The Department of Surgery, Auckland City Hospital, New Zealand.
HPB (Oxford). 2013 Jan;15(1):61-70. doi: 10.1111/j.1477-2574.2012.00583.x. Epub 2012 Oct 16.
Haemostasis after liver resection may be difficult to achieve as a result of the presence of challenging bleeding, the anatomic landscape of the liver and the quality of tissue making up the hepatic parenchyma. The fibrin pad (FP) is a topical absorbable haemostat designed to be effective in a variety of tissues and across multiple bleeding intensities. This is the first clinical trial to evaluate the hemostat's safety and effectiveness in controlling bleeding during elective hepatic resection.
This prospective, randomized, controlled superiority trial enrolled 104 subjects undergoing elective hepatectomy in 5 countries. After parenchymal transection, subjects with an appropriately defined target bleeding site (TBS) were stratified according to the type of hepatic parenchyma and immediately randomized 1:1: FP versus Standard of Care (SoC). SoC comprised manual compression with the use of an approved topical absorbable haemostat. The primary endpoint was haemostasis at 4 min from identification of the TBS, with no re-bleeding requiring re-treatment prior to abdominal closure. Results were stratified for both normal and abnormal (steatosis or cirrhosis) hepatic parenchyma. All subjects were followed for 60 days post-operatively.
The intent-to-treat (ITT) analysis showed an overall treatment difference of 53.0% (P < 0.001), 82.5% (33/40 FP) versus 29.5% (13/44 SoC) in achieving haemostasis at 4 min with no re-bleeding requiring treatment up to wound closure. The per protocol analysis showed an overall treatment difference of 65.7% (P < 0.001), with 33/35 successes (94.3%) in the FP group and 12/42 in the SoC group (28.6%). The stratification results showed treatment differences between the normal parenchyma group, 63.6% (95.8% FP versus 32.3% SoC P < 0.001) and a larger difference of 72.7% in the abnormal parenchyma group (90.9% FP versus 18.2% SoC P = 0.0003). Post-operative intra-abdominal fluid collections were less frequent in the FP group (3.4% FP versus 13.3% SoC P = 0.059). There was no difference in the safety profile between the FP or SoC groups.
The FP is safe and effective when used as an adjunct to achieve haemostasis during hepatic surgery. The success rate of achieving haemostasis with a FP remained high compared with the SOC group, especially in steatotic or cirrhotic liver tissue where the control success rates diminish. In addition, FP treatment of hepatic parenchymal surfaces may reduce the risk of post-operative biliary and fluid collections.
由于存在具有挑战性的出血、肝脏的解剖结构和组成肝实质的组织质量等因素，肝切除术后可能难以实现止血。纤维蛋白垫（FP）是一种局部可吸收的止血剂，旨在在多种组织和多种出血强度下有效。这是首次评估止血剂在控制择期肝切除术中出血方面的安全性和有效性的临床试验。
本前瞻性、随机、对照优效性试验纳入了 5 个国家的 104 例接受择期肝切除术的患者。在实质切开后，根据肝实质的类型和适当定义的靶出血部位（TBS）对患者进行分层，并立即按 1:1 随机分配 FP 与标准治疗（SoC）。SoC 包括使用批准的局部可吸收止血剂进行手动压迫。主要终点是从确定 TBS 后 4 分钟的止血情况，在腹部关闭前无需再次出血且无需再次治疗。结果针对正常和异常（脂肪变性或肝硬化）肝实质进行分层。所有患者均在术后 60 天内进行随访。
意向治疗（ITT）分析显示，总体治疗差异为 53.0%（P < 0.001），4 分钟内无再出血且无需治疗直至伤口关闭时，FP 组为 82.5%（33/40），SoC 组为 29.5%（13/44）。方案分析显示，总体治疗差异为 65.7%（P < 0.001），FP 组 35 例中有 33 例（94.3%）成功，SoC 组 42 例中有 12 例（28.6%）成功。分层结果显示，正常肝实质组的治疗差异为 63.6%（FP 组 95.8%，SoC 组 32.3%，P < 0.001），异常肝实质组的治疗差异更大，为 72.7%（FP 组 90.9%，SoC 组 18.2%，P = 0.0003）。FP 组术后腹腔内积液的发生率较低（FP 组为 3.4%，SoC 组为 13.3%，P = 0.059）。FP 组和 SoC 组之间的安全性特征没有差异。
FP 在肝外科手术中作为辅助手段用于实现止血时是安全且有效的。与 SoC 组相比，FP 组达到止血的成功率仍然很高，尤其是在脂肪变性或肝硬化的肝组织中，SoC 组的控制成功率降低。此外，FP 处理肝实质表面可能会降低术后胆道和液体积聚的风险。
