Clinical trial NCT03117283: Laparoscopic Total Gastrectomy With Versus Without 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Laparoscopic Gastrectomy
Laparoscopic Bursectomy
A Left Outside Bursa Omentalis Approach
Keywords: Laparoscopic surgery
Radical total gastrectomy
Bursectomy
Advanced posterior gastric wall cancer
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Early morbidity
timeFrame: 30 days
Secondary outcomes:
measure: Operative time
timeFrame: Intraoperative
measure: Lymph node
timeFrame: 14 days
measure: First ambulation
timeFrame: 30 days
measure: 3-year survival
timeFrame: 3 years
measure: 5-year survival
timeFrame: 5 years
measure: Estimated blood loss
timeFrame: Intraoperative
measure: First flatus
timeFrame: 30 days
measure: First liquid diet
timeFrame: 30 days
measure: Hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Wei Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Wenjun Xiong
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hundahl SA. The potential value of bursectomy in operations for trans-serosal gastric adenocarcinoma. Gastric Cancer. 2012 Jan;15(1):3-4. doi: 10.1007/s10120-011-0121-6. No abstract available.
citation: Japanese Gastric Cancer Association Registration Committee; Maruyama K, Kaminishi M, Hayashi K, Isobe Y, Honda I, Katai H, Arai K, Kodera Y, Nashimoto A. Gastric cancer treated in 1991 in Japan: data analysis of nationwide registry. Gastric Cancer. 2006;9(2):51-66. doi: 10.1007/s10120-006-0370-y.
citation: Fujita J, Kurokawa Y, Sugimoto T, Miyashiro I, Iijima S, Kimura Y, Takiguchi S, Fujiwara Y, Mori M, Doki Y. Survival benefit of bursectomy in patients with resectable gastric cancer: interim analysis results of a randomized controlled trial. Gastric Cancer. 2012 Jan;15(1):42-8. doi: 10.1007/s10120-011-0058-9. Epub 2011 May 15.
citation: Imamura H, Kurokawa Y, Kawada J, Tsujinaka T, Takiguchi S, Fujiwara Y, Mori M, Doki Y. Influence of bursectomy on operative morbidity and mortality after radical gastrectomy for gastric cancer: results of a randomized controlled trial. World J Surg. 2011 Mar;35(3):625-30. doi: 10.1007/s00268-010-0914-5.
citation: Kayaalp C, Piskin T, Olmez A. Complications of bursectomy after radical gastrectomy for gastric cancer. World J Surg. 2012 Jan;36(1):229; author reply 230. doi: 10.1007/s00268-011-1218-0. No abstract available.
citation: Hirao M, Kurokawa Y, Fujita J, Imamura H, Fujiwara Y, Kimura Y, Takiguchi S, Mori M, Doki Y; Osaka University Clinical Research Group for Gastroenterological Study. Long-term outcomes after prophylactic bursectomy in patients with resectable gastric cancer: Final analysis of a multicenter randomized controlled trial. Surgery. 2015 Jun;157(6):1099-105. doi: 10.1016/j.surg.2014.12.024. Epub 2015 Feb 20.
citation: Wang W, Xiong W, Liu Z, Luo L, Zheng Y, Tan P, Diao D, Zou L, Wan J. Clinical significance of No. 10 and 11 lymph nodes posterior to the splenic vessel in D2 radical total gastrectomy: An observational study. Medicine (Baltimore). 2016 Aug;95(32):e4581. doi: 10.1097/MD.0000000000004581.
citation: Wang W, Liu Z, Xiong W, Zheng Y, Luo L, Diao D, Wan J. Totally laparoscopic spleen-preserving splenic hilum lymph nodes dissection in radical total gastrectomy: an omnibearing method. Surg Endosc. 2016 May;30(5):2030-5. doi: 10.1007/s00464-015-4438-9. Epub 2015 Jul 23.