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Open Versus Laparoscopically-assisted Esophagectomy for Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Christophe MARIETTE, University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT00937456
First received: July 10, 2009
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  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: esophagectomy with extended two-field lymphadenectomy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall morbidity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • disease free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • economical interest of the surgical technique apprehended through a hospital point of view [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2009
Estimated Study Completion Date: October 2014
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: esophagectomy with extended two-field lymphadenectomy
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
Active Comparator: Open esophagectomy
Conventional open esophagectomy: Esophagectomy with extended 2-field lymphadenectomy through laparotomy and right thoracotomy (Ivor-Lewis standard procedure)
 Procedure: esophagectomy with extended two-field lymphadenectomy
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

Detailed Description:

Open Versus Laparoscopically-assisted Esophagectomy for Cancer

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Institut Mutualiste Montsouris
Paris, France, 75014
Hopital St Louis Ap-Hp
Paris, France, 75 010
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

No publications provided by University Hospital, Lille

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christophe MARIETTE, MD, PhD, University Hospital, Lille
ClinicalTrials.gov Identifier: NCT00937456     History of Changes
Other Study ID Numbers: 2009-A00144-53, PHRC 2008/1907, 2008_24/0904
Study First Received: July 10, 2009
Last Updated: October 22, 2012
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Ministry of Health
France: Institutional Ethical Committee

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

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

ClinicalTrials.gov processed this record on June 17, 2013