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Comment & Response
May 26, 2021

A Randomized Clinical Trial on Anterior Approach vs Conventional Hepatectomy for Resection of Colorectal Liver Metastasis—To Terminate or Not to Terminate the Study

Author Affiliations
  • 1Stanford University Medical Center, Department of Medicine, Stanford University School of Medicine, Stanford, California
  • 2The University of Texas MD Anderson Cancer Center, Department of Biostatistics, Houston
  • 3Department of Medicine, Stanford University School of Medicine, VA Palo Alto Health Care System, Palo Alto, California
JAMA Surg. 2021;156(9):893-894. doi:10.1001/jamasurg.2021.1800

To the Editor With great interest, we read the article by Rahbari et al1 who conducted a randomized clinical trial to examine the efficacy of hepatectomy in patients with colorectal liver metastasis via anterior approach hepatectomy vs conventional hepatectomy by measuring the number of circulating tumor cells (CTCs). The investigators determined the sample size to be 150 patients (75 in each arm) with 90% power to detect a 30% difference between the 2 groups, assuming 50% to 55% of patients undergoing conventional hepatectomy vs 15% to 20% of the anterior approach hepatectomy group will have detectable CTC. The clinical trial protocol states that the trial will be terminated if the P value is greater than .65 owing to lack of significant difference between the 2 approaches. However, the study was terminated prematurely, while the interim analysis rendered a P value of .54, which is less than .65. We were perplexed to discover that the premature termination of the study was “in line with the study protocol.”1 We are concerned that premature termination of the study could lead to inconclusive results with the potential of misleading interpretation.

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