Experimental Establishment And Clinical Application Research On The Novel Technique Of Balloon-Occluded Esophageal Varices Obliteration

Background and aims: Esophageal variceal bleeding(EVB)are common complications in patients with decompensated liver cirrhosis,with an incidence of 15% annually.Once esophageal varices(EVs)are ruptured,the mortality rate of EVs is up to 20%,and the mortality rate of EVs in patients without any prevention and treatment is up to 60% in one year.Currently,endoscopic variceal ligation(EVL)and endoscopic injection sclerotherapy(EIS)are two principal methods for the prevention and treatment of EVs in patients with cirrhosis.EVL eradicates EVs by the way of mechanical ligation,but it is limited to effective eradication for deep varix.Endoscopic injection sclerotherapy(EIS)is also widely used in the treatment of esophageal variceal bleeding(EVB)as well as EVs.However,the intravaginally injected sclerosant may flow out to the drainage vein,thus impairing the effectiveness of EIS and increasing the risk of ectopic embolism.The rupture of EVs is life-threatening and requires effective and rapid intervention.Furthermore,the management of esophageal variceal bleeding(EVB)remains clinically challenging.The aims of the current study were: 1.To establish and evaluate the safety and feasibility of a novel technology,termed balloon-occluded esophageal varices obliteration(BEVO),for the treatment of EVs.2.The present study aimed to compare BEVO with EVL in the management of patients with cirrhosis and F2-EVs,and to assess the risk factors associated with the recurrence of EVs.3.The present study evaluated the efficacy and safety of BEVO in the management of F3-EVs,compared to the EIS.Furthermore,the current study predicted the shortest time of balloon compression needed related to the first eradication of F3-EVs and evaluated the clinical significance of subgroup analysis in different groups.Materials and methods: 1.Patients with cirrhosis who had a history of EVs and were admitted to The First Affiliated Hospital of Anhui Medical University(Hefei,China)were enrolled in the present study.The present study was performed according to the Declaration of Helsinki,which was approved by the institutional review board of The First Affiliated Hospital of Anhui Medical University.Endoscopic treatment was repeated every month as long as the patients were in good condition until the complete eradication of F3-EVs.Follow-up EGD was performed 3 months after the eradication of F3-EVs,and then every 6 months in the absence of recurrence.Demographic characteristics,endoscopic data,and complications were collected.2.SPSS random block method was used for randomization and a random sequence number was generated.The patients who met the inclusion criteria were randomly divided into the BEVO group and the EVL group.The preoperative,intraoperative,and postoperative clinical data of the patients were recorded.The primary outcomes(the rate of EV recurrence rate and eradication)and secondary outcomes(the rate of EV rebleeding and procedure-related complications)were compared between the two groups.Univariate and multivariate logistic regression analysis was used to explore the independent risk factors of EV recurrence in cirrhotic patients.3.The general demographic and clinical data of patients treated with BEVO and EIS were retrospectively collected,and the clinical efficacy of management in F3-EVs was compared between the two groups.The ROC curve was used to predict the shortest balloon occlusion time associated with the intraoperative balloon occlusion time and the initial EV eradication.Moreover,the safety and efficacy of the treatment of EVs in different balloon occlusion times subgroups were evaluated.Results: 1.(1)A total of 105 patients with EVs(mean age,53.07 ± 10.35 years)received BEVO.The average injection points and dose of sclerosant were 2.90 ± 1.34 and 17.49 ± 8.39 ml,respectively.Seventy(66.67%,70/105)patients presented oozing bleeding,and only six(5.71%,6/105)patients showed spurting bleeding.A total of 29(27.62%,29/105)patients required compression of the transparent cap to stop the bleeding,while 47(44.76%,47/105)patients required compression of the needle sheath to stop the bleeding,and 29(27.62%,29/105)patients there was a spontaneous cessation of bleeding.The mean operation time of each session was 13.67 ± 4.87 min.(2)The rate of technical success was 100%(105/105).Immediate hemostasis was achieved in all patients(100%,31/31)with active EVB.Complete eradication of EVs was obtained in 98.10%(103/105)patients after 3 sessions.However,3 patients(2.86%)were diagnosed with EV recurrence on routine follow-up endoscopic examination after complete EV eradication and received another successful BEVO treatment.10 of 105(9.52%)patients experienced retrosternal chest discomfort on postoperative day 1,which was spontaneously relieved after a few days.Mild abdominal bloating and distension were recorded in 2 patients(1.90%)a few hours after the procedure,and there were no serious surgery-related complications.2.