远端胃癌根治术Billroth-Ⅰ式与Billroth-Ⅱ式消化道重建术后中长期生活质量比较:基于病例登记数据库的队列研究

Comparison of postoperative mid-term and long-term quality of life between Billroth-I gastroduodenostomy and Billroth-II gastrojejunostomy after radical distal gastrectomy in patients with gastric cancer: a cohort study based on a case registry database

目的分析比较远端胃癌根治术Billroth-Ⅰ式(B-Ⅰ)与Billroth-Ⅱ式(B-Ⅱ)消化道重建患者术后的中长期生活质量。方法采用回顾性队列研究方法,收集四川大学华西医院胃肠外科中心胃癌外科病例登记数据库中2016年1月至2020年12月期间,行远端胃癌根治术的859例患者临床病理和随访资料。纳入标准:(1)术前经胃镜和活检明确胃癌诊断;(2)按照日本胃癌学会胃癌治疗指南择期实施根治性远端胃大部切除;(3)术后病理分期为Ⅰ~Ⅲ期的患者,TNM分期参照美国癌症联合会第8版标准;(4)术中联合脏器切除术只涉及胆囊或阑尾;(5)消化道重建方式为B-Ⅰ或B-Ⅱ;(6)临床病理资料完整;(7)截止随访区间2021年12月15日至2022年1月15日内存活。排除标准:(1)随访依从性不佳;(2)问卷评价信息不全;(3)带瘤存活者;(4)合并其他系统恶性肿瘤;(5)合并精神系统疾病、神经系统疾病等严重影响问卷调查客观性或患者认知受干扰的情况。由固定的研究者于2021年12月至2022年1月开展电话随访,以欧洲肿瘤治疗与研究组织研发的标准化问卷(EORTC)QLQ-C30评分(症状领域、功能领域和总体健康状况)和EORTC QLQ-STO22评分(包括吞咽困难、疼痛、反流、进食受限、焦虑5个症状;口干、味觉、躯体形象、脱发4个单项项目)进行术后生活质量评价。全组859例患者,女性271例,男性588例;中位年龄57.0(49.5,66.0)岁。按术后随访年限,将纳入病例分为术后随访1年组(202例)、术后随访2年组(236例)、术后随访3年组(148例)、术后随访4年组(129例)和术后随访5年组(144例);每组再根据患者消化道重建方式为B-Ⅰ重建组和B-Ⅱ重建组,除术后随访4年组中B-Ⅰ重建组与B-Ⅱ重建组的肿瘤T分期、术后随访5年组中B-Ⅰ重建组与B-Ⅱ重建组的患者年龄、肿瘤T分期和肿瘤TNM分期比较,差异具有统计学意义(均P<0.05)外,其余术后随访各年份组中的B-Ⅰ重建组与B-Ⅱ重建组在人口学、体质指数(BMI)、肿瘤TNM分期和肿瘤病理分级以及术后远期并发症发生情况方面比较,差异均无统计学意义(均P>0.05),提示术后各年份组中B-Ⅰ重建组与B-Ⅱ重建组基线资料具有可比性。主要观察指标:比较各年份组中B-Ⅰ重建组与B-Ⅱ重建组患者的生活质量评价指标(包括EORTC QLQ-C30和EORTC QLQ-STO22量表)及与营养相关的实验室检查指标(血清血红蛋白、白蛋白、总蛋白、甘油三酯)。对于非正态分布的连续型变量,采用M(Q_(1),Q_(3))表述,使用Wilcoxon铁和检验(paired=False)比较,分类变量的组间比较采用χ^(2)检验或Fisher精确概率法。结果EORTC QLQ-C30量表显示,术后随访各年份组中B-Ⅰ重建组与B-Ⅱ重建组各项评分比较,除术后随访3年组的角色功能评分比较差异有统计学意义(W=748.0,P<0.001)外,其余差异均无统计学意义(均P>0.05)。EORTC STO22量表显示,B-Ⅰ重建组与B-Ⅱ重建组在术后随访2年组中的疼痛和进食评分以及在术后随访3年组中的进食、躯体和脱发症状评分比较,差异均具有统计学意义(均P<0.05)外,其余术后随访各年份组中的B-Ⅰ重建组与B-Ⅱ重建组其他各项症状领域评分比较,差异均无统计学意义(均P>0.05)。术后随访1年组中B-Ⅱ重建组的甘油三酯水平较B-Ⅰ重建组更高(W=2060.5,P=0.038);且B-Ⅱ重建组高脂血症(高甘油三脂>1.85 mmol/L)患者占比(19/168,11.3%)高于B-Ⅰ重建组(0),差异有统计学意义(χ^(2)=0.047,P=0.030)。术后随访5年组中的B-Ⅱ重建组白蛋白水平较B-Ⅰ重建组更低(W=482.5,P=0.036);且B-Ⅱ重建组低蛋白血症(低蛋白血症<40 g/L)患者占比(19/125,15.2%)高于B-Ⅰ重建组(0),但差异无统计学意义(χ^(2)=0.341,P=0.164)。其他与营养相关的临床实验室检查指标在术后随访各年份组中B-Ⅰ重建与B-Ⅱ重建两组比较,差异均无统计学意义(均P>0.05)。结论B-Ⅰ式和B-Ⅱ式两种消化道重建方法对患者术后中长期生活质量的影响相当。远端胃癌根治术在选择消化道重建方式时可根据个体情况、术者操作习惯和便捷性综合决定。

