Background:The results of studies comparing Billroth-I(B-I)with Roux-en-Y(R-Y)reconstruction on the quality of life(QoL)are still inconsistent.The aim of this trial was to compare the long-term QoL of B-I with R-Y ana...Background:The results of studies comparing Billroth-I(B-I)with Roux-en-Y(R-Y)reconstruction on the quality of life(QoL)are still inconsistent.The aim of this trial was to compare the long-term QoL of B-I with R-Y anastomosis after curative distal gastrectomy for gastric cancer.Methods:A total of 140 patients undergoing curative distal gastrectomy with D2 lymphadenectomy in West China Hospital,Sichuan University from May 2011 to May 2014 were randomly assigned to the B-I group(N=70)and R-Y group(N=70).The follow-up time points were 1,3,6,9,12,24,36,48,and 60 months after the operation.The final follow-up time was May 2019.The clinicopathological features,operative safety,postoperative recovery,long-term survival as well as QoL were compared,among which QoL score was the primary outcome.An intention-to-treat analysis was applied.Results:The baseline characteristics were comparable between the two groups.There were no statistically significant differences in terms of postoperative morbidity and mortality rates,and postoperative recovery between the two groups.Less estimated blood loss and shorter surgical duration were found in the B-I group.There were no statistically significant differences in 5-year overall survival(79%[55/70]of the B-I group vs.80%[56/70]of the R-Y group,P=0.966)and recurrence-free survival rates(79%[55/70]of the B-I group vs.78%[55/70]of the R-Y group,P=0.979)between the two groups.The scores of the global health status of the R-Y group were higher than those of the B-I group with statistically significant differences(postoperative 1 year:85.4±13.1 vs.88.8±16.1,P=0.033;postoperative 3 year:87.3±15.2 vs.92.8±11.3,P=0.028;postoperative 5 year:90.9±13.7 vs.96.4±5.6,P=0.010),and the reflux(postoperative 3 year:8.8±12.9 vs.2.8±5.3,P=0.001;postoperative 5 year:5.1±9.8 vs.1.8±4.7,P=0.033)and epigastric pain(postoperative 1 year:11.8±12.7 vs.6.1±8.8,P=0.008;postoperative 3 year:9.4±10.6 vs.4.6±7.9,P=0.006;postoperative 5 year:6.0±8.9 vs.2.7±4.6,P=0.022)were milder in the R-Y group than those of the B-I group at the postoperative 1,3,and 5-year time points.Conclusions:Compared with B-I group,R-Y reconstruction was associated with better long-term QoL by reducing reflux and epigastric pain,without changing survival outcomes.Trial Registration:ChiCTR.org.cn,ChiCTR-TRC-10001434.展开更多
基金Domestic support from the Foundation of Science&Technology Department of Sichuan Province(Nos.2020YJ0212 and 2023YFS0060)1.3.5 project for disciplines of excellence,West China Hospital,Sichuan University(No.ZYJC21006)
文摘Background:The results of studies comparing Billroth-I(B-I)with Roux-en-Y(R-Y)reconstruction on the quality of life(QoL)are still inconsistent.The aim of this trial was to compare the long-term QoL of B-I with R-Y anastomosis after curative distal gastrectomy for gastric cancer.Methods:A total of 140 patients undergoing curative distal gastrectomy with D2 lymphadenectomy in West China Hospital,Sichuan University from May 2011 to May 2014 were randomly assigned to the B-I group(N=70)and R-Y group(N=70).The follow-up time points were 1,3,6,9,12,24,36,48,and 60 months after the operation.The final follow-up time was May 2019.The clinicopathological features,operative safety,postoperative recovery,long-term survival as well as QoL were compared,among which QoL score was the primary outcome.An intention-to-treat analysis was applied.Results:The baseline characteristics were comparable between the two groups.There were no statistically significant differences in terms of postoperative morbidity and mortality rates,and postoperative recovery between the two groups.Less estimated blood loss and shorter surgical duration were found in the B-I group.There were no statistically significant differences in 5-year overall survival(79%[55/70]of the B-I group vs.80%[56/70]of the R-Y group,P=0.966)and recurrence-free survival rates(79%[55/70]of the B-I group vs.78%[55/70]of the R-Y group,P=0.979)between the two groups.The scores of the global health status of the R-Y group were higher than those of the B-I group with statistically significant differences(postoperative 1 year:85.4±13.1 vs.88.8±16.1,P=0.033;postoperative 3 year:87.3±15.2 vs.92.8±11.3,P=0.028;postoperative 5 year:90.9±13.7 vs.96.4±5.6,P=0.010),and the reflux(postoperative 3 year:8.8±12.9 vs.2.8±5.3,P=0.001;postoperative 5 year:5.1±9.8 vs.1.8±4.7,P=0.033)and epigastric pain(postoperative 1 year:11.8±12.7 vs.6.1±8.8,P=0.008;postoperative 3 year:9.4±10.6 vs.4.6±7.9,P=0.006;postoperative 5 year:6.0±8.9 vs.2.7±4.6,P=0.022)were milder in the R-Y group than those of the B-I group at the postoperative 1,3,and 5-year time points.Conclusions:Compared with B-I group,R-Y reconstruction was associated with better long-term QoL by reducing reflux and epigastric pain,without changing survival outcomes.Trial Registration:ChiCTR.org.cn,ChiCTR-TRC-10001434.
