Open Versus Laparoscopically-assisted Esophagectomy for Cancer

April 17, 2026 updated by: University Hospital, Lille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open Versus Laparoscopically-assisted Esophagectomy for Cancer

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33604
        • Hopîtal du Haut Lévêque
      • Boulogne-Billancourt, France, 92 100
        • Hopital Ambroise Pare Ap-Hp
      • Clermont-Ferrand, France, 63 058
        • Hotel Dieu
      • Colombes, France, 92 701
        • Hopital Louis Mourier
      • Lyon, France, 69 317
        • Hopital de la croix rousse
      • Marseille, France, 13 274
        • Hopital St Marguerite Ap-Hm
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
      • Paris, France, 75 010
        • Hopital St Louis Ap-Hp
      • Rennes, France, 35 033
        • Hopitalpontchaillou
      • Strasbourg, France, 67 098
        • Hôpitaux Universitaires de Strasbourg
      • Toulouse, France, 31 059
        • Hopital Purpan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Squamous cell or adenocarcinoma of the thoracic esophagus T1, T2, T3, N0-N1, M0, before any treatment
  • 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:

  1. General criteria: PO2 ≤ 60 mmHg; PCO2 > 45 mmHg; FEV ≤ 1000 ml/sec

    • Hepatic cirrhosis
    • Recent myocardial infarction (in the previous 6 months) or progressive coronary disease
    • Distal arteritis (Leriche-Fontaine stage II upwards)
    • Concomitant cancer, other than subcarinal esophageal cancer

  2. Disease-related factors

    • Invasion of subclavicular lymph nodes in a clinical examination or on biospy
    • Lymph nodes near the origin of the celiac artery with a diameter ≥ 1 cm on CT or that appear to be suspect on endoscopic ultrasound (to differentiate them from the paracardial or left gastric lymph nodes, which does not constitute an exclusion criterion)
    • Recurrent nerve palsy
    • Evidence of extension to the tracheobronchial tree
    • Signs of mediastinal invasion (vertebral contact, aortic contact ≥ 90°, or invasion of nonresectable neighboring organs such as the aorta, trachea, main bronchi, etc.)
    • Distant metastasis

  3. Laparoscopy-related factors

    • Patient presenting a general contraindication to laparoscopy
    • A history of median or subcostal laparotomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • esophagectomy with extended two-field lymphadenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To decrease postoperative major 30-days morbidity from 45% in the open arm to 25% in the laparoscopically-assisted arm.
Time Frame: 30 days
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 7, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 10, 2009

First Submitted That Met QC Criteria

July 10, 2009

First Posted (Estimated)

July 13, 2009

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008_24/0904
  • PHRC 2008/1907 (Other Identifier: DHOS)
  • 2009-A00144-53. (Other Identifier: ID-RCB number, ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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