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

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · May 28, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new surgical approach called robotic assisted proximal gastrectomy with a double-flap technique for patients with early-stage stomach cancer located in the upper part of the stomach. This method aims to improve patients' nutritional status and quality of life compared to traditional total gastrectomy, which removes the entire stomach but can lead to significant nutritional issues and discomfort after surgery. The double-flap technique helps reduce a common problem after surgery called reflux esophagitis, where stomach acid flows back into the esophagus, causing heartburn and other unpleasant symptoms.

To participate in this trial, individuals must be between 20 and 80 years old, have a confirmed diagnosis of early-stage stomach cancer, and are scheduled for this specific type of surgery. Potential participants will need to sign a consent form and undergo a thorough evaluation to ensure they are suitable for robotic surgery. Those who qualify can expect to receive care from experienced medical professionals and will be monitored carefully after the procedure to assess their recovery and quality of life. This study aims to gather more evidence on the safety and effectiveness of this innovative surgical technique, which could benefit many future patients facing similar health challenges.

Gender

ALL

Eligibility criteria

• 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