Status:
NOT_YET_RECRUITING
Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract After Proximal Gastrectomy
Lead Sponsor:
Changzhi People's Hospital Affiliated to Changzhi Medical College
Conditions:
Proximal Gastric Adenocarcinoma
Gastrectomy
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
The efficacy of three different reconstruction methods after proximal gastrectomy will be investigated in this study through a prospective, multicenter, randomized controlled trial.
Detailed Description
In the trial, 180 patients with proximal early gastric cancer will be enrolled and then randomly assigned to one of three groups: Group A (Kamikawa, n = 60), Group B (single-tract jejunal interpositio...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06062225
Start Date
October 1 2023
End Date
October 1 2026
Last Update
October 5 2023
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