Open Versus Laparoscopically-assisted Esophagectomy for Cancer

University Hospital, Lille

Status: Completed

Conditions: Esophageal Cancer

Treatments: Procedure: Laparoscopically-assisted esophagectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00937456

2009-A00144-53. (Other Identifier)

PHRC 2008/1907 (Other Identifier)

2008_24/0904

Details and patient eligibility

About

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.

Full description

Open Versus Laparoscopically-assisted Esophagectomy for Cancer

Enrollment: 207 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 2 patient groups

Laparoscopically-assisted esophagectomy

Experimental group

Description:

Laparoscopically-assisted esophagectomy: standard abdominal procedure of gastric mobilisation but through laparoscopic route. Right thoracotomy as usual.

Treatment:

Procedure: Laparoscopically-assisted esophagectomy

Open esophagectomy

Active Comparator group

Description:

Conventional open esophagectomy: Esophagectomy with extended 2-field lymphadenectomy through laparotomy and right thoracotomy (Ivor-Lewis standard procedure)

Treatment:

Procedure: Laparoscopically-assisted esophagectomy