Preliminary Efficacy Analysis of "C" Single Flap Plasty Reconstruction After Laparoscopic Proxima… (NCT06741501) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Preliminary Efficacy Analysis of "C" Single Flap Plasty Reconstruction After Laparoscopic Proximal Gastrectomy
China50 participantsStarted 2025-01-01
Plain-language summary
The incidence of proximal gastric cancer has increased significantly in recent years. This may be due to weight gain, alcohol consumption, gastroesophageal reflux disease (GERD), and precancerous lesions. With a deeper understanding of the pattern of lymph node metastasis and the emergence of anti-reflux procedures, proximal gastrectomy has gradually received clinical attention. For early-stage upper gastric cancer and esophagogastric combination cancer cases that are expected to have a good prognosis, the ideal surgical procedure should be to preserve the distal stomach to improve the quality of life and to choose a reasonable digestive tract reconstruction method to prevent reflux. The anti-reflux effect of various proximal gastrectomy digestive tract reconstruction methods and the advantages and disadvantages of various surgical procedures are controversial, and the recognized ideal reconstruction method has not yet been established. Therefore, we propose a reconstruction called the "C" Single Flap Plasty Reconstruction. This study aimed to investigate the efficacy and safety of proximal gastrectomy combined with "C" Single Flap Plasty Reconstruction in the treatment of gastric cancer.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
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Inclusion criteria
. Age between 18-80 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) according to the eighth edition of the AJCC ;
. No distant metastasis was 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 signed the informed consent form and participated in the study;
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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 that 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, and 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.).