NCT03117283

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 17, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

April 7, 2017

Last Update Submit

April 12, 2017

Conditions

Laparoscopic GastrectomyLaparoscopic BursectomyA Left Outside Bursa Omentalis Approach

Keywords

Laparoscopic surgeryRadical total gastrectomyBursectomyAdvanced posterior gastric wall cancer

Outcome Measures

Primary Outcomes (1)

  • Early morbidity

    The early morbidity is defined as the adverse event observed during peri-operative time.

    30 days

Secondary Outcomes (9)

  • Operative time

    Intraoperative

  • Lymph node

    14 days

  • First ambulation

    30 days

  • 3-year survival

    3 years

  • 5-year survival

    5 years

  • +4 more secondary outcomes

Study Arms (2)

LTG with Bursectomy

EXPERIMENTAL

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

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

LTG without Bursectomy

SHAM COMPARATOR

laparoscopic D2 radical total gastrectomy without bursectomy

Procedure: Laparoscopic D2 radical total gastrectomy without bursectomy

Interventions

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

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 with Bursectomy
Laparoscopic D2 radical total gastrectomy without bursectomyPROCEDURE

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.

LTG without Bursectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (8)

  • 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.

    PMID: 22160297RESULT

  • 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.

    PMID: 16767357RESULT

  • 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.

    PMID: 21573917RESULT

  • 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.

    PMID: 21161652RESULT

  • 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.

    PMID: 21833663RESULT

  • 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.

    PMID: 25704429RESULT

  • 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.

    PMID: 27512888RESULT

  • 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.

    PMID: 26201417RESULT

Study Officials

  • Wei Wang

    Guangdong Provincial Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Wenjun Xiong

    Guangdong Provincial Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+86-13922255515wangwei16400@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wei Wang M.D., PhD.

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 17, 2017

Study Start

March 28, 2017

Primary Completion

April 1, 2020

Study Completion

April 1, 2022

Last Updated

April 17, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

The data has not been published.

Locations

CN(1)