Open Versus Laparoscopically-assisted Esophagectomy for Cancer

• ClinicalTrials.gov Identifier: NCT00937456
• Recruitment Status: Completed
• First Posted: July 13, 2009
• Last Update Posted: June 26, 2018
• Sponsor: University Hospital, Lille
• Information provided by (Responsible Party): University Hospital, Lille

Tracking Information

• First Submitted Date: July 10, 2009
• First Posted Date: July 13, 2009
• Last Update Posted Date: June 26, 2018
• Study Start Date: October 7, 2009
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 10, 2009): To decrease postoperative major 30-days morbidity from 45% in the open arm to 25% in the laparoscopically-assisted arm. [ Time Frame: 30 days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 10, 2009)

• overall morbidity [ Time Frame: 30 days ]
• disease free survival [ Time Frame: 2 years ]
• overall survival [ Time Frame: 2 years ]
• quality of life [ Time Frame: 2 years ]
• economical interest of the surgical technique apprehended through a hospital point of view [ Time Frame: 6 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open Versus Laparoscopically-assisted Esophagectomy for Cancer
• Official Title: Open vs Laparoscopically-assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial
• 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
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Esophageal Cancer

Intervention

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

Other Name: esophagectomy with extended two-field lymphadenectomy

Study Arms

• Experimental: Laparoscopically-assisted esophagectomy
  Laparoscopically-assisted esophagectomy: standard abdominal procedure of gastric mobilisation but through laparoscopic route. Right thoracotomy as usual.
  Intervention: Procedure: Laparoscopically-assisted esophagectomy
• Active Comparator: Open esophagectomy
  Conventional open esophagectomy: Esophagectomy with extended 2-field lymphadenectomy through laparotomy and right thoracotomy (Ivor-Lewis standard procedure)
  Intervention: Procedure: Laparoscopically-assisted esophagectomy

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 13, 2015): 207
• Original Estimated Enrollment (submitted: July 10, 2009): 200
• Actual Study Completion Date: October 1, 2015
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00937456
• Other Study ID Numbers: 2008_24/0904; PHRC 2008/1907 ( Other Identifier: DHOS ); 2009-A00144-53. ( Other Identifier: ID-RCB number, ANSM )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Lille
• Original Responsible Party: Professor Christophe MARIETTE, University Hospital of Lille
• Current Study Sponsor: University Hospital, Lille
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Christophe Mariette, MD, PhD; University Hospital of Lille, France

• PRS Account: University Hospital, Lille
• Verification Date: June 2018