Open Versus Laparoscopically-assisted Esophagectomy for Cancer

Study Overview
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Brief Summary
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To compare laparoscopically-assisted gastric mobilization versus open gastric mobilization in Ivor-Lewis esophagectomy for esophageal cancer, with open thoracic approach in the 2 arms.

Detailed Description
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Open Versus Laparoscopically-assisted Esophagectomy for Cancer

Official Title
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Open vs Laparoscopically-assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Procedure: Laparoscopically-assisted esophagectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Squamous cell or adenocarcinoma of the thoracic esophagus T1, T2, T3, N0-N1, M0, before any treatment Middle or lower third esophageal carcinoma, junctional tumor Siewert type I Patients who underwent or not neoadjuvant chemotherapy or chemoradiation Tumor deemed to be resectable in a curative intent at the preoperative setting Age less than 75 years old, OMS status 0, 1 or 2 Patient who can undergo one or the other surgical modality Written informed consent form Possible follow-up Exclusion Criteria: General criteria: PO2 ≤ 60 mmHg; PCO2 > 45 mmHg; FEV ≤ 1000 ml/sec Hepatic cirrhosis Recent myocardial infarction (in the previous 6 months) or progressive coronary disease Distal arteritis (Leriche-Fontaine stage II upwards) Concomitant cancer, other than subcarinal esophageal cancer Disease-related factors Invasion of subclavicular lymph nodes in a clinical examination or on biospy Lymph nodes near the origin of the celiac artery with a diameter ≥ 1 cm on CT or that appear to be suspect on endoscopic ultrasound (to differentiate them from the paracardial or left gastric lymph nodes, which does not constitute an exclusion criterion) Recurrent nerve palsy Evidence of extension to the tracheobronchial tree Signs of mediastinal invasion (vertebral contact, aortic contact ≥ 90°, or invasion of nonresectable neighboring organs such as the aorta, trachea, main bronchi, etc.) Distant metastasis Laparoscopy-related factors Patient presenting a general contraindication to laparoscopy A history of median or subcostal laparotomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopically-assisted esophagectomy<br>Laparoscopically-assisted esophagectomy: standard abdominal procedure of gastric mobilisation but through laparoscopic route. Right thoracotomy as usual. | Procedure: Laparoscopically-assisted esophagectomy<br>* To compare during the abdominal approach the laparoscopic route to the open route for gastric mobilization. Thoracic approach will be the same between the 2 arms through thoracotomy with extended two field lymphadenectomy<br>* Other names: esophagectomy with extended two-field lymphadenectomy;|
| Active Comparator: Open esophagectomy<br>Conventional open esophagectomy: Esophagectomy with extended 2-field lymphadenectomy through laparotomy and right thoracotomy (Ivor-Lewis standard procedure) | Procedure: Laparoscopically-assisted esophagectomy<br>* To compare during the abdominal approach the laparoscopic route to the open route for gastric mobilization. Thoracic approach will be the same between the 2 arms through thoracotomy with extended two field lymphadenectomy<br>* Other names: esophagectomy with extended two-field lymphadenectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To decrease postoperative major 30-days morbidity from 45% in the open arm to 25% in the laparoscopically-assisted arm. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall morbidity |  | 30 days | 
| disease free survival |  | 2 years | 
| overall survival |  | 2 years | 
| quality of life |  | 2 years | 
| economical interest of the surgical technique apprehended through a hospital point of view |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagus, Cancer, Surgery, Laparoscopy, Randomized trial, Esophageal cancer deemed to be resectable