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

Launched by CHANGZHI PEOPLE'S HOSPITAL AFFILIATED TO CHANGZHI MEDICAL COLLEGE · Sep 25, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness of three different ways to reconnect the digestive tract after a surgery called proximal gastrectomy, which is performed to remove cancer from the upper part of the stomach. The goal is to find out which method works best for patients recovering from this type of surgery. The study will involve multiple healthcare centers and will randomly assign participants to one of the three methods to see how well each one helps patients heal and reduces complications.

To be eligible for this trial, participants need to be between the ages of 20 and 75, diagnosed with a specific type of stomach cancer located in the upper part of the stomach, and have certain health criteria that allow them to undergo surgery. They should not have any distant spread of cancer or serious health issues that could complicate the surgery. While the study is not yet recruiting participants, those who join will receive information and support throughout the process, including signing an informed consent form to ensure they understand what the study involves. This research aims to improve recovery for future patients undergoing similar surgeries.

Gender

ALL

Eligibility criteria

• 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;