Status:
COMPLETED
Open Versus Laparoscopically-assisted Esophagectomy for Cancer
Lead Sponsor:
University Hospital, Lille
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 7 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00937456
Start Date
October 7 2009
End Date
October 1 2015
Last Update
June 26 2018
Active Locations (11)
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1
Hopital Du Haut Leveque
Bordeaux, France, 33604
2
Hopital Ambroise Pare Ap-Hp
Boulogne-Billancourt, France, 92 100
3
Hotel Dieu
Clermont-Ferrand, France, 63 058
4
Hopital Louis Mourier
Colombes, France, 92 701