Totally Versus Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer (NCT07408999) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Totally Versus Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer
France327 participantsStarted 2026-03-31
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Inclusion criteria for screening - part A (for patients receiving a neo-adjuvant treatment)
* Age ≥ 18 years and ≤ 80 years For patients between 70 and 80 years old : score G8 ≥ 14 or oncogeratrician approval
* Squamous cell carcinoma or adenocarcinoma of the esophagus or esogastric junction
* Clinical stage T1, T2, T3, T4a, N0-N3, M0 before any treatment
* Tumors of the middle or lower third of the esophagus, or tumor of the esogastric junction Siewert 1 or 2
* With or without neoadjuvant (radio) chemotherapy ± targeted therapy
* Disease deemed curatively resectable preoperatively
* Requiring a 2-stage Ivor-Lewis esophagectomy
* Performance status 0, 1 or 2
* Patient capable of receiving either surgical treatment
* Patient informed of the terms of the study and having given written consent
* Patient able to read and understand the language and content of the study documents and agreeing to adhere to the protocol requirements.
* Covered by a medical/health insurance
* Willingness and ability to comply with scheduled visits and study procedures
Inclusion criteria before surgery (after neo-adjuvant treatment or for patients receiving primary surgery)
* Age ≥ 18 years and ≤ 80 years For patients between 70 and 80 years old : score G8 ≥ 14 or oncogeratrician approval
* Squamous cell carcinoma or adenocarcinoma of the esophagus or esogastric junction
* Clinical stage T1, T2, T3, N0-N3, M0 before surgery
* Tumors of the middle or lower third of the esophagus…