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

Not Applicable

Recruiting

• Conditions: Gastric Cancer Stage II; Gastric Cancer Stage III
• Interventions: Procedure: Laparoscopic D2 lymphadenectomy; Procedure: Laparoscopic bursectomy and D2 lymphadenectomy

• Registration Number: NCT02969148
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-10
• Study First Submitted QC: 2016-11-17
• Last Update Submitted: 2016-11-17
• Study First Posted: 2016-11-21
• Last Update Posted: 2016-11-21
• Primary Completion: 2022-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The D2 lymphadenectomy	Laparoscopic D2 lymphadenectomy	Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach is that D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN) without dissociation of anterior lobe of transverse mesocolon and capsula pancreatis.
The bursectomy and D2 lymphadenectomy	Laparoscopic bursectomy and D2 lymphadenectomy	Laparoscopic bursectomy and D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach are that 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)

Primary Outcome Measures

Name	Time	Method
the 3-year disease-free survival rate	up to 36 months

Secondary Outcome Measures

Name	Time	Method
the 3-year overall survival rate	up to 36 months
the number of lymph nodes dissected	up to 36 months
the 5-year overall survival rate	up to 5 years
the operation time	up to 36 months
the number of conversion to open laparotomy	up to 36 months
the number of bowel obstruction	up to 36 months
the 5-year disease-free survival rate	up to 5 years
the number of pancreatic leakage	up to 36 months
the total blood loss	up to 36 months

Trial Locations

Locations (1)

GI surgery,Guangdong Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China