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Open Versus Laparoscopically-assisted Esophagectomy for Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT00937456
First received: July 10, 2009
Last updated: August 13, 2015
Last verified: August 2015

July 10, 2009
August 13, 2015
October 2009
October 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00937456 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Open Versus Laparoscopically-assisted Esophagectomy for Cancer
Open vs Laparoscopically-assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial
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.
Open Versus Laparoscopically-assisted Esophagectomy for Cancer
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
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
  • Experimental: Laparoscopically-assisted esophagectomy
    Laparoscopically-assisted esophagectomy: standard abdominal procedure of gastric mobilisation but through laparoscopic route. Right thoracotomy as usual.
    Intervention: Procedure: Laparoscopically-assisted esophagectomy
  • Active Comparator: Open esophagectomy
    Conventional open esophagectomy: Esophagectomy with extended 2-field lymphadenectomy through laparotomy and right thoracotomy (Ivor-Lewis standard procedure)
    Intervention: Procedure: Laparoscopically-assisted esophagectomy
Briez N, Piessen G, Bonnetain F, Brigand C, Carrere N, Collet D, Doddoli C, Flamein R, Mabrut JY, Meunier B, Msika S, Perniceni T, Peschaud F, Prudhomme M, Triboulet JP, Mariette C. Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial - the MIRO trial. BMC Cancer. 2011 Jul 23;11:310. doi: 10.1186/1471-2407-11-310.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
July 2015
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00937456
2008_24/0904, PHRC 2008/1907, 2009-A00144-53.
Yes
Not Provided
Not Provided
University Hospital, Lille
University Hospital, Lille
Not Provided
Principal Investigator: Christophe Mariette, MD, PhD University Hospital of Lille, France
University Hospital, Lille
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP