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Rectal Indomethacin for Post-ERCP Pancreatitis Prophylaxis in Average Risk Patients: Too Early to Terminate and Too Early to Conclude.

1 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 Dear Editors: We read with great interest the study by Levenick et al entitled, “Rectal Indomethacin Does not Prevent Post-ERCP Pancreatitis in Consecutive Patients.” The authors evaluated the efficacy of rectal indomethacin vs placebo for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in a predominately average risk population (70%) and concluded that it is ineffective for PEPprophylaxis (odds ratio [OR], 1.51; 95%CI, 0.68-3.33).We are concerned about the early termination of the trial by the Data Safety Monitoring Board after an interim analysis suggested futility of the anticipated primary endpoint. Although interim analysis with stopping rules for efficacy or safety are often used, the stopping rules for futility are controversial and must be modified based on objectives of the trial and interventions utilized. The authors anticipated a sample size of 1398 to detect a 50% reduction in the incidence of PEP from 5% to 2.5% while recruiting consecutive or “average risk” patients with a power of 80% and significance of .05. However, the study was terminated after only a total of 449 patients were recruited resulting in only 20% power to demonstrate the hypothesized difference with a significance of .05. The conclusion of the study is therefore concerning for a type II statistical error (failing to observe an effect when one actually exists). Although prior randomized controlled trials (RCTs) evaluating pancreatic stent placement for PEP prophylaxis have been terminated for futility, the statistical approach used to assess futility in the current study is unclear. Further, terminating trials for futility is rarely used when the treatment is approved by the Food and Drug Administration and considered safe, inexpensive, and widely available. In fact, trials terminated for futility may even demonstrate a moderate effect if they are taken to completion. Early termination for futility can also occur in trials with slow recruitment. Although the authors reported an ambitious target recruitment of 60 patients per month in the protocol documented on clinicaltrials.gov, the actual recruitment seems to have been 20 patients per month. This suggests that there may have been other reasons to terminate as opposed to futility. If the trial was terminated owing to lower than expected recruitment, then the conclusion regarding whether rectal indomethacin is ineffective is not valid. The authors also report an increased relative risk of pancreatitis (28%) among patients receiving both rectal