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 Esophagogast...
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BMJ Publishing Group
2025-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/8/e104365.full |
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| author | Jian Wang Jun Hong Ya-Ping Wang Han-Kun Hao Wen-liang Cui Ze-Qin Wang Xue-Liang Shi Ming-Ye Ma Zi-Hao Wang |
| author_facet | Jian Wang Jun Hong Ya-Ping Wang Han-Kun Hao Wen-liang Cui Ze-Qin Wang Xue-Liang Shi Ming-Ye Ma Zi-Hao Wang |
| author_sort | Jian Wang |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a6c49b625484437fa39c1450a9c3f2de |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-a6c49b625484437fa39c1450a9c3f2de2025-08-20T03:36:38ZengBMJ Publishing GroupBMJ Open2044-60552025-08-0115810.1136/bmjopen-2025-104365Application of Hao’s Esophagogastrostomy by Fissure Technique (HEFT) in proximal gastrectomy: protocol for a prospective, multicentre, randomised controlled studyJian Wang0Jun Hong1Ya-Ping Wang2Han-Kun Hao3Wen-liang Cui4Ze-Qin Wang5Xue-Liang Shi6Ming-Ye Ma7Zi-Hao Wang8Division of Gastrointestinal Surgery, Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, ChinaDivision of Gastrointestinal Surgery, Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, ChinaDivision of Gastrointestinal Surgery, Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, ChinaDivision of Gastrointestinal Surgery, Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, ChinaDivision of Gastrointestinal Surgery, Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, ChinaDivision of Gastrointestinal Surgery, Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, ChinaDivision of Gastrointestinal Surgery, Qidong People’s Hospital, Qidong, Jiangsu, ChinaDivision of Gastrointestinal Surgery, Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, ChinaDivision of Gastrointestinal Surgery, Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, ChinaBackground 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.https://bmjopen.bmj.com/content/15/8/e104365.full |
| spellingShingle | Jian Wang Jun Hong Ya-Ping Wang Han-Kun Hao Wen-liang Cui Ze-Qin Wang Xue-Liang Shi Ming-Ye Ma Zi-Hao Wang Application of Hao’s Esophagogastrostomy by Fissure Technique (HEFT) in proximal gastrectomy: protocol for a prospective, multicentre, randomised controlled study BMJ Open |
| title | Application of Hao’s Esophagogastrostomy by Fissure Technique (HEFT) in proximal gastrectomy: protocol for a prospective, multicentre, randomised controlled study |
| title_full | Application of Hao’s Esophagogastrostomy by Fissure Technique (HEFT) in proximal gastrectomy: protocol for a prospective, multicentre, randomised controlled study |
| title_fullStr | Application of Hao’s Esophagogastrostomy by Fissure Technique (HEFT) in proximal gastrectomy: protocol for a prospective, multicentre, randomised controlled study |
| title_full_unstemmed | Application of Hao’s Esophagogastrostomy by Fissure Technique (HEFT) in proximal gastrectomy: protocol for a prospective, multicentre, randomised controlled study |
| title_short | Application of Hao’s Esophagogastrostomy by Fissure Technique (HEFT) in proximal gastrectomy: protocol for a prospective, multicentre, randomised controlled study |
| title_sort | application of hao s esophagogastrostomy by fissure technique heft in proximal gastrectomy protocol for a prospective multicentre randomised controlled study |
| url | https://bmjopen.bmj.com/content/15/8/e104365.full |
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