Prediction model for hepatocellular carcinoma risk in treatment-naive chronic hepatitis B patients receiving entecavir/tenofovir.

BACKGROUND/AIM: Accurate assessment of hepatocellular carcinoma (HCC) risk in chronic hepatitis B (CHB) patients receiving entecavir (ETV)/tenofovir disoproxil fumarate (TDF) is likely to play a pivotal role in post-treatment follow-up strategy. We aimed to develop a simple and reliable predictive model for HCC risk in these patients. PATIENTS AND METHODS: A database of 1242 consecutive treatment-naive CHB patients who initially underwent ETV/TDF between February 2007 and January 2017 at four referral hospitals in South Korea was analyzed. The HCC risk model was constructed on the basis of a multivariable Cox proportional hazards model in the derivation dataset (n=944) and was validated using Harrell's C-statistic in a validation dataset (n=298). RESULTS: The 3/5-year cumulative incidence rates of HCC were 3.9/6.5 and 4.2/11.6% in the derivation and the validation dataset, respectively (P=0.08). In the derivation dataset, we identified four factors associated with HCC, namely, age, albumin, sex, and liver cirrhosis. The AASL (age, albumin, sex, liver cirrhosis)-HCC scoring system was developed on the basis of these factors, and simplified to an integer scoring system. AASL-HCC scores were found to have high discriminating performance for the prediction of HCC development at 5 years in the derivation (C-statistics=0.802, 95% confidence interval: 0.716-0.888) and validation dataset (C-statistics=0.805, 95% confidence interval: 0.671-0.939). When AASL-HCC scores were classified as 5 or less, 6-19, and at least 20 (low-risk, intermediate-risk, and high-risk groups, respectively), the 5-year cumulative incidence rates of HCC were 0, 4.2, and 17.6%, respectively, in the derivation dataset. CONCLUSIONS: The AASL-HCC model was simple and reliable for HCC risk prediction in treatment-naive CHB patients receiving ETV/TDF, and is easily applicable in the clinical setting.

Efficacy and Safety of Daclatasvir and Asunaprevir in Patients with Hepatitis C Virus Genotype 1b Infection on Hemodialysis.

Background/Aims: We evaluated the efficacy and safety of daclatasvir (DCV) and asunaprevir (ASV) in patients with chronic hepatitis C virus (HCV) infection on hemodialysis. Methods;: We performed a single-arm, multicenter prospective study. Twenty-one chronic hemodialysis patients with HCV infection were prospectively enrolled from February 2016 to April 2017. We evaluated the virological responses at weeks 4, 12, and 24 (end of treatment [EOT]) and the sustained virological response at 12 weeks after the EOT (SVR12). The tolerability and safety of the drugs were also assessed. Results: None of the 20 patients had the NS5A resistance-associated variant (NS5A RAV), and one patient was indeterminate for the NS5A RAV. Seventeen patients (80%) completed the 24 weeks of treatment with DCV and ASV. Four patients discontinued the study prior to week 12. In an intention-to-treat analysis, the SVR12 was 76.1%. In a per-protocol analysis, patients who completed DCV and ASV treatment achieved an SVR12 of 100%. DCV and ASV were well tolerated by the majority of patients. Three patients discontinued treatment due to adverse events (AEs) including dizziness, dyspnea, and neutropenia. The patient with indeterminate NS5A RAV showed viral breakthrough and discontinued treatment. Conclusions: DCV and ASV combination therapy in chronic hemodialysis patients with HCV infection achieved a high SVR12 rate with few AEs. To maximize the SVR12 rate, it is important to identify candidates by baseline RAV testing. Close monitoring of the safety and tolerability of DCV and ASV may be necessary in HCV-infected patients on hemodialysis. (ClinicalTrials.gov ID NCT02580474).

Efficacy and safety of sofosbuvir plus ribavirin for Korean patients with hepatitis C virus genotype 2 infection: A retrospective multi-institutional study.

