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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastric Cancer Stage II, Gastric Cancer Stage III

Intervention / Treatment
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* Procedure: Laparoscopic bursectomy and D2 lymphadenectomy
* Procedure: Laparoscopic D2 lymphadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age limits is 18-80 years old; T3-T4 resectable gastric carcinoma,confirmed by CT and pathology. The preoperative imaging confirmed that the tumor did not involve adjacent organs; American Society of anesthesiologists (ASA) score less than or equal to Level 3; Criteria of performance status karnofsky is greater than or equal to 60. Exclusion Criteria: The patients' age limits is Less than 18 years old, or more than 80 years old; The preoperative imaging confirmed that the tumor involve adjacent organs; The tumor have been finding distant metastases; American Society of anesthesiologists (ASA) score more than 3; Criteria of performance status karnofsky is lower than 60; There is a laparoscopic surgery contraindications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The bursectomy and D2 lymphadenectomy<br>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) | Procedure: Laparoscopic bursectomy and D2 lymphadenectomy<br>* 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.<br>|
| Active Comparator: The D2 lymphadenectomy<br>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. | Procedure: Laparoscopic D2 lymphadenectomy<br>* D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the 3-year disease-free survival rate |  | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 operation time |  | up to 36 months | 
| the total blood loss |  | up to 36 months | 
| the number of pancreatic leakage |  | up to 36 months | 
| the number of lymph nodes dissected |  | up to 36 months | 
| the number of conversion to open laparotomy |  | up to 36 months | 
| the number of bowel obstruction |  | up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bursectomy, Laparoscopic, D2 lymphadenectomy, Gastric Cancer