Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
All Genders
NCT05892289

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

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-05-25

42

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

Sponsors

S

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Lead Sponsor

F

First Affiliated Hospital of Guangxi Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 reflux oesophagitis through reconstruction a simulative cardia. At present, the technique has been carried out in some hospitals in China but still lack large-scale prospective studies and evidence of evidence-based medicine. At present, some retrospective studies have shown that robotic assisted proximal gastrectomy with double-flap technique is safe and effective, and the learning curve is shorter than laparoscopic surgery. The applicant have finished two robotic assisted proximal gastrectomy with double-flap technique cases. Two patients recovered well after surgery, with no occurrence of anastomotic leakage or stenosis and the postoperative quality of life was good. Now we plan to conduct a multi-center, single arm study on proximal early gastric cancer patients(T1N0-1M0 and T2N0M0) to evaluate the feasibility of robotic assisted proximal gastrectomy with double-flap technique , and to evaluate the surgical and oncological safety of this surgical method. Aim to provide initial evidence of evidence-based medicine for its clinical application..

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 20 and 80 years
  • Primary gastric lesions located in the proximal third of the stomach
  • Histologically confirmed gastric adenocarcinoma by preoperative gastrofiberscopy
  • Clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) based on endoscopic ultrasonography and/or contrast-enhanced CT
  • Scheduled for robotic assisted proximal gastrectomy with D1+/D2 lymphadenectomy suitable for R0 surgery
  • Preoperative physical status classified as American Society of Anesthesiologists (ASA) I-III
  • Cardiopulmonary function sufficient to tolerate robotic assisted surgery
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • History of upper abdominal surgery making robotic assisted surgery unsuitable
  • Tumor invading the esophagus more than 3 cm above the gastro-esophageal junction (Z-line)
  • Having other malignant diseases or history of malignancy within the past 5 years
  • Excessive tension for esophagogastric anastomosis requiring change in reconstruction procedure
  • Women who are pregnant or breastfeeding
  • Suffering from serious mental illness
  • History of continuous systemic corticosteroid or immunosuppressive drug treatment within 1 month

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Actively Recruiting

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Research Team

Y

Yang bin, associate professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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