| Background:China has gradually entered the aging society,the patients with gastric cancer in our country,which the average age of onset is 65 years old,and more than 75 years old age accounted for about 29%.Laparoscopy-assisted distal gastrectomy(LDG)for the treatment of early gastric cancer(EGC)has been supported by high-quality evidences,and LDG with D2 lymphadenectomy can be safely performed in patients with advanced gastric cancer(AGC)by experienced surgeons at high-volume specialized institutions in CLASS-01.Unfortunately,there are rare studies specializing into the LAG for the gastric cancer patients of>65 years old.The purpose of this study is to investigate the feasibility,safety and short-term efficacy of laparoscopy in the treatment of lower gastric cancer in the elderly(≥65 years).Methods:1.Single-arm analysis of elderly patients with gastric cancer undergoing laparoscopic distal radical gastrectomy from December 2004 to August 2014 in our hospital,which to evaluate the safety and short-term efficacy of laparoscopic radical gastrectomy for these type of patients;2.Retrospectively analyze the difference of clinical data between 1:1 case control matching laparoscopic group and traditional open group in elderly patients with gastric cancer,and to compare the safety and short-term efficacy of laparoscopic and conventional open surgery for elderly patients with gastric cancer in the same time period and same center;3.To design a prospective,randomized,controlled clinical trial of laparoscopic and traditional open radical gastrectomy for the treatment of elderly patients with gastric cancer in short-term efficacy,and to make interim analysis.Results:1.A retrospective single-arm analysis of 109 cases of elderly patients with gastric cancer undergoing laparoscopic radical distal gastric cancer surgery,The average age of 71.4 years old,In term of reconstruction(B-I,48 people,44%;B-Ⅱ,59 people,54.1%;Roux-en-Y,2 people,1.8%);in term of combined resection(11 people,10.1%);in term of surgical time(192.0±45 min),in term of estimated blood loss(126.5±101.3 ml);in term of proximal resection margin(4.4±2.4 cm);in term of distal resection margin(3.8±2.3 cm);in term of lymph node(30.9±19.6);in term of time of ambulation(3.5±2.8 days);in term of time to first flatus(4.0±2.4 days),in term of time to first liquid intake(4.8±2.8 days);in term of postoperative hospital stay(10.0±3.9 days);in term of rate of morbidity(23,21.1%;Clavien-Dindo I degree,2 people,C-D II degree,18 people;C-D III degree,3people).2.Retrospective analysis of 1:1 matching 166 elderly patients with gastric cancer who underwent distal gastrectomy,and eventually laparoscopic group and conventional open group were matched for the number of 53 cases for each group.Laparoscopic group of 35 males and 18 females,mean age 71.6 years old;the traditional open group of 32 males and 21 females,with an average age of 70.5 years old;Compared to the laparoscopic group and the traditional open group was characterized by Sex,Age,BMI,ECOG,Comorbidity,Tumor size,Histology,Metastatic lymph node,Pathologic T,N,TNM stage,Recomstruction,Lymphadenectomy,Combined resection,Intraoperative blood transfusion,Proximal resection margin,Distal resection margin,Rate of morbidity,Clavien-Dindo classification has no difference between two groups(p>0.05).In term of surgical time(LDG 195±50.1min vs.ODG 159.4±34.4min,p<0.001),Estimated blood loss(LDG 142.3±112.0ml vs.ODG 197.2±139.2ml,p=0.029),Time to ambulation(LDG 3.7±3.1 days vs.ODG 4.9±1.8 days,p=0.019);Time to first flatus(LDG 4.0±2.7 days vs.ODG 5.3±1.4 days,p=0.002),Time to first liquid intake(LDG 5.0±2.9 days vs.ODG 6.8±2.1days,p=0.001),Postoperative hospital stay(LDG 10.4±4.1 days vs.ODG 14.2±6.3 days,p<0.001)has difference between two groups.3.The results of RCT’s interim analysis:the average age was 69.8±4.6 years old in the laparoscopic group,and the average age was 70.2±4.6 years old in the traditional open surgery group;In term of Lymph node dissection,reconstruction method,operation time,intraoperative blood transfusion,there was no statistical difference(p>0.05);In term of intraoperative blood loss(LDG:85.1±53 ml vs.ODG:157.2±153.2 ml;p=0.003),incision length(LDG:7.1±1.7cm vs.ODG:19.1±1.7cm;p<0.001),nunber of lymph nodes examined(LDG:50.9±20.8vs.ODG:41.8±17.3;p=0.022),time to ambulation(LDG:2.2±1.2 daysvs.ODG:4.0±5.2 days;p=0.023),time to first flatus(LDG:2.7±1.1 days vs.ODG:4.2±3.7days;p=0.009),time to first liquid intake(LDG:3.6±1.7 days vs.ODG:5.3±4.2 days;p=0.011),drainage tube retention time(LDG:5.6±2.7 days vs.ODG:8.2±6.0 days;p=0.009),postoperative hospital stay(LDG:8.2±2.8 days vs.ODG:10.8±6.2 days;p=0.011);In term of intraoperative complication rate(LDG:16.3%vs.ODG:23.4%;p>0.05),postoperative complications rate(LDG:24.5%vs.ODG:23.4%;p>0.05),There were no deaths in both groups.Conclusion:Laparoscopic distal gastrectomy in elderly patients with gastric cancer is feasible and safe,and there is less blood loss,and quicker recovery,shorter hospital stays and so on. |