Prospective Randomized Controlled Trial On The Prevention Of Perioperative Venous Thromboembolism In Patients With Esophageal Cancer

Object:To observe the occurrence of venous thromboembolism(VTE)in perioperative patients with esophageal cancer using 6000 U and 3000 U enoxaparin preventive anticoagulant therapy,to investigate the influencing factors of VTE after esophageal cancer surgery,analyze the difference in efficacy and use safety of two doses of enoxaparin.Method:Patients with esophageal cancer who had undergone surgery in the three wards of Sichuan Provincial Cancer Hospital from August 2016 to December 2017 were randomly divided into high-dose(6000U)and low-dose(3000U)enoxaparin groups,Physical measures combined with enoxaparin prophylactic anticoagulation during perioperative period.Observe and analyze the occurrence of VTE,the risk factors of VTE and related adverse events in the enrolled patients after two doses of enoxaparin preventive anticoagulan t therapy.Comparing the difference between laboratory indicators of thrombus-negative group and thrombus-positive group,high-dose group and low-dose group.Result:1.A total of 76 patients with esophageal cancer are planned to be included.38 patients in the experimental and control groups.86 patients were enrolled before surgery.5 patients were excluded according to exclusion criteria.The final 81 patients were included in the study.There were 42 patients in the high-dose group and 39 in the low-dose group.,26 patients with VTE.The incidence is 32.1%.2.All VTEs were found within 7 days after surgery.24 patients with deep venous thrombosis and only 1 patient with superficial venous thrombosis.One patient had both deep vein thrombosis and superficial venous thrombosis.The sites of thrombosis were left and right subclavian veins,noble veins,axillary veins,Central venous catheter tube wall,lower limb intermuscular veins,and great saphenous veins.Thrombus size: 11.08±11.77 mm(0.6 mm-39 mm).3.The incidence of VTE was significantly higher in patients with esophageal cancer during prophylactic anticoagulation than in lung cancer(32.10% vs 10.62%,P=0.000).4.Risk factors for VTE during perioperative prophylactic anticoagulant therapy in patients with esophageal cancer were age greater than 60 years,perioperative blood transfusion therapy,and continuous bed rest time >72 hours.5.There was no significant difference in preoperative and postoperative Caprini score between the thrombus-positive group and the thrombus-negative group(3.81±1.06 VS 3.53±1.14,p=0.293;7.92±1.35 VS 7.67±1.11,p=0.380).In the thrombus-positive group,high-sens itivity C-reactive protein,D-dimer,and fibrinogen degradation products(FDP)were significantly higher on the third postoperative day than in the thrombus-negative group.D-Dimer and FDP were significantly higher on the 7th postoperative day than in the thrombus-negative group.D-dimer and fibrinogen(FIB)were significantly higher than in the thrombus-negative group In the month after surgery(P < 0.05).Over time,the trends of D-Dimer and FDP were also significantly different(P < 0.05).6.The baseline of clinical data was generally balanced between the high-dose group and the low-dose group.The incidence of postoperative VTE was(20.51% VS42.86%,p=0.031),with significant differences.No major adverse events such as major bleeding,coagulation dysfunction,and thrombocytopenia occurred in both groups of patients after treatment.7.Compared with the high-dose group and low-dose group,the C-reactive protein in the high-dose group was lower than the low-dose group on the third postoperative day,and fibrinogen was lower than the low-dose group one month after the operation(P < 0.05).),The remaining hematological indicators showed no significant difference.D-Dimer and FDP began to increase significantly on the first postoperative day,gradually decreased on the seventh day after surgery,and returned to normal one month after surgery.There was no significant difference in the trends of D-Dimer and FDP between the two groups over time(P = 0.772,P = 0.720).Conclusion:1.The incidence of VTE is high during perioperative prophylactic anticoagulation in esophageal cancer patients,clinical attention should be paid to it.2.Risk factors for postoperative VTE in patients with esophageal cancer were older than 60 years old,bed rest time was more than 72 hours,and perioperative blood transfusion was performed.3.During the period of periprocedural anticoagulant therapy in patients with esophageal cancer,the inc idence of VTE was significantly lower than that of 6000 U enoxaparin.It is safe and does not cause postoperative coagulation dysfunction and does not increase the risk of major bleeding.4.Perioperative prophylactic anticoagulant therapy for patients with esophageal cancer should last until one month afte r surgery,which is more beneficial in preventing the occurrence of VTE.5.When using 6000 U enoxaparin prophylactic anticoagulant therapy,patients with esophageal cancer still had an inc idence of 20.51% of VTE during the perioperative period,which fully demonstrated the necessity of further in-depth study in order to find a more effective and safe prevention program.