(1)A total of 157 patients were randomly treated in the BEVO group(n = 79)and EVL group(n = 78).The rate of EV recurrence in the BEVO group was lower than that in the EVL group(3.80%,3/79 vs.21.79%,17/78;P = 0.001).The rate of EV eradication in the BEVO group was significantly higher than that in the EVL group,and the difference between the two groups was statistically significant(96.20%,76/79;vs.74.36%,58/78;P < 0.001).The rate of EV rebleeding in the BEVO group was significantly lower than that in the EVL group(7.59%,6/79 vs.20.51%,16/78;P = 0.020).In terms of postoperative dysphagia symptoms in the EVL group were higher than those in the BEVO group,and the difference was statistically significant(10.26%,8/78 vs.1.27%,1/79;P = 0.015).(2)Logistic regression showed that the independent risk factors related to EV recurrence after eradication were low serum albumin [OR(95%CI): 16.498(3.046-89.348),P = 0.001],uncomplete eradication of EVs [OR(95%CI): 6.980(1.790-27.215),P = 0.005].Compared to EVL treatment,BEVO treatment is protective factors for EVs [OR(95%CI): 0.116(0.023-0.579),P = 0.009].3.A total of 105 patients were retrospectively collected,including 41 patients in the EIS group and 64 patients in the BEVO group.The rate of EV eradication in the BEVO group was significantly higher than that of the EIS group after three sessions,and the difference was statistically significant(100%,64/64 vs.58.54%,24/41;P < 0.001).The dose of sclerosant in the BEVO group was less than that in the EIS group(18.47 ± 7.77 ml vs.21.80 ± 7.70 ml,P = 0.034).The incidence of intraoperative bleeding,which was represented as oozing and spurting,in the BEVO group was markedly lower than that in the EIS group(43.75%,28/64;vs.60.98%,25/41 and 9.38%,6/64;vs.39.02%,16/41 respectively;P = 0.043).A total of 75.61%(31/41)patients required compression of the transparent cap to stop the bleeding,while 24.39%(10/41)required compression of the needle sheath to stop the bleeding and in 0 %(0/41)patients there was a spontaneous cessation of bleeding,respectively,and those in the BEVO group were: 31.25%(20/64),39.06%(25/64),29.69%(19/64),the difference was statistically significant(P < 0.001).The median hospital stay of all enrolled patients was 9 days(range,5-30 days).The hospital stay was shorter in the BEVO group than in the EIS group(8 vs.11,P = 0.009).Patients in the BEVO group showed a significantly lower incidence of rebleeding than in the EIS group(0%,0/64;vs.17.07%,7/41;P = 0.001).Retrosternal discomfort tended to be more common in the EIS group than in the BEVO group(17.19%,11/64;Vs.58.54%,24/41;P < 0.001).(2)The cut-off value of 11.5-min appeared to have a maximum combined sensitivity and specificity of 80.0% and 58.8%,respectively.The area under the curve was 0.708(95% confidence interval=0.576-0.839;P = 0.004).(3)According to the shortest balloon compression time,64 patients in the BEVO group were further divided into < 11.5 min group(group A)and ≥11.5 min group(group B).The rate of EV eradication after the initial eradication in group B was significantly higher than that in group A(63.16%,24/38 vs.23.08%,6/26;P = 0.002).In addition,the rate of EV eradication in group B was significantly higher than that in group A after 2 and 3 sessions(92.11% vs.69.23%;100% vs.84.62%,P < 0.05).The median number of injection sites in group B was less than that in group A(2 vs.3,P = 0.008),and the dose of sclerosant in group B was lower than that in group A(16.1 ± 8.8 ml vs.20.1 ± 6.6 ml,P = 0.044).Conclusions: 1.The rate of intraoperative immediate hemostasis and technical success for BEVO in the treatment of EVs was 100%.Results of the present study demonstrated that BEVO exerted a higher success rate of complete eradication(98.10%)after 3 sessions and fewer intraoperative bleeding signs and the dose of sclerosant.BEVO was easy to perform and was safe and effective for treatment in patients with EVs as well as EVB.2.Results of the present study demonstrated that BEVO exerted a higher success rate of complete eradication and fewer procedural complications,recurrences,and rebleeding,compared with EVL for the treatment of F2-EVs.Univariate and multivariate Logistic regression analysis showed that low serum albumin,uncomplete varicose vein eradication were independent risk factors for EV recurrence,but BEVO treatment is protective factors for EVs.3.BEVO could achieve a higher variceal eradication rate and milder intraoperative bleeding signs in F3-EVs.Furthermore,11.5-min appeared to be the shortest occlusion time in BEVO,and the rate of eradication in the≥11.5-min subgroup is higher than in the <11.5-min subgroup.