BACKGROUND/AIMS: Sofosbuvir plus ribavirin is a standard treatment for patients infected with chronic hepatitis C virus (HCV) genotype 2 in Korea. The purpose of this study was to examine the efficacy and safety of this treatment in Korean patients with chronic HCV genotype 2 infection. METHODS: We retrospectively analyzed clinical data of patients treated with sofosbuvir plus ribavirin for chronic HCV genotype 2 from May 2016 to December 2017 at eight hospitals located in the Daejeon-Chungcheong area. RESULTS: A total of 172 patients were treated with sofosbuvir plus ribavirin. Of them, 163 patients completed the treatment, and 162 patients were tested for sustained virologic response 12 weeks after treatment discontinuation (SVR12). Mean age was 59.6±12.3 years (27-96), and 105 (64.4%) patients were female. Of the total patients, 49 (30.1%) were diagnosed with cirrhosis, and 31 of them were treated for 16 weeks. Sofosbuvir plus ribavirin was the first-line treatment for 144 (88.3%) patients. Eleven (6.7%) patients were intolerant to previous interferon-based treatment. Eight (5.0%) patients relapsed after interferon-based treatment. HCV RNA non-detection rate at 4, 8, and 12 weeks was 97.5%, 99.1%, and 99.3%, respectively, and SVR12 was 98.8% (161/163). During treatment, 18 (11.0%) patients had to reduce their administrated dose of ribavirin because of anemia. One patient stopped the treatment because of severe anemia. Other adverse events, including dizziness, indigestion, and headache, were found in 26 (16.0%) patients. CONCLUSION: A 12-16 week treatment with sofosbuvir plus ribavirin is remarkably effective and well tolerated in Korean patients with chronic HCV genotype 2 infection.

Effectiveness of cholangioscopy using narrow band imaging for hepatobiliary malignancies.

PURPOSE: Recently, cholangioscopy using narrow band imaging (NBI) has been used as a diagnostic modality for better visualization in hepatobiliary malignancies; however, there are few reports on it. Our aim is to evaluate the effectiveness of cholangioscopy using NBI in hepatobiliary malignancies. METHODS: Between January 2007 and December 2016, 152 cholangioscopies using percutaneous approach were conducted in total 123 patients. Among these, 36 patients were suspicious of hepatobiliary malignancies. Thirteen patients with an ambiguous margin on endoscopic retrograde cholangiopancreatography (ERCP) or magnetic resonance cholangiopancreatography (MRCP), for whom NBI tipped the balance in diagnosis of lesion and decision of lesion extent by adding NBI, were involved in our study. RESULTS: Underlying diseases were all malignant in 13 patients (11 bile duct cancers, 1 liver cancer, 1 pancreas cancer with common bile duct invasion). In 7 cases with papillary type tumor, minute superficial spreading tumor was detected by NBI more easily, and NBI provided a better visualization of tumor vessel and margin evaluation in 4 cases with infiltrative tumor. In 2 cases with mucin-hypersecreting tumor, NBI showed better penetration through the mucin and gave us a much clearer image. Nine patients ultimately underwent surgical resection. The margins predicted by NBI cholangioscopy were consistent with the pathological margins on the resected specimens. CONCLUSION: In conclusion, cholangioscopy using NBI is very useful for evaluation of suspected hepatobiliary malignancies with an ambiguous margin on ERCP or MRCP. It can give us an accurate pathologic mapping, and this information seems to be essential before deciding on a treatment strategy.

Pathway engineering of Enterobacter aerogenes to improve acetoin production by reducing by-products formation.

Enterobacter aerogenes was metabolically engineered for acetoin production. To remove the pathway enzymes that catalyzed the formation of by-products, the three genes encoding a lactate dehydrogenase (ldhA) and two 2,3-butanediol dehydrogenases (budC, and dhaD), respectively, were deleted from the genome. The acetoin production was higher under highly aerobic conditions. However, an extracellular glucose oxidative pathway in E. aerogenes was activated under the aerobic conditions, resulting in the accumulation of 2-ketogluconate. To decrease the accumulation of this by-product, the gene encoding a glucose dehydrogenase (gcd) was also deleted. The resulting strain did not produce 2-ketogluconate but produced significant amounts of acetoin, with concentration reaching 71.7g/L with 2.87g/L/h productivity in fed-batch fermentation. This result demonstrated the importance of blocking the glucose oxidative pathway under highly aerobic conditions for acetoin production using E. aerogenes.

High-Grade Mixed Adenoneuroendocrine Carcinoma in the Cecum: A Case Report.

