AIM:To evaluate the long-term treatment outcomes of tenofovir therapy in patients in a real world Australian tertiary care setting.METHODS:We performed a retrospective analysis of treatment outcomes among treatment-naïve and treatment-experienced patients receiving a minimum 3 mo tenofovir therapy through St Vincent's Hospital Melbourne, Australia. We included patients receiving tenofovir [tenofovir disoproxil fumarate (TDF)] monotherapy, as well as patients treated with TDF in combination with a second antiviral agent. Patients were excluded if they demonstrated human immune-deficiency virus/hepatitis C virus/hepatitis delta virus coinfection or were less than 18 years of age. We considered virological and biochemical response, as well as safety outcomes. Virological response was determined by measurement of hepatitis B virus (HBV) DNA using sensitive assays; biochemical response was determined via serum liver function tests; histological response was determined from liver biopsy and fibroscan; safety analysis focused on glomerular renal function and bone mineral density. The primary efficacy endpoint was complete virological suppression over time, defined by HBV DNA < 20 IU/mL. Secondary efficacy endpoints included rates of biochemical response, and HB e antigen (HBeAg)/HB surface antigen loss and seroconversion over time.RESULTS:Ninety-two patients were identified who fulfilled the enrolment criteria. Median follow-up was 26 mo (range 3-114). Mean age was 46 (24-78) years, 64 (70%) were male and 77 (84%) were of Asian origin. 55 (60%) patients were treatment-naïve and 62 patients (67%) were HBeAg-negative. Complete virological suppression was achieved by 45/65 (71%) patients at 12 mo, 37/46 (80%) at 24 mo and 25/28 (89%) at 36 mo. Partial virological response (HBV DNA 20-2000 IU/mL) was achieved by 89/92 (96.7%) of patients. Multivariate analysis showed a significant relationship between virological suppression at end of follow-up and baseline HBV DNA level (OR = 0.897, 95%CI: 0.833-0.967, P = 0.0046) and HBeAg positive status (OR = 0.373, 95%CI: 0.183-0.762, P = 0.0069). There was no difference in response comparing treatment-naïve and treatment-experienced patients. Three episodes of virological breakthrough occurred in the setting of non-compliance. Tenofovir therapy was well tolerated.CONCLUSION:Tenofovir is an efficacious, safe and well-tolerated treatment in an Australian real-world tertiary care setting. Our data are similar to the reported experience from registration trials.
Routine intra-op use of transesophageal echocardiography may cause severe GI bleeding, especially for trans-gastric view. Early detection and timely management are essential for salvage.
BACKGROUND AND AIM:IL28B genotype predicts response to pegylated interferon (peg-IFN)-based therapy in chronic hepatitis C. However, the utility of IL28B genotyping in chronic hepatitis B (CHB) cohorts treated with peg-IFN is unclear. It was investigated whether IL28B genotype is associated with peg-IFN treatment outcomes in a predominantly Asian CHB cohort. METHODS:This was a retrospective analysis of CHB patients treated with 48 weeks of peg-IFN monotherapy. IL28B genotype (rs12979860) was determined (TaqMan allelic discrimination kit). Baseline hepatitis B virus (HBV)-DNA, alanine aminotransferase, and liver histology were available. The primary end-points were HBV e antigen (HBeAg) seroconversion with HBV-DNA < 2000 IU/mL 24 weeks post-therapy (HBeAg-positive patients) and HBV-DNA < 2000 IU/mL 24 weeks after peg-IFN (HBeAg-negative patients). The association between IL28B genotype and peg-IFN outcomes was analyzed. RESULTS:IL28B genotype was determined for 96 patients. Eighty-eight percent were Asian, 62% were HBeAg positive, and 13% were METAVIR stage F3-4. Median follow-up time was 39.3 months. The majority of patients carried the CC IL28B genotype (84%). IL28B genotype did not differ according to HBeAg status. The primary end-points were achieved in 27% of HBeAg-positive and 61% of HBeAg-negative patients. There was no association between IL28B genotype and the primary end-point in either group. Furthermore, there was no difference in HBeAg loss alone, HBV surface antigen, alanine aminotransferase normalization, or on-treatment HBV-DNA levels according to IL28B genotype. CONCLUSIONS:In the context of a small possible effect size and high frequency in Asian populations, IL28B genotyping is likely to have, at best, limited clinical utility for predicting peg-IFN treatment outcome for CHB patients in the Asia-Pacific region.
