Postoperative Complications Clinical Trial
Official title:
Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract (Kamikawa Versus Single-Tract Jejunal Interposition Versus SOFY Reconstruction) After Proximal Gastrectomy
The efficacy of three different reconstruction methods after proximal gastrectomy will be investigated in this study through a prospective, multicenter, randomized controlled trial.
Status | Not yet recruiting |
Enrollment | 180 |
Est. completion date | October 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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; - Patients without contraindications to surgery; - Patients and their families voluntarily signing the informed consent form and participating in the study; Exclusion Criteria: - 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; - Patients who were diagnosed with diabetes mellitus, uncontrolled or controlled with insulin; - Patients with organ failure such as heart, lung, liver, brain, kidney failure; - Patients with ascites or cachexia preoperatively in poor general conditions; - Patients diagnosed with immunodeficiency, immunosuppression or autoimmune diseases (such as allogeneic bone marrow transplant, immunosuppressive drugs, SLE, etc.). - Patients refusing to sign the informed consent of the study; |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Changzhi People's Hospital Affiliated to Changzhi Medical College |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of reflux esophagitis | The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group. | 24 months after surgery | |
Secondary | incidence of anastomotic leakage | The percentage (%) of patients developing postoperative anastomotic leakage after surgery in each group. | 14 days after surgery | |
Secondary | incidence of anastomotic stenosis | The percentage (%) of patients developing anastomotic stenosis after surgery in each group. | 24 months after surgery | |
Secondary | operative time | The duration, measured in minutes, spent on reconstructing the digestive tract using specific method (Kamikawa, STJI or SOFY) following proximal gastrectomy. | 1 day after surgery | |
Secondary | 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. | 1 day after surgery |
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