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

April 7, 2017 updated by: Wei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 2

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jin Wan
        • Principal Investigator:
          • Wenjun Xiong

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:

  • 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

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: Laparoscopic-assisted total gastrectomy
Patients including in the laparoscopic-assisted total gastrectomy (LATG) group will undergo LATG with spleen-preserving splenic hilum lymph nodes dissection.
Procedure: Laparoscopic-assisted total gastrectomy
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.
Other Names:
  • LATG
Active Comparator: Open total gastrectomy
Patients who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.
Procedure: Open total gastrectomy
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.
Other Names:
  • OTG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Intraoperative
Intraoperative
Time of splenic hilum lymph nodes dissection
Time Frame: Intraoperative
Intraoperative
Operative blood loss
Time Frame: Intraoperative
It will be assessed with the unit of "ml".
Intraoperative
Incision length
Time Frame: 7 days
7 days
Number of total lymph nodes harvested
Time Frame: 7 days
7 days
Number of group No.10 lymph nodes harvested
Time Frame: 7 days
7 days
Number of lymph nodes posterior to splenic vessel
Time Frame: 7 days
7 days
Poster-operative recovery course
Time Frame: 30 days
Time to first ambulation, flatus, liquid diet and duration of hospital stay are used to assess the postoperative recovery course.
30 days
3-year disease free survival rate
Time Frame: 3 years
3 years
5-year overall survival rate
Time Frame: 5 years
5 years
Metastasis rate of lymph nodes posterior to splenic vessel
Time Frame: 7 days
7 days

Collaborators and Investigators

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

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Wei Wang, M.D., PH.D., Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine

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

October 1, 2015

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 12, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDPHCM-GI-01

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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