepatocellular Carcinoma Patients with Spinal Metastasis.

Chai Hong RIM ; Chiwhan CHOI ; Jinhyun CHOI ; Jinsil SEONG

Gut and Liver.2017;11(4):535-542. doi:10.5009/gnl16486

BACKGROUND/AIMS: Hepatocellular carcinoma (HCC) patients with spinal metastasis (SM) show heterogeneous lengths of survival. In this study, we develop and propose a graded prognostic assessment for HCC patients with SM (HCC-SM GPA). METHODS: We previously reported the outcomes of 192 HCC patients with SM who received radiotherapy from April 1992 to February 2012. Prognostic factors that significantly affected survival in that study were used to establish the HCC-SM GPA. Validation was performed using an independent cohort of 63 patients recruited from September 2011 to March 2016. RESULTS: We developed the HCC-SM GPA using the following factors: Eastern Cooperative Oncology Group performance status (0–2, 0 point; 3–4, 1 point), controlled primary HCC (yes, 0 point; no, 2 points), and extrahepatic metastases other than bone (no, 0 point; yes, 1 point). Patients were stratified into low (GPA=0), intermediate (GPA=1 to 2), and high risk (GPA=3 to 4). When applied to the validation cohort, the HCC-SM GPA determined median survival durations of 13.6, 4.8, and 2.6 months and 1-year overall survival rates of 58.3%, 17.8%, and 7.3% for the low-, intermediate-, and high-risk patient groups, respectively (p<0.001). CONCLUSIONS: Our newly proposed HCC-SM GPA successfully predicted survival outcomes.
Carcinoma, Hepatocellular* ; Cohort Studies ; Humans ; Neoplasm Metastasis* ; Radiotherapy ; Survival Rate

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A Novel Model for Predicting Hepatocellular Carcinoma Development in Patients with Chronic Hepatitis B and Normal Alanine Aminotransferase Levels.

Dong Hyun SINN ; Jeong Hoon LEE ; Kyunga KIM ; Joong Hyun AHN ; Ji Hyeon LEE ; Jung Hee KIM ; Dong Hyeon LEE ; Jung Hwan YOON ; Wonseok KANG ; Geum Youn GWAK ; Yong Han PAIK ; Moon Seok CHOI ; Joon Hyeok LEE ; Kwang Cheol KOH ; Seung Woon PAIK

Gut and Liver.2017;11(4):528-534. doi:10.5009/gnl16403

BACKGROUND/AIMS: Hepatocellular carcinoma (HCC) can develop in chronic hepatitis B (CHB) patients with normal alanine aminotransferase (ALT) levels. Therefore, methods that can stratify an individual's HCC risk are needed. METHODS: A simple HCC risk score was developed from 971 patients with CHB who had elevated hepatitis B virus DNA levels (>2,000 IU/mL) with normal or mildly elevated ALT levels (<80 U/L). The score was validated from an independent cohort of 507 patients. RESULTS: A 4-point risk scale was developed, with HCC risk ranging from 0% to 17.8% at 5 years for the lowest and highest risk scores. The D2AS score had high area under the receiver operating curves (AUROCs) for predicting development of HCC at 3/5 years (0.895/0.884). The calculated AUROCs to predict the development of HCC at 3/5 years were 0.889/0.876 in the validation cohort, with 5-year HCC incidence rates ranging from 0% to 13.8% at 5 years for the lowest and highest risk scores. CONCLUSIONS: The D2AS risk score can play a valuable role in risk stratification and may be useful for guiding clinical decisions for enhanced surveillance or treatment to reduce the HCC risk in CHB patients with normal or mildly elevated ALT levels.
Alanine Transaminase* ; Alanine* ; Carcinoma, Hepatocellular* ; Cohort Studies ; DNA ; Hepatitis B ; Hepatitis B virus ; Hepatitis B, Chronic* ; Hepatitis, Chronic* ; Humans ; Incidence ; Liver Function Tests

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Comparison of the Efficacy and Safety of Single- versus Double-Balloon Enteroscopy Performed by Endoscopist Experts in Single-Balloon Enteroscopy: A Single-Center Experience and Meta-Analysis.

Tae Jun KIM ; Eun Ran KIM ; Dong Kyung CHANG ; Young Ho KIM ; Sung Noh HONG

Gut and Liver.2017;11(4):520-527. doi:10.5009/gnl16330

BACKGROUND/AIMS: Studies concerning the efficacy and safety of single-balloon enteroscopy (SBE) compared with that of double-balloon enteroscopy (DBE) often appear to be conflicting. However, previous studies were performed by endoscopists who were less experienced in SBE compared with DBE. METHODS: We performed a retrospective analysis of SBE and DBE data performed by a single enteroscopist, with expertise in SBE, using a prospective balloon-assisted enteroscopy registry from 2013 to 2015. Furthermore, we performed a comprehensive literature search and meta-analysis of available studies, including the current study, to clarify the efficacy and safety of SBE versus DBE. RESULTS: A total of 65 procedures in 44 patients with SBE and 74 procedures in 69 patients with DBE were analyzed. There were no significant differences in diagnostic yield (61.1% vs 77.3%, respectively, p=0.397), therapeutic yield (39.1% vs 31.8%, respectively, p=0.548), and complication rate (4.4% vs 2.3%, p=1.000). In the meta-analysis, which included four randomized controlled trials and three observational studies, there were no significant differences in the pooled relative risk and odds ratio for diagnostic and therapeutic yield and complications of SBE compared with those of DBE. CONCLUSIONS: The performance of SBE appears to be similar to that of DBE in terms of diagnostic and therapeutic yield and complications.
Double-Balloon Enteroscopy* ; Humans ; Odds Ratio ; Prospective Studies ; Retrospective Studies

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Association of Inflammatory Bowel Disease (IBD) with Depressive Symptoms in the United States Population and Independent Predictors of Depressive Symptoms in an IBD Population: A NHANES Study.

Sanjay BHANDARI ; Michael E LARSON ; Nilay KUMAR ; Daniel STEIN

Gut and Liver.2017;11(4):512-519. doi:10.5009/gnl16347

BACKGROUND/AIMS: There is a paucity of population-based studies on the association between inflammatory bowel disease (IBD) and depression in the U.S. population. We sought to study this association using the National Health and Nutrition Examination Survey (NHANES) database. METHODS: We used NHANES data from 2009 to 2010. Our study included 190,269,933 U.S. adults without IBD and 2,325,226 with IBD. We sought to determine whether IBD is an independent risk factor for depressive symptoms (DS) in the U.S. population and studied the independent predictors of DS in IBD population. RESULTS: DS was present in 49% of the IBD population versus 23% of the non-IBD population (p<0.001). During the multivariate analysis, we found that IBD was independently associated with DS in the U.S. population (p=0.002). The independent predictors of DS in the IBD population were older age (p=0.048) and divorced/separated/widowed status (p=0.005). There was nonsignificant increase in suicidal risk in IBD population with DS versus that in non-IBD population with DS (27% vs 12%, respectively, p=0.080). Only 36% of IBD individuals with DS visited mental health professional or psychiatrist within the past year. CONCLUSIONS: IBD is independently associated with DS in the U.S. population. Further research is warranted on risk stratification, screening and management of those with IBD who are at risk of depression.
Adult ; Depression* ; Humans ; Inflammatory Bowel Diseases* ; Mass Screening ; Mental Health ; Multivariate Analysis ; Nutrition Surveys* ; Psychiatry ; Risk Factors ; United States*

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Pantoprazole Does Not Reduce the Antiplatelet Effect of Clopidogrel: A Randomized Controlled Trial in Korea.

