Open Versus Laparoscopically-assisted Esophagectomy for Cancer
NCT ID: NCT00937456
Last Updated: 2018-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
207 participants
INTERVENTIONAL
2009-10-07
2015-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laparoscopically-assisted esophagectomy
Laparoscopically-assisted esophagectomy: standard abdominal procedure of gastric mobilisation but through laparoscopic route. Right thoracotomy as usual.
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
Open esophagectomy
Conventional open esophagectomy: Esophagectomy with extended 2-field lymphadenectomy through laparotomy and right thoracotomy (Ivor-Lewis standard 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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Christophe Mariette, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Lille, France
Locations
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Hopital Du Haut Leveque
Bordeaux, , France
Hopital Ambroise Pare Ap-Hp
Boulogne-Billancourt, , France
Hotel Dieu
Clermont-Ferrand, , France
Hopital Louis Mourier
Colombes, , France
Hopital de La Croix Rousse
Lyon, , France
Hopital St Marguerite Ap-Hm
Marseille, , France
Hopital St Louis Ap-Hp
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Hopitalpontchaillou
Rennes, , France
Hopitaux Universitaires de Strasbourg
Strasbourg, , France
Hopital Purpan
Toulouse, , France
Countries
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References
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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.
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.
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.
Other Identifiers
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PHRC 2008/1907
Identifier Type: OTHER
Identifier Source: secondary_id
2009-A00144-53.
Identifier Type: OTHER
Identifier Source: secondary_id
2008_24/0904
Identifier Type: -
Identifier Source: org_study_id
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