Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract After Proximal Gastrectomy

Study Overview
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Brief Summary
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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
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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 interposition, n = 60), or Group C (SOFY reconstruction, n = 60). The general information, past medical history, laboratory and imaging findings, and surgical procedures of each patient will be recorded. Patients in Group A, Group B and Group C will receive Kamikaze reconstruction, single-tract jejunal interposition reconstruction and SOFY reconstruction respectively after standard proximal gastrectomy and lymph nodes dissection. The primary endpoint will be the incidence of reflux esophagitis, while the incidence of anastomotic leakage, anastomotic stenosis, operative time, and intraoperative blood loss will be secondary endpoints to compare the efficacy of these three reconstruction methods after proximal gastrectomy.

Official Title
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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

Conditions
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Proximal Gastric Adenocarcinoma, Gastrectomy, Anastomosis, Reflux Esophagitis, Postoperative Complications

Intervention / Treatment
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* Procedure: Kamikawa
* Procedure: STJI
* Procedure: SOFY


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kamikawa reconstruction<br>Patients will be administered Kamikawa reconstruction after proximal gastrectomy. | Procedure: Kamikawa<br>* Kamikawa reconstruction after proximal gastrectomy<br>|
| Active Comparator: STJI reconstruction<br>Patients will be administered Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy. | Procedure: STJI<br>* Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy<br>|
| Active Comparator: SOFY reconstruction<br>Patients will be administered SOFY reconstruction after proximal gastrectomy. | Procedure: SOFY<br>* SOFY reconstruction after proximal gastrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of reflux esophagitis | The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group. | 24 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of anastomotic leakage | The percentage (%) of patients developing postoperative anastomotic leakage after surgery in each group. | 14 days after surgery | 
| incidence of anastomotic stenosis | The percentage (%) of patients developing anastomotic stenosis after surgery in each group. | 24 months after surgery | 
| 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 | 
| 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 |