ANZ Journal of SurgeryVolume 82, Issue 4 p. 282-283 Endoscopic ultrasound-guided fine needle aspirate: a useful method in the diagnosis of pancreatic tuberculosis Quetzalihuitl Arroyo Martínez MD, Quetzalihuitl Arroyo Martínez MD Department of Gastroenterology, Virgen Macarena's Hospital, Seville, SpainSearch for more papers by this authorPeter DeCruz MBBS, FRACP, Peter DeCruz MBBS, FRACP Department of Gastroenterology, St. Vincent's HospitalSearch for more papers by this authorAravinth Murugananthan MBBS, MRCP, Aravinth Murugananthan MBBS, MRCP Department of Gastroenterology, Western Health, Melbourne, AustraliaSearch for more papers by this authorPaul Desmond MBBS, FRACP, Paul Desmond MBBS, FRACP Department of Gastroenterology, St. Vincent's HospitalSearch for more papers by this authorRobert Chen MD, FRACP, Robert Chen MD, FRACP Department of Gastroenterology, St. Vincent's HospitalSearch for more papers by this author Quetzalihuitl Arroyo Martínez MD, Quetzalihuitl Arroyo Martínez MD Department of Gastroenterology, Virgen Macarena's Hospital, Seville, SpainSearch for more papers by this authorPeter DeCruz MBBS, FRACP, Peter DeCruz MBBS, FRACP Department of Gastroenterology, St. Vincent's HospitalSearch for more papers by this authorAravinth Murugananthan MBBS, MRCP, Aravinth Murugananthan MBBS, MRCP Department of Gastroenterology, Western Health, Melbourne, AustraliaSearch for more papers by this authorPaul Desmond MBBS, FRACP, Paul Desmond MBBS, FRACP Department of Gastroenterology, St. Vincent's HospitalSearch for more papers by this authorRobert Chen MD, FRACP, Robert Chen MD, FRACP Department of Gastroenterology, St. Vincent's HospitalSearch for more papers by this author First published: 21 March 2012 https://doi.org/10.1111/j.1445-2197.2012.06006.xCitations: 1Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat References 1 Lumb R, Bastian I, Carter R et al. Tuberculosis in Australia: bacteriologically confirmed cases and drug resistance, 2008 and 2009. Commun. Dis. Intell. 2011; 35: 154–61. 2 Nair N, Wares F, Sahu S. Tuberculosis in the WHO south-east asia region. Bull. World Health Organ. 2010; 88: 164. 3 Paraf A, Menager C, Texier J. Tuberculosis of the pancreas and tuberculosis of yhe lymph nodes of upper region of the abdomen. Rev. Med. Chir. Mal. Foie 1966; 41: 101–26. 4 Song TJ, Lee SS, Park DH et al. Yield of EUS-guided FNA on the diagnosis of pancreatic/peripancreatic tuberculosis. Gastrointest. Endosc. 2009; 69: 484–91. Citing Literature Volume82, Issue4April 2012Pages 282-283 ReferencesRelatedInformation
Background and Aim: Diminutive polyps measuring <= 5 mm in size constitute 80% of polyps in the colon. We prospectively assessed the performance of high-definition white light endoscopy (hWLE) and narrow band imaging (NBI) in differentiating diminutive colorectal polyps.Methods: In this prospective, multicenter study, videos of 50 diminutive polyps (31 hyperplastic, 19 adenomatous) in hWLE followed by NBI (total 100 videos) were initially obtained and placed in random order into five separate folders (each folder 20 videos). Eight endoscopists were then invited to predict the histology (each endoscopist 100 videos, 800 video assessments in all). Polyps were classified into types 1-3 (hyperplastic) and type 4 (adenoma). Feedback on individual performance was given after each folder (20 videos) was assessed.Results: The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in differentiating hyperplastic from adenomatous polyps by hWLE (400 videos) and NBI (400 videos) were 67.8%, 90.7%, 81.7%, 82.1%, and 82.0%; and 82.2%, 81.5%, 73.1%, 88.2%, and 81.8%, respectively. In the pretest and post-test analysis, the accuracy with NBI improved markedly from 68.8% to 91.3% (P = 0.001) compared with hWLE, 76.3-78.8% (P = 0.850). Overall, the interobserver agreement was 0.46 for hWLE (moderate) and 0.64 for NBI (good).Conclusions: NBI was as accurate as hWLE in differentiating diminutive colorectal polyps. Once a learning curve was reached, NBI achieved significantly higher accuracies with good interobserver agreement. Using a simplified classification, a didactic learning session and feedback on performance, diminutive colorectal polyps could be predicted with high accuracies with NBI.
