Laparoscopic Total Gastrectomy With Versus Without Bursectomy

Laparoscopic Gastrectomy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03117283
• Other study ID #: GDPHCM-GI-02
• Status: Recruiting
• Phase: Phase 2
• First received: April 7, 2017
• Last updated: April 12, 2017
• Start date: March 28, 2017
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2017
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: Wei Wang, M.D., PH.D.
• Phone: +86-13922255515
• Email: wangwei16400[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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: ?to ?

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

Related Conditions & MeSH terms

• A Left Outside Bursa Omentalis Approach
• Laparoscopic Bursectomy
• Laparoscopic Gastrectomy

Intervention

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

Locations

Country	Name	City	State
China	Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (8)

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 Cance — View 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 canc — View 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. — View 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 — View 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; — View 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. — View 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. Epu — View 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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early morbidity	The early morbidity is defined as the adverse event observed during peri-operative time.	30 days
Secondary	Operative time	The mean operative time of the procedures	Intraoperative
Secondary	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
Secondary	First ambulation	The time to first ambulation	30 days
Secondary	3-year survival	3-year disease free survival rate	3 years
Secondary	5-year survival	5-year overall survival rate	5 years
Secondary	Estimated blood loss	The mean estimated blood loss	Intraoperative
Secondary	First flatus	The time to first flatus	30 days
Secondary	First liquid diet	The time to liquid diet	30 days
Secondary	Hospital stay	Postoperative hospital stay	30 days