腹腔镜全胃切除术中Later-cut Overlap吻合与Roux-en-Y吻合的倾向评分匹配疗效分析

Efficacy analysis of Later-cut overlap anastomosis versus Roux-en-Y anastomosis in laparoscopic total gastrectomy using propensity score matching

  • 摘要: 目的:探讨腹腔镜全胃切除术中Later-cut Overlap吻合和Roux-en-Y吻合的疗效。
    方法:采用倾向性评分匹配和回顾性队列研究方法。收集2014年1月至2019年3月福建医科大学附属协和医院收治的1 804例行腹腔镜全胃切除术胃癌患者的临床病理资料;男1 346例,女458例;中位年龄为63岁,年龄范围为18~91岁。1 804例患者中,100例全腹腔镜全胃切除术中消化道重建行Later-cut Overlap吻合术设为改良组;1 704例腹腔镜辅助全胃切除术中消化道重建行传统Roux-en-Y吻合术设为传统组。观察指标:(1)倾向性评分匹配情况及匹配后两组患者一般资料比较。(2)术中和术后情况。(3)并发症情况。(4)随访情况:①倾向评分匹配后两组患者欧洲癌症观察和治疗组织 (EORTC)生命质量问卷30版(QLQ-C30)的功能子量表评估。②倾向评分匹配后两组患者EORTC-QLQ-C30的症状量表评估。③倾向评分匹配后两组患者EORTC胃癌特殊模块(QLQ-STO22)的症状量表评估。④亚组分析。(5)Later-cut Overlap吻合术的学习曲线。采用门诊、登门拜访、Email及电话方式进行术后随访,术后2年内每3个月随访1次,术后3~5年内每6个月随访1次,了解患者术后生命质量情况。随访时间截至2019年12月。改良组和传统组进行1∶1最近邻匹配法匹配。正态分布的计量资料以±s表示,组间比较采用t检验。计数资料以绝对数或百分比表示,组间比较采用x2检验。等级资料采用非参数秩和检验。偏态分布以M(P25,P75)或M(范围)表示,组间比较采用U检验。应用累积和曲线图分析个例数据与整体数据间微小变化,累积和曲线计算公式为CUSUM= ),xi为每例患者食管-空肠吻合时间, μ为患者食管-空肠吻合时间的平均值,n为患者序号。
    结果:(1)倾向性评分匹配情况及匹配后两组患者一般资料比较:1 804例患者中,200例配对成功,其中改良组100例,传统组100例。倾向评分匹配前改良组患者性别(男、女),年龄,肿瘤直径,肿瘤位置(胃上部、胃中部、全胃),肿瘤分化程度(分化、未分化),术前白蛋白,肿瘤T分期(T1期、T2期、T3期、T4a期),肿瘤N分期(N0期、N1期、N2期、N3期),肿瘤国际抗癌联盟分期(Ⅰ期、Ⅱ期、Ⅲ期)分别为62、38例,(55±13)岁,4.5 cm(1.5 cm,7.5 cm),22、67、11例,72、28例,(42±4)g/L,36、11、39、14例,58、16、8、18例,44、29、27例;传统组上述指标分别为1 284、420例,(62±11)岁,6.5 cm(2.5 cm,8.0 cm),891、675、138例,1 392、312例,(39±7)g/L,148、200、393、963例,498、517、257、432例,322、604、778例,两组患者上述指标比较,差异均有统计学意义(x2=8.89,t=5.69,Z=2.75, x2=35.31,5.80,t=3.91,Z=-9.97, -5.44,-5.41,P<0.05)。倾向评分匹配后改良组患者上述指标分别为62、38例,(55±13)岁,4.0 cm (1.5 cm,7.5 cm),22、67、11例,82、18例,(42±4)g/L,36、11、39、14例,58、16、8、18例,44、29、27例;传统组上述指标分别为68、32例,(56±11)岁,4.0 cm(1.5 cm,7.4 cm),12、74、14例,87、13例,(41±5)g/L,23、18、45、14例,54、18、10、18例,42、40、18例,两组患者上述指标比较,差异均无统计学意义(x2=0.79,t=0.30,Z=0.87, x2=3.65,0.95,t=1.49,Z=-0.94,1.43,-0.50,P>0.05)。(2)术中和术后情况:倾向评分匹配后改良组患者手术时间、术中出血量、淋巴结清扫数目、术后首次肛门排气时间、术后首次进食流质食物时间、术后住院时间、治疗费用分别为(195±41)min、72 mL(5~125 mL),(44±15)枚、(3.4±1.1)d、(4.1±1.3)d、(10.7±4.3)d、(74 299±20 102)元;传统组患者上述指标分别为(192±78)min、67 mL(10~195 mL),(40±18)枚、(3.7±1.2)d、(4.5±1.9)d、(14.0±9.2)d、(71 029±12 231)元,两组患者手术时间、淋巴结清扫数目、术后首次肛门排气时间、术后首次进食流质食物时间、治疗费用比较,差异均无统计学意义(t=0.35,1.73,1.84,1.74,1.38,P>0.05)。两组患者术中出血量、术后住院时间比较,差异均有统计学意义(Z=0.62,t=3.25,P<0.05)。(3)并发症情况:改良组患者术后3例患者发生并发症,其中吻合口漏2例、腹腔感染1例;传统组4例患者发生术后并发症,其中吻合口漏2例、吻合口出血1例、腹腔感染1例,两组患者术后并发症比较,差异无统计学意义(x2=0.00,P>0.05)。