Background and Study Aims: Diagnostic yield of endoscopic ultrasound (EUS)-fine-needle aspiration (FNA) varies depending on the equipment used and the site targeted. Multiple needle passes are usually required to obtain a diagnosis. A new needle incorporating a side-port carries a theoretical advantage regarding acquisition of cytological material. The aim of the study was to demonstrate the safety and efficacy of the Olympus side-port needle in solid upper gastrointestinal indications. Patients and Methods: A prospective multicenter evaluation of patients referred for EUS-FNA for solid lesions was performed across six tertiary gastroenterology referral centers in four capital cities in Australia. The main outcome measures include cytological diagnosis, number of needle passes required for diagnosis and complication rates. Results: Thirty patients (17 men; 13 women) with a mean age of 67.5 years were studied. Indications included pancreatic or biliary mass in 24 patients, retroperitoneal or periduodenal mass in 2, enlarged lymph node in 2, a gastric submucosal tumor in 1 and a subcarinal mass in 1. The mean size of the lesions was 3.47 cm (range, 0.58 cm). All but one case had a diagnosis made (96.7%). The mean number of passes required to reach a diagnosis was 1.7. In neoplastic lesions the diagnosis was made with a mean of 1.6 passes. No complications were encountered. Conclusions: The new EUS-FNA needle with side port appears effective and safe in solid upper gastrointestinal EUS-FNA indications.
Background: Before a new test is introduced in clinical practice, evidence is needed to demonstrate that its use will lead to improvements in patient health outcomes. Studies reporting test accuracy may not be sufficient, and clinical trials of tests that measure patient health outcomes are rarely feasible. Therefore, the consequences of testing on patient management are often investigated as an intermediate step in the pathway. There is a lack of guidance on the interpretation of this evidence, and patient management studies often neglect a discussion of the limitations of measuring patient management as a surrogate for health outcomes.Methods: We discuss the rationale for measuring patient management, describe the common study designs and provide guidance about how this evidence should be reported.Results: Interpretation of patient management studies relies on the condition that patient management is a valid surrogate for downstream patient benefits. This condition presupposes two critical assumptions: the test improves diagnostic accuracy; and the measured changes in patient management improve patient health outcomes. The validity of this evidence depends on the certainty around these critical assumptions and the ability of the study design to minimise bias. Three common designs are test RCTs that measure patient management as a primary endpoint, diagnostic before-after studies that compare planned patient management before and after testing, and accuracy studies that are extended to report on the actual treatment or further tests received following a positive and negative test result.Conclusions: Patient management can be measured as a surrogate outcome for test evaluation if its limitations are recognised. The potential consequences of a positive and negative test result on patient management should be pre-specified and the potential patient benefits of these management changes clearly stated. Randomised comparisons will provide higher quality evidence about differences in patient management using the new test than observational studies. Regardless of the study design used, the critical assumption that patient management is a valid surrogate for downstream patient benefits or harms must be discussed in these studies.
Removal of small sessile colonic polyps is recommended to reduce the risk of colorectal cancer and to determine appropriate surveillance intervals. A number of resection techniques including snare devices, with or without electrocautery, can be used. This study prospectively audited the removal of small sessile polyps to compare safety of polypectomy techniques.
Background and Aim: Pegylated interferon-a (PEG-IFN) provides potential advantages over nucleos(t)ide analogues in the treatment of chronic hepatitis B (CHB) given its finite course, durability and lack of drug resistance. Much of the evidence is derived from controlled studies and it is unclear whether these results can be replicated in an everyday, non-controlled setting. The aim of this study was to examine the efficacy and tolerability of PEG-IFN-a2A in CHB patients in a clinical setting. Methods: Chronic hepatitis B patients treated with PEG-IFN-a2A (180 mu g/week, 48 weeks) at five tertiary hospitals were retrospectively identified. Baseline demographic and clinical data, on-treatment virological and serological responses and adverse events (AE) were recorded. Treatment outcomes were defined as alanine aminotransferase (ALT) normalization, hepatitis B virus DNA < 351 IU/mL and hepatitis B e antigen (HBeAg) seroconversion. Results: Sixty three HBeAg positive patients were identified (65% male, 80% born in Asia, 84% with viral loads > 6log IU/mL, 9.5% advanced fibrosis). Six months after therapy 46% achieved normalization of ALT, 16% had viral loads < 351 IU/mL and 32% achieved HBeAg seroconversion. 29 HBeAg negative patients were treated (75% male, 86% born in Asia, 48% had viral loads > 6log IU/mL, 24% advanced fibrosis). Six months post-treatment, 55% and 36% maintained a normalized ALT and HBV DNA < 351 IU/mL, respectively. Optimal viral suppression was maintained in 5075% of patients over 2 years of follow up. 6.5% of all patients discontinued therapy due to AEs. Conclusion: In everyday clinical practice PEG-IFN therapy in CHB is well tolerated and can achieve a similar efficacy to that seen in large controlled trials.
