Gastric Cancer Stage II, Gastric Cancer Stage III
Conditions
Keywords
Laparoscopic, Bursectomy, D2 lymphadenectomy, Gastric Cancer
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.
Interventions
PROCEDURELaparoscopic 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.
PROCEDURELaparoscopic D2 lymphadenectomy
D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN).
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the 3-year disease-free survival rate | up to 36 months |
Secondary
| Measure | Time frame |
|---|---|
| the 3-year overall survival rate | up to 36 months |
| the 5-year disease-free survival rate | up to 5 years |
| the 5-year overall survival rate | up to 5 years |
| the number of conversion to open laparotomy | up to 36 months |
| the number of bowel obstruction | up to 36 months |
| the number of pancreatic leakage | up to 36 months |
| the number of lymph nodes dissected | up to 36 months |
| the operation time | up to 36 months |
| the total blood loss | up to 36 months |
Other
| Measure | Time frame |
|---|---|
| the time to firstly flaunt | up to 36 months |
| the time of hospital stay | up to 36 months |
Countries
China
Contacts
Primary ContactJin Wan, professor
Backup ContactLiao-nan Zou, professor
Outcome results
None listed