NCT05892289

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

Recruiting now NA Last updated 25 May 2025

What this trial tests

NA trial testing Robotic assisted proximal gastrectomy with double-flap technique in Stomach Neoplasms in 42 participants. Currently enrolling.

Timeline

10 June 2024

Primary endpoint
10 December 2026

10 December 2026

Quick facts

Lead sponsor	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	10 June 2024
Primary completion	10 December 2026
Estimated completion	10 December 2026
Sites	1 location across China

Drugs / interventions tested

• Robotic assisted proximal gastrectomy with double-flap technique

Conditions studied

• Stomach Neoplasms — all drugs for Stomach Neoplasms →

Sponsor

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

Who can join

Adults 20 to 80, any sex, with Stomach Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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..

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Kamikawa anastomosis in proximal gastrectomy for gastric cancer: A systematic review and meta-analysis.
   Liu CC, Yang J, Yin G, Tian Z, et al · · 2025 · PMID 40949392 · DOI 10.4240/wjgs.v17.i8.107706
2. Assessing the feasibility and safety of robotic-assisted proximal gastrectomy with double-flap technique for proximal early gastric cancer: study protocol for a phase II, multicentre, single-arm clinical trial.
   Zhong G, Xie Y, Chen G, Zhu Y, et al · · 2025 · PMID 40789587 · DOI 10.1136/bmjopen-2024-094661