Gastrointestinal neoplasms with an exocrine and a neuroendocrine component are rare. Such neoplasms are called "mixed adenoneuroendocrine carcinomas" (MANECs) according to the most recent World Health Organization classification of gastrointestinal tract neoplasms. MANECs have no specific findings that distinguish them from pure adenocarcinomas. In addition, the optimal management strategy of MANECs is largely unknown. We describe the case of a 32-year-old man with dizziness and abdominal bloating. A cecal mass was suspected based on an image study done at a local clinic. We evaluated the cecal mass by using colonoscopy, contrast enhanced computed tomography of the abdomen, positron emission tomography-computed tomography, and laboratory studies. The patient underwent a right hemicolectomy and adjuvant chemotherapy. The final histopathological diagnosis was a high-grade MANEC of the ascending colon, tumor stage T3N2M0.

In Vivo Evaluation of Commercially Available Gel-Type Polyethylene Glycol Membrane for Carrier of Recombinant Human Bone Morphogenetic Protein-2.

PURPOSE: This study evaluated a commercially available, 3-dimensional gel-type polyethylene glycol (PEG) membrane as a carrier for recombinant human bone morphogenetic protein-2 (rhBMP-2) using a rat calvarial defect model. Another gel-type carrier, fibrin-fibronectin system (FFS), was used as a positive control. MATERIALS AND METHODS: Critical-size defects were made in the rat calvarium, which were allocated to 1 of 10 groups comprising 2 healing periods and biomaterial conditions: 1) sham control, 2) FFS only, 3) FFS plus BMP-2, 4) PEG only, and 5) PEG plus BMP-2. Radiographic and histologic analyses were performed at 2 and 8 weeks after surgery. RESULTS: After 2 weeks, some parts of the FFS were biodegraded and extensive cellular infiltration was observed at sites that received FFS or FFS plus BMP-2. The PEG membrane retained its augmented volume without cellular infiltration at sites that received PEG or PEG plus BMP-2. After 8 weeks, the FFS was completely degraded and replaced by new bone and connective tissues. In contrast, the volume of residual PEG was similar to that at 2 weeks, with slight cellular infiltration. In particular, there was progressive bone regeneration around micro-cracks and resorbed outer surface in the PEG + BMP-2 group. Although the PEG + BMP-2 group showed increased area and percentage of new bone, there was no statistical relevance after 2 and 8 weeks in histomorphometric analyses. However, the appearance of the healing differed (with new bone formation along micro-cracks in the PEG + BMP-2 group), and further studies with longer healing periods are needed to draw conclusions about clinical applications. CONCLUSION: Evidence of mechanical stability and new bone formation along micro-cracks when using PEG plus BMP-2 might support the PEG membrane as a candidate carrier material for rhBMP-2.

Factors and outcomes associated with pancreatic duct disruption in patients with acute necrotizing pancreatitis.

BACKGROUND AND AIMS: Acute necrotizing pancreatitis (ANP) can affect main pancreatic duct (MPD) as well as parenchyma. However, the incidence and outcomes of MPD disruption has not been well studied in the setting of ANP. METHODS: This retrospective study investigated 84 of 465 patients with ANP who underwent magnetic resonance cholangiopancreatography and/or endoscopic retrograde cholangiopancreatography. The MPD disruption group was subclassified into complete and partial disruption. RESULTS: MPD disruption was documented in 38% (32/84) of the ANP patients. Extensive necrosis, enlarging/refractory pancreatic fluid collections (PFCs), persistence of amylase-rich output from percutaneous drainage, and amylase-rich ascites/pleural effusion were more frequently associated with MPD disruption. Hospital stay was prolonged (mean 55 vs. 29 days) and recurrence of PFCs (41% vs. 14%) was more frequent in the MPD disruption group, although mortality did not differ between ANP patients with and without MPD disruption. Subgroup analysis between complete disruption (n = 14) and partial disruption (n = 18) revealed a more frequent association of extensive necrosis and full-thickness glandular necrosis with complete disruption. The success rate of endoscopic transpapillary pancreatic stenting across the stricture site was lower in complete disruption (20% vs. 92%). Patients with complete MPD disruption also showed a high rate of PFC recurrence (71% vs. 17%) and required surgery more often (43% vs. 6%). CONCLUSIONS: MPD disruption is not uncommon in patients with ANP with clinical suspicion on ductal disruption. Associated MPD disruption may influence morbidity, but not mortality of patients with ANP. Complete MPD disruption is often treated by surgery, whereas partial MPD disruption can be managed successfully with endoscopic transpapillary stenting and/or transmural drainage. Further prospective studies are needed to study these items.

