Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer

Summary

This study is an investigator-initiated, randomized, controlled, parallel group, and non-inferiority trial comparing robot-assisted gastrectomy with D2 nodal dissection for locally advanced gastric cancer patients with laparoscopic procedure.

Conditions

• Gastric Cancer

Interventions

PROCEDURE

Robotic distal gastrectomy with D2 nodal dissection

After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, robotic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.

PROCEDURE

Laparoscopic distal gastrectomy with D2 nodal dissection

After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.

Sponsors & Collaborators

• Chinese PLA General Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Xijing Hospital of Digestive Diseases

  collaborator OTHER

• Nanjing PLA General Hospital

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Qingdao University

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• Central South University

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Jilin Provincial Tumor Hospital

  collaborator OTHER

• Lanzhou General Hospital of PLA

  collaborator OTHER

• Southwest Hospital, China

  lead OTHER

Principal Investigators

• Peiwu Yu, M.D. · Southwest Hospital, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-25

Primary Completion

2019-09-25

Completion

2022-09-25

Countries

• China

Study Locations