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Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer

RecruitingNAAges 20 Years - 80 YearsAllSun Yat-Sen Memorial Hospital of Sun Yat-Sen Univ…
NCT05892289 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Proximal early gastric cancer can choose radical total gastrectomy or proximal gastrectomy. The patients have poor nutritional status and quality of life after total gastrectomy. Compare to total gastrectomy, the nutritional status can improve after proximal gastrectomy . But if use simple esophagogastric anastomosis for proximal gastrectomy, the incidence of postoperative reflux esophagitis is high, which seriously affects the quality of life, and the short-term outcome is poorer than the total gastrectomy. If the incidence of postoperative reflux esophagitis can be reduced, proximal gastrectomy would be the treatment choice for proximal early gastric cancer, which may more improve both quality of life and nutritional condition than total gastrectomy. Double-flap technique is a new surgical reconstruction procedure between esophagus and remnant stomach. It can reduce the occurrence of

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 20 years ≤ age ≤ 80 years 2. The primary gastric lesions were located in the proximal third of the stomach 3. histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy) 4. clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 8th edition of the American Joint Committee on Cancer System(Clinical stage was determined based on the finding of endoscopic ultrasonography and/or thoraco-abdominal contrast-enhanced computed tomography) 5. scheduled for robotic assisted proximal gastrectomy with D1+/D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition).). 6. The preoperative American Society of Anesthesiologists (ASA) physical status was I-III; 7. The patient's cardiopulmonary function can tolerate robotic assisted surgery; 8. The subjects have signed the informed consent form. Exclusion Criteria: 1. history of upper abdominal surgery and not suitable for robotic assisted surgery 2. the tumor invades the esophagus 3cm above gastro-esophageal junction (Z-line) 3. with other malignant diseases or have suffered from other malignant diseases within 5 years 4. Excessive tension for esophagogastric anastomosis and require changing the reconstruction procedure 5. women are pregnant or in lactation period 6. Suffering from serious mental illness 7. history of continuous systemic corticosteroid or immunosuppressive drug treatment within 1 month
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What it tests

  • Robotic assisted proximal gastrectomy with double-flap technique
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Where

1 site
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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