About this trial
The efficacy of three different reconstruction methods after proximal gastrectomy will be investigated in this study through a prospective, multicenter, randomized controlled trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 20-75 years old, male or female;
Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer: Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) (14) according to the eighth edition of the AJCC (15);
No distant metastasis observed on preoperative chest radiograph, abdominal ultrasound or upper abdominal CT;
ASA grade 1-3;
Disqualifiers
Patients diagnosed with primary tumors or distant metastasis;
Patients whose tumor is located in the greater curvature side of the stomach;
Patients with coagulation dysfunction which could not be corrected;
Patients who were diagnosed with viral hepatitis and cirrhosis;
Trial design
Parallel
Treatments tested in this trial
Kamikawa
Procedure/SurgeryKamikawa reconstruction after proximal gastrectomy
STJI
Procedure/SurgerySingle-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy
SOFY
Procedure/SurgerySOFY reconstruction after proximal gastrectomy
Treatment groups
Trial outcomes
Primary outcomes
incidence of reflux esophagitis
The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group.
Secondary outcomes
incidence of anastomotic leakage
The percentage (%) of patients developing postoperative anastomotic leakage after surgery in each group.
incidence of anastomotic stenosis
The percentage (%) of patients developing anastomotic stenosis after surgery in each group.
operative time
The duration, measured in minutes, spent on reconstructing the digestive tract using specific method (Kamikawa, STJI or SOFY) following proximal gastrectomy.
intraoperative blood loss
The amount of blood, measured in milliliters, lost during the reconstruction of digestive tract using specific method (Kamikawa, STJI or SOFY) following proximal gastrectomy.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: