Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract After … (NCT06062225) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract After Proximal Gastrectomy
180 participantsStarted 2023-10
Plain-language summary
The efficacy of three different reconstruction methods after proximal gastrectomy will be investigated in this study through a prospective, multicenter, randomized controlled trial.
Who can participate
Age range20 Years – 75 Years
SexALL
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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;
What they're measuring
1
incidence of reflux esophagitis
Timeframe: 24 months after surgery
Trial details
NCT IDNCT06062225
SponsorChangzhi People's Hospital Affiliated to Changzhi Medical College