Metal versus plastic stents for drainage of malignant biliary obstruction before primary surgical resection.

BACKGROUND AND AIMS: Preoperative biliary drainage (PBD) with stent placement has been commonly used for patients with malignant biliary obstruction. In PBD, the placement of fully covered self-expandable metal stents (FCSEMSs) may provide better patency duration and a lower incidence of cholangitis compared with plastic stents. We aimed to evaluate which type of stent showed better outcomes in PBD. METHODS: In this multicenter, prospective randomized trial, we compared PBD with FCSEMSs versus plastic stents in 86 patients with malignant biliary obstruction between January 2012 and December 2014. Patients with obstructive jaundice were randomly assigned to undergo PBD either with plastic stents or FCSEMS placement. RESULTS: Baseline characteristics were not significantly different between the 2 groups. Endoscopic stent placement was technically successful in all patients. Procedure-related adverse events were not significantly different between the 2 groups (plastic vs FCSEMS group; 16.3% vs 16.3%, P = 1.0). Reintervention was required in 16.3% of the plastic stent group and 14.0% of the FCSEMS group (P = .763). The interval to surgery after PBD (plastic vs FCSEMS group; 14.2 ± 8.3 vs 12.3 ± 6.9 days, P = .426) was not significantly different between groups. Surgery-related adverse events occurred in 43.6% of the plastic stent group and 40.0% of the FCSEMS group (P = .755). CONCLUSIONS: In patients with resectable malignant biliary obstruction, the outcomes of PBD with plastic stents and FCSEMSs were similar. Considering the cost-effectiveness, PBD with plastic stents may be preferable to FCSEMS placement. (Clinical trial registration number: NCT01789502.).

Outcomes of ERCP in Billroth II gastrectomy patients.

BACKGROUND AND AIMS: ERCP is a difficult procedure to perform in Billroth II gastrectomy patients because of altered anatomy. We investigated the outcomes and risk factors for adverse events with ERCP using a cap-fitted forward-viewing endoscope with endoscopic papillary balloon dilation (EPBD) in Billroth II gastrectomy patients. METHODS: The records for Billroth II gastrectomy patients who underwent ERCP using a cap-fitted forward-viewing endoscope with EPBD at 5 institutions between August 2008 and April 2014 were retrospectively reviewed. The outcomes and risk factors for adverse events resulting from this treatment were analyzed. RESULTS: In total, 165 patients were identified. ERCP was technically successful in 144 patients (87.3%) and clinically successful in 141 patients (85.5%). Adverse events occurred in 38 patients (23.0%): perforation in 3 cases (1.8%), pancreatitis in 13 cases (7.9%), and asymptomatic hyperamylasemia in 22 patients (13.3%). In univariate analysis, ≥2 ERCP sessions, periampullary diverticulum, and common bile duct (CBD) stone size ≥ 12 mm were found to be associated with ERCP-related adverse events. In multivariate analysis, ≥2 ERCP sessions (odds ratio [OR], 4.762; 95% confidence interval [CI], 1.472-15.402; P = .009) and a CBD stone size ≥ 12 mm (OR, 3.213; 95% CI, 1.140-9.057; P = .027) were significant. CONCLUSIONS: ERCP using a cap-fitted forward-viewing endoscope with EPBD is feasible in Billroth II gastrectomy patients. In patients with ≥2 ERCP sessions or a CBD stone size ≥ 12 mm, special attention should be paid to the possible occurrence of significant adverse events.

Choline Essentiality and Its Requirement in Diets for Juvenile Parrot Fish (Oplegnathus fasciatus).

A 12-wk feeding trial was conducted to evaluate the essentiality of choline supplementation in diets for parrot fish. Five isonitrogenous and isocaloric diets were supplemented with 0 (as control), 500, 1,000, and 2,000 mg choline per kg diet, and a positive control diet without choline contained 0.3% of 2-amino-2-methyl-1-propanol as choline biosynthesis inhibitor (designated as Con, C500, C1000, C2000 and Con(+), respectively). Triplicate groups of fish (body weight, 8.8±0.01 g) were fed one of the experimental diets at a rate of 4% body weight twice daily. The fish fed Con(+) diet revealed significantly lower growth performance and feed utilization efficiency than other fish groups. Supplementation of choline to the basal diet did not significantly influence fish growth. The highest liver lipid content was observed in fish fed the Con(+) diet and inversely correlated with liver choline concentration although the differences were not significant. Also, significantly higher liver linoleic, eicosapentaenoic and docosahexaenoic acid contents were found in fish fed the Con(+) diet. Innate immune parameters including respiratory burst and myeloperoxidase activities were not significantly affected by dietary choline levels. The findings in this study conclude that choline concentration of approximately 230 mg kg(-1) diet meets the requirement of parrot fish.

