Clinical trial NCT02969148: Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in Advanced Gastric Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer Stage II
Gastric Cancer Stage III
Keywords: Laparoscopic
Bursectomy
D2 lymphadenectomy
Gastric Cancer
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the 3-year disease-free survival rate
timeFrame: up to 36 months
Secondary outcomes:
measure: the 3-year overall survival rate
timeFrame: up to 36 months
measure: the 5-year disease-free survival rate
timeFrame: up to 5 years
measure: the 5-year overall survival rate
timeFrame: up to 5 years
measure: the operation time
timeFrame: up to 36 months
measure: the total blood loss
timeFrame: up to 36 months
measure: the number of pancreatic leakage
timeFrame: up to 36 months
measure: the number of lymph nodes dissected
timeFrame: up to 36 months
measure: the number of conversion to open laparotomy
timeFrame: up to 36 months
measure: the number of bowel obstruction
timeFrame: up to 36 months
Other outcomes:
measure: the time to firstly flaunt
timeFrame: up to 36 months
measure: the time of hospital stay
timeFrame: up to 36 months
Locations:
city: Guangzhou
country: China
facility: GI surgery,Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Jin Wan, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Liao-nan Zou, professor
role: STUDY_DIRECTOR
References:
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. doi: 10.3892/ol.2015.3226. Epub 2015 May 19.
citation: 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/s00464-015-4702-z. Epub 2015 Dec 16.