Clinical trial NCT00937456: Open Versus Laparoscopically-assisted Esophagectomy for Cancer
Official title: Open vs Laparoscopically-assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Keywords: Esophagus
Cancer
Surgery
Laparoscopy
Randomized trial
Esophageal cancer deemed to be resectable
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2009-07-13
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Open Versus Laparoscopically-assisted Esophagectomy for Cancer

Eligibility criteria: 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

Primary outcomes:
measure: To decrease postoperative major 30-days morbidity from 45% in the open arm to 25% in the laparoscopically-assisted arm.
timeFrame: 30 days
Secondary outcomes:
measure: overall morbidity
timeFrame: 30 days
measure: disease free survival
timeFrame: 2 years
measure: overall survival
timeFrame: 2 years
measure: quality of life
timeFrame: 2 years
measure: economical interest of the surgical technique apprehended through a hospital point of view
timeFrame: 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Du Haut Leveque
city: Boulogne Billancourt
country: France
facility: Hopital Ambroise Pare Ap-Hp
city: Clermont Ferrand
country: France
facility: Hotel Dieu
city: Colombes
country: France
facility: Hopital Louis Mourier
city: Lyon
country: France
facility: Hopital de La Croix Rousse
city: Marseille
country: France
facility: Hopital St Marguerite Ap-Hm
city: Paris
country: France
facility: Hopital St Louis Ap-Hp
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Rennes
country: France
facility: Hopitalpontchaillou
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg
city: Toulouse
country: France
facility: Hopital Purpan
Study officials:
affiliation: University Hospital of Lille, France
name: Christophe Mariette, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.