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OpenTrials
Completed

NCT Number: NCT00937456

Open Versus Laparoscopically-assisted Esophagectomy for Cancer

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Du Haut Leveque, Bordeaux, France

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About this study

Open Versus Laparoscopically-assisted Esophagectomy for Cancer

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopically-assisted esophagectomy

Procedure

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 names: esophagectomy with extended two-field lymphadenectomy

Primary outcomes

  1. 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 outcomes

  1. overall morbidity

    Time frame: 30 days

  2. disease free survival

    Time frame: 2 years

  3. overall survival

    Time frame: 2 years

  4. quality of life

    Time frame: 2 years

  5. economical interest of the surgical technique apprehended through a hospital point of view

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2015
First posted
Jul 13, 2009
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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