Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in Advanced Gastric Cancer

Gastric Cancer Stage III Clinical Trial

— LBDL  

Official title:

Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in II,III Stage Gastric Carcinoma: A Prospective, Randomized, Single Blind, Parallel Group Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02969148
• Other study ID #: LBDL1
• Status: Recruiting
• Phase: N/A
• First received: November 10, 2016
• Last updated: November 17, 2016
• Start date: November 2016
• Est. completion date: November 2024

Study information

• Verified date: November 2016
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: Jin Wan, professor
• Phone: 0086-020-13710637721
• Email: reiqiwj[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To investigate the clinical efficacy and safety of laparoscopic bursectomy and D2 lymphadenectomy (LBDL group) versus laparoscopic D2 lymphadenectomy (LDL group) in advanced gastric cancer by prospective randomized controlled clinical trial.

Description:

To compare the LBDL group and LDL group in the advanced gastric cancer. A prospective randomized controlled trial will be performed in the GI department, Guangdong provincial hospital of Chinese Medicine from November 2016 to November 2024. The sample size，100 cases with advanced gastric cancer, will be needed after calculated by the statistics. The 100 cases will be randomly divided into two groups: LBDL group and LDL group. Primary outcomes are the 3 years' Disease-free survival (DFS) rate, The secondary outcomes are the 3 years' and 5 years' Disease-free survival (DFS) rate, the 3 years and 5 years Overall survival（OS）rate, operative time, the total blood loss, the intra-operative complication and the post-operative complication, the number of lymph nodes dissected, the number of conversion to open laparotomy, and the other outcomes are the average time of ground activities, the hospital stay. The data in two groups will be compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2024
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The age limits is 18-80 years old;

2. T3-T4 resectable gastric carcinoma,confirmed by CT and pathology.

3. The preoperative imaging confirmed that the tumor did not involve adjacent organs;

4. American Society of anesthesiologists (ASA) score less than or equal to Level 3;

5. Criteria of performance status karnofsky is greater than or equal to 60.

Exclusion Criteria:

1. The patients' age limits is Less than 18 years old, or more than 80 years old;

2. The preoperative imaging confirmed that the tumor involve adjacent organs;

3. The tumor have been finding distant metastases;

4. American Society of anesthesiologists (ASA) score more than 3;

5. Criteria of performance status karnofsky is lower than 60;

6. There is a laparoscopic surgery contraindications.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer Stage II
• Gastric Cancer Stage III
• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic bursectomy and D2 lymphadenectomy
The anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN) by laparoscopy,this is Laparoscopic bursectomy and D2 lymphadenectomy.
• Laparoscopic D2 lymphadenectomy
D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN).

Locations

Country	Name	City	State
China	GI surgery,Guangdong Provincial Hospital of Traditional 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 (2)

Zou L, Xiong W, Mo D, Chen G, He Y, Li H, Tan P, Wang W, Wan J. Totally laparoscopic complete bursectomy and D2 lymphadenectomy in radical total gastrectomy: an outside bursa omentalis approach. Surg Endosc. 2016 Sep;30(9):4152. doi: 10.1007/s00464-015-47 — View Citation

Zou LN, He YB, Li HM, Diao DC, Mo DL, Wang W, Wan J. Surgical skills for laparoscopic resection of the bursa omentalis and lymph node scavenging with radical gastrectomy. Oncol Lett. 2015 Jul;10(1):99-102. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the time to firstly flaunt		up to 36 months	Yes
Other	the time of hospital stay		up to 36 months	Yes
Primary	the 3-year disease-free survival rate		up to 36 months	No
Secondary	the 3-year overall survival rate		up to 36 months	No
Secondary	the 5-year disease-free survival rate		up to 5 years	No
Secondary	the 5-year overall survival rate		up to 5 years	No
Secondary	the operation time		up to 36 months	Yes
Secondary	the total blood loss		up to 36 months	Yes
Secondary	the number of pancreatic leakage		up to 36 months	Yes
Secondary	the number of lymph nodes dissected		up to 36 months	Yes
Secondary	the number of conversion to open laparotomy		up to 36 months	Yes
Secondary	the number of bowel obstruction		up to 36 months	Yes