Analysis of Randomized Controlled Trials on Hepatopancreatic Surgery

The randomized controlled trial (RCT) is an important research method, providing the highest evidence and playing a pivotal role in the performance of evidence-based medicine. However, RCTs on hepatopancreatic surgery have been performed less frequently than RCTs in other fields. Therefore, this review analyzes the characteristics of RCTs on hepatic and pancreatic surgery to propose a breakthrough. We retrieved studies performed via a MEDLINE search to identify prospective RCTs on hepatopancreatic surgery in the last decade. Eligible RCTs were analyzed using the following items: study design, publication year, geographical area, sample size, multicenter study, and impact factor. Studies comparing surgical technique or methods have composed the majority of the RCTs involving hepatectomy and pancreatectomy. About half of the RCTs on hepatectomy have been performed in East Asia, whereas most of the RCTs on pancreatectomy were undertaken in Western countries. The average sample number of RCT on hepatectomy is significantly smaller than those in other fields. Moreover, multicenter studies are less frequently performed on hepatectomy compared with pancreatectomy. Promoting the organization of multicenter studies would be the best way to increase the number and sample size of RCTs on hepatectomy. Adequate RCTs observing the Consolidated Standards of Reporting Trials statements are necessary to obtain reliable evidence.