Esophageal Cancer
Conditions
Keywords
Esophagus, Cancer, Surgery, Laparoscopy, Randomized trial, Esophageal cancer deemed to be resectable
Brief summary
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
Open Versus Laparoscopically-assisted Esophagectomy for Cancer
Interventions
PROCEDURELaparoscopically-assisted esophagectomy
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
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
1. 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 2. 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 3. Laparoscopy-related factors * Patient presenting a general contraindication to laparoscopy * A history of median or subcostal laparotomy
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORChristophe Mariette, MD, PhD
University Hospital of Lille, France
Outcome results
None listed