Laparoscopic Total Gastrectomy With Versus Without Bursectomy

NCT ID: NCT03117283

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-28
• Study Completion Date: 2022-04-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LTG with Bursectomy

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

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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.

LTG without Bursectomy

laparoscopic D2 radical total gastrectomy without bursectomy

Group Type: SHAM_COMPARATOR

Laparoscopic D2 radical total gastrectomy without bursectomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Wei Wang

Wei Wang M.D., PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Wang

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Wenjun Xiong

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Wang, M.D., PH.D.

Role: CONTACT

wangwei16400@163.com

+86-13922255515

Facility Contacts

Wei Wang, M.D.,PH.D.

Role: primary

wangwei16400@163.com

+86-13922255515

Wenjun Xiong, M.D.

Role: backup

xiongwj1988@163.com

+86-15920553177

References

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.

Reference Type: RESULT

PMID: 22160297 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16767357 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21573917 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21161652 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21833663 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25704429 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27512888 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26201417 (View on PubMed)

Other Identifiers

GDPHCM-GI-02

Identifier Type: -

Identifier Source: org_study_id