Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in Advanced Gastric Cancer
LBDL
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 10, 2016
CompletedFirst Posted
Study publicly available on registry
November 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedNovember 21, 2016
November 1, 2016
6 years
November 10, 2016
November 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the 3-year disease-free survival rate
up to 36 months
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Other Outcomes (2)
the time to firstly flaunt
up to 36 months
the time of hospital stay
up to 36 months
Study Arms (2)
The bursectomy and D2 lymphadenectomy
EXPERIMENTALLaparoscopic 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)
The D2 lymphadenectomy
ACTIVE COMPARATORLaparoscopic 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.
Interventions
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.
D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GI surgery,Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120, China
Related Publications (2)
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.
PMID: 26170983RESULTZou 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.
PMID: 26675932RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin Wan, professor
Guangdong Provincial Hospital of Traditional Chinese Medicine
- STUDY DIRECTOR
Liao-nan Zou, professor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
November 10, 2016
First Posted
November 21, 2016
Study Start
November 1, 2016
Primary Completion
November 1, 2022
Study Completion
November 1, 2024
Last Updated
November 21, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share