Fisher William E, Chai Christy, Hodges Sally E, Wu Meng-Fen, Hilsenbeck Susan G, Brunicardi F Charles
The Elkins Pancreas Center, Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, TX, USA.
J Gastrointest Surg. 2008 May;12(5):882-90. doi: 10.1007/s11605-008-0479-x. Epub 2008 Feb 14.
Despite numerous modifications of surgical technique, pancreatic fistula remains a serious problem and occurs in about 10% of patients following pancreas resection. BioGlue is a new sealant that creates a flexible mechanical seal within minutes independent of the body's clotting mechanism.
Application of BioGlue sealant will reduce the incidence of pancreatic fistula following pancreas resection.
A retrospective cohort study was performed with 64 patients undergoing pancreas resection. BioGlue sealant was applied to the pancreatic anastomosis (Whipple) or resection margin (distal pancreatectomy) in 32 cases. Factors that could affect the rate of postoperative pancreatic fistula were recorded. Pancreatic fistula was defined as greater than 50 ml of drain output with an amylase content greater than three times normal serum value after postoperative day 10. To improve the sensitivity of our study, we also examined pancreatic fistula with a strict definition of any drain output on or after postoperative day 3 with a high amylase content and graded the fistulas in terms of clinical severity. Grade A leaks were defined as subclinical. Grade B leaks required some response such as making the patient nil per os, parenteral nutrition, octreotide, antibiotics, or a prolonged hospital stay. Grade C leaks were defined as serious and life threatening. They were associated with hemorrhage, sepsis, resulted in deterioration of other organ systems, and mandated intensive care. Comparisons between the two groups were made using the chi-square test or Fisher's exact test for categorical variables and by the Wilcoxon rank-sum test for continuous variables. P values of 0.05 or less were deemed statistically significant.
There were no differences between the patients who received BioGlue and the control cohort in terms of comorbid conditions, tumor location, texture of the pancreas, size of the pancreatic duct, or surgical technique. By the common definition, pancreatic fistula occurred in 6% (control) vs. 22% (BioGlue). By the strict definition, a fistula occurred in 41% (control) vs. 60% (BioGlue). In the control group, ten were subclinical (grade A) and two were clinically apparent leaks (grade B). In the BioGlue group, seven were subclinical (grade A), five were clinically apparent (grade B), and three were severe (grade C). There were no statistically significant differences in the incidence or severity grades of postoperative pancreatic fistulas between the two groups.
Application of BioGlue sealant probably does not reduce the incidence of pancreatic fistula following pancreas resection.
尽管手术技术有诸多改进，但胰瘘仍然是一个严重问题，在胰腺切除术后约10%的患者中发生。生物胶是一种新型密封剂，可在数分钟内形成灵活的机械密封，独立于人体凝血机制。
应用生物胶密封剂将降低胰腺切除术后胰瘘的发生率。
对64例行胰腺切除术的患者进行回顾性队列研究。32例患者在胰肠吻合口（Whipple手术）或切除边缘（胰体尾切除术）应用生物胶密封剂。记录可能影响术后胰瘘发生率的因素。胰瘘定义为术后第10天引流量大于50 ml且淀粉酶含量高于正常血清值三倍。为提高研究的敏感性，我们还对术后第3天及以后任何引流量且淀粉酶含量高的情况采用严格定义检查胰瘘，并根据临床严重程度对胰瘘进行分级。A级渗漏定义为亚临床。B级渗漏需要一些应对措施，如让患者禁食、肠外营养、使用奥曲肽、抗生素或延长住院时间。C级渗漏定义为严重且危及生命。它们与出血、脓毒症相关，导致其他器官系统恶化，需要重症监护。两组之间的比较采用卡方检验或Fisher精确检验用于分类变量，采用Wilcoxon秩和检验用于连续变量。P值小于或等于0.05被认为具有统计学意义。
接受生物胶治疗的患者与对照组在合并症、肿瘤位置、胰腺质地、胰管大小或手术技术方面无差异。按照通用定义，对照组胰瘘发生率为6%，生物胶组为22%。按照严格定义，对照组胰瘘发生率为41%，生物胶组为60%。对照组中，10例为亚临床（A级），2例为临床明显渗漏（B级）。生物胶组中，7例为亚临床（A级），5例为临床明显（B级），3例为严重（C级）。两组术后胰瘘的发生率或严重程度分级无统计学差异。
应用生物胶密封剂可能不会降低胰腺切除术后胰瘘的发生率。
