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Open Versus Laparoscopically-assisted Esophagectomy for Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00937456
First Posted: July 13, 2009
Last Update Posted: August 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Lille
  Purpose
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 Intervention Phase
Esophageal Cancer Procedure: Laparoscopically-assisted esophagectomy Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

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

Enrollment: 207
Study Start Date: October 2009
Study Completion Date: July 2015
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Open Versus Laparoscopically-assisted Esophagectomy for Cancer
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  • 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:

  • Presence of detectable visceral metastases or peritoneal carcinomatosis
  • Another malignant tumor within the last 5 years (not including basal cell skin carcinoma or cancer of the cervix)
  • Weight loss exceeding 15%
  • Any other simultaneous experimental treatment
  Contacts and Locations
Information from the National Library of Medicine

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
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
Principal Investigator: Christophe Mariette, MD, PhD University Hospital of Lille, France
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT00937456     History of Changes
Other Study ID Numbers: 2008_24/0904
PHRC 2008/1907 ( Other Identifier: DHOS )
2009-A00144-53. ( Other Identifier: ID-RCB number, ANSM )
First Submitted: July 10, 2009
First Posted: July 13, 2009
Last Update Posted: August 14, 2015
Last Verified: August 2015

Keywords provided by University Hospital, Lille:
Esophagus
Cancer
Surgery
Laparoscopy
Randomized trial
Esophageal cancer deemed to be resectable

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases