Laparoscopic Total Gastrectomy With Versus Without Bursectomy

Study Overview
=================
Brief Summary
-----------------
Bursectomy is widely performed in open surgery for advanced gastric cancer in East Asia. However laparoscopic D2 radical total gastrectomy with complete bursectomy is difficult and rare performed. Herein, we conduct a single-centre randomized controlled trial to explore the safety and feasibility of totally laparoscopic D2 radical total gastrectomy using a left outside bursa omentalis approach for achieving complete bursectomy.

Detailed Description
-----------------
Although, the clinical value of bursectomy in addition to D2 lymphadenectomy in radical gastrectomy for curable gastric cancer is controversial. Data analysis of the nationwide registry of gastric cancer in Japanese revealed that 10.7% of patients with subserosal and serosal positive cancer developed peritoneal recurrence after radical gastrectomy. Some trials, although, indicated a biologically reasonable but statistically non-significant advantage to bursectomy. But for patients with posterior gastric wall trans-serosal disease, such micrometastases can constitute the seeds of later recurrence. The non-bursectomy showed worse overall survival. Early removal of micrometastases and cancer cells deposited might prove beneficial and a possible therapeutic effect. In any case, the authors reasonably concluded that bursectomy should not be abandoned at this time. The hypothesis that it might actually enhance survival should be entertained. In the past decades, Japanese, Korea, Chinese and even Turkey, surgeons have continued to performed bursectomy and lymph nodes dissection as the conventional open procedures for advanced gastric cancer. Lymph nodes dissection and bursectomy is routinely regarded as a standard surgical procedure during radical open gastrectomy for tumors penetrating the serosa of the posterior gastric wall. Complete bursectomy and lymphadenectomy in open radical gastrectomy may represents a formidable challenge to the best of surgeons and its influences on operative morbidity and mortality, but it can be also safely performed in high volume experience centers or by experienced surgeons with mortality rate of <1% and morbidity rates around 14%. Generally speaking, bursectomy is incomplete without total gastrectomy. The concept of bursectomy mentioned above is always almost confined to removal of the local anterior membrane of the transverse mesocolon and pancreatic capsule and to open radical gastrectomy. With the generalization and development of laparoscopic technology, laparoscopic surgery for advanced gastric cancer as clinical study has extensively performed in Asia.The investigators take the lead in carrying out laparoscopic bursectomy and D2 radical gastrectomy by. Herein, the investigators conduct a single-centre randomized controlled trial to explore the safety and feasibility of totally laparoscopic D2 radical total gastrectomy using a left outside bursa omentalis approach for achieving complete bursectomy.

Official Title
-----------------
Laparoscopic Total Gastrectomy With Bursectomy in a Left Outside Bursa Omentalis Approach Versus Laparoscopic Total Gastrectomy Without Bursectomy for Advanced Posterior Gastric Wall Cancer: a Randomized Controlled Study

Conditions
-----------------
Laparoscopic Gastrectomy, Laparoscopic Bursectomy, A Left Outside Bursa Omentalis Approach

Intervention / Treatment
-----------------
* Procedure: Laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach
* Procedure: Laparoscopic D2 radical total gastrectomy without bursectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary gastric adenocarcinoma diagnosed pathologically by endoscopic biopsy Tumor located in the posterior wall of upper and middle third stomach estimated by endoscopy and CT scan Informed consent Eastern Cooperative Oncology Group (ECOG): 0 ot 1 American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ Exclusion Criteria: Pregnancy or female in suckling period Contraindication to general anesthesia (severe cardiac and/or pulmonary disease) Severe mental disease Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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: LTG with Bursectomy<br>laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach | Procedure: Laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach<br>* Patients with advanced posterior gastric wall cancer including in the laparoscopic total gastrectomy (LTG) with bursectomy group will undergo laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach.<br>|
| Sham Comparator: LTG without Bursectomy<br>laparoscopic D2 radical total gastrectomy without bursectomy | Procedure: Laparoscopic D2 radical total gastrectomy without bursectomy<br>* Patients who are included in the laparoscopic total gastrectomy (LTG) without bursectomy group will undergo laparoscopic D2 radical total gastrectomy without bursectomy in a conventional manner.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early morbidity | The early morbidity is defined as the adverse event observed during peri-operative time. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | The mean operative time of the procedures | Intraoperative | 
| Lymph node | This outcome consists of the number of total lymph nodes harvested and the number of lymph nodes in the wall of bursa omentalis | 14 days | 
| First ambulation | The time to first ambulation | 30 days | 
| 3-year survival | 3-year disease free survival rate | 3 years | 
| 5-year survival | 5-year overall survival rate | 5 years | 
| Estimated blood loss | The mean estimated blood loss | Intraoperative | 
| First flatus | The time to first flatus | 30 days | 
| First liquid diet | The time to liquid diet | 30 days | 
| Hospital stay | Postoperative hospital stay | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic surgery, Radical total gastrectomy, Bursectomy, Advanced posterior gastric wall cancer