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Open Versus Laparoscopically-assisted Esophagectomy for Cancer

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ClinicalTrials.gov Identifier: NCT00937456
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Procedure: Laparoscopically-assisted esophagectomy Not Applicable

Detailed Description:
Open Versus Laparoscopically-assisted Esophagectomy for Cancer
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open vs Laparoscopically-assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial
Study Start Date : October 7, 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 1, 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Laparoscopically-assisted esophagectomy
Laparoscopically-assisted esophagectomy: standard abdominal procedure of gastric mobilisation but through laparoscopic route. Right thoracotomy as usual.
 Procedure: Laparoscopically-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
Other Name: esophagectomy with extended two-field lymphadenectomy
Active Comparator: Open esophagectomy
Conventional open esophagectomy: Esophagectomy with extended 2-field lymphadenectomy through laparotomy and right thoracotomy (Ivor-Lewis standard procedure)
 Procedure: Laparoscopically-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
Other Name: esophagectomy with extended two-field lymphadenectomy


Outcome Measures
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Primary Outcome Measures :
  1. To decrease postoperative major 30-days morbidity from 45% in the open arm to 25% in the laparoscopically-assisted arm. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. overall morbidity [ Time Frame: 30 days ]
  2. disease free survival [ Time Frame: 2 years ]
  3. overall survival [ Time Frame: 2 years ]
  4. quality of life [ Time Frame: 2 years ]
  5. economical interest of the surgical technique apprehended through a hospital point of view [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937456


Locations
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France
Hopital Du Haut Leveque
Bordeaux, France, 33604
Hopital Ambroise Pare Ap-Hp
Boulogne Billancourt, France, 92 100
Hotel Dieu
Clermont Ferrand, France, 63 058
Hopital Louis Mourier
Colombes, France, 92 701
Hopital de La Croix Rousse
Lyon, France, 69 317
Hopital St Marguerite Ap-Hm
Marseille, France, 13 274
Hopital St Louis Ap-Hp
Paris, France, 75 010
Institut Mutualiste Montsouris
Paris, France, 75014
Hopitalpontchaillou
Rennes, France, 35 033
Hopitaux Universitaires de Strasbourg
Strasbourg, France, 67 098
Hopital Purpan
Toulouse, France, 31 059
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Christophe Mariette, MD, PhD University Hospital of Lille, France
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT00937456    
Other Study ID Numbers: 2008_24/0904
PHRC 2008/1907 ( Other Identifier: DHOS )
2009-A00144-53. ( Other Identifier: ID-RCB number, ANSM )
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Keywords provided by University Hospital, Lille:
Esophagus
Cancer
Surgery
 Laparoscopy
Randomized trial
Esophageal cancer deemed to be resectable
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases