ABSTRACT
OBJECTIVE: To validate the 2016 ISGPS definition and grading scheme and investigate whether it segregates into distinct subclasses. METHODS: A total of 522 patients undergone pancreaticoduodenectomy in two pancreatic centers were reviewed. The 2016 ISGPS scheme was validated by comparing clinical and economic outcomes between different ISGPS grades. B-POPF were divided into 2 subgroups as B1(without invasive procedures) and B2(with invasive procedures) then outcomes were analyzed across the subgroups. RESULTS: Biochemical leak(BL) did not differ from the non-fistula condition in all outcomes except postoperative hospital stay and cost. Non-fistula/BL,B-POPF and C-POPF condition differed significantly in terms of all clinical and economic outcomes except 30-day readmission rate.B1 differ from B2 subgroup greatly in terms of most critical terms of outcomes such as hemorrhage(15.2% vs. 34.3%,P=0.045),biliary fistula(13.0% vs 34.3%,P=0.023),postoperative hospital stay(32.0 d vs. 39.0 d,P=0.011). CONCLUSION: The present study has confirmed the effectiveness of the 2016 ISGPS definition and grading scheme in identifying three conditions that differ in terms of clinical and economic outcomes. Subclassification of B-POPF according to whether invasive procedures has been used has potential implications for accurate reporting and performance evaluation.
ABSTRACT
<p><b>BACKGROUND</b>Hemocoagulase Agkistrodon for injection is a single component thrombin which has passed phases I and II clinical trials. The purpose of this phase III clinical trial was to evaluate the effect of Hemocoagulase Agkistrodon on hemostasis and coagulation in abdominal skin and subcutaneous incisions and to assess the safety of this agent in surgical patients.</p><p><b>METHODS</b>This is a phase III, prospective, randomized, double-blind, and controlled multicenter clinical trial including 432 consecutive patients randomized into either a study group (injected with hemocoagulase Agkistrodon at 2 U, n = 324) or a control group (injected with hemocoagulase Atrox, n = 108). The hemostatic time, hemorrhagic volume, hemorrhagic volume per unit area, blood coagulation, and adverse events were measured and compared between the two groups.</p><p><b>RESULTS</b>The mean hemostatic time in the study group was (36.8 +/- 18.7) seconds; the hemorrhagic volume was (3.77 +/- 3.93) g; and the hemorrhagic volume per unit area was (0.091 +/- 0.125) g/cm(2). In the control group, the corresponding values were (38.1 +/- 19.7) seconds, (4.00 +/- 4.75) g, and (0.095 +/- 0.101) g/cm(2), respectively. No significant difference in values existed between the two groups (P > 0.05). Blood coagulation results and hepatic and renal function were also similar between the two groups. Adverse events were reported in two cases, but were deemed non-drug-related.</p><p><b>CONCLUSIONS</b>Hemocoagulase Agkistrodon has good hemostatic and coagulative function and is safe for the use of arresting capillary hemorrhage that occurs while incising the abdomen during surgery.</p>