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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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..

Eligibility criteria

Qualifiers

20 years ≤ age ≤ 80 years

The primary gastric lesions were located in the proximal third of the stomach

histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)

clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 8th edition of the American Joint Committee on Cancer System(Clinical stage was determined based on the finding of endoscopic ultrasonography and/or thoraco-abdominal contrast-enhanced computed tomography)

Disqualifiers

history of upper abdominal surgery and not suitable for robotic assisted surgery

the tumor invades the esophagus 3cm above gastro-esophageal junction (Z-line)

with other malignant diseases or have suffered from other malignant diseases within 5 years

Excessive tension for esophagogastric anastomosis and require changing the reconstruction procedure

Trial design

Treatments tested in this trial

  • Robotic assisted proximal gastrectomy with double-flap technique

Treatment groups

42 Participants
are divided into 1 treatment group

Sponsors and collaborators

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

Lead sponsor

First Affiliated Hospital of Guangxi Medical University

Collaborator

First Affiliated Hospital of Kunming Medical University

Collaborator

First Hospital of China Medical University

Collaborator

Gansu Provincial Hospital

Collaborator

Qilu Hospital of Shandong University

Collaborator

Shandong Provincial Hospital

Collaborator

Sichuan Cancer Hospital and Research Institute

Collaborator

Sichuan Provincial People's Hospital

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

LanZhou University

Collaborator

Third Affiliated Hospital, Sun Yat-Sen University

Collaborator

Tianjin Medical University Cancer Institute and Hospital

Collaborator

Zunyi Medical College

Collaborator

Liaoning Cancer Hospital & Institute

Collaborator

Qinghai Province Fifth People's Hospital

Collaborator