吻合口漏和腹腔感染均经过通畅引流、营养支持、消炎等保守治疗治愈;吻合口出血通过输血、止血药物治疗后治愈。两组患者围术期均无死亡病例。(4)随访情况:146例患者获得术后6个月的生命质量评估,其中改良组78例,传统组68例。①倾向评分匹配后改良组患者EORTC-QLQ-C30的功能子量表评估中,总体健康身体功能、身体功能、角色功能、认知功能、情感功能和社会功能评分分别为31分(22分,48分)、(75±27)分、(77±21)分、(79±15)分、(80± 21)分和(76±29)分;传统组上述指标分别为38分(22分,57分)、(77±30)分、(79±27)分、(82±30)分、 (82±31)分和(78±30)分;两组患者上述指标比较,差异均无统计学意义(Z=0.46,t=0.39,0.40,0.66,0.49,P>0.05)。②倾向评分匹配后改良组患者EORTC-QLQ-C30的症状量表评估中,疲劳、恶心呕吐、疼痛、呼吸困难、失眠、食欲减退、便秘、腹泻、经济困难评分分别为(75±22)分、(89±19)分、(82±19)分、(77±19)分、(90±23)分、(74±14)分、(67±27)分、(74±28)分、(61±29)分;传统组患者上述指标分别为(72± 28)分、(88±23)分、(91±23)分、(72±19)分、(88±19)分、(79±29)分、(68±28)分、(72±23)分、(61±24)分。两组患者疲劳、恶心呕吐、呼吸困难、失眠、食欲减退、便秘、腹泻、经济困难评分比较,差异均无统计学意义(t=0.70,0.26,1.56,0.49,0.43,0.20,0.43,0.09,P>0.05);两组患者疼痛评分比较,差异有统计学意义 (t=2.48,P<0.05)。③倾向评分匹配后改良组患者EORTC-QLQ-STO22的症状量表评估中,吞咽困难、胸痛或腹痛、胃食管反流、进食障碍、焦虑、口干、味觉障碍、外形困扰、脱发评分分别为11分(6分,20分)、 13分(4分,22分)、9分(4分,21分)、11分(7分,20分)、23分(11分,34分)、24分(10分,31分)、11分(5分,21分)、19分(11分,35分)、11分(6分,25分);传统组患者上述指标分别为16分(7分,31分)、 14分(6分,22分)、7分(5分,16分)、11分(6分,20分)、22分(13分,29分)、28分(12分,33分)、9分 (5分,17分)、20分(10分,25分)、13分(5分,23分)。两组患者胸痛或腹痛、胃食管反流、进食障碍、焦虑、口干、味觉障碍、外形困扰、脱发评分比较,差异均无统计学意义(Z=0.41,-0.01,0.99,-0.03,0.52,0.46,-0.20,0.44,P>0.05);两组患者吞咽困难评分比较,差异有统计学意义(Z=-2.07,P<0.05)。④亚组分析:倾向评分匹配后改良组和传统组患者EORTC-QLQ-C30症状量表中疼痛项目疼痛感觉程度(无、轻度、中度、重度)分别为49、24、4、1例和43、9、14、2例,两组比较差异有统计学意义(Z=-2.519,P<0.05)。(5)Later-cut Overlap吻合术的学习曲线:100例改良组患者食管-空肠吻合时间的累积和曲线图分析显示:曲线在第33例时出现拐点,将1~33例设为学习期、34~100例设为学成期。学习期患者手术时间、吻合时间、术中出血量、淋巴结清扫数目、术后首次肛门排气时间、术后首次进食流质食物时间、住院时间、治疗费用分别为(216±60)min、(28±10)min、70 mL(10~204 mL),(41±17)枚、(4.5±0.9)d、(5.0±0.8)d、(11.1±4.3)d、68 722元(52 312~94 943元);学成期患者上述指标分别为(189±51)min、 (23±8)min,65 mL(5~200 mL)、(43±16)枚、(4.4±1.0)d、(5.3±1.1)d、(10.6±6.8)d、67 380元(49 289~92 732元);两者手术时间和吻合时间比较,差异均有统计学意义(t=2.27、2.87,P<0.05);两者术中出血量、淋巴结清扫数目、术后首次肛门排气时间、术后首次进食流质食物时间、住院时间、治疗费用比较,差异均无统计学意义(Z=0.57,t=0.69,0.49,1.39,0.39,Z=0.69,P>0.05)。
    结论:Later-cut Overlap吻合是一种可学习的全腹腔镜全胃切除术后消化道重建方式。该手术方式可以减少术中出血量,缓解患者术后进食梗阻和疼痛,改善患者术后生命质量。

     

    Abstract: Objective:To investigate the clinical efficacy of Later-cut overlap anastomosis versus Roux-en-Y anastomosis in laparoscopic total gastrectomy.
