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.

Abstract

Robotic-assisted proximal gastrectomy with double flap technique (RPG-DFT) reconstruction has been used to treat proximal early gastric cancer and reconstruct the digestive tract in recent years. However, due to the complexity of this surgical procedure, all of the reports were retrospective. The application of RPG-DFT in the context of proximal early gastric cancer remains a nascent area of investigation. Large-scale, prospective trials are necessary to assess the feasibility and safety of RPG-DFT for proximal early gastric cancer. This study is a phase II, multicentre, single-arm clinical trial that investigates the feasibility and safety of RPG-DFT for proximal early gastric cancer. A total of 42 eligible patients who met the inclusion criteria will be allocated to the RPG-DFT group. General and clinical data will be collected at the time of patient enrolment and maintained in accordance with the patient's progress throughout their medical and follow-up care. The primary endpoint is the proportion of patients with reflux oesophagitis (Los Angeles Grade B or more) within 12 months postoperatively. The secondary endpoints included intraoperative outcomes, postoperative recovery, postoperative pain assessment, pathological outcomes, postoperative quality of life, postoperative nutritional status, morbidity and mortality rate. The protocol was approved by the Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Ethics Committee (registration number: SYSKY-2022-275-02) on 28 September 2022. We will report the findings in international peer-reviewed journals. NCT05892289.