Randomised phase II trial of photodynamic therapy plus oral fluoropyrimidine, S-1, versus photodynamic therapy alone for unresectable hilar cholangiocarcinoma.

BACKGROUND: Hilar cholangiocarcinoma is an uncommon cancer and its overall incidence is increasing. Photodynamic therapy (PDT) has been proposed as palliative management for unresectable hilar cholangiocarcinoma (UHC). To date, little is known about the role of the addition of systemic chemotherapy to PDT for UHC. We performed a prospective, randomised, phase II trial to compare PDT plus S-1 and PDT alone for UHC. METHODS: Patients with UHC were randomly assigned (in a 1:1 ratio) to PDT plus S-1 or PDT alone. The primary end-point was overall survival. The secondary end-points were progression-free survival, complications, re-intervention rate and quality of life. This trial is registered with clinicalTrials.gov, number NCT00869635. FINDINGS: Between February 2009 and May 2012, we randomly assigned 21 patients to receive PDT plus S-1 and 22 to receive PDT alone. The UHC patients treated with PDT plus S-1 showed higher 1-year survival rate compared with the patients treated with PDT alone (76.2% versus 32%, P=0.003) and prolonged overall survival (median 17 months, 95% confidence interval [CI]: 12.6-21.4, versus 8 months, 95% CI: 6-10, P=0.005, hazard ratio [HR], 0.36; 95% CI: 0.17-0.75). Regarding the secondary end-points, PDT plus S-1 was associated with prolonged progression-free survival compared with PDT alone (median 10 months [95% CI: 4.1-16] versus 2 months [95% CI: 0.4-3.5], P=0.009 (HR for progression 0.39, 95% CI: 0.19-0.83). There were no differences in the number of PDT sessions, the frequency of cholangitis, overall adverse events or the quality of life in either group. INTERPRETATIONS: PDT plus S-1 was well tolerated and was associated with a significant improvement of overall survival and progression-free survival compared with PDT alone in patients with UHC. These findings warrant further clinical investigation of PDT plus S-1 in patients with UHC.

Clinical characteristics of intraductal papillary mucinous neoplasm manifesting as acute pancreatitis or acute recurrent pancreatitis.

BACKGROUND AND AIM: Comparatively little is known about acute pancreatitis or acute recurrent pancreatitis (AP/ARP) with intraductal papillary mucinous neoplasm of the pancreas (IPMN) as the causative lesion although there have been many reports about the malignant potential of IPMN as a premalignant lesion. METHODS: From 2000 to 2008, in a single tertiary referral center, out of 784 patients coded by the International Classification of Disease-10 with IPMN, 489 patients fulfilled our diagnostic criteria of IPMN. After careful exclusion of all known causes of AP/ARP, 34 patients with IPMN as the cause of AP/ARP were enrolled. RESULTS: AP/ARP caused by IPMN occurred in 34 (7%) out of 488 patients with IPMN, and the prevalence rate of AP/ARP was higher in the main-duct/combined type than in the branch-duct type (14% [16/111] vs 5% [18/378], respectively, P = 0.002). The severity of pancreatitis was mild, based on the computed tomography severity index score (median 2, range 0-4). Histologic review of 24 patients with surgical resection revealed four adenomas (17%), 17 borderline malignancies (71%), two carcinomas in situ (8%), and one invasive carcinoma (4%). AP/ARP did not recur in any of the 24 surgically resected patients during the follow-up period (median 52 months, range 38-115 months). CONCLUSIONS: AP/ARP caused by IPMN was of infrequent occurrence. AP/ARP caused by IPMN occurred more frequently in the main-duct/combined type than in the branch-duct type. Most cases were mild in severity and benign in histopathology. AP/ARP can be an initial manifestation of IPMN, though uncommon, which leads to diagnosis.

EUS-guided radiofrequency ablation of the porcine pancreas.

BACKGROUND: EUS-guided radiofrequency ablation (EUS-RFA) could be used as an adjunct and effective alternative mode of treatment for unresectable locally advanced and nonmetastatic pancreatic adenocarcinoma. However, its translation into clinical practice has been restricted because of limited data and high procedure-related risk. OBJECTIVE: To evaluate the feasibility, efficacy, and safety of EUS-RFA in the normal porcine pancreas. DESIGN: Prospective, endoscopic, experimental study in a porcine model. SETTING: Tertiary-care referral center animal laboratory. PATIENTS: Animal study. INTERVENTION: EUS-RFA of the pancreas was attempted on 10 adult mini pigs. An 18-gauge endoscopic RFA electrode was used to puncture the body and tail of the pancreas, with an output power of 50 W for 5 minutes. MAIN OUTCOME MEASUREMENTS: The feasibility, efficacy, and safety of EUS-RFA. RESULTS: A spherical necrotic lesion surrounded by fibrous tissue localized in the pancreatic parenchyma was observed on histopathologic examination. The mean diameter of the ablated tissue was 23.0 ± 6.9 mm. No major procedure-related complications were noted, and all pigs survived without any distress behavioral pattern for 7 days until autopsy. LIMITATIONS: Small sample size with short-term observation and the lack of evaluation of the head of the pancreas. CONCLUSION: EUS-RFA of the pancreatic body and tail was feasible, effective, and relatively safe in a porcine model. More animal studies to assess damage to adjacent organs are required before human trials can be conducted.

Osteoinductive activity of biphasic calcium phosphate with different rhBMP-2 doses in rats.

OBJECTIVE: The aim of the current study was to determine whether a hydroxyapatite (HA)/beta-tricalcium phosphate (ß-TCP) ratio of 20/80 impregnated with recombinant human bone morphogenetic protein (rhBMP-2) enhances new bone formation and to evaluate the dose-dependent response of rhBMP-2. STUDY DESIGN: Critical-sized calvarial defects were made in rats, and biphasic calcium phosphate (BCP) with different rhBMP-2 doses was loaded into rat calvarial defects. The animals were allowed to heal for either 2 or 8 weeks. RESULTS: The percentages of new bone after 2 and 8 weeks of healing were significantly greater in the rhBMP-2-treated groups (at all doses) than in the control groups. The percentage of remaining BCP was significantly lower at 8 weeks than at 2 weeks in all groups that included BCP. CONCLUSIONS: rhBMP-2 administered using a BCP carrier significantly induces new bone formation. A dose-dependent response was not shown in the present study.

Diagnostic role of endoscopic ultrasonography-guided fine needle aspiration of gallbladder lesions.

BACKGROUND/AIMS: Endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) is a well-established diagnostic technique for examining various organs of the gastrointestinal tract and pancreas, but little is known about its use in the diagnostic work-up of GB lesions. The objective of this retrospective study was to evaluate the efficacy of EUS-FNA of GB lesions. METHODOLOGY: Twenty-eight patients who underwent EUS-FNA for evaluation of GB lesions were enrolled. The pathological results and complications were assessed. RESULTS: EUS-FNA of GB was performed in 13 patients and that of enlarged lymph nodes was done in 18. Of the 13 GB lesions sampled by EUS-FNA, 10 were diagnosed as malignant and 3 were negative for malignant cells. Of the latter 3, two were false negatives for malignancy. All 14 metastatic lymphadenopathy cases were diagnosed with EUS-FNA of lymph nodes. EUS-FNA could differentiate adenocarcinomas and other malignant diseases. Cholecystitis occurred in one patient after EUS-FNA of the GB. CONCLUSIONS: EUS-FNA is a feasible, safe and reliable method for obtaining samples from GB lesions. EUS-FNA of lymph nodes is complementary to EUS-FNA of the GB and provides nodal stage as well as histological diagnosis.

Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis.

