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Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection

Primary Purpose

Gastric Cancer, Splenic Hilum Lymph Nodes Dissection, Total Gastrectomy

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Laparoscopic-assisted total gastrectomy
Open total gastrectomy
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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with advanced proximal gastric cancer (T2-T4a,N0-N3,M0)
  • Informed consent
  • Eastern Cooperative Oncology Group (ECOG): 0 ot 1
  • American Society of Anesthesiologists (ASA) score: Ⅰto Ⅲ

Exclusion Criteria:

  • Pregnancy or female in suckling period
  • Contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
  • Severe mental disease
  • Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor
  • Body mass index (BMI) > 30 kg/m2

Sites / Locations

  • Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic-assisted total gastrectomy

Open total gastrectomy

Arm Description

Patients including in the laparoscopic-assisted total gastrectomy (LATG) group will undergo LATG with spleen-preserving splenic hilum lymph nodes dissection.

Patients who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.

Outcomes

Primary Outcome Measures

Early complication rate
The early complication rate is defined as the event observed during operation and within 30 days after surgery.

Secondary Outcome Measures

Operative time
Time of splenic hilum lymph nodes dissection
Operative blood loss
It will be assessed with the unit of "ml".
Incision length
Number of total lymph nodes harvested
Number of group No.10 lymph nodes harvested
Number of lymph nodes posterior to splenic vessel
Poster-operative recovery course
Time to first ambulation, flatus, liquid diet and duration of hospital stay are used to assess the postoperative recovery course.
3-year disease free survival rate
5-year overall survival rate
Metastasis rate of lymph nodes posterior to splenic vessel

Full Information

First Posted
March 9, 2016
Last Updated
April 7, 2017
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02711033
Brief Title
Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection
Official Title
Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
April 2019 (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
No

5. Study Description

Brief Summary
This study investigates the safety and feasibility of laparoscopic-assisted total gastrectomy with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy.
Detailed Description
For advanced proximal gastric cancer, total gastrectomy with D2 lymphadenectomy is the standard surgical therapy. Apparently, lymph nodes (LNs) dissection along the splenic artery (No.11) and the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines. Nevertheless, complete removal of the No. 10 and No. 11d LNs is technically challenging due to the tortuous splenic vessels and the high possibility of injury to the parenchyma of the spleen and pancreas. Recently, the application of minimally invasive surgery for advanced gastric cancer is gaining popularity. However, laparoscopic-assisted total gastrectomy (LATG) with standard D2 lymphadenectomy was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph node dissection were mainly challenging manipulations for laparoscopic surgeons. Herein, we aim to investigate the safety and feasibility of LATG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy (OTG).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Splenic Hilum Lymph Nodes Dissection, Total Gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic-assisted total gastrectomy
Arm Type
Experimental
Arm Description
Patients including in the laparoscopic-assisted total gastrectomy (LATG) group will undergo LATG with spleen-preserving splenic hilum lymph nodes dissection.
Arm Title
Open total gastrectomy
Arm Type
Active Comparator
Arm Description
Patients who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic-assisted total gastrectomy
Other Intervention Name(s)
LATG
Intervention Description
When patients with advanced proximal gastric cancer are randomized in the laparoscopic-assisted total gastrectomy (LATG) group, they will received LATG with spleen-preserving splenic hilum lymph nodes dissection.
Intervention Type
Procedure
Intervention Name(s)
Open total gastrectomy
Other Intervention Name(s)
OTG
Intervention Description
When patients with advanced proximal gastric cancer are randomized in the open total gastrectomy (OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.
Primary Outcome Measure Information:
Title
Early complication rate
Description
The early complication rate is defined as the event observed during operation and within 30 days after surgery.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Operative time
Time Frame
Intraoperative
Title
Time of splenic hilum lymph nodes dissection
Time Frame
Intraoperative
Title
Operative blood loss
Description
It will be assessed with the unit of "ml".
Time Frame
Intraoperative
Title
Incision length
Time Frame
7 days
Title
Number of total lymph nodes harvested
Time Frame
7 days
Title
Number of group No.10 lymph nodes harvested
Time Frame
7 days
Title
Number of lymph nodes posterior to splenic vessel
Time Frame
7 days
Title
Poster-operative recovery course
Description
Time to first ambulation, flatus, liquid diet and duration of hospital stay are used to assess the postoperative recovery course.
Time Frame
30 days
Title
3-year disease free survival rate
Time Frame
3 years
Title
5-year overall survival rate
Time Frame
5 years
Title
Metastasis rate of lymph nodes posterior to splenic vessel
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with advanced proximal gastric cancer (T2-T4a,N0-N3,M0) Informed consent Eastern Cooperative Oncology Group (ECOG): 0 ot 1 American Society of Anesthesiologists (ASA) score: Ⅰto Ⅲ Exclusion Criteria: Pregnancy or female in suckling period Contraindication to general anesthesia (severe cardiac and/or pulmonary disease) Severe mental disease Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor Body mass index (BMI) > 30 kg/m2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Wang, M.D., PH.D.
Phone
+86-13922255515
Email
wangwei16400@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Wang, M.D., PH.D.
Organizational Affiliation
Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of 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
Wei Wang, M.D.,PH.D.
Phone
+86-13922255515
Email
wangwei16400@163.com
First Name & Middle Initial & Last Name & Degree
Wenjun Xiong, M.D.
Phone
+86-15920553177
Email
xiongwj1988@163.com
First Name & Middle Initial & Last Name & Degree
Wei Wang
First Name & Middle Initial & Last Name & Degree
Jin Wan
First Name & Middle Initial & Last Name & Degree
Wenjun Xiong

12. IPD Sharing Statement

Plan to Share IPD
No

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Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection

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