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Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in Advanced Gastric Cancer (LBDL)

Primary Purpose

Gastric Cancer Stage II, Gastric Cancer Stage III

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic bursectomy and D2 lymphadenectomy
Laparoscopic D2 lymphadenectomy
Sponsored by
Guangdong Provincial Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer Stage II focused on measuring Laparoscopic, Bursectomy, D2 lymphadenectomy, Gastric Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GI surgery,Guangdong Provincial Hospital of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The bursectomy and D2 lymphadenectomy

The D2 lymphadenectomy

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

the 3-year disease-free survival rate

Secondary Outcome Measures

the 3-year overall survival rate
the 5-year disease-free survival rate
the 5-year overall survival rate
the operation time
the total blood loss
the number of pancreatic leakage
the number of lymph nodes dissected
the number of conversion to open laparotomy
the number of bowel obstruction

Full Information

First Posted
November 10, 2016
Last Updated
November 17, 2016
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02969148
Brief Title
Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in Advanced Gastric Cancer
Acronym
LBDL
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Recruiting
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer Stage II, Gastric Cancer Stage III
Keywords
Laparoscopic, Bursectomy, D2 lymphadenectomy, Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The bursectomy and D2 lymphadenectomy
Arm Type
Experimental
Arm Description
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)
Arm Title
The D2 lymphadenectomy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic bursectomy and D2 lymphadenectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic D2 lymphadenectomy
Intervention Description
D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN).
Primary Outcome Measure Information:
Title
the 3-year disease-free survival rate
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
the 3-year overall survival rate
Time Frame
up to 36 months
Title
the 5-year disease-free survival rate
Time Frame
up to 5 years
Title
the 5-year overall survival rate
Time Frame
up to 5 years
Title
the operation time
Time Frame
up to 36 months
Title
the total blood loss
Time Frame
up to 36 months
Title
the number of pancreatic leakage
Time Frame
up to 36 months
Title
the number of lymph nodes dissected
Time Frame
up to 36 months
Title
the number of conversion to open laparotomy
Time Frame
up to 36 months
Title
the number of bowel obstruction
Time Frame
up to 36 months
Other Pre-specified Outcome Measures:
Title
the time to firstly flaunt
Time Frame
up to 36 months
Title
the time of hospital stay
Time Frame
up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Wan, professor
Phone
0086-020-13710637721
Email
reiqiwj@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liao-nan Zou, professor
Phone
0086-020-13423663496
Email
13423663496@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Wan, professor
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liao-nan Zou, professor
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
GI surgery,Guangdong Provincial Hospital of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
liao-nan Zou, professor
Phone
0086-020-13423663496
Email
13423663496@163.com
First Name & Middle Initial & Last Name & Degree
xin-quan Lu, Dr
Phone
0086-020-18898607919
Email
18898607919@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
26170983
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.
Results Reference
result
PubMed Identifier
26675932
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.
Results Reference
result

Learn more about this trial

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

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