BACKGROUND & AIMS: Endoscopic ultrasound-guided transmural gallbladder drainage (EUS-GBD) is an alternative to percutaneous transhepatic gallbladder drainage (PTGBD) for patients with acute, high-risk, or advanced-stage cholecystitis who do not respond to initial medical treatment and cannot undergo emergency cholecystectomy. However, the technical feasibility, efficacy, and safety of EUS-GBD and PTGBD have not been compared. METHODS: Fifty-nine patients with acute cholecystitis, who did not respond to initial medical treatment and were unsuitable for an emergency cholecystectomy, were chosen randomly to undergo EUS-GBD (n = 30) or PTGBD (n = 29). The technical feasibility, efficacy, and safety of EUS-GBD and PTGBD were compared. RESULTS: EUS-GBD and PTGBD showed similar technical (97% [29 of 30] vs 97% [28 of 29]; 95% 1-sided confidence interval lower limit, -7%; P = .001 for noninferiority margin of 15%) and clinical (100% [29 of 29] vs 96% [27 of 28]; 95% 1-sided confidence interval lower limit, -2%; P = .0001 for noninferiority margin of 15%) success rates, and similar rates of complications (7% [2 of 30] vs 3% [1 of 29]; P = .492 in the Fisher exact test) and conversions to open cholecystectomy (9% [2 of 23] vs 12% [3 of 26]; P = .999 in the Fisher exact test). The median post-procedure pain score was significantly lower after EUS-GBD than after PTGBD (1 vs 5; P < .001 in the Mann-Whitney U test). CONCLUSIONS: EUS-GBD is comparable with PTGBD in terms of the technical feasibility and efficacy; there were no statistical differences in the safety. EUS-GBD is a good alternative for high-risk patients with acute cholecystitis who cannot undergo an emergency cholecystectomy.

Comparison of clinical findings between histologically confirmed type 1 and type 2 autoimmune pancreatitis.

BACKGROUND AND AIM: Type 2 autoimmune pancreatitis (AIP) has been reported mainly in Western countries and is thought to be very rare in Asia. The aim of this study was to compare the prevalence, clinical profiles, detailed radiological findings, and steroid responsiveness between type 1 and type 2 AIP in Korea. METHODS: From 120 patients diagnosed with AIP between January 2003 and August 2010, 52 patients with histologically confirmed type 1 (n = 37) or type 2 (n = 15) AIP were included. RESULTS: The median age of patients with type 2 AIP was significantly lower than that of patients with type 1 AIP (61 vs 34 years, P < 0.05). At initial presentation, severe abdominal pain and presentation with acute pancreatitis were more frequent in patients with type 2 AIP (P < 0.05). On computed tomography scan, the extent of pancreatic enlargement and the frequency of low-density mass did not differ significantly between the two groups. Detailed pancreatographic findings on endoscopic retrograde cholangiopancreatography/magnetic resonance cholangiopancreatography were not significantly different between the two groups. All patients with steroids therapy improved clinically and radiologically in response (25/25 in type 1 AIP and 14/14 in type 2 AIP). During the follow-up period, none of the patients with type 2 AIP experienced relapse. CONCLUSIONS: Type 2 AIP in all histologically confirmed AIP cases in Korea may not be as rare as originally thought, with an estimated prevalence rate of 28.8% (15/52). The detailed radiological findings of type 1 and type 2 AIP were not significantly different, and both subtypes responded well to steroids.

Randomized clinical trial on the efficacy of Escherichia coli-derived rhBMP-2 with ß-TCP/HA in extraction socket.

PURPOSE: This randomized clinical trial was conducted to assess the safety and effectiveness of the ErhBMP-2 in alveolar bone regeneration as well as preservation of the ß-TCP bone graft material that contains ErhBMP-2. MATERIALS AND METHODS: This study involved 72 patients at the 3 study centers. The patients, who were divided into 2 groups: the experiment group who had ErhBMP-2 coated TCP/HA and the control group who had TCP/HA graft material alone transplanted immediately after tooth extraction. CT was taken before and 3 months after the transplantation and healing status was compared between the two groups. The efficacy endpoints that were used to measure the degree of bone induction included alveolar bone height and 3 measurements of bone width. The paired t test was used to determine the significance of the changes (P<.05). RESULTS: Changes in alveolar bone height were -1.087 ± 1.413 mm in the control group and -.059 ± 0.960 mm in the experimental group (P<.01). At 25% extraction socket length [ESL], the changes were 0.006 ± 1.149 mm in the control group and 1.279 ± 1.387 mm in the experimental group. At 50% ESL, the changes were 0.542 ± 1.157 mm and 1.239 ± 1.249 mm, respectively (P<.01 for 25% ESL, and P<.05 for 50% ESL). During the experiment, no adverse reactions to the graft material were observed. CONCLUSION: ErhBMP-2 coated ß-TCP/HA were found to be more effective in preserving alveolar bone than conventional ß-TCP/HA alloplastic bone graft materials.