Midterm outcome of a half-blind, random, control research: a new therapy that treat hypovascular liver cancer with balloon catheter to block the main artery temporarily, and then pressurize chemoembolization

Abstract

Objective To investigate efficacy and effect on liver function of the experimental therapy with balloon catheter to block the main artery temporarily and then pressurize chemoembolization to treat hypovascular liver cancer. Methods Eighty patients with hypovascular liver cancer requiring interventional therapy were randomly divided into two groups.The experimental group was treated with the new therapy and the control group was treated with traditional therapy. The lipiodol-filling status and maximum diameter of the tumor was analyzed for a midterm outcome,and the change of AFP and liver function were evaluated.Mann-Whitney test was used for data between two groups,Friedman test was used for data of each group,and Spearman nonparameter relevant analysis was used for efficacy indexes.Results ( 1 ) All Patients have confirmed diagnosis of hypocvascular liver cancer and got balanced baseline. ( 2 ) Lipiodol-filling status:the clinical efficacy and benefit rates of patients from experimental group were higher than that from control group and showed statistically significant difference in 1,3,12 months (Z =-2.135,- 2.939,- 2.686 ; P =0.034,0.004,0.007 ),but no statistically significant difference in 6 month ( Z =- 1.170,P =0.242 ).The status of lipiodol-filling of experimental group ( x2 =2.593,P =0.459 ) was more stable than control group ( x2 =10.886,P =0.012).(3) Maximum diameter of the tumor:the clinical efficacy and benefit rates of patients from experimental group were higher than that from control group and showed statistically significant difference in 3,12 months ( Z =- 2.734,- 2.733 ; P =0.006,0.006),but no statistically significant difference in 1,6 month ( Z =- 1.692,- 1.895 ;P =0.091,0.058). But neither of two groups showed statistically significant difference in change of maximum diameter of the tumor ( x2 =5.500,P =0.139 ; x2 =6.509,P =0.089 ).Relation between lipiodol-filling and maximum diameter showed positive correlation in 3 month ( r =0.257,P =0.035 ). (4) Stratified analysis was used for data of AFP according to AFP value before therapy,and two groups showed no statistically significant difference for patients belonging to 20-1000 μg/L by Pearson Chi-square test. (5)Two groups showed no statistically significant difference for data of liver function before therapy and in 1,3,6months ( Z =- 1.073,- 1.314,-0.518,-0.549;P=0.308,0.189,0.604,0.583).Conclusions According to the midterm result of this experiment,the experimental therapy increased lipiodol-filling and decreased maximum diameter of the tumor significantly in 3 and 12 months correspondingly,but no significant difference was observed in AFP and liver function between groups yet. So the long-term efficacy and its influence to lung metastasis and survival rate need further research. Key words: Liver neoplasms; Chemoembolization, therapeutic; Tomography, X-ray computed ; Hypovascular