Evidence map›Paper›PMID 21781337›Full record

Trial reportBMC cancer2011

Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial - the MIRO trial.

Nicolas Briez, Guillaume Piessen, Franck Bonnetain, Cécile Brigand, Nicolas Carrere, Denis Collet, Christophe Doddoli, Renaud Flamein, Jean-Yves Mabrut, Bernard Meunier and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00937456 (Open vs Laparoscopically-assisted Esophagectomy for Cancer), which is not on this map. Cited by 78 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 4 pooled it
8.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00937456 nacompletednot on this map

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

TypeinterventionalSponsorUniversity Hospital, LilleRan2009 to 2015Enrolled207ConditionsEsophageal CancerArmsLaparoscopically-assisted esophagectomy
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 4 syntheses or guidelines pooled it, 170 citations in OpenAlex.

  1. Does thoracoscopic esophagectomy really reduce post-operative pneumonia in all cases?Esophagus : official journal of the Japan Esophageal Society · 2021
    Pooled it
  2. Pooled it
  3. Meta-analysis shows clinically relevant and long-lasting deterioration in health-related quality of life after esophageal cancer surgery.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2014
    Pooled it
  4. Meta-analysis shows clinically relevant and long-lasting deterioration in health-related quality of life after esophageal cancer surgery.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2014
    Pooled it
  5. Trial
  6. Trial
  7. Article
  8. Review
  9. Article
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  11. Article
  12. Review
  13. Article
  14. History and evidence for state of the art of lymphadenectomy in esophageal cancer surgery.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2024
    Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Article
  20. Review

18 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 12 institutions in 1 country.

Nicolas BriezDepartment of Digestive and Oncological Surgery, University Hospital, Place de Verdun, Lille, F-59037, France.
Guillaume Piessen
Franck Bonnetain
Cécile Brigand
Nicolas Carrere
Denis Collet
Christophe Doddoli
Renaud Flamein
Jean-Yves Mabrut
Bernard Meunier
Simon Msika
Thierry Perniceni
Frédérique Peschaud
Michel Prudhomme
Jean-Pierre Triboulet
Christophe Mariette
Université de Lille · FRCentre Georges François Leclerc · FRHôpital Ambroise-Paré · FRHôpital de la Croix-Rousse · FRHôpital Louis-Mourier · FRHôpital Nord · FRHôpital Pontchaillou · FRHôpital Purpan · FRInstitute Mutualiste Montsouris · FRUniversité Clermont Auvergne · FRUniversité de Bordeaux · FRUniversité de Nîmes · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOpen transthoracic oesophagectomy is the standard treatment for infracarinal resectable oesophageal carcinomas, although it is associated with high mortality and morbidity rates of 2 to 10% and 30 to 50%, respectively, for both the abdominal and thoracic approaches. The worldwide popularity of laparoscopic techniques is based on promising results, including lower postoperative morbidity rates, which are related to the reduced postoperative trauma. We hypothesise that the laparoscopic abdominal approach (laparoscopic gastric mobilisation) in oesophageal cancer surgery will decrease the major postoperative complication rate due to the reduced surgical trauma. METHODS/

designThe MIRO trial is an open, controlled, prospective, randomised multicentre phase III trial. Patients in study arm A will receive laparoscopic-assisted oesophagectomy, i.e., a transthoracic oesophagectomy with two-field lymphadenectomy and laparoscopic gastric mobilisation. Patients in study arm B will receive the same procedure, but with the conventional open abdominal approach. The primary objective of the study is to evaluate the major postoperative 30-day morbidity. Secondary objectives are to assess the overall 30-day morbidity, 30-day mortality, 30-day pulmonary morbidity, disease-free survival, overall survival as well as quality of life and to perform medico-economic analysis. A total of 200 patients will be enrolled, and two safety analyses will be performed using 25 and 50 patients included in arm A. DISCUSSION: Postoperative morbidity remains high after oesophageal cancer surgery, especially due to major pulmonary complications, which are responsible for 50% of the postoperative deaths. This study represents the first randomised controlled phase III trial to evaluate the benefits of the minimally invasive approach with respect to the postoperative course and oncological outcomes in oesophageal cancer surgery.

trial registrationNCT00937456 (ClinicalTrials.gov).

Indexed as

LaparoscopyAdenocarcinomaAdultAgedCarcinoma, Squamous CellEsophageal NeoplasmsEsophagectomyEsophagusFollow-Up StudiesHumansKaplan-Meier EstimateLymph Node ExcisionMiddle AgedPostoperative CarePreoperative CareProspective Studies

Identifiers

PMID21781337
PMCPMC3156811
OpenAlexW2165908615

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.