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

Tracking Information

First Received Date ^ICMJE

July 10, 2009

Last Updated Date

October 22, 2012

Start Date ^ICMJE

October 2009

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00937456 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Open Versus Laparoscopically-assisted Esophagectomy for Cancer

Official Title ^ICMJE

Open vs Laparoscopically-assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial

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.

Detailed Description

Open Versus Laparoscopically-assisted Esophagectomy for Cancer

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Esophageal Cancer

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

October 2014

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00937456

Other Study ID Numbers ^ICMJE

2009-A00144-53, PHRC 2008/1907, 2008_24/0904

Has Data Monitoring Committee

Yes

Responsible Party

Christophe MARIETTE, University Hospital, Lille

Study Sponsor ^ICMJE

University Hospital, Lille

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Christophe Mariette, MD, PhD

University Hospital of Lille, France

Information Provided By

University Hospital, Lille

Verification Date

October 2012

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

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