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
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