J.Jpn. Surg. Soc.
ISSN 1880-1129

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J.Jpn. Surg. Soc.. 125(2): 139-145, 2024

Feature topic

RANDOMIZED, CONTROLLED TRIALS IN HEPATOBILIARY AND PANCREATIC SURGERY:THE ROAD TO TOP JOURNALS

1) Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, Kashiwa, Japan
2) Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan
3) Department of Medical Oncology, Tochigi Cancer Center, Utsunomiya, Japan

Masaru Konishi1), Masafumi Ikeda2), Kohei Nakachi3)

In the Japan Clinical Oncology Group 1202 study, a randomized, controlled trial (RCT) was conducted to evaluate the efficacy of S-1 as adjuvant therapy after radical resection of biliary tract cancer, comparing a group receiving S-1 for 6 months after surgery with a resection-only group. The results showed that S-1 significantly prolonged overall survival, as the primary endpoint of the study. This was the first study showing the efficacy of adjuvant therapy for biliary tract cancer under an intention-to-treat protocol and was published in The Lancet. Based on the experience of conducting this study, we believe that the following factors are important to achieve publication in top journals: a very precise protocol; a study design with sufficient consensus within the research group; extensive surveillance of qualified cases for enrollment; rigorous assessment of the impact of the results; appropriate timing for the release of the results; a research organization that can respond quickly; and adequate data management.

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