Yoon Jin CHOI ; Nayoung KIM ; In Jin JANG ; Joo Youn CHO ; Ryoung Hee NAM ; Ji Hyun PARK ; Hyun Jin JO ; Hyuk YOON ; Cheol Min SHIN ; Young Soo PARK ; Dong Ho LEE ; Hyun Chae JUNG

Gut and Liver.2017;11(4):504-511. doi:10.5009/gnl16352

BACKGROUND/AIMS: Concerns that proton pump inhibitors (PPIs) diminish the efficacy of clopidogrel could hamper the appropriate prescription of PPIs. We evaluated the influence of pantoprazole on the antiplatelet effect of clopidogrel compared with ranitidine, which is regarded as safe, after stratification of the population according to the presence of a cytochrome (CYP) 2C19 polymorphism in Korea. METHODS: Forty patients who underwent dual antiplatelet therapy were randomized to receive pantoprazole (n=20) or ranitidine (n=20). Platelet aggregation was evaluated by impedance aggregometry at baseline (D0) and 8 days after acid-lowering treatments (D9). CYP2C19 was genotyped by polymerase chain reaction restriction fragment length polymorphism. RESULTS: After co-treatment, the percentage of clopidogrel low-response was 11.1% (2/18) in the pantoprazole group and 10.5% (2/19) in the ranitidine group (p=0.954). The impedance values with adenosine diphosphate stimulus after acid-lowering treatments did not significantly differ between the two groups. In a multiple regression analysis, only ST-elevation myocardial infarction was marginally associated with a reduced antiplatelet effect (odds ratio, 12.07; 95% confidence interval, 0.84 to 173.78). However, pantoprazole use did not affect the antiplatelet effect after correction for the CYP2C19 polymorphism. CONCLUSIONS: This study showed that pantoprazole does not increase platelet aggregation in patients receiving dual antiplatelet therapy (ClinicalTrials.gov number: NCT02733640).
Adenosine Diphosphate ; Cytochrome P-450 CYP2C19 ; Cytochromes ; Drug Interactions ; Electric Impedance ; Humans ; Korea* ; Myocardial Infarction ; Platelet Aggregation ; Polymerase Chain Reaction ; Polymorphism, Restriction Fragment Length ; Prescriptions ; Proton Pump Inhibitors ; Ranitidine

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Endoscopic Treatment of Diverse Complications Caused by Laparoscopic Adjustable Gastric Banding: A Study in Eastern Asia.

Su Young KIM ; Kyong Yong OH ; Jun Won CHUNG ; Yoon Jae KIM ; Kyoung Oh KIM ; Kwang An KWON ; Dong Kyun PARK ; Kyoung Kon KIM ; Seong Min KIM

Gut and Liver.2017;11(4):497-503. doi:10.5009/gnl16089

BACKGROUND/AIMS: The use of laparoscopic adjustable gastric banding (LAGB) is increasing proportionally with the obesity epidemic. However, some postoperative complications have been highlighted as major problems associated with LAGB. There is no consensus concerning the endoscopic management of these adverse events. The aim of this study was to retrospectively review the feasibility and effectiveness of endoscopic treatment for LAGB complications. METHODS: We retrospectively evaluated 352 patients who underwent LAGB between 2011 and 2015. LAGB-associated complications developed in 26 patients (7.4%). This study involved six patients (1.7%) who received endoscopic treatment. RESULTS: Types of LAGB-induced complications in our series included intragastric migration (n=3), gastric leaks (n=2), and gastric fistulas (n=1). The endoscopic treatment of these complications was successful in four of the six patients. Endoscopic band removal was successful in two patients. All gastric leaks were successfully closed via an endoscopic procedure. In two cases (intragastric migration and gastric fistula), endoscopic treatment was not sufficient, and surgery was performed. CONCLUSIONS: Endoscopic procedures afforded acceptable treatment of band migration and gastric leaks after LAGB. However, the results were poor in patients with gastric fistula.
Bariatric Surgery ; Consensus ; Endoscopy ; Far East* ; Gastric Fistula ; Humans ; Obesity ; Postoperative Complications ; Retrospective Studies

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