Meta-analysis and trial sequential analysis of pancreatic stump closure using a hand-sewn or stapler technique in distal pancreatectomy

Abstract

This study aimed to compare outcomes of hand-sewn and stapler closure techniques of pancreatic stump in patients undergoing distal pancreatectomy (DP). Impact of stapler closure reinforcement using mesh on outcomes was also evaluated. Literature search was carried out using multiple data sources to identify studies that compared hand-sewn and stapler closure techniques in management of pancreatic stump following DP. Odds ratio (OR) was determined for clinically relevant postoperative pancreatic fistula (POPF) via random-effects modelling. Subsequently, trial sequential analysis was performed. Thirty-two studies with a total of 4,022 patients undergoing DP with hand-sewn (n = 1,184) or stapler (n = 2,838) closure technique of pancreatic stump were analyzed. Hand-sewn closure significantly increased the risk of clinically relevant POPF compared to stapler closure (OR: 1.56, p = 0.02). When stapler closure was considered, staple line reinforcement significantly reduced formation of such POPF (OR: 0.54, p = 0.002). When only randomized controlled trials were considered, there was no significant difference in clinically relevant POPF between hand-sewn and stapler closure techniques (OR: 1.20, p = 0.64) or between reinforced and standard stapler closure techniques (OR: 0.50, p = 0.08). When observational studies were considered, hand-sewn closure was associated with a significantly higher rate of clinically relevant POPF compared to stapler closure (OR: 1.59, p = 0.03). Moreover, when stapler closure was considered, staple line reinforcement significantly reduced formation of such POPF (OR: 0.55, p = 0.02). Trial sequential analysis detected risk of type 2 error. In conclusion, reinforced stapler closure in DP may reduce risk of clinically relevant POPF compared to hand-sewn closure or stapler closure without reinforcement. Future randomized research is needed to provide stronger evidence.

Keywords: Distal pancreatectomy; Hand-sewn closure; Pancreatic stump; Stapler closure.

Fig. 1

Study flow diagram.

Fig. 2

Risk of bias summary and graph showing authors’ judgments about each risk of bias item for (A) randomized controlled trials, and (B) observational studies.

Fig. 3

Forest plots of comparison of hand-sewn versus stapler pancreatic stump on clinically relevant postoperative pancreatic fistula. Solid squares denote odds ratio. Horizontal lines represent 95% CIs. Diamond denotes pooled effect size. M-H, Mantel Haenszel test; CI, confidence interval.

Fig. 4

Forest plots of comparison of reinforced versus standard pancreatic stump on clinically relevant postoperative pancreatic fistula. Solid squares denote odds ratio. Horizontal lines represent 95% CIs. Diamond denotes pooled effect size. M-H, Mantel Haenszel test; CI, confidence interval.

Fig. 5

Results of trial sequential analysis for clinically relevant postoperative pancreatic fistula. Red inward-sloping dashed lines make up trial sequential monitoring boundaries. To the right, outward sloping red dashed lines make up the futility region. Solid blue line is cumulative Z curve. Solid green line presents penalised Z-value.