EUS education in the Americas (A. Chak): Medical education in the United States begins after 12 years of high school and 4 years of college. Following four years of medical school, which results in the MD degree and three years of internal medicine residency physicians become eligible for specialty training, a fellowship in gastroenterology. Physicians who are board certified in internal medicine learn basic endoscopy during their three years of gastroenterology training and then become eligible to take board examinations in gastroenterology. To become an endosonographer most physicians who are board certified or eligible in gastroenterology obtain EUS training during an additional year of apprenticed training generally at an academic University hospital where such training is available.
EUS FNA remains a challenge for many providers. Despite excellent results published from expert centers surveys from US centers has suggested a positive FNA results in only 71% of patients. Additionally, many authors have recommended as few as 5 passes are required for pancreatic masses to maximize the diagnostic yield. This is time consuming, and may lend itself to increased complications. Side-hole FNA (SH FNA) was developed recently by author AJK and Olympus Corporation and a pilot study (DDW 2009) demonstrated a possible benefit for solid lesions with an excellent cellular yield with fewer passes.
BACKGROUND:The impact of endoscopic ultrasonography (EUS) on the management of pancreatic cystic lesions remains unclear, and there are no published studies of the Australian experience in this area. The aim of this study was to review the experience of EUS for such lesions within our institution.METHODS:A retrospective review was undertaken of data collected prospectively over a two-year period within the EUS database of St. Vincent's Hospital. Patients who underwent EUS for suspected pancreatic cystic lesions were identified. Data were collected on demographic variables, EUS findings, the results of EUS-guided fine-needle aspiration (FNA) and the findings on clinical and radiological follow-up.RESULTS:Fifty-nine patients were identified. Two thirds were female. Most lesions were located at the pancreatic head. Median diameter was 25 mm. FNA was performed in 36 cases (61%). On cytology, six (17%) showed features of mucinous tumours and five (14%) showed adenocarcinoma. The remainder contained either non-specific benign cells or insufficient epithelial tissue. Follow-up data on 48 cases (83%), after a median duration of 15 months, revealed that 15 lesions (31%) had been resected, including six serous and six mucinous tumours. The level of carcinoembryonic antigen in FNA specimens appeared to be higher in mucinous than in serous neoplasms. Twenty-four lesions had undergone repeat radiological imaging: only three had grown in size.CONCLUSIONS:EUS and FNA are useful procedures for assessing pancreatic cystic lesions. Malignant features are demonstrated in only a small minority. The majority of the remainder show no signs of progression during follow-up.
80% of polyps encountered during colonoscopy are diminutive (≤ 5mm). The aims of this study was: 1) to evaluate the performance of White light endoscopy (WLE) vs Narrow Band Imaging (NBI) in differentiating diminutive adenomatous and hyperplastic colorectal polyps, 2) to assess the impact of a learning curve and 3) to validate a simplified classification for predicting polyp histology.
Pancreatic cystic lesions are increasingly detected incidentally with cross-sectional imaging. A significant proportion (10-15 percent) of these cysts are neoplastic (both pre-malignant and malignant). Endoscopic (EUS) has become an increasingly available modality in the diagnosis of pancreatic cyst neoplasms. However little is known as to whether EUS actually changes management in these patients. The aim of this study was to determine prospectively the impact of EUS in the management of pancreatic cysts.
Western endoscopists routinely use the term "large sessile polyp" to describe a heterogeneous group of adenomas. Large size is often presumed to correlate with increased likelihood of submucosal invasion (SMI) and biopsies taken for confirmation. We hypothesized that size is of lesser importance and simple endoscopic criteria can stratify the risk of SMI and inform endoscopic treatment strategies.
Although the diagnostic yield of capsule endoscopy (CE) for obscure gastrointestinal bleeding is high, some patients have no findings on CE. In this ongoing prospective trial we assess the predictive value of a combined Guaiac and FIT FOBT prior to CE for significant findings on CE.
Piecemeal EMR is the predominant technique for colonic LSTs (≥20mm) in the Western world. However, outcomes data are limited by retrospective, single operator/center studies, without intention to treat (ITT) analysis, standardized technique or comprehensive follow-up. We aimed to determine the safety, efficacy and predictors of success for EMR of colonic LSTs.