Totally Versus Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer

Официальное название

Totally Versus Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer - A Multicentric Phase III Prospective Randomized Controlled Trial

Обзор

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.

Вмешательства

• Процедура 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 r
• Процедура 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 r

Первичные конечные точки

• Severe postoperative complications after surgery. [Срок оценки: 90 days]

Вторичные конечные точки (11)

• Rate of patients experiencing complication equal to or greater than 2 according to the Clavien-Dindo classification [Срок оценки: 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) [Срок оценки: 90 days]
• Respiratory complication rate [Срок оценки: 90 days]
• Anastomotic leak rate [Срок оценки: 90 days]
• Mortality rate [Срок оценки: 90 days]
• Length of stay in the ICU. [Срок оценки: 90 days]
• Length of hospital stay. [Срок оценки: 90 days]
• Level of pain [Срок оценки: 14 days]
• Presence of neuropathic pain [Срок оценки: 6 months]
• Change from baseline in quality of life level [Срок оценки: 1 months, 6 months, 1 year, 3 years, 5 years]
• Change from baseline in quality of life level [Срок оценки: 1 months, 6 months, 1 year, 3 years, 5 years]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• CHU de Lille — Lille

Идентификаторы

NCT: NCT07408999 · 2023_0831

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