435 Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Trials Comparing Standard Versus Extended Lymphadenectomy Pancreatoduodenectomy For Adenocarcinoma of The Head of Pancreas

Abstract

Abstract Aim To compare baseline demographics, operative, and survival outcomes of randomized controlled trials (RCTs) comparing standard versus extended lymphadenectomy in patients undergoing pancreaticoduodenectomy for pancreatic head cancer Method we performed a meta-analysis of baseline demographics, operative, and survival outcomes of RCTs comparing standard versus extended lymphadenectomy in patients undergoing pancreaticoduodenectomy for pancreatic head cancer. The uncertainties associated with varying follow-up periods among the included studies were resolved by analysis of time-to-event outcomes. Moreover, we performed trial sequential analysis (TSA) to determine whether the available evidence is conclusive and to assess the risk of type 1 or type 2 errors. Results Overall, 724 patients from 5 RCTs were included. There was no difference between standard and extended lymphadenectomy in terms of pancreatic fistula (OR0.64, P = 0.11), delayed gastric emptying (OR 0.68, P = 0.40), bile leak (OR 0.33, P = 0.06), wound infection (OR 0.53, P = 0.06), abscess (OR 0.83, P = 0.63), total complications (OR 0.73, P = 0.27), postoperative mortality (OR 1.01, P = 0.85), and overall survival (HR 1.10, P = 0.46). TSA suggested that meta-analysis was conclusive with low risk of type 2 error. Conclusions Robust evidence from randomized controlled trials (Level 1) suggests no difference in postoperative and survival outcomes between standard and extended lymphadenectomy in patients undergoing pancreaticoduodenectomy for pancreatic head cancer. The findings were consistent in patients with positive and negative lymph node status and in studies from the West or East.