Application of Hao's Esophagogastrostomy by Fissure Technique (HEFT) in proximal gastrectomy: protocol for a prospective, multicentre, randomised controlled study.

BACKGROUND

Proximal gastrectomy (PG) has emerged as the preferred surgical approach for adenocarcinoma of the upper 1/3 stomach and selected cases of oesophagogastric junction adenocarcinoma. We developed a novel oesophagogastric anastomosis technique with an antireflux mechanism (Hao's Esophagogastrostomy by Fissure Technique). It may have a superior effect on patient weight maintenance compared with the double-tract reconstruction. We intend to conduct a prospective, multicentre, randomised controlled clinical trial to validate this hypothesis.

METHODS AND ANALYSIS

The primary objective evaluates body weight loss at 12 months postoperatively. Secondary objectives assess surgical safety through comprehensive analysis of complication rates and nutritional parameters, including serial haematological evaluations during follow-up. The study will enrol 52 participants across multiple centres with planned 3-year longitudinal monitoring to evaluate both immediate postoperative outcomes and intermediate-term clinical impacts.

ETHICS AND DISSEMINATION

This study was approved by the hospital institutional review board of Huashan Hospital, Fudan University (2024-1173) and is being conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice guidelines. On completion of the study, the results will be published in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER

NCT06679244.