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

Guangdong Provincial Hospital of Traditional Chinese Medicine100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Gastric Cancer Stage II Gastric Cancer Stage III

Interventions

Laparoscopic bursectomy and D2 lymphadenectomyPROCEDURE

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 lymphadenectomyPROCEDURE

D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

GI surgery,Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

the 3-year disease-free survival rate

Time frame: up to 36 months

Secondary Outcomes

the 3-year overall survival rate

Time frame: up to 36 months

the 5-year disease-free survival rate

Time frame: up to 5 years

the 5-year overall survival rate

Time frame: up to 5 years

the operation time

Time frame: up to 36 months

the total blood loss

Time frame: up to 36 months

the number of pancreatic leakage

Time frame: up to 36 months

the number of lymph nodes dissected

Time frame: up to 36 months

the number of conversion to open laparotomy

Time frame: up to 36 months

the number of bowel obstruction

Time frame: up to 36 months

Central Contacts

Jin Wan, professor

CONTACT

0086-020-13710637721 reiqiwj@aliyun.com

Liao-nan Zou, professor

CONTACT

0086-020-13423663496 13423663496@163.com

Data from ClinicalTrials.gov

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