NCT07408999尚未招募不适用
Totally Versus Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer - A Multicentric Phase III Prospective Randomized Controlled Trial
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 327 人开始时间: 2026年3月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- Severe postoperative complications after surgery.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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, 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
排除标准
- •Non inclusion criteria for screening - part A (for patients receiving a neo-adjuvant treatment)
- •Patient-related non-inclusion criteria
- •Performance status 3 or 4
- •Documented liver cirrhosis or portal hypertension
- •Recent myocardial infarction (less than 6 months old) or progressive coronary artery disease
- •Distal arteritis from stage IIb (200 m) of Leriche and Fontaine
- •Synchronous cancer, other than subcarinal esophageal
- •Neoplasic history except for cancers without recurrence after at least 5 years of surveillance
- •History of xyphopubic laparotomy
- •Patients with prior thoracic surgery or thoracic traum of the right hemithorax
- •Patient refusal
- •Patient under guardianship or curatorship
- •Pregnant or breastfeeding woman or patient expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 6 months after the last dose of adjuvant chemotherapy
- •ASA score> 3
- •Disease-related non-inclusion criteria
- •Histology other than squamous cell carcinoma or adenocarcinoma
- •Tumors of the upper third of the thoracic esophagus, cervical esophagus or pharyngo-esophageal junction or tumor of the esogastric junction Siewert 3
- •Supraclavicular nodes invaded clinically or on puncture
- •Recurrent nerve paralysis
- •Evidence of extension to the tracheobronchial tree
- •Signs of mediastinal invasion (vertebral adhesion, aortic overlap > 90°, invasion of unresectable neighboring organs such as the aorta, trachea…)
- •Distant metastatic extension
- •Non inclusion criteria before surgery (after neo-adjuvant treatment or for patients receiving primary surgery)
- •Performance status 3 or 4
- •Forced expiratory volume in 1 second < 1000 ml
- •Documented liver cirrhosis or portal hypertension
- •Recent myocardial infarction (less than 6 months old) or progressive coronary artery disease
- •Distal arteritis from stage IIb (200 m) of Leriche and Fontaine
- •Weight loss of more than 15% of body weight, not recovered after appropriate nutritional management
- •Synchronous cancer, other than subcarinal esophageal
- •Neoplasic history except for cancers without recurrence after at least 5 years of surveillance
- •History of xyphopubic laparotomy
- •Patients with prior thoracic surgery or thoracic traum of the right hemithorax
- •Patient refusal
- •Patient under guardianship or curatorship
- •Pregnant or breastfeeding woman or patient expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 6 months after the last dose of adjuvant chemotherapy
- •ASA score> 3
- •IESG ≤ -5 (Very high risk patients)
- •Disease-related non-inclusion criteria
- •Histology other than squamous cell carcinoma or adenocarcinoma
- •Tumors of the upper third of the thoracic esophagus, cervical esophagus or pharyngo-esophageal junction or tumor of the esogastric junction Siewert 3
- •Supraclavicular nodes invaded clinically or on puncture
- •Recurrent nerve paralysis
- •Evidence of extension to the tracheobronchial tree
- •Signs of mediastinal invasion (vertebral adhesion, aortic overlap > 90°, invasion of unresectable neighboring organs such as the aorta, trachea…)
- •Distant metastatic extension
研究组 & 干预措施
Totally Minimally Invasive Esophagectomy (TMIE)
Experimental
干预措施: Totally Minimally Invasive Esophagectomy (TMIE) (Procedure)
Hybrid Esophagectomy (HE)
Active Comparator
干预措施: Hybrid Esophagectomy (HE) (Procedure)
结局指标
主要结局
Severe postoperative complications after surgery.
时间窗: 90 days
Severe postoperative complications after surgery, defined as any postoperative complication of grade 3 or higher according to the Clavien-Dindo (grade III : requiring surgical, endoscopic or radiological intervention (not under general anesthesia) to grade V : death of a patient.
次要结局
- Rate of patients experiencing complication equal to or greater than 2 according to the Clavien-Dindo classification(90 days)
- Rate of patients experiencing complication equal to or greater than 2 according to the Comprehensive Complication Index scale (0 = no complications, 100 = Death)(90 days)
- Respiratory complication rate(90 days)
- Anastomotic leak rate(90 days)
- Mortality rate(90 days)
- Length of stay in the ICU.(90 days)
- Length of hospital stay.(90 days)
- Level of pain(14 days)
- Presence of neuropathic pain(6 months)
- Change from baseline in quality of life level(1 months, 6 months, 1 year, 3 years, 5 years)
研究者
研究点 (1)
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