Effect of prophylactic endoscopic clipping for prevention of delayed bleeding after endoscopic papillectomy for ampullary neoplasm: a multicenter randomized trial
Park SW, Song TJ, Park JS, Jun JH, Park TY, Oh DW, Lee SS, Kim MH
BACKGROUND : Endoscopic clip placement is technically challenging using a duodenoscope, limiting their application for treatment of bleeding after endoscopic papillectomy. This study evaluated the efficacy of newly designed clips to prevent bleeding after endoscopic papillectomy. METHODS : Patients (n = 80) with suspected benign adenomas on the major papilla who were scheduled for endoscopic papillectomy with or without clipping were randomized. A new duodenoscope-compatible clip capable of being rotated, reopened, and repeatedly repositioned was used. The primary end point was incidence of delayed bleeding. RESULTS : The clipping procedure was successful in all patients. The incidence of delayed bleeding was nonsignificantly higher in the no-clipping group than in the clipping group (31.6 % [95 % confidence interval (CI) 19.1-47.5] vs. 15.0 % [95 %CI 7.1-29.1]). The incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis did not differ significantly between the groups (clipping vs. no-clipping: 17.5 % [95 %CI 8.7-31.9] vs. 5.3 % [95 %CI 1.5-17.3]), and all cases were mild. CONCLUSIONS : Placement of the newly designed rotatable clip was technically feasible and tended to have a protective effect by preventing delayed bleeding after endoscopic papillectomy, although statistical significance was not reached.
Effects of ribavirin dose reduction vs erythropoietin for boceprevir-related anemia in patients with chronic hepatitis C virus genotype 1 infection - a randomized trial
Poordad F, Lawitz E, Reddy KR, Afdhal NH, Hezode C, Zeuzem S, Lee SS, Calleja JL, Brown RS Jr, Craxi A, et al
BACKGROUND & AIMS Treatment of hepatitis C virus (HCV) infection with boceprevir, peginterferon, and ribavirin can lead to anemia, which has been managed by reducing ribavirin dose and/or erythropoietin therapy. We assessed the effects of these anemia management strategies on rates of sustained virologic response (SVR) and safety. METHODS Patients (n= 687) received 4 weeks of peginterferon and ribavirin followed by 24 or 44 weeks of boceprevir (800 mg, 3 times each day) plus peginterferon and ribavirin. Patients who became anemic (levels of hemoglobin approximately <=10 g/dL) during the study treatment period (n= 500) were assigned to groups that were managed by ribavirin dosage reduction (n= 249) or erythropoietin therapy (n= 251). RESULTS Rates of SVR were comparable between patients whose anemia was managed by ribavirin dosage reduction (71.5%) vs erythropoietin therapy (70.9%), regardless of the timing of the first intervention to manage anemia or the magnitude of ribavirin dosage reduction. There was a threshold for the effect on rate of SVR: patients who received <50% of the total milligrams of ribavirin assigned by the protocol had a significantly lower rate of SVR (P < .0001) than those who received >=50%. Among patients who did not develop anemia, the rate of SVR was 40.1%. Eleven thromboembolic adverse events were reported in 9 of 295 patients who received erythropoietin, compared with 1 of 392 patients who did not receive erythropoietin. CONCLUSIONS Reduction of ribavirin dosage can be the primary approach for management of anemia in patients receiving peginterferon, ribavirin, and boceprevir forHCV infection. Reduction in ribavirin dosage throughout the course of triple therapy does not affect rates of SVR. However, it is important that the patient receives at least 50% of the total amount (milligrams) of ribavirin assigned by response-guided therapy. ClinicalTrials.gov number, NCT01023035. Copyright 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.