Open Versus Laparoscopically-assisted Esophagectomy for Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by University Hospital, Lille.
Recruitment status was  Active, not recruiting
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

July 10, 2009
October 22, 2012
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: 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
  • Experimental: Laparoscopically-assisted esophagectomy
    Laparoscopically-assisted esophagectomy: standard abdominal procedure of gastric mobilisation but through laparoscopic route. Right thoracotomy as usual.
    Intervention: Procedure: 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)
    Intervention: Procedure: esophagectomy with extended two-field lymphadenectomy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
October 2014
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
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00937456
2009-A00144-53, PHRC 2008/1907, 2008_24/0904
Yes
Christophe MARIETTE, University Hospital, Lille
University Hospital, Lille
Not Provided
Principal Investigator: Christophe Mariette, MD, PhD University Hospital of Lille, France
University Hospital, Lille
October 2012

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