Evidence mapping of randomized clinical trials in hepatobiliary surgery.

Abstract

Surgery is the best therapeutic option for improving the quality of life of most patients with benign and malignant lesions of the liver as well as diseases of the gallbladder and bile duct1. Technological advances in surgical techniques and early diagnosis of hepatobiliary tumours have improved surgical interventions2,3. As the number of surgical interventions has increased, so has the number of clinical studies investigating these interventions3. RCTs are considered to provide the best evidence for estimating the efficacy of a therapy4,5. However, RCTs are more challenging in surgical fields because of practical and ethical issues2,5, so there are fewer surgical RCTs and those that have been published have a lower methodological and reporting quality than non-surgical RCTs. Therefore, only a minor part of surgical decision-making can be based on high-quality evidence from RCTs6,7. Despite the increased demand for evidence-based approaches, there is no systematic review of all RCTs published in the field of hepatobiliary surgery. The aim of the present study was to undertake a systematic review of RCTs in hepatobiliary surgery published in the past five decades, and to assess the trends of these trials over time, including where the studies were conducted, and also providing an evidence map based on the primary diseases they investigated.