3D Versus 2D Laparoscopic Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection

December 4, 2016 updated by: Lin Chen, Chinese PLA General Hospital

3D Versus 2D Laparoscopic Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial

The investigators will perform a prospective randomized comparison between 3D and 2D laparoscopic total gastrectomy with splenic hilum lymph nodes dissection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A prospective randomized comparison of 3D and 2D laparoscopic surgery for advanced gastric cancer with spleen-preserving splenic hilum lymph nodes dissection will be performed, to evaluate the safety and feasibility for the extensive application of the novel 3D laparoscopic technique. The evaluation parameters are number of group No.10 lymph nodes harvested, perioperative clinical efficacy, postoperative life quality and 3-year survival and recurrence rates.

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100853
        • Chinese PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;
  2. cT2-4aN0-3M0 at preoperative evaluation according to 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D Laparoscopic total gastrectomy
Participants including in the 3D laparoscopic total gastrectomy (3D-LTG) group will undergo 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection.
Procedure: 3D Laparoscopic total gastrectomy
When participants with advanced proximal gastric cancer are randomized in the 3D laparoscopic-assisted totalgastrectomy (3D-LTG) group, they will received 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection
Other Names:
  • 3D-LTG
Active Comparator: 2D Laparoscopic total gastrectomy
Participants including in the 2D laparoscopic total gastrectomy (2D-LTG) group will undergo 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection.
Procedure: 2D Laparoscopic total gastrectomy
When participants with advanced proximal gastric cancer are randomized in the 2D laparoscopic-assisted totalgastrectomy (2D-LTG) group, they will received 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection
Other Names:
  • 2D-LTG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of splenic hilum lymph nodes harvested
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year overall survival rate
Time Frame: 3 years
3 years
Early complication rate
Time Frame: 30 days
The early complication rate is defined as the event observed during operation and within 30 days after surgery.
30 days
Operative blood loss
Time Frame: Intraoperative
It will be assessed with the unit of "ml".
Intraoperative
Number of total lymph nodes harvested
Time Frame: 7 days
7 days
3-year disease free survival rate
Time Frame: 3 years
3 years
Operative time
Time Frame: Intraoperative
It will be assessed with the unit of "minute".
Intraoperative
Time of splenic hilum lymph nodes dissection
Time Frame: Intraoperative
It will be assessed with the unit of "minute"
Intraoperative
Poster-operative recovery course
Time Frame: 30 days
Time to first ambulation (unit of hour), flatus (unit of hour), liquid diet (unit of hour) and duration of hospital stay (unit of day) are used to assess the postoperative recovery course.
30 days
Quality of life
Time Frame: 1 year
It will be assessed with questionnaire of "WHO-QOL-100" (WHO was short for world health organization)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Lin Chen, The Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 4, 2016

First Posted (Estimate)

December 7, 2016

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 4, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Experiment20161201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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