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Esophageal CancerNCT00937456

Open Versus Laparoscopically-assisted Esophagectomy for Cancer

A study testing Laparoscopically-assisted esophagectomy in people with Esophageal Cancer, run by University Hospital, Lille at 11 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Cancer
What is being tested?
Laparoscopically-assisted esophagectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
207 participants
Where
11 sitesFrance
Study dates
7 Oct 2009to 1 Oct 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Disease-related factors
Show all 15Show fewer
  • 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
  • Laparoscopy-related factors
  • Patient presenting a general contraindication to laparoscopy
  • A history of median or subcostal laparotomy

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • Hopital Du Haut Leveque

    Bordeaux, 33604

  • Hopital Ambroise Pare Ap-Hp

    Boulogne-Billancourt, 92 100

  • Hotel Dieu

    Clermont-Ferrand, 63 058

  • Hopital Louis Mourier

    Colombes, 92 701

  • Hopital de La Croix Rousse

    Lyon, 69 317

  • Hopital St Marguerite Ap-Hm

    Marseille, 13 274

  • Hopital St Louis Ap-Hp

    Paris, 75 010

  • Institut Mutualiste Montsouris

    Paris, 75014

  • Hopitalpontchaillou

    Rennes, 35 033

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, 67 098

  • Hopital Purpan

    Toulouse, 31 059

Other trials in France

About this study

Official title: 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.

Read the detailed description

Open Versus Laparoscopically-assisted Esophagectomy for Cancer

Being tested
Laparoscopically-assisted esophagectomy
Keywords
Esophagus, Cancer, Surgery, Laparoscopy, Randomized trial, Esophageal cancer deemed to be resectable
Medical subject headings
Esophageal Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopically-assisted esophagectomyProcedure or surgery

    Also called 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 groups in NCT00937456
Study groupRoleWhat they receive
Laparoscopically-assisted esophagectomyExperimentalLaparoscopically-assisted esophagectomy: standard abdominal procedure of gastric mobilisation but through laparoscopic route. Right thoracotomy as usual.
Receives: Procedure: Laparoscopically-assisted esophagectomy
Open esophagectomyActive comparatorConventional open esophagectomy: Esophagectomy with extended 2-field lymphadenectomy through laparotomy and right thoracotomy (Ivor-Lewis standard procedure)
Receives: Procedure: Laparoscopically-assisted esophagectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To decrease postoperative major 30-days morbidity from 45% in the open arm to 25% in the laparoscopically-assisted arm.

    Measured: 30 days

Secondary outcomes (5)

  1. overall morbidity

    Measured: 30 days

  2. disease free survival

    Measured: 2 years

  3. overall survival

    Measured: 2 years

  4. quality of life

    Measured: 2 years

  5. economical interest of the surgical technique apprehended through a hospital point of view

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2009 (estimated)
  2. Study start7 Oct 2009
  3. Primary completionOct 2011
  4. Study completion1 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00937456
Sponsor's protocol ID
2008_24/0904
Other IDs
PHRC 2008/1907, 2009-A00144-53.
Status last verified
Jun 2018
First submitted
10 Jul 2009
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Nuytens F, Dabakuyo-Yonli TS, Meunier B, Gagniere J, Collet D, D'Journo XB, Brigand C, Perniceni T, Carrere N, Mabrut JY, Msika S, Peschaud F, Prudhomme M, Markar SR, Piessen G; Federation de Recherche en Chirurgie (FRENCH) and French Eso-Gastric Tumors (FREGAT) Working Groups. Five-Year Survival Outcomes of Hybrid Minimally Invasive Esophagectomy in Esophageal Cancer: Results of the MIRO Randomized Clinical Trial. JAMA Surg. 2021 Apr 1;156(4):323-332. doi: 10.1001/jamasurg.2020.7081.

    PubMed 33595631

  • 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.

    PubMed 21781337

  • Mariette C, Markar SR, Dabakuyo-Yonli TS, Meunier B, Pezet D, Collet D, D'Journo XB, Brigand C, Perniceni T, Carrere N, Mabrut JY, Msika S, Peschaud F, Prudhomme M, Bonnetain F, Piessen G; Federation de Recherche en Chirurgie (FRENCH) and French Eso-Gastric Tumors (FREGAT) Working Group. Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer. N Engl J Med. 2019 Jan 10;380(2):152-162. doi: 10.1056/NEJMoa1805101.

    PubMed 30625052

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopically-assisted esophagectomy in people with Esophageal Cancer, run by University Hospital, Lille at 11 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00937456, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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