G. Parisi

Long-term maintenance treatment in ulcerative colitis: a 10-year follow-up.

BACKGROUND With the extensive use of mesalamine, the natural history of ulcerative colitis is probably changed. AIM To evaluate the relapse rate and the duration of remission in patients with ulcerative colitis on maintenance treatment with mesalamine. PATIENTS AND METHODS Enrolled in the study were 95 patients divided into 4 groups according to macroscopic location of the disease and treated with the same therapy starting from the date of enrolment. Patients in all 4 groups were followed-up until relapse occurred. The disease activity was evaluated by the Clinical Activity Index and Endoscopic Index. Patients suitable for recruitment showed a Clinical Activity Index and Endoscopic Index lower than 6 and 4, respectively. The patients with ulcerative pancolitis or left-sided colitis were treated with 1.6 g/day while the cases with proctosigmoiditis or proctitis were treated with 5-acetylsalicylic acid enemas 4 g/day Each patient was evaluated with clinical and endoscopic assessment at a 6-month interval. Relapse was defined as an increase in Clinical Activity Index and Endoscopic Index, of more than 6 and 4, respectively. RESULTS Five patients dropped-out. All enrolled patients showed a clinical and/or endoscopic relapse within 10 years, the majority 2 or 3 years after diagnosis: pancolitis and left-sided colitis within 2-3 years and patients with distal colitis within 9-10 years. CONCLUSIONS A relapse was observed in most cases within 3 years, and in all recruited patients within a space of ten years. The extent of the disease in the colon is an important prognostic factor, as patients with distal colitis showed a lesser tendency to relapse.

High-dose interferon plus ribavirin in chronic hepatitis C not responding to recombinant alpha-interferon.

BACKGROUND Recently, the combination treatment of recombinant alpha-interferon plus ribavirin has been proposed for chronic hepatitis C patients unresponsive to previous therapy with recombinant alpha-interferon alone. AIM To determine the effectiveness of the combination therapy for the re-treatment of chronic hepatitis C patients unresponsive to previous interferon therapy. Immediate and long-term follow-up data are reported. PATIENTS AND METHODS A series of 100 patients with chronic hepatitis C not responding to recombinant alpha-interferon 3 MU tiw, were randomly assigned to two groups of 50 patients each: Group A, treated with recombinant alpha-interferon therapy for an additional six months but at a double dosage (6 MU tiw) in association with ribavirin. Group B, same treatment as group A but without ribavirin. All patients responsive to therapy were then followed-up for at least 12 months. At the end of the treatment and at the end of the follow-up period, we distinguished between complete responses (return to normal of alanine aminotransferase with undetectable serum HCV-RNA] and biochemical responses (return to normal of alanine aminotransferase still with detectable viraemia). RESULTS Side-effects were observed only in patients treated with recombinant alpha-interferon plus ribavirin: 12% discontinued the therapy due to haemolytic anaemia. In group A, the percentages of end-of-treatment complete response, end-of-treatment biochemical response, sustained complete response, and sustained biochemical response, were 38%, 20%, 8%, and 14%, respectively, whilst in group B, these percentages were 12%, 16%, 6%, and 16%, respectively. CONCLUSION The results indicate that in patients with chronic hepatitis C unresponsive to previous recombinant alpha-interferon therapy, re-treatment with higher recombinant alpha-interferon doses, either alone or in combination with ribavirin, lead to mild long-term benefit. However, the satisfactory end of treatment complete response in group A suggests that a significant percentage of patients are sensitive to the combination therapy; and that a more aggressive therapeutic protocol in this selected subset of patients could result in a larger number of long-lasting responses leading, in turn, to a more favourable cost-effect ratio.

