New study tests if All-Keyhole surgery beats hybrid approach for esophageal cancer
NCT ID NCT07408999
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial will compare two surgical techniques for esophageal cancer: totally minimally invasive esophagectomy (TMIE) using only keyhole incisions, versus a hybrid approach that combines keyhole and open chest surgery. The study aims to see if TMIE reduces severe complications after surgery. About 327 adults with resectable esophageal or gastroesophageal junction cancer will take part across multiple centers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Totally Minimally Invasive Esophagectomy (TMIE) - a surgical procedure using thoracoscopy instead of open chest surgery
- What this could lead to
- If TMIE proves better, it could become the new standard surgical approach for esophageal cancer, leading to fewer severe complications and faster recovery.
- What could go wrong
- This is a surgical technique comparison, not a new drug or cure. The trial is not yet recruiting, and results may show no significant difference between the two approaches.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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About 327 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- 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 80 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Inclusion criteria for screening - part A (for patients receiving a neo-adjuvant treatment) * Age ≥ 18 years and ≤ 80 years For patients between 70 and 80 years old : score G8 ≥ 14 or oncogeratrician approval * Squamous cell carcinoma or adenocarcinoma of the esophagus or esogastric junction * Clinical stage T1, T2, T3, T4a, N0-N3, M0 before any treatment * Tumors of the middle or lower third of the esophagus, or tumor of the esogastric junction Siewert 1 or 2 * With or without neoadjuvant (radio) chemotherapy ± targeted therapy * Disease deemed curatively resectable preoperatively * Requiring a 2-stage Ivor-Lewis esophagectomy * Performance status 0, 1 or 2 * Patient capable of receiving either surgical treatment * Patient informed of the terms of the study and having given written consent * Patient able to read and understand the language and content of the study documents and agreeing to adhere to the protocol requirements. * Covered by a medical/health insurance * Willingness and ability to comply with scheduled visits and study procedures Inclusion criteria before surgery (after neo-adjuvant treatment or for patients receiving primary surgery) * Age ≥ 18 years and ≤ 80 years For patients between 70 and 80 years old : score G8 ≥ 14 or oncogeratrician approval * Squamous cell carcinoma or adenocarcinoma of the esophagus or esogastric junction * Clinical stage T1, T2, T3, N0-N3, M0 before surgery * Tumors of the middle or lower third of the esophagus, or tumor of the esogastric junction Siewert 1 or 2 * With or without neoadjuvant (radio) chemotherapy ± targeted therapy * Disease deemed curatively resectable preoperatively * Requiring a 2-stage Ivor-Lewis esophagectomy * Performance status 0, 1 or 2 * Patient capable of receiving either surgical treatment * Patient informed of the terms of the study and having given written consent * Patient able to read and understand the language and content of the study documents and agreeing to adhere to the protocol requirements. * Covered by a medical/health insurance * Willingness and ability to comply with scheduled visits and study procedures Exclusion Criteria: Non inclusion criteria for screening - part A (for patients receiving a neo-adjuvant treatment) Patient-related non-inclusion criteria * Performance status 3 or 4 * Documented liver cirrhosis or portal hypertension * Recent myocardial infarction (less than 6 months old) or progressive coronary artery disease * Distal arteritis from stage IIb (200 m) of Leriche and Fontaine * Synchronous cancer, other than subcarinal esophageal * Neoplasic history except for cancers without recurrence after at least 5 years of surveillance * History of xyphopubic laparotomy * Patients with prior thoracic surgery or thoracic traum of the right hemithorax * Patient refusal * Patient under guardianship or curatorship * Pregnant or breastfeeding woman or patient expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 6 months after the last dose of adjuvant chemotherapy * ASA score\> 3 Disease-related non-inclusion criteria * Histology other than squamous cell carcinoma or adenocarcinoma * Tumors of the upper third of the thoracic esophagus, cervical esophagus or pharyngo-esophageal junction or tumor of the esogastric junction Siewert 3 * Supraclavicular nodes invaded clinically or on puncture * Recurrent nerve paralysis * Evidence of extension to the tracheobronchial tree * Signs of mediastinal invasion (vertebral adhesion, aortic overlap \> 90°, invasion of unresectable neighboring organs such as the aorta, trachea…) * Distant metastatic extension Non inclusion criteria before surgery (after neo-adjuvant treatment or for patients receiving primary surgery) * Performance status 3 or 4 * Forced expiratory volume in 1 second \< 1000 ml * Documented liver cirrhosis or portal hypertension * Recent myocardial infarction (less than 6 months old) or progressive coronary artery disease * Distal arteritis from stage IIb (200 m) of Leriche and Fontaine * Weight loss of more than 15% of body weight, not recovered after appropriate nutritional management * Synchronous cancer, other than subcarinal esophageal * Neoplasic history except for cancers without recurrence after at least 5 years of surveillance * History of xyphopubic laparotomy * Patients with prior thoracic surgery or thoracic traum of the right hemithorax * Patient refusal * Patient under guardianship or curatorship * