Objective: 

The aim of the study was to evaluate the impact of the use of a reinforced stapler (RS) during distal pancreatectomy (DP) on postoperative outcomes.

Background: 

DP remains associated with significant postoperative morbidity owing to pancreatic fistula (PF). To date, there is no consensus on the management of the pancreatic stump. The use of an RS potentially represents a simple way to decrease the rate of PF.

Methods: 

The REPLAY study (NCT03030170) is a prospective, multicenter, randomized study. Patients who underwent DP were randomized (1:1 ratio) in 2 groups for the use of a standard stapler (SS) or an RS to close remnant pancreatic parenchyma. The primary endpoint was the rate of overall PF. Secondary endpoints included severity of PF, length of hospital stay, overall morbidity, and rate of readmission for a PF within 90 days. Participants were blinded to the procedure actually carried out.

Results: 

A total of 199 were analyzed (SS, n=99; RS, n=100). One patient who did not undergo surgery was excluded. Baseline characteristics were comparable in both groups. The rate of overall PF was higher in RS group (SS: 67.7%, RS: 83%, P=0.0121), but the rate of clinically relevant PF was similar (SS: 11.1%, RS: 14%, P=0.5387). Mean length of total hospital stay, readmission for PF, postoperative morbidity, and mortality at 90 days were similar.

Conclusion: 

The results of this randomized clinical trial did not favor the use of RS during DP to reduce the rate of PF.

中文翻译：

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使用强化吻合器对远端胰腺切除术后胰瘘发生的影响：REPLAY（远端胰腺切除术中胰腺的强化）多中心随机临床试验的结果

客观的： 

该研究的目的是评估在远端胰腺切除术 (DP) 期间使用加固缝合器 (RS) 对术后结果的影响。

背景： 

由于胰瘘（PF），DP仍然与显着的术后发病率相关。迄今为止，关于胰腺残端的处理尚未达成共识。RS 的使用可能代表了一种降低 PF 率的简单方法。

方法： 

REPLAY 研究 (NCT03030170) 是一项前瞻性、多中心、随机研究。接受 DP 的患者被随机分为 2 组（比例为 1:1），使用标准吻合器 (SS) 或 RS 闭合残余胰腺实质。主要终点是总体 PF 率。次要终点包括 PF 的严重程度、住院时间、总体发病率和 90 天内 PF 的再入院率。参与者对实际进行的程序视而不见。

结果： 

共分析了 199 个（SS，n=99；RS，n=100）。一名未接受手术的患者被排除在外。两组的基线特征具有可比性。RS组总体PF率较高（SS：67.7%，RS：83%，P = 0.0121），但临床相关PF率相似（SS：11.1%，RS：14%，P = 0.5387） . 平均总住院时间、PF 再入院时间、术后发病率和 90 天死亡率相似。

结论： 

这项随机临床试验的结果不支持在 DP 期间使用 RS 来降低 PF 率。