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.
This study will enroll patients with proximal gastric cancer scheduled to undergo laparoscopic proximal gastrectomy. The patients will be randomly divided into two groups. One group will undergo laparoscopic proximal gastrectomy with double-flap technique (DFT) anastomosis, while the other group will undergo laparoscopic proximal gastrectomy with double-tract reconstruction (DTR). The primary endpoint is the proportion of patients who develop reflux esophagitis within 12 months after surgery. The secondary endpoints include postoperative complications, surgery-related indicators, and postoperative nutritional status.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
DFT (experiment group). Patients receive double flap technique after laparoscopic proximal gastrectomy. DTR (control group). Patients receive double-tract reconstruction after laparoscopic proximal gastrectomy.
Proportion of patients with reflux esophagitis
The percentage (%) of patients developing postoperative reflux esophagitis after surgery in the two group.
Time frame: Within 12 months after surgery
Postoperative complications
Evaluated using the Clavien-Dindo classification to assess the severity of postoperative complications.
Time frame: Within 12 months after surgery
Operation time
From the beginning of surgery to the end of surgery
Time frame: Perioperative period
Kamikawa anastomosis time
The time of making the seromuscular flap and the time of esophagogastrostomy were included
Time frame: Perioperative period
intraoperative blood loss
The operation begins to end the amount of bleeding.
Time frame: Perioperative period
Weight change
Calculated in kilograms
Time frame: Within 12 months after surgery
Body Mass Index (BMI)
weight and height will be combined to report BMI in kg/m\^2
Time frame: Within 12 months after surgery
Albumin value
The concentration of albumin in the blood, expressed in g/L.
Time frame: Within 12 months after surgery
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Pre albumin value
The concentration of pre albumin in the blood, expressed in g/L.
Time frame: Within 12 months after surgery
Hemoglobin value
The concentration of Hemoglobin in the blood, expressed in g/L.
Time frame: Within 12 months after surgery
Folic acid value
The concentration of Folic acid value in the blood, expressed in ng/mL.
Time frame: Within 12 months after surgery
Vitamin B12 value
The concentration of Vitamin B12 value in the blood, expressed in uug/L.
Time frame: Within 12 months after surgery
Ferritin value
The concentration of Vitamin B12 value in the blood, expressed in ug/L.
Time frame: Within 12 months after surgery
Nutritional risk screening 2002
The nutritional status is assessed using the Nutrition Risk Screening 2002 (NRS-2002) scale, with a scoring range of 0 to 7 points. A higher score indicates a worse nutritional status.
Time frame: Within 12 months after surgery