Meta-analysis and trial sequential analysis of randomised controlled trials comparing standard versus extended lymphadenectomy in pancreatoduodenectomy for adenocarcinoma of the head of pancreas.

Abstract

To compare baseline demographics, operative, and survival outcomes of randomised controlled trials (RCTs) comparing standard lymphadenectomy versus extended lymphadenectomy in patients undergoing pancreaticoduodenectomy for pancreatic head cancer METHODS: In compliance with PRISMA standards we performed a meta-analysis of baseline demographics, operative, and survival outcomes of RCTs comparing standard lymphadenectomy 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. Overall, 724 patients from 5 RCTs were included. The included populations were comparable in terms of baseline characteristics. There was no difference between standard and extended lymphadenectomy in terms of pancreatic fistula (OR 0.64, 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. The results remained consistent through subgroup analyses based on lymph node positive or negative status and studies from the West and East. Robust evidence from randomised 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.