Adherence to EASL-EORTC clinical guidelines for the management of hepatocellular carcinoma in field practice: Results from the ITALICA database

Introduction: Data on adherence to joint guidelines for the management of hepatocellular carcinoma (HCC) published in 2012 by the European Association for the Study of the Liver (EASL) and the European Organization for Research and Treatment of Cancer (EORTC) are lacking. Aim: We retrospectively evaluated the adherence to EASLEORTC guidelines in field-practice, using data from HCC patients registered in the Nation-wide Italian database ITA.LI.CA. and diagnosed from 2012. Methods: The ITA.LI.CA. database contains data of 5428 HCC patients treated at 18 Italian Centers. Patients were stratified according to Child-Pugh (CP) and and the Barcelona Clinic Liver Cancer (BCLC) classifications. We investigated the adherence to surveillance, diagnosis, and first-line treatment recommendations. Results: In ITALICA, 600 patients were diagnosed of HCC since 2012 (466 males; mean± SD age 67.4±10.9 years; 277(46.2%) CP-A and 163(27.2%) CP-B; 44(8%) BCLC-0, 193(35.1%) BCLC-A, 93(16.9%) BCLC-B, 172(31.3%) BCLC-C, 48(8.7%) BCLC-D). Overall, 317(55.2%) were diagnosed during a surveillance program. Of them, 231(57.9%) were cirrhotic (median surveillance duration: 6 months). Four-hundred-ninety-six (85.3%, 449 cirrhotic) patients were diagnosed applying a radiological, 80(13.7%) a histological, and6(1%) a cytological criterion. Five (9.7%) patients in BCLC stage 0 with CPA, and single nodules underwent tumour resection; 3(1.4%) patients in BCLC-A received liver transplantation, and 83(43.1%) received radiofrequency ablation or Percutaneous Ethanol Injection. Intermediate HCC-stage patients (BCLC-B) receiving TACE were 45(47.9%), and advanced-stage patients (BCLC-C) receiving sorafenib were 38(21.9%). Palliative care was provided to terminal stage patients (BCLC-D) in 31(64.3%) cases. Conclusions: Theoverall adherence in a “real-world” practice to EASL-EORTC guidelines was low, particularly in patients with early stageHCC. Difficulties inpatients staging and the high prevalence of older patients with relevant co-morbidities may partially explain these findings. Strategies to help improve adherence to international guidelines for HCC in field-practice and new scoring criteria are required.

OC.02.5: ENDOTICS SYSTEM VS COLONSCOPY FOR THE DETECTION OF POLYPS

Background and aim: To compare the endotics system (ES), a set of new medical equipment for diagnostic colonoscopy, with video-colonoscopy in the detection of polyps. Material and methods: Patients with clinical or familial risk of colonic polyps/carcinomas were eligible for this study. After a standard colonic cleaning, detection of polyps by the ES and by video-colonoscopy was performed in each patient on the same day. In each single patient, the assessment of the presence of polyps was performed by two independent endoscopists, who were randomly assigned to evaluate, in a blind fashion, the presence of polyps either by ES or by standard colonoscopy. The frequency of successful procedures (i.e. reaching to the cecum), the time for endoscopy, and the need for sedation were recorded. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the ES were also calculated. Results: A total of 71 patients (40 men, mean age 51.9±12.0 years) were enrolled. The cecum was reached in 81.6% of ES examinations and in 94.3% of colonoscopies (P = 0.03). The average time of endoscopy was 45.1±18.5 and 23.7±7.2 min for the ES and traditional colonoscopy, respectively (P<0.0001). No patient required sedation during ES examination, compared with 19.7% of patients undergoing colonoscopy (P < 0.0001). The sensitivity and specificity of ES for detecting polyps were 93.3% (95% CI: 68-98) and 100% (95% CI: 76.8-100), respectively. PPV was 100% (95% CI: 76.8-100) and NPV was 97.7% (95% CI: 88-99.9). Conclusions: The ES allows the visualization of the entire colonic mucosa in most patients, with good sensitivity/specificity for the detection of lesions and without requiring sedation.