NCT00937456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

October 7, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

April 22, 2026

Status Verified

June 1, 2018

Enrollment Period

2 years

First QC Date

July 10, 2009

Last Update Submit

April 17, 2026

Conditions

Esophageal Cancer

Keywords

EsophagusCancerSurgeryLaparoscopyRandomized trialEsophageal cancer deemed to be resectable

Outcome Measures

Primary Outcomes (1)

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

    30 days

Secondary Outcomes (5)

  • overall morbidity

    30 days

  • disease free survival

    2 years

  • overall survival

    2 years

  • quality of life

    2 years

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

    6 months

Study Arms (2)

Laparoscopically-assisted esophagectomy

EXPERIMENTAL

Laparoscopically-assisted esophagectomy: standard abdominal procedure of gastric mobilisation but through laparoscopic route. Right thoracotomy as usual.

Procedure: Laparoscopically-assisted esophagectomy

Open esophagectomy

ACTIVE COMPARATOR

Conventional open esophagectomy: Esophagectomy with extended 2-field lymphadenectomy through laparotomy and right thoracotomy (Ivor-Lewis standard procedure)

Procedure: Laparoscopically-assisted esophagectomy

Interventions

Laparoscopically-assisted esophagectomyPROCEDURE

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

Also known as: esophagectomy with extended two-field lymphadenectomy
Laparoscopically-assisted esophagectomyOpen esophagectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Invasion of subclavicular lymph nodes in a clinical examination or on biospy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hopital Du Haut Leveque

Bordeaux, 33604, France

Location

Hopital Ambroise Pare Ap-Hp

Boulogne-Billancourt, 92 100, France

Location

Hotel Dieu

Clermont-Ferrand, 63 058, France

Location

Hopital Louis Mourier

Colombes, 92 701, France

Location

Hopital de La Croix Rousse

Lyon, 69 317, France

Location

Hopital St Marguerite Ap-Hm

Marseille, 13 274, France

Location

Hopital St Louis Ap-Hp

Paris, 75 010, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Hopitalpontchaillou

Rennes, 35 033, France

Location

Hopitaux Universitaires de Strasbourg

Strasbourg, 67 098, France

Location

Hopital Purpan

Toulouse, 31 059, France

Location

Related Publications (3)

  • 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.

    PMID: 33595631BACKGROUND

  • 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.

    PMID: 21781337BACKGROUND

  • 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.

    PMID: 30625052RESULT

MeSH Terms

Conditions

Esophageal NeoplasmsNeoplasms

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Christophe Mariette, MD, PhD

    University Hospital of Lille, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 13, 2009

Study Start

October 7, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2015

Last Updated

April 22, 2026

Record last verified: 2018-06

Locations

FR(11)