Gheorghe L

Contrast-enhanced ultrasound (CEUS) for the evaluation of focal liver lesions - a prospective multicenter study of its usefulness in clinical practice.

PURPOSE To assess the value of contrast-enhanced ultrasound (CEUS) for differentiating malignant from benign focal liver lesions (FLLs) and for diagnosing different FLL types. MATERIAL AND METHODS CEUS performed in 14 Romanian centers was prospectively collected between February 2011 and June 2012. The inclusion criteria were: age > 18 years; patients diagnosed with 1 - 3 de novo FLLs on B-mode ultrasound; reference method (computed tomography (CT), magnetic resonance imaging (MRI) or biopsy) available; patients informed consent. FLL lesions were characterized during CEUS according to the European Federation of Societies for Ultrasound in Medicine and Biology guidelines. For statistical analysis, indeterminate FLLs at CEUS were rated as false classifications. RESULTS A total number of 536 cases were included in the final analysis, 344 malignant lesions (64.2 %) and 192 benign lesions (35.8 %). The reference method was: CT/MRI - 379 cases (70.7 %), pathological exam - 150 cases (27.9 %) and aspiration of liver abscesses - 7 cases (1.4 %). CEUS was conclusive in 89.3 % and inconclusive in 10.7 % of cases. To differentiate between malignant and benign FLLs, CEUS had 85.7 % sensitivity, 85.9 % specificity, 91.6 % positive predictive value, 77.1 % negative predictive value and 85.8 % accuracy. The CEUS accuracy for differentiation between malignant and benign liver lesions was similar in tumors with diameter ≤ 2 cm and those with diameter > 2 cm. CONCLUSION CEUS represents a useful method in clinical practice for differentiating between malignant and benign FLLs detected on standard ultrasonography, and the results of this study are in concordance with previous multicenter studies: DEGUM (Germany) and STIC (France).

Evaluation of Tumor Response Using Alpha-fetoprotein and Des-gamma-carboxy Prothrombin in Hepatocellular Carcinoma Patients Who Underwent Transarterial Chemoembolization

Introduction: The aim of the study is to evaluate the role of alpha-fetoprotein (AFP) and des-y-carboxy prothrombin (DCP) in the assessment of treatment response at one month in patients with hepatocellular carcinoma (HCC) treated with trans-arterial chemoembolization (TACE). Methods: From March 2016 to April 2017 a number of 59 patients diagnosed with HCC were prospectively enrolled. A TACE procedure as initial treatment modality was performed in 41 patients. AFP and DCP serum levels were measured and clinical features were determined for all the patients that were included. The Wilcoxon rank test was used to compare variables at baseline and at one month after the procedure. Results: Treatment was performed in 86.4% of the patients diagnosed with HCC, 27 patients received a classical TACE procedure, 14 patients were treated with DEB-TACE, radiofrequency ablation was performed in 3 patients and 4 patients received a liver transplant as initial treatment. Systemic therapy with Sorafenib was started in 3 patients (5%) and in 8 cases no treatment was performed. AFP value significantly decreased at one month in patients that underwent TACE therapy (median value 240.3 vs. 123.7 ng/mL, p=0.020). The same significant decrease was noted for DCP values (median value 1376.8 vs. 769 mAU/mL, p=0.0033). Both AFP (85.5 vs. 18.7 ng/mL, p=0.035) and DCP values (693.2 vs. 58.2 ng/mL, p=0.0003) were significantly lower only in subjects who achieved complete response after TACE and not in patients with partial response. In patients treated with TACE therapy, there was a down-sizing of the maximum diameter of the tumor nodule (30 vs. 27 mm, p=0.02). CONCLUSION There was a significant decrease of AFP and DCP values after complete response in HCC patients treated with TACE. DCP is a more effective tumor marker in predicting response than AFP, with no benefit found in their combination.

Sa1263 Endoscopic Follow Up of Patients With IBD and Biological Treatment: Achievement and Persistence of Mucosal Healing in Patients With Clinical Remission

Background and aim: Biological therapy is now the mainstay treatment for the patients with moderate/severe IBD. The efficacy of treatment is no longer measured only in the induction of clinical remission, endoscopic healing being considered more important since its achievement can influence the long term outcome of the disease. The majority of clinical trials report endoscopic results after one year of maintenance treatment. The aim of our study was to observe the frequency of mucosal healing and its persistence in a group of IBD patients with clinical response to biological therapy during long term follow up (over 2 years). Methods: All patients with IBD that received biological treatment admitted in our department were prospectively followed. In all ileocolonoscopies were performed at 6 months intervals with description of all lesions encountered (periodic endoscopic or radiologic evaluations are part of the protocol issued by National Health Insurance House and are required for the approval of reimbursed biological treatment). Mucosal healing (MH) was defined as lack of ulcers, ulcerations or aftous erosions. The presence of erythema, edema, and inflammatory pseudopolyps did not preclude the diagnosis of MH. Demographic and clinical data were noted as well as the type, dose, and frequency of biological and associated (e.g. immunosuppressive) treatments. Only patients treated over 2 years were included in the analysis. Results: 52 patients (27 males, 25 females, mean age 36.9+/-12.2 years) received biological therapy (38 infliximab and 14 adalimumab) for a period longer than 24 months (24-72, mean 38.67 months), 43 with Crohns disease (CD) and 9 with ulcerative colitis (UC). Mucosal healing was obtained in 80.77% patients. The mean time to MH was of 10.85 (6-36) months. 26.19% of patients needed more than one year to achieve MH. From patients with MH, 40.48% experienced recurrent endoscopic lesions and clinical flare during follow up. The only factor associated with long term MH (maintained during the observation period) was the presence of MH 6 months after initiation of maintenance treatment with biologics (p=0.022). The combined treatment with immunosupressors or the use of biological therapy at first flare of disease did not influence the occurrence or persistence of MH in our group of patients. Conclusions: In patients with clinical remission obtained with biological treatment long term endoscopic follow up shows that mucosal healing can be achieved in the majority of cases. A rapid endoscopic response (mucosal healing after the first 6 months of maintenance therapy) predicts sustained, long term, endoscopic remission.

Treatment of hepatitis C genotype 1 patients with severe fibrosis or compensated cirrhosis: the telaprevir early access program in patients from Romania

Methods Patients were treated with telaprevir in combination with peginterferon alfa and ribavirin (PR) for 12 weeks, followed by PR for 12 or 36 weeks. Severe fibrosis/cirrhosis was defined by liver biopsy (Metavir F3-4 or Ishak 3-6) or noninvasive tests. Platelet count >90,000/cmm was required at entry. HCV RNA was evaluated at baseline and Weeks 4 and 12 of treatment. Virological response was defined as serum HCV RNA not detected, for the Intent to Treat (ITT) population.

Management and outcomes of side effects with focus on anaemia in patients with hepatitis C genotype 1 infection: the telaprevir early access program in patients from Romania

Management and outcomes of side effects with focus on anaemia in patients with hepatitis C genotype 1 infection: the telaprevir early access program in patients from Romania Adrian Streinu-Cercel, Anca Victorița Trifan, Florin Alexandru Căruntu, Ioan Sporea, Liliana Simona Gheorghe, Manuela Curescu, Mihai Mircea Diculescu, Mihai Voiculescu, Oliviu Pascu, Isabelle Lonjon-Domanec, Andrew Martin Hill, Sorin Rugină