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Open Versus Laparoscopically-assisted Esophagectomy for Cancer

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Laparoscopically-assisted esophagectomy
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophagus, Cancer, Surgery, Laparoscopy, Randomized trial, Esophageal cancer deemed to be resectable

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Du Haut Leveque
  • Hopital Ambroise Pare Ap-Hp
  • Hotel Dieu
  • Hopital Louis Mourier
  • Hopital de La Croix Rousse
  • Hopital St Marguerite Ap-Hm
  • Hopital St Louis Ap-Hp
  • Institut Mutualiste Montsouris
  • Hopitalpontchaillou
  • Hopitaux Universitaires de Strasbourg
  • Hopital Purpan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopically-assisted esophagectomy

Open esophagectomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

overall morbidity
disease free survival
overall survival
quality of life
economical interest of the surgical technique apprehended through a hospital point of view

Full Information

First Posted
July 10, 2009
Last Updated
June 21, 2018
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT00937456
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 7, 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophagus, Cancer, Surgery, Laparoscopy, Randomized trial, Esophageal cancer deemed to be resectable

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopically-assisted esophagectomy
Arm Type
Experimental
Arm Description
Laparoscopically-assisted esophagectomy: standard abdominal procedure of gastric mobilisation but through laparoscopic route. Right thoracotomy as usual.
Arm Title
Open esophagectomy
Arm Type
Active Comparator
Arm Description
Conventional open esophagectomy: Esophagectomy with extended 2-field lymphadenectomy through laparotomy and right thoracotomy (Ivor-Lewis standard procedure)
Intervention Type
Procedure
Intervention Name(s)
Laparoscopically-assisted esophagectomy
Other Intervention Name(s)
esophagectomy with extended two-field lymphadenectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
To decrease postoperative major 30-days morbidity from 45% in the open arm to 25% in the laparoscopically-assisted arm.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
overall morbidity
Time Frame
30 days
Title
disease free survival
Time Frame
2 years
Title
overall survival
Time Frame
2 years
Title
quality of life
Time Frame
2 years
Title
economical interest of the surgical technique apprehended through a hospital point of view
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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 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 Laparoscopy-related factors Patient presenting a general contraindication to laparoscopy A history of median or subcostal laparotomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Mariette, MD, PhD
Organizational Affiliation
University Hospital of Lille, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Du Haut Leveque
City
Bordeaux
ZIP/Postal Code
33604
Country
France
Facility Name
Hopital Ambroise Pare Ap-Hp
City
Boulogne Billancourt
ZIP/Postal Code
92 100
Country
France
Facility Name
Hotel Dieu
City
Clermont Ferrand
ZIP/Postal Code
63 058
Country
France
Facility Name
Hopital Louis Mourier
City
Colombes
ZIP/Postal Code
92 701
Country
France
Facility Name
Hopital de La Croix Rousse
City
Lyon
ZIP/Postal Code
69 317
Country
France
Facility Name
Hopital St Marguerite Ap-Hm
City
Marseille
ZIP/Postal Code
13 274
Country
France
Facility Name
Hopital St Louis Ap-Hp
City
Paris
ZIP/Postal Code
75 010
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopitalpontchaillou
City
Rennes
ZIP/Postal Code
35 033
Country
France
Facility Name
Hopitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67 098
Country
France
Facility Name
Hopital Purpan
City
Toulouse
ZIP/Postal Code
31 059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33595631
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.
Results Reference
derived
PubMed Identifier
30625052
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.
Results Reference
derived
PubMed Identifier
21781337
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.
Results Reference
derived

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Open Versus Laparoscopically-assisted Esophagectomy for Cancer

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