Preemptive Administration of Albumin during Pancreatectomy Does Not Reduce Postoperative Complications: A Prospective Randomized Controlled Trial
Jeong H, Kim JA, Yang M, Ahn HJ, Heo J, Han IW, Shin SH, Lee NY, Kim WJ
Journal of clinical medicine. 2022;11(3)
Despite the empirical use of human albumin during pancreatectomy to replace intraoperative volume loss while preventing fluid overload and edema, its impact on postoperative outcomes remains unclear. In addition, most previous studies have focused on the effects of therapeutic albumin usage. Here, we investigated whether preemptive administration of human albumin to prevent edema during pancreatectomy could reduce the incidence of moderate postoperative complications. Adult patients undergoing pancreatectomy were assigned to either the albumin group (n = 100) or the control group (n = 100). Regardless of the preoperative albumin level, 200 mL of 20% albumin was administered to the albumin group after induction of anesthesia. The primary outcome was the incidence of moderate postoperative complications as defined by a Clavien-Dindo classification grade ≥ 2 at discharge. Intraoperative net-fluid balance, a known risk factor of postoperative complication after pancreatectomy, was lower in the albumin group than in the control group (p = 0.030), but the incidence of moderate postoperative complications was not different between the albumin and control groups (47/100 vs. 38/100, respectively; risk ratio: 1.24, 95% CI: 0.89 to 1.71; p = 0.198). Therefore, preemptive administration of human albumin to prevent fluid overload and edema during pancreatectomy is not recommended because of its lack of apparent benefit in improving postoperative outcomes.
The Effect of Fibrinogen/Thrombin-Coated Collagen Patch (TachoSil((R))) Application in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreaticoduodenectomy: A Randomized Clinical Trial
Kwon J, Shin SH, Lee S, Park G, Park Y, Lee SJ, Lee W, Song KB, Hwang DW, Kim SC, et al
World journal of surgery. 2019
BACKGROUND Fibrin sealants and topical glue have been studied to reduce the incidence of postoperative pancreatic fistulas (POPF) after pancreatico-enteric anastomosis, but a definitive innovation is still needed. We aim to evaluate the effectiveness of fibrin sealant patch applied to pancreatico-enteric anastomosis to reduce postoperative complications, including POPF. METHODS This study was a single-center, prospective, randomized, phase IV trial involving three pancreaticobiliary surgeons. The primary outcome was POPF; secondary outcomes included complications, drain removal days, hospital stay, readmission rate, and cost. Risk factors for POPF were identified by logistic regression analysis. RESULTS A total of 124 patients were enrolled. Biochemical leakage (BL) or POPF occurred in 16 patients (25.8%) in the intervention group and 23 patients (37.1%) in the control group (no statistical significance). Clinically relevant POPF occurred in 4 patients (6.5%) in both the intervention and control groups (p = 1.000). Hospital stay (11.6 days vs. 12.1 days, p = 0.585) and drain removal days (5.7 days vs. 5.3 days, p = 0.281) were not statistically different between two groups. Complication rates were not different between the two groups (p = 0.506); nor were readmission rates (12.9% vs. 11.3%, p = 1.000) or cost ($13,549 vs. $15,038, p = 0.103). In multivariable analysis, age and soft pancreas texture were independent risk factors for BL or POPF in this study. Applying fibrin sealant patch is not a negative risk factor, but the p value may indicate a likelihood of reducing the incidence of BL (p = 0.084). CONCLUSIONS Fibrin sealant patches after pancreaticojejunostomy did not reduce the incidence of POPF or other postoperative complications. This study was registered at clinicaltrials.gov (NCT03269955).