纤维蛋白胶预防肝切除术后与切除面相关并发症的随机对照试验。

Fibrin sealant for prevention of resection surface-related complications after liver resection: a randomized controlled trial.

机构信息

Department of HPB Surgery and Liver Transplantation, University Medical Center Groningen, Groningen, The Netherlands.

出版信息

Ann Surg. 2012 Aug;256(2):229-34. doi: 10.1097/SLA.0b013e3182602819.

DOI:10.1097/SLA.0b013e3182602819

PMID:22791099

Abstract

OBJECTIVE

To evaluate the efficacy of fibrin sealant in reducing resection surface-related complications in liver surgery.

BACKGROUND

Bile leakage, bleeding, and abscess formation are major resection surface-related complications after liver resection. It is unclear whether application of fibrin sealant to the resection surface is effective in reducing these complications.

METHODS

In a multicenter, randomized trial in 310 noncirrhotic patients undergoing liver resection, we compared prophylactic application of fibrin sealant to the resection surface (156 patients) with no application of fibrin sealant (154 patients). In addition to clinical assessments, patients underwent protocolized computerized tomography (CT) scan 1 week postoperatively. Primary endpoint was a composite of postoperative resection surface-related complications (bile leakage, bleeding, or abscess), as adjudicated by a clinical-events committee that was unaware of the study-group assignments.

RESULTS

Overall rate of resection surface-related complications was not different between the 2 groups: 24% (38/156 patients) in the fibrin sealant group and 24% (37/154 patients) in the control group. Bile leakage was detected in 14% of patients in the fibrin sealant group and in 14% of controls. CT scans showed a fluid collection at the resection surface 100 mL or more in 28% of patients in the fibrin sealant group and in 26% of controls (P = 0.800). The rate of reinterventions for resection surface-related complications (12% vs 10%; P = 0.492) and severity of complications did also not differ between the 2 groups.

CONCLUSIONS

This randomized multicenter trial shows that prophylactic application of fibrin sealant at the resection surface after liver resections does not lead to a reduction in the incidence or severity of postoperative bile leakage or other resection surface-related complications (Controlled trial number, ISRCTN85205641).

摘要

目的

评估纤维蛋白胶在减少肝外科手术中与切除面相关并发症的疗效。

背景

肝切除术后，胆漏、出血和脓肿形成是主要的与切除面相关的并发症。目前尚不清楚在切除面上应用纤维蛋白胶是否能有效减少这些并发症。

方法

在一项对 310 例非肝硬化患者进行的多中心随机试验中，我们比较了纤维蛋白胶在切除面上的预防性应用（156 例患者）与无纤维蛋白胶应用（154 例患者）。除了临床评估外，患者在术后 1 周还接受了协议化的计算机断层扫描（CT）扫描。主要终点是由一个对研究组分配不知情的临床事件委员会裁定的术后与切除面相关的并发症（胆漏、出血或脓肿）的综合结果。

结果

两组患者与切除面相关的并发症发生率无差异：纤维蛋白胶组为 24%（38/156 例），对照组为 24%（37/154 例）。纤维蛋白胶组有 14%的患者出现胆漏，对照组为 14%。CT 扫描显示纤维蛋白胶组有 28%的患者在切除面有 100 毫升或更多的液体积聚，对照组为 26%（P=0.800）。与切除面相关的并发症需要再干预的发生率（12%比 10%；P=0.492）和并发症的严重程度在两组之间也没有差异。