Objective The pattern of digestive tract reconstruction in radical gastrectomy for gastric cancer is still inconclusive.This study aims to compare mid-term and long-term quality of life after radical gastrectomy for distal gastric cancer between Billroth-I(B-I)and Billroth-II(B-II)reconstruction.Methods A retrospective cohort study was conducted.Clinicopathological and follow-up data of 859 gastric cancer patients were colected cellected from the surgical case registry database of Gastrointestinal Surgery Center of Sichuan University West China Hospital,who underwent radical distal gastric cancer resection between January 2016 and December 2020.Inclusion criteria:(1)gastric cancer confirmed by preoperative gastroscopy and biopsy;(2)elective radical distal major gastrectomy performed according to the Japanese Society for Gastric Cancer treatment guidelines for gastric cancer;(3)TNM staging referenced to the American Cancer Society 8th edition criteria and exclusion of patients with stage IV by postoperative pathology;(4)combined organ resection only involving the gallbladder or appendix;(5)gastrointestinal tract reconstruction modality of B-I or B-II;(6)complete clinicopathological data;(7)survivor during the last follow-up period from December 15,2021 to January 15,2022.Exclusion criteria:(1)poor compliance to follow-up;(2)incomplete information on questionnaire evaluation;(3)survivors with tumors;(4)concurrent malignancies in other systems;(5)concurrent psychiatric and neurological disorders that seriously affected the objectivity of the questionnaire or interfered with patient's cognition.Telephone follow-up was conducted by a single investigator from December 2021 to January 2022,and the standardized questionnaire EORTC QLQ-C30 scale(symptom domains,functional domains and general health status)and EORTC QLQ-STO22 scale(5 symptoms of dysphagia,pain,reflux,restricted eating,anxiety;4 single items of dry mouth,taste,body image,hair loss)were applied to evaluate postoperative quality of life.In 859 patients,271 were females and 588 were males;the median age was 57.0(49.5,66.0)years.The included cases were divided into the postoperative follow-up first year group(202 cases),the second year group(236 cases),the third year group(148 cases),the fourth year group(129 cases)and the fifth year group(144 cases)according to the number of years of postoperative follow-up.Each group was then divided into B-I reconstruction group and B-II reconstruction group according to procedure of digestive tract reconstruction.Except for T-stage in the fourth year group,and age,tumor T-stage and tumor TNM-stage in the fifth year group,whose differences were statistically significant between the B-I and B-II reconstruction groups(all P<0.05),the differences between the B-I and B-II reconstruction groups in terms of demographics,body mass index(BMI),tumor TNM-stage and tumor pathological grading in postoperative follow-up each year group were not statistically significant(all P>0.05),suggesting that the baseline information between B-I reconstruction group and the B-II reconstruction group in postoperative each year group was comparable.Evaluation indicators of quality of life(EORTC QLQ-C30 and EORTC QLQ-STO22 scales)and nutrition-related laboratory tests(serum hemoglobin,albumin,total protein,triglycerides)between the B-I reconstruction group and B-II reconstruction group in each year group were compared.Non-normally distributed continuous variables were presented as median(Q_(1),Q_(3)),and compared by using the Wilcoxon rank sum test(paired=False).Theχ^(2) test or Fisher's exact test was used for comparison of categorical variables between groups.Results There were no statistically significant differences in all indexes EORTC QLQ-30 scale between the B-I reconstruction group and the B-II reconstruction group among all postoperative follow-up year groups(all P>0.05).The EORTC QLQ-STO22 scale showed that significant differences in pain and eating scores between the B-I reconstruction group and the B-II reconstruction group were found in the second year group,and significant differences in eating,body and hair loss scores between the B-I reconstruction group and the B-II reconstruction group were found in the third year group(all P<0.05),while no significant differences of other item scores between the B-I reconstruction group and the B-II reconstruction group were found in postoperative follow-up of all year groups(P>0.05).Triglyceride level was higher in the B-II reconstruction group than that in the B-I reconstruction group(W=2060.5,P=0.038),and the proportion of patients with hyperlipidemia(triglycerides>1.85 mmol/L)was also higher in the B-II reconstruction group(19/168,11.3%)than that in the B-I reconstruction group(0/34)(χ^(2)=0.047,P=0.030)in the first year group with significant difference.Albumin level was lower in the B-II reconstruction group than that in the B-I reconstruction group(W=482.5,P=0.036),and the proportion of patients with hypoproteinemia(albumin<40 g/L)was also higher in the B-II reconstruction group(19/125,15.2%)than that in the B-I reconstruction group(0/19)in the fifth year group,but the difference was not statistically significant(χ^(2)=0.341,P=0.164).Other nutrition-related clinical laboratory tests were not statistically different between the B-I reconstruction and the B-II reconstruction in each year group(all P>0.05).Conclusions The effects of both B-I and B-II reconstruction methods on postoperative mid-term and long-term quality of life are comparable.The choice of reconstruction method after radical resection of distal gastric cancer can be based on a combination of patients'condition,sugenos'eoperience and operational convenience.