    Methods:The propensity score matching and retrospective cohort study was conducted. The clinicopathological data of 1 804 patients with gastric cancer who underwent laparoscopic total gastrectomy in Fujian Medical University Union Hospital from January 2014 to March 2019 were collected. There were 1 346 males and 458 females, aged from 18 to 91 years, with a median age of 63 years. Of 1 804 patients, 100 undergoing Later-cut overlap anastomosis for digestive tract reconstruction in totally laparoscopic total gastrectomy and 1 704 undergoing Roux-en-Y anastomosis in laparoscopic-assisted total gastrectomy were allocated into modified group and traditional group, respectively. Observation indicators: (1) the propensity score matching conditions and comparison of general data between the two groups after propensity score matching; (2) intraoperative and postoperative situations; (3) complications; (4) follow-up, including ① functional scales of European Organization for Research and Treatment of Cancer quality of life questionnaire-core 30 (EORTC-QLQ-C30) for two groups after propensity score matching, ② symptom scales of EORTC-QLQ-C30 for two groups after propensity score matching, ③ symptom scales of European Organization for Research and Treatment of Cancer quality of life questionnaire of stomach 22 (EORTC-QLQ-STO22) for two groups after propensity score matching, ④ subgroup analysis; (5) learning curve of Later-cut overlap anastomosis. Patients were followed up by outpatient examination, paying a visit, Email and telephone interview once every 3 months within postoperative 2 years and once every 6 months within postoperative 3-5 years to detect postoperative life quality up to December 2019. The propensity score matching was conducted by 1∶1 matching using the nearest neighbor method. Measurement data with normal distribution were represented as Mean±SD, and comparison between groups was done using the t test. Count data were represented as absolute numbers or percentages, and comparison between groups was analyzed using the chi-square test. Comparison of ordinal data between groups was analyzed using the nonparametric rank sum test. Measurement data with skewed distribution were represented as M (P25, P75) or M (range), and comparison between groups was done using the U test. The cumulative sum curve was used to analysis minor changes between individual and overall data, with the equation of CUSUM= (),xi as esophagojejunostomy time of individuals, μ as the average time of esophagojejunostomy, n as serial number of patients.
