Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer

Summary

Proximal early gastric cancer can choose radical total gastrectomy or proximal gastrectomy. The patients have poor nutritional status and quality of life after total gastrectomy. Compare to total gastrectomy, the nutritional status can improve after proximal gastrectomy . But if use simple esophagogastric anastomosis for proximal gastrectomy, the incidence of postoperative reflux esophagitis is high, which seriously affects the quality of life, and the short-term outcome is poorer than the total gastrectomy. If the incidence of postoperative reflux esophagitis can be reduced, proximal gastrectomy would be the treatment choice for proximal early gastric cancer, which may more improve both quality of life and nutritional condition than total gastrectomy.

Double-flap technique is a new surgical reconstruction procedure between esophagus and remnant stomach. It can reduce the occurrence of reflux oesophagitis through reconstruction a simulative cardia. At present, the technique has been carried out in some hospitals in China but still lack large-scale prospective studies and evidence of evidence-based medicine. At present, some retrospective studies have shown that robotic assisted proximal gastrectomy with double-flap technique is safe and effective, and the learning curve is shorter than laparoscopic surgery. The applicant have finished two robotic assisted proximal gastrectomy with double-flap technique cases. Two patients recovered well after surgery, with no occurrence of anastomotic leakage or stenosis and the postoperative quality of life was good. Now we plan to conduct a multi-center, single arm study on proximal early gastric cancer patients(T1N0-1M0 and T2N0M0) to evaluate the feasibility of robotic assisted proximal gastrectomy with double-flap technique , and to evaluate the surgical and oncological safety of this surgical method. Aim to provide initial evidence of evidence-based medicine for its clinical application..

Conditions

• Stomach Neoplasms

Interventions

PROCEDURE

Robotic assisted proximal gastrectomy with double-flap technique

Patients in this group receive robotic assisted proximal gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA：Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p；D2 for stage IB: Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p and 11d).The double-flap technique is used for the digestive tract reconstruction.

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Gansu Provincial Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Zunyi Medical College

  collaborator OTHER

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• Qinghai Province Cancer Hospital

  collaborator UNKNOWN

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-10

Primary Completion

2026-12-10

Completion

2026-12-10

Countries

• China

Study Locations