The State of the Highest Level of Evidence: An Overview of Systematic Reviews of Pancreaticobiliary Disease Customized for the Gastroenterologist and GI Surgeon

Trends emerged as randomized controlled trials (RCTs) on pancreaticobiliary disease were reviewed by each panel of experts. There were few RCTs. Although studies observed statistical differences between their treatment groups, many of them were underpowered. The studies with the most patients were sponsored by industry—on adjuvant therapy and biliary stents. Two subjects did not have an RCT [necrotizing pancreatitis and intraductal papillary mucinous tumors (IPMN) of the pancreas]. Constant heterogeneity between RCTs was observed. A good example was the 22 variations in study designs noted between the 5 RCTs of the adjuvant chemotherapy panel. Some of these RCTs had no inclusion criteria while a more recent trial utilized very specific measures. Many trials had insufficient follow-up (6 months in one study of chronic pancreatitis surgery). Each randomized controlled trial may have reached a different conclusion than another one on the same topic although they had similar results (adjuvant treatment for resected pancreatic cancer). From this review of the highest level of evidence in the literature for pancreaticobiliary disease, it is apparent that the lack of quantity and quality of the highest level of evidence provides us with a challenge to improve the quality of our literature. Cooperation is required, which might begin by an international consensus on definitions, inclusion criteria, and the minimum length of follow-up.