RecruitingNot ApplicableNCT05892289

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

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


Sponsor

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

Enrollment

42 participants

Start Date

Jun 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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..


Eligibility

Min Age: 20 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether robotic-assisted surgery using a technique that preserves the stomach opening (double-flap technique) is safe and feasible for removing early-stage stomach cancer located in the upper part of the stomach. **You may be eligible if...** - You are between 20 and 80 years old - Your tumor is in the upper third of the stomach, confirmed as gastric adenocarcinoma by endoscopy - Your cancer is early stage (clinical stage IA or IB with no distant spread) **You may NOT be eligible if...** - Your tumor is in the middle or lower stomach - Your cancer is at an advanced stage or has spread - You are outside the 20–80 age range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERobotic assisted proximal gastrectomy with double-flap technique

Patients in this group receive robotic assisted proximal gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA:Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9,11p;D2 for stage IB: Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9,11p and 11d).The double-flap technique is used for the digestive tract reconstruction.


Locations(1)

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

Guangzhou, Guangdong, China

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NCT05892289


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