Robotic surgery for early gastric cancer using a new technique

Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer: a Phase II, Multi-center, Single-arm Clinical Study

This study is testing a new robotic surgery technique for early stomach cancer to see if it can help patients recover better and have fewer problems after surgery compared to the usual method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05892289 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 80 with histologically confirmed proximal gastric adenocarcinoma at clinical stage IA or IB.

Not a fit: Patients with advanced gastric cancer or those unable to tolerate robotic-assisted surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life and nutritional outcomes for patients with proximal early gastric cancer.

How similar studies have performed: While similar robotic surgical techniques have shown promise, the specific double-flap technique is relatively novel and has not been extensively tested in prior studies.

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

Where this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Yang bin, associate professor

Conditions Stomach Neoplasms; Robotic Surgical Procedures; minimally invasive surgical procedures; stomach neoplasm; Gastrectomy; Reflux Esophagitis