Less invasive surgery may cut complications in esophageal cancer patients
NCT ID NCT00937456
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compared two surgical methods for removing esophageal cancer: open surgery versus a less invasive approach using a laparoscope. The goal was to see if the laparoscopic method reduces serious complications within 30 days after surgery. The trial involved 207 patients with esophageal cancer who were candidates for curative surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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207 people
The number who actually took part.
- Start date
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Oct 2009
- Finished
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Oct 2015
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hopital Ambroise Pare Ap-Hp
Boulogne-Billancourt, 92 100, France
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Hopital Du Haut Leveque
Bordeaux, 33604, France
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Hopital Louis Mourier
Colombes, 92 701, France
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Hopital Purpan
Toulouse, 31 059, France
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Hopital St Louis Ap-Hp
Paris, 75 010, France
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Hopital St Marguerite Ap-Hm
Marseille, 13 274, France
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Hopital de La Croix Rousse
Lyon, 69 317, France
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Hopitalpontchaillou
Rennes, 35 033, France
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Hopitaux Universitaires de Strasbourg
Strasbourg, 67 098, France
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Hotel Dieu
Clermont-Ferrand, 63 058, France
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Institut Mutualiste Montsouris
Paris, 75014, France
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Other studies related to the condition(s) this trial covers.
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