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Totally Versus Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer
Sponsor: University Hospital, Lille
Summary
Esophageal and gastroesophageal junction cancers remain associated with poor survival despite progress in multimodal treatment. Surgery, especially Ivor-Lewis esophagectomy, combined with peri-operative therapy improves survival but is burdened by major morbidity, mainly respiratory and anastomotic complications, which compromise recovery and adjuvant treatment. Minimally invasive approaches such as totally minimally invasive esophagectomy (TMIE) have shown potential to reduce postoperative morbidity compared to the hybrid approach (HE). However, existing studies are heterogeneous, mostly retrospective, and insufficient to establish a standard. This trial aims to provide high-level evidence comparing TMIE to HE, including robotic techniques, with integrated analyses of clinical outcomes, quality of life, and health economics.
Official title: Totally Versus Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer - A Multicentric Phase III Prospective Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
327
Start Date
2026-03-31
Completion Date
2031-03-31
Last Updated
2026-02-13
Healthy Volunteers
No
Interventions
Totally Minimally Invasive Esophagectomy (TMIE)
All patients will undergo an Ivor-Lewis procedure with the same laparoscopic abdominal approach. The thoracic approach differs between the two groups: HE with open thoracotomy in the 5th or 6th intercostal space and TMIE with thoracoscopic approach. The main aspects of the surgical technique will be standardized. All patients will receive a transthoracic en-bloc esophagectomy with termino-lateral or latero-lateral anastomosis in the upper chest, including an abdominal lymphadenectomy (left and right paracardial regions along the lesser curve of the left gastric artery, celiac axis, origin of the common hepatic artery and splenic artery) and an extended en bloc mediastinal lymphadenectomy including paratracheal, subcarinal, left and right bronchial, lower posterior mediastinum, para-aortic, para-esophageal lymph with or without resection of the thoracic duct), i.e., an extended two- field lymphadenectomy. The esophagus will be replaced by the stomach in all cases.
Hybrid Esophagectomy (HE)
All patients will undergo an Ivor-Lewis procedure with the same laparoscopic abdominal approach. The thoracic approach differs between the two groups: HE with open thoracotomy in the 5th or 6th intercostal space and TMIE with thoracoscopic approach. The main aspects of the surgical technique will be standardized. All patients will receive a transthoracic en-bloc esophagectomy with termino-lateral or latero-lateral anastomosis in the upper chest, including an abdominal lymphadenectomy (left and right paracardial regions along the lesser curve of the left gastric artery, celiac axis, origin of the common hepatic artery and splenic artery) and an extended en bloc mediastinal lymphadenectomy including paratracheal, subcarinal, left and right bronchial, lower posterior mediastinum, para-aortic, para-esophageal lymph with or without resection of the thoracic duct), i.e., an extended two- field lymphadenectomy. The esophagus will be replaced by the stomach in all cases.
Locations (1)
CHU de Lille
Lille, France