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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Totally Minimally Invasive Esophagectomy (TMIE) | Experimental |
| |
| Hybrid Esophagectomy (HE) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Totally Minimally Invasive Esophagectomy (TMIE) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Severe postoperative complications after surgery. | 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients experiencing complication equal to or greater than 2 according to the Clavien-Dindo classification | Clavien-Dindo (grade III : requiring surgical, endoscopic or radiological intervention (not under general anesthesia) to grade V : death of a patient. | 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) |
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Inclusion Criteria:
Inclusion criteria for screening - part A (for patients receiving a neo-adjuvant treatment)
Inclusion criteria before surgery (after neo-adjuvant treatment or for patients receiving primary surgery)
Exclusion Criteria:
Non inclusion criteria for screening - part A (for patients receiving a neo-adjuvant treatment)
Patient-related non-inclusion criteria
Disease-related non-inclusion criteria
Non inclusion criteria before surgery (after neo-adjuvant treatment or for patients receiving primary surgery)
Disease-related non-inclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thibault VORON, Dr | Contact | 0171970187 | thibault.voron@aphp.fr | |
| Guillaume PIESSEN, Pr | Contact | 0320445506 | guillaume.piessen@chu-lille.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lille | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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National, multicentric, phase III, open-label, randomized controlled trial with two parallel arms.
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| Hybrid Esophagectomy (HE) | Procedure | 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. |
|
| 90 days |
| Respiratory complication rate | respiratory complication rate is defined as any respiratory event detailed by the ECCG classification (Esophagectomy Complications Consensus Group), including pneumonia, pleural effusion requiring additional drainage procedure, pneumothorax requiring intervention, atelectasis mucous plugging requiring bronchoscopy, respiratory failure requiring reintubation, acute respiratory distress syndrome, acute aspiration, tracheobronchial injury and chest drain requirement for air leak for more than 10 days postoperatively | 90 days |
| Anastomotic leak rate | anastomotic leak rate defined as full thickness GI defect involving esophagus, anastomosis, staple line, or conduit irrespective of presentation or method of identification. Anastomotic leaks will be classified into 3 types according to the treatment required, according to the international classification. | 90 days |
| Mortality rate | The mortality is defined as any death occurring within 90 days of surgery. | 90 days |
| Length of stay in the ICU. | The length of stay in the ICU is defined as the number of postoperative days within 90 days of surgery | 90 days |
| Length of hospital stay. | The length of hospital stay is defined by the number of postoperative days the patient spends in the intensive care unit or in a conventional ward. | 90 days |
| Level of pain | The level of pain during the first 14 days after surgery is assessed by visual analog scale (score from 0 = no pain, to 10 = wort imaginable pain) on a daily basis, from the day of surgery until 14 days after surgery or until discharge of the patient. | 14 days |
| Presence of neuropathic pain | neuropathic pain will be assessed using the Neuropathic Pain Symptom Inventory (NPSI) (from 0 = not present to 10 = worst imaginable). | 6 months |
| Change from baseline in quality of life level | The change from baseline (before surgery, V1) in quality of life level on validated EORTC QLQC-30 (European Organisation for Research and Treatment of Cancer Quality of Life Core 30) questionnaire at 1 month, 6 months, 1 year, 3 years and 5 years postoperatively. | 1 months, 6 months, 1 year, 3 years, 5 years |
| Change from baseline in quality of life level | The change from baseline (before surgery, V1) in quality of life level on validated EQ-5D-5L (EuroQol 5-Dimension 5-Level) questionnaire at 1 month, 6 months, 1 year, 3 years and 5 years postoperatively. | 1 months, 6 months, 1 year, 3 years, 5 years |