Laparoscopic Total Gastrectomy With Versus Without Bursectomy
- Conditions
- A Left Outside Bursa Omentalis ApproachLaparoscopic BursectomyLaparoscopic Gastrectomy
- Interventions
- Procedure: Laparoscopic D2 radical total gastrectomy without bursectomyProcedure: Laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach
- Registration Number
- NCT03117283
- Lead Sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 56
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LTG without Bursectomy Laparoscopic D2 radical total gastrectomy without bursectomy laparoscopic D2 radical total gastrectomy without bursectomy LTG with Bursectomy Laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach
- Primary Outcome Measures
Name Time Method Early morbidity 30 days The early morbidity is defined as the adverse event observed during peri-operative time.
- Secondary Outcome Measures
Name Time Method First flatus 30 days The time to first flatus
Estimated blood loss Intraoperative The mean estimated blood loss
Lymph node 14 days This outcome consists of the number of total lymph nodes harvested and the number of lymph nodes in the wall of bursa omentalis
5-year survival 5 years 5-year overall survival rate
Operative time Intraoperative The mean operative time of the procedures
First ambulation 30 days The time to first ambulation
First liquid diet 30 days The time to liquid diet
3-year survival 3 years 3-year disease free survival rate
Hospital stay 30 days Postoperative hospital stay
Trial Locations
- Locations (1)
Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China