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Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Laparoscopic total gastrectomy
Open total gastrectomy
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Splenic Hilum Lymph Nodes Dissection, Gastrectomy

Eligibility Criteria

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

Inclusion Criteria:

  1. Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;
  2. cT2-4aN0-3M0 at preoperative evaluation according to American Joint Committee On Cancer (AJCC) Cancer Staging Manual, 7th Edition.
  3. Eastern Cooperative Oncology Group (ECOG): 0 or 1;
  4. American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ;
  5. Written informed consent.

Exclusion Criteria:

  1. Pregnant or breast-feeding women;
  2. Severe mental disorder;
  3. Previous upper abdominal surgery (except laparoscopic cholecystectomy);
  4. Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection;
  5. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;
  6. Other malignant disease within the past 5 years;
  7. Previous neoadjuvant chemotherapy or radiotherapy;
  8. Contraindication to general anesthesia (severe cardiac and/or pulmonary disease);
  9. Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic total gastrectomy

Open total gastrectomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of group Splenic Hilum (No.10) lymph nodes harvested

Secondary Outcome Measures

Early complication rate
The early complication rate is defined as the event observed during operation
Operative time
Operative blood loss
Time of splenic hilum lymph nodes dissection
Number of total lymph nodes harvested
Post-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
3-year overall survival rate
Quality of life
It will be assessed by questionnaire (WHO quality of life-100)

Full Information

First Posted
November 30, 2016
Last Updated
December 5, 2016
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02980861
Brief Title
Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection
Official Title
Laparoscopic 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
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer.
Detailed Description
Total gastrectomy with D2 lymphadenectomy remains the standard surgical therapy for patients with advanced proximal gastric cancer. Although lymph nodes dissection along with the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines, however, complete removal of the No. 10 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 total gastrectomy (LTG) 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. Therefore,the investigators aim to investigate the safety and feasibility of LTG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compare 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
Keywords
Gastric Cancer, Splenic Hilum Lymph Nodes Dissection, Gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic total gastrectomy
Arm Type
Experimental
Arm Description
Participants including in the laparoscopic total gastrectomy (LTG) group will undergo LTG with spleen-preserving splenic hilum lymph nodes dissection.
Arm Title
Open total gastrectomy
Arm Type
Active Comparator
Arm Description
Participants 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 total gastrectomy
Other Intervention Name(s)
LTG
Intervention Description
When the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG 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 the participants 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
Number of group Splenic Hilum (No.10) lymph nodes harvested
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Early complication rate
Description
The early complication rate is defined as the event observed during operation
Time Frame
30 days
Title
Operative time
Time Frame
Intraoperative
Title
Operative blood loss
Time Frame
Intraoperative
Title
Time of splenic hilum lymph nodes dissection
Time Frame
Intraoperative
Title
Number of total lymph nodes harvested
Time Frame
7 days
Title
Post-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
3-year overall survival rate
Time Frame
3 years
Title
Quality of life
Description
It will be assessed by questionnaire (WHO quality of life-100)
Time Frame
1 year

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: Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy; cT2-4aN0-3M0 at preoperative evaluation according to American Joint Committee On Cancer (AJCC) Cancer Staging Manual, 7th Edition. Eastern Cooperative Oncology Group (ECOG): 0 or 1; American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ; Written informed consent. Exclusion Criteria: Pregnant or breast-feeding women; Severe mental disorder; Previous upper abdominal surgery (except laparoscopic cholecystectomy); Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection; Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging; Other malignant disease within the past 5 years; Previous neoadjuvant chemotherapy or radiotherapy; Contraindication to general anesthesia (severe cardiac and/or pulmonary disease); Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongqing Xi, Master
Phone
010-66938128
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Chen
Organizational Affiliation
the Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Chen, Master
Phone
86-13801290395
Email
chenlinbj@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26940944
Citation
Bian S, Xi H, Wu X, Cui J, Ma L, Chen R, Wei B, Chen L. The Role of No. 10 Lymphadenectomy for Advanced Proximal Gastric Cancer Patients Without Metastasis to No. 4sa and No. 4sb Lymph Nodes. J Gastrointest Surg. 2016 Jul;20(7):1295-304. doi: 10.1007/s11605-016-3113-3. Epub 2016 Mar 3.
Results Reference
background
PubMed Identifier
30380145
Citation
Guo X, Peng Z, Lv X, Cui J, Zhang K, Li J, Jin N, Xi H, Wei B, Chen L. Randomized controlled trial comparing short-term outcomes of laparoscopic and open spleen-preserving splenic hilar lymphadenectomy for advanced proximal gastric cancer: An interim report. J Surg Oncol. 2018 Dec;118(8):1264-1270. doi: 10.1002/jso.25262. Epub 2018 Oct 31.
Results Reference
derived

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Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection

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