Robotic surgery for early gastric cancer using a new technique

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the feasibility and safety of a robotic-assisted proximal gastrectomy using a double-flap technique for patients with proximal early gastric cancer. The study aims to compare this innovative surgical approach to traditional total gastrectomy, focusing on reducing postoperative reflux esophagitis and improving nutritional status and quality of life. Participants will undergo robotic surgery with lymphadenectomy, and their outcomes will be monitored to assess the effectiveness of the new technique. The trial is designed to provide insights into the potential benefits of this minimally invasive procedure.

Why it matters

Who can join: the full rules

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

Where it's running

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yang bin, associate professor
• Email: yyzsu@163.com
• Phone: 13798163278

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.