| Background:Roux-en-Y esophagojejunostomy was generally performed extracorporeally via an 8-10cm mini-laparotomy in the upper abdomen during laparoscopic total gastrectomy(LTG).However,the anvil insertion and purse-string suturing were difficult even in experienced hands,especially for the patients demanding higher resection of the distal esophagus,with a narrow thoracic or obesity appears.To gain potential clinical benefits from an easier anvil insertion and purse-string suturing than extracorporeal anastomosis,intracorporeal esophagojejunostomy using a transorally inserted anvil system(OrVilTM)during LTG was introduced.However,its short-term outcomes have not yet been verified thoroughly with high-rank evidence.Thus,the purpose of this study is to evaluate the safety and feasibility of intracorporeal esophagojejunostomy via OrVilTMsystem during LTG for gastric cancer.Chapter I:Surgical safety of intracorporeal esophagojejunostomy by transorally inserted anvil:a retrospective single arm trial.Methods:Single-arm analysis of the surgical safety of intracorporeal esophagojejunostomy by transorally inserted anvil system during LTG for gastric cancer patients from January 2011 to April 2014 in our hospital.Results:A total of 25 patients were analysed.Means of operative time,duration of reconstruction,time for anvil insertion completion,blood loss,length of mini-laparotomy were 216.5±24.9min,44.4±9.4 min and 9.9±2.4min,100(135)ml and 5.6±0.4cm,respectively.In terms of the postoperative recovery course,means of time to postoperative first leave bed,time to first flatus,time to first liquid diet intake,time to first soft diet intake and the postoperative hospital stay were 2.6±0.8d,3.1±0.8d,4.2±1.2 d and 5.9±2.0d,and 8.8±5.5d,respectively.As for the operation-related complications,the occurrence rate of intraoperative complication was 8%while postoperative complication rate within 30 days was 28%.Among the cases developing postcomplications,3 cases were intra-abdominal infection,3 cases were pneumonia and 1 case was wound infection.According to the Clavien-Dindo classification,the 7 cases postoperation complications could be classified as C-D ?grade(6 patients)and C-D ?a grade(1 patient).Conclusions:Intracorporeal esophagojejunostomy using OrVilTM system is safe and feasible.However,the rank of evidence of this retrospective single arm trial is not high enough.Thus,the study comparing the safety of intracorporeal Roux-en-Y esophagojejunostomy using a transorally inserted anvil versus extracorporeal anastomosis by circular stapler based on well-designed cohort studies are awaited.Chapter II:Surgical safety of intracorporeal esophagojejunostomy by transorally inserted anvil system versus extracorporeal anastomosis via mini-laparotomy during laparoscopic total gastrectomy for gastric cancer:a propensity score matching analysisMethods:From March 2010 to December 2016,414 consecutive gastric patients underwent either intracorporeal Roux-en-Y esophagojejunostomy(n=43)via OrVilTMor extracorporeal circular anastomosis(n=371)during LTG.After generating propensity scores with six covariates,including gender,age,body mass index(BMI),neoadjuvant chemotherapy,tumor location,tumour size,43 patients performed with the OrVilTMmethod(OrVil TM group)were one-to-one matched with 43 patients operated with the extracorporeal approach(extracorporeal group).In the OrVilTM group,the OrVilnvt anvil was inserted transorally and the esophagojejunal anastomosis was performed under laparoscopic view after reestablishing pneumoperntoneum.While in the extracorporeal group,the anvil was inserted via a small midline incision of 8-10cm through which the extracorporeal esophagojejunostomy was completed.The early postoperative safety was compared between the two groups.Results:Both groups were balanced regarding baseline variables.The total operative time(235.63±49.80 min versus 221.12146.45min,t=1.397,P=0.166)and anvil insertion completion(10.000±3.23min versus 10.57±4.53min,t=0.671,P=0.504)were not significantly different between the two groups,whereas the duration of reconstruction and the mean length of mini-laparotomy(48.33±12.OOmin versus 55.91±12.25min,t=2.899,P=0.005;5.57±0.63cm versus 8.09±2.24,t=7.118,P=0.001)in the OrVilTMgroup was superior.While the number of retrieved lymph node,the mean blood loss and the proximal resection margin were comparable(P>0.05).As a whole,the OrVilTMgroup has an advantage over extracorporeal group during the postoperative recovery course:although the leaving bed time and the postoperative hospital stay were similar between two groups(P>0.05),the time to liquid resumption(3,7±1.8d versus 6.2±7.2d,t=2.236,P=0.030),liquid diet(4.8±2.3d versus 7.2±7.1d,t=2.013,P=0.048),and soft diet(6.7±2.9d versus 10.2±9.6d,t=2.24,P=0.029)were significantly shorter in OrVilTMgroup.The occurrence rate of intraoperative complication(OrVilTMgroup:6.98%(3/43),Extracorporeal group:4.95%(2/43),?2<0.001,P=1.000)and postoperative complications(Intracorporeal group:30.2%(13/43),Extracorporeal group:20.9%(9/43),x2=1.484,P=0.223),and even the distribution of severity(P=0.990)were similar between the two groups.The occurrence rate of anastomotic leakage(AL)were 9.3%(4/43)and 18.6%(8/43)in the OrViflTMgroup and extracorporeal group,respectively(?2=1.550,P=0.213).Notably,the multivariate analysis showed that the OrVillTManastomosis was not the risk factor of AL(HR=0.663,95%CI:0.120?3.674,P=0.638).Conclusions:Intracorporeal esophagojejunostomy using the OrVilTMsystem is more minimally invasive and convenient to operate without increasing the risk of operation-related complications.Thus it may be a potential safe approach to optimize the reconstruction for LTG.Therefore,the well-designed randomized controlled trial could be conducted to perform a comprehensive and longer-time evaluation of the short outcomes of intracorporeal esophagojejunostomy during LTG for gastric cancer.Chapter III:Randomized controlled trial on short-term outcomes of intracorporeal versus extracorporeal esophagojejunostomy during laparoscopic total gastrectomy for gastric cancerParticipants:Patients were diagnosed with primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy in Nanfang Hospital can be recruited when meeting the inclusion criteria:age from over 18 to under 75 years;the tumor located at middle or upper third of stomach while laparoscopic total gastrectomy is the planning surgery.Furthermore,the tumor invasion is less than 3cm above the esophagogastric junction;performance status of 0 or 1 on ECOG(Eastern Cooperative Oncology Group)scale;ASA(American Society of Anesthesiology)score class ?,?,or?.Design:A prospective randomized controlled trial in one center.Arms and InterventionsExperimental(Arm A):Intracorporeal Roux-en-Y esophagojejunostomy.During LTGQ Roux-en-Y esophagojejunostomy intracorporeally using a transorally inserted anvil(OrVilTM)will be performed for the patients assigned to this arm.Active Comparator(Arm B):Extracorporeal Roux-en-Y esophagojejunostomy During LTCS Roux-en-Y esophagojejunostomy extracorporeally using a transabdominal inserted anvil will be performed for the patients assigned to this arm.Sample size:146(Arm A:73;Arm B:73)Primary endpoint:Anastomosis-related early complication rateSecondary Outcome Measures:Reconstruction timeMorbidity and mortality ratesPostoperative recovery coursePostoperative quality of life... |
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