远端胰腺切除术标准与加固吻合器断端对术后胰瘘的影响：多中心随机临床试验。

Reinforced versus standard stapler transection on postoperative pancreatic fistula in distal pancreatectomy: multicentre randomized clinical trial.

机构信息

Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.

Division of Surgery, Department of Clinical Sciences, Intervention and Technology (CLINTECH), Karolinska Institutet at Centre for Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden.

出版信息

Br J Surg. 2021 Apr 5;108(3):265-270. doi: 10.1093/bjs/znaa113.

DOI:10.1093/bjs/znaa113

PMID:33793753

Abstract

BACKGROUND

Postoperative pancreatic fistula is the leading cause of morbidity after distal pancreatectomy. Strategies investigated to reduce the incidence have been disappointing. Recent data showed a reduction in postoperative pancreatic fistula with the use of synthetic mesh reinforcement of the staple line.

METHODS

An RCT was conducted between May 2014 and February 2016 at four tertiary referral centres in Sweden. Patients scheduled for distal pancreatectomy were eligible. Enrolled patients were randomized during surgery to stapler transection with biological reinforcement or standard stapler transection. Patients were blinded to the allocation. The primary endpoint was the development of any postoperative pancreatic fistula. Secondary endpoints included morbidity, mortality, and duration of hospital stay.

RESULTS

Some 107 patients were randomized and 106 included in an intention-to-treat analysis (56 in reinforced stapling group, 50 in standard stapling group). No difference was demonstrated in terms of clinically relevant fistulas (grade B and C): 6 of 56 (11 per cent) with reinforced stapling versus 8 of 50 (16 per cent) with standard stapling (P = 0.332). There was no difference between groups in overall postoperative complications: 45 (80 per cent) and 39 (78 per cent) in reinforced and standard stapling groups respectively (P = 0.765). Duration of hospital stay was comparable: median 8 (range 2-35) and 9 (2-114) days respectively (P = 0.541).

CONCLUSION

Biodegradable stapler reinforcement at the transection line of the pancreas did not reduce postoperative pancreatic fistula compared with regular stapler transection in distal pancreatectomy. Registration number: NCT02149446 (http://www.clinicaltrials.gov).

摘要

背景

术后胰腺瘘是胰体尾切除术术后发病率的主要原因。为降低发病率而进行的策略研究结果令人失望。最近的数据显示，使用合成网片加强吻合口可以减少术后胰腺瘘的发生。

方法

这项随机对照试验于 2014 年 5 月至 2016 年 2 月在瑞典的四个三级转诊中心进行。接受胰体尾切除术的患者符合入组条件。入组患者在手术期间随机分为使用生物强化吻合器横断或标准吻合器横断。患者对分组情况设盲。主要终点是任何术后胰腺瘘的发生。次要终点包括发病率、死亡率和住院时间。

结果

共有 107 例患者被随机分配，106 例患者按意向治疗进行分析（强化吻合组 56 例，标准吻合组 50 例）。在临床上有意义的瘘（B 级和 C 级）方面，强化吻合组有 6 例（11%），标准吻合组有 8 例（16%），差异无统计学意义（P=0.332）。两组的总体术后并发症无差异：强化吻合组 45 例（80%），标准吻合组 39 例（78%）（P=0.765）。住院时间也无差异：中位时间分别为 8 天（范围 2-35 天）和 9 天（范围 2-114 天）（P=0.541）。