    Results:(1) The propensity score matching conditions and comparison of general data between the two groups after propensity score matching: 200 of 1 804 patients had successful matching, including 100 in the modified group and 100 in the traditional group respectively. Before propensity score matching, the gender (males or females), age, tumor diameter, cases with tumor located at upper, middle or total stomach (tumor location), cases with differentiated or undifferentiated tumor (tumor differentiation degree), level of preoperative Alb, cases in stage T1, T2, T3, T4a (T staging), cases in stage N0, N1, N2, N3 (N staging), cases in stage Ⅰ, Ⅱ, Ⅲ (Union International Control Cancer staging) were 62, 38, (55±13)years, 4.5 cm(1.5 cm, 7.5 cm), 22, 67, 11, 72, 28, (42±4)g/L, 36, 11, 39, 14, 58, 16, 8, 18, 44, 29, 27 of the modified group, versus 1 284, 420, (62±11)years, 6.5 cm(2.5 cm, 8.0 cm), 891, 675, 138, 1 392, 312, (39±7)g/L, 148, 200, 393, 963, 498, 517, 257, 432, 322, 604, 778 of the traditional group, showing significant differences in the above indicators between the two groups (x2=8.89, t=5.69, Z=2.75, x2=35.31, 5.80, t=3.91, Z=-9.97, -5.44, -5.41, P<0.05). After propensity score matching, the above indicators were 62, 38, (55±13)years, 4.0 cm(1.5 cm, 7.5 cm), 22, 67, 11, 82, 18, (42±4)g/L, 36, 11, 39, 14, 58, 16, 8, 18, 44, 29, 27 of the modified group, versus 68, 32, (56±11)years, 4.0 cm(1.5 cm, 7.4 cm), 12, 74, 14, 87, 13, (41±5)g/L, 23, 18, 45, 14, 54, 18, 10, 18, 42, 40, 18 of the traditional group, showing no significant difference in the above indicators between the two groups (x2=0.79, t=0.30, Z=0.87, x2=3.65, 0.95, t=1.49, Z=-0.94, 1.43, -0.50, P>0.05). (2) Intraoperative and postoperative situations: after propensity score matching, the operation time, volume of intraoperative blood loss, the number of lymph node dissected, time to the first flatus, time to fluid diet intake, duration of postoperative hospital stay, treatment expenses were (195±41)minutes, 72 mL(range, 5-125 mL), 44±15, (3.4±1.1)days, (4.1±1.3)days, (10.7±4.3)days, (74 299±20 102)yuan of the modified group, versus (192±78)minutes, 67 mL(range, 10-195 mL), 40±18, (3.7±1.2)days, (4.5±1.9)days, (14.0±9.2)days, (71 029±12 231)yuan of the the traditional group, respectively. There was no significant difference in the operation time, the number of lymph node dissected, time to the first flatus, time to fluid diet intake, or treatment expenses between the two groups (t=0.35, 1.73, 1.84, 1.74, 1.38, P>0.05). There were significant differences in the volume of intraoperative blood loss and duration of postoperative hospital stay between the two groups (Z=0.62, t=3.25, P<0.05). (3) Complications: three patients in the modified group had complications, including 2 cases of anastomotic leakage and 1 case of abdominal infection. Four patients in the traditional group had complications, including 2 cases of anastomotic leakage, 1 case of anastomotic hemorrhage, 1 case of abdominal infection. There was no significant difference in the complications between the two groups (x2=0.00, P>0.05). Patients with anastomotic leakage and abdominal infection were cured after conservative treatments including adequate drainage, nutritional support, anti-inflammation. Patients with anastomotic hemorrhage were cured after blood transfusion and hemostatic therapy. There was no perioperative death in either group. (4) Follow-up: 146 patients received life quality evaluation at postoperative 6 months, including 78 in the modified group and 68 in the traditional group. ① Functional scales of EORTC-QLQ-C30 for two groups after propensity score matching: the scores of overall health functioning, physical functioning, role functioning, cognitive functioning, emotional functioning, social functioning were 31(22,48), 75±27, 77±21, 79±15, 80±21, 76±29 for the modified group, respectively, versus 38(22,57), 77±30, 79±27, 82±30, 82±31, 78±30 for the traditional group, showing no significant difference between the two groups (Z=0.46, t=0.39, 0.40, 0.66, 0.49, P>0.05). ② Symptom scales of EORTC-QLQ-C30 for two groups after propensity score matching: the scores of fatigue, nausea and vomiting, pain, dyspnea, hyposomnia, anorexia, constipation, diarrhea, financial difficulty were 75±22, 89±19, 82±19, 77±19, 90±23, 74±14, 67±27, 74±28, 61±29 for the modified group, respectively, versus 72±28, 88±23, 91±23, 72±19, 88±19, 79±29, 68±28, 72±23, 61±24 for the traditional group; there was no significant difference in the scores of fatigue, nausea and vomiting, dyspnea, hyposomnia, anorexia, constipation, diarrhea or financial difficulty between the two groups (t=0.70, 0.26, 1.56, 0.49, 0.43, 0.20, 0.43, 0.09, P>0.05), while there was a significant difference in the score of pain (t=2.48, P<0.05). ③ Symptom scales of EORTC-QLQ-STO22 for two groups after propensity score matching: the scores of dysphagia, chest pain or abdominal pain, gastroesophageal reflux, eating disorder, anxiety, dryness of mouth, taste disorder, appearance disturbance, hair loss were 11(6, 20), 13(4, 22), 9(4, 21), 11(7, 20), 23(11, 34), 24(10, 31), 11(5, 21), 19(11, 35), 11(6, 25) for the modified group, respectively, versus 16 (7, 31), 14 (6, 22), 7(5, 16), 11(6, 20), 22 (13, 29), 28 (12, 33), 9 (5, 17), 20 (10, 25), 13 (5, 23) for the traditional group; there was no significant difference in the scores of chest pain or abdominal pain, gastroesophageal reflux, eating disorder, anxiety, dryness of mouth, taste disorder, appearance disturbance, hair loss between the two groups (Z=0.41, -0.01, 0.99, -0.03, 0.52, 0.46, -0.20, 0.44, P>0.05), while there was a significant difference in the score of dysphagia (Z=-2.07, P<0.05). ④ Subgroup analysis: after propensity score matching, cases with no, mild, moderate, severe pain (degree of pain perception) for pain-related items in EORTC-QLQ-C30 were 49, 24, 4, 1 of the modified group, versus 43, 9, 14, 2 of the traditional group, showing a significant difference between the two groups (Z=-2.519, P<0.05). (5)Learning curve of Later-cut overlap anastomosis. The cumulative sum curve for esophagojejunostomy time of the 100 patients in the modified group showed a inflection point at the 33th patient, so the 1st-33th patients were allocated into learning phase and the 34th-100th patients were allocated into stable phase. The operation time, anastomosis time, volume of intraoperative blood loss, the number of lymph node dissected, time to first flatus, time to postoperative liquid diet intake, duration of hospital stay, treatment expenses for patients in the learning phase were (216±60)minutes, (28±10)minutes, 70 mL(range, 10-204 mL), 41±17, (4.5± 0.9)days, (5.0±0.8)days, (11.1±4.3)days, 68 722 yuan(range, 52 312-94 943 yuan), respectively, versus (189±51)minutes, (23±8)minutes, 65 mL(range, 5-200 mL), 43±16, (4.4±1.0)days, (5.3±1.1)days, (10.6±6.8)days, 67 380 yuan(range, 49 289-92 732 yuan) for patients in the stable phase. There were significant differences in the operation time and anastomosis time between the two groups (t=2.27, 2.87, P<0.05). There was no significant difference in the volume of intraoperative blood loss, the number of lymph node dissected, time to first flatus, time to postoperative liquid diet intake, duration of hospital stay or treatment expenses between the two groups (Z=0.57, t=0.69, 0.49, 1.39, 0.39, Z=0.69, P>0.05).
    Conclusion: Later-cut overlap anastomosis is a digestive tract reconstruction method after totally laparoscopic total gastrectomy, which can reduce the volume of intraoperative blood loss, relieve postoperative eating obstruction and pain and improve postoperative life quality of patients.

     

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