About this trial
This study is a multicenter, open-label, prospective, randomized parallel-controlled trial. The purpose is to explore whether the incidence rate of reflux esophagitis (RE) within 12 months after surgery is non-inferior for the DFT group compared to the DTR group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 20 and 80 years, regardless of gender;
Patients diagnosed with gastric cancer through tissue biopsy;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
American Society of Anesthesiologists (ASA) classification of I to III;
Disqualifiers
Received preoperative chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
Presence of contraindications to surgery;
Multiple malignant lesions in the stomach;
Presence of other malignancies that may affect the preservation of stomach function;
Trial design
Parallel
Treatments tested in this trial
double-flap technique(DFT); double-tract reconstruction(DTR),
Procedure/SurgeryDFT (experiment group). Patients receive double flap technique after laparoscopic proximal gastrectomy. DTR (control group). Patients receive double-tract reconstruction after laparoscopic proximal gastrectomy.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients with reflux esophagitis
The percentage (%) of patients developing postoperative reflux esophagitis after surgery in the two group.
Secondary outcomes
Postoperative complications
Evaluated using the Clavien-Dindo classification to assess the severity of postoperative complications.
Operation time
From the beginning of surgery to the end of surgery
Kamikawa anastomosis time
The time of making the seromuscular flap and the time of esophagogastrostomy were included
intraoperative blood loss
The operation begins to end the amount of bleeding.
Locations
Sponsors and contacts
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