Laparoscopic Total Gastrectomy With Versus Without Bursectomy

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status and phase: Unknown; Phase 2

Conditions: Laparoscopic Bursectomy; A Left Outside Bursa Omentalis Approach; Laparoscopic Gastrectomy

Treatments: Procedure: Laparoscopic D2 radical total gastrectomy without bursectomy; Procedure: Laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach

Study type: Interventional

Funder types: Other

Identifiers

NCT03117283

GDPHCM-GI-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

LTG with Bursectomy

Experimental group

Description:

laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach

Treatment:

Procedure: Laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach

LTG without Bursectomy

Sham Comparator group

Description:

laparoscopic D2 radical total gastrectomy without bursectomy

Treatment:

Procedure: Laparoscopic D2 radical total gastrectomy without bursectomy