Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
To date, Roux-en-Y esophagojejunostomy transabdominal extracorporeally by circular stapler was the most common used method during laparoscopy-assisted total gastrectomy for gastric cancer, even though it was not totally laparoscopic surgery in which intracorporeal anastomosis should be performed. To gain potential clinical benefits from a smaller length of minilaparotomy and an easier anastomosis technique than extracorporeal anastomosis, intracorporeal Roux-en-Y anastomosis using a transorally inserted anvil (OrVil™) during totally laparoscopic total gastrectomy was adopted by experienced surgeons recently. However, the safety of intracorporeal Roux-en-Y esophagojejunostomy using a transorally inserted anvil (OrVil™) has not yet been evaluated. Thus, the study comparing the safety of intracorporeal versus extracorporeal Roux-en-Y esophagojejunostomy by circular stapler based on a well designed randomized controlled trial is needed.

Official Title
-----------------
Randomized Controlled Trial on Surgical Safety of Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer

Conditions
-----------------
Stomach Neoplasms, Minimally Invasive Surgery, Anastomosis

Intervention / Treatment
-----------------
* Procedure: Intracorporeal Roux-en-Y esophagojejunostomy
* Procedure: Extracorporeal Roux-en-Y esophagojejunostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from over 18 to under 75 years Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy Tumor located at middle or upper third of stomach while laparoscopic total gastrectomy is the planning surgery 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 I, II, or III Written informed consent Exclusion Criteria: Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except laparoscopic cholecystectomy) Conversion to open surgery before reconstruction

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracorporeal Roux-en-Y esophagojejunostomy<br>During totally laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy intracorporeally using a transorally inserted anvil (OrVil™) will be performed for the patients assigned to this arm. | Procedure: Intracorporeal Roux-en-Y esophagojejunostomy<br>* During totally laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy intracorporeally using a transorally inserted anvil (OrVil™) will be performed.<br>|
| Active Comparator: Extracorporeal Roux-en-Y esophagojejunostomy<br>During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally using a transabdominally inserted anvil will be performed for the patients assigned to this arm. | Procedure: Extracorporeal Roux-en-Y esophagojejunostomy<br>* During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally using a transabdominally inserted anvil will be performed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomosis-related early complication rate | Anastomotic leakage, intraluminal bleeding, or stenosis were considered as anastomosis-related early complication. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reconstruction time | Experimental group (Intracorporeal group): time from the esophagus was transected to reconstruction was completed. Active Comparator (Extracorporeal group): time from the minilaparotomy was made to reconstruction was completed. | During operation | 
| Morbidity and mortality rates | The early postoperative complication was defined as the event observed within 30 days after surgery. | 30 days | 
| Postoperative recovery course | Time to first ambulation, flatus, liquid diet, soft diet, and postoperative hospital stay were used to assess the postoperative recovery course. | 2 weeks | 
| Postoperative quality of life | EORTC questionaire (STO-22 and C30) were used to access the postoperative quality of life at 0,1,3,6 months after surgery. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Roux-en-Y Anastomosis, laparoscopic surgery, minilaparotomy, stomach neoplasms