Open Versus Laparoscopically-assisted Esophagectomy for Cancer

Not Applicable

Completed

• Conditions: Esophageal Cancer
• Interventions: Procedure: Laparoscopically-assisted esophagectomy

• Registration Number: NCT00937456
• Lead Sponsor: University Hospital, Lille

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

Study Timeline

• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Study Start: 2009-10-07
• Primary Completion: 2011-10
• Study Completion: 2015-10-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopically-assisted esophagectomy	Laparoscopically-assisted esophagectomy	Laparoscopically-assisted esophagectomy: standard abdominal procedure of gastric mobilisation but through laparoscopic route. Right thoracotomy as usual.
Open esophagectomy	Laparoscopically-assisted esophagectomy	Conventional open esophagectomy: Esophagectomy with extended 2-field lymphadenectomy through laparotomy and right thoracotomy (Ivor-Lewis standard procedure)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
quality of life	2 years
overall survival	2 years
disease free survival	2 years
economical interest of the surgical technique apprehended through a hospital point of view	6 months
overall morbidity	30 days

Trial Locations

Locations (11)

Hopital Ambroise Pare Ap-Hp; 🇫🇷 Boulogne Billancourt, France

Hopital Du Haut Leveque; 🇫🇷 Bordeaux, France

Hopital Louis Mourier; 🇫🇷 Colombes, France

Hotel Dieu; 🇫🇷 Clermont Ferrand, France

Hopital de La Croix Rousse; 🇫🇷 Lyon, France

Hopital St Marguerite Ap-Hm; 🇫🇷 Marseille, France

Hopitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Hopital Purpan; 🇫🇷 Toulouse, France

Hopital St Louis Ap-Hp; 🇫🇷 Paris, France

Hopitalpontchaillou; 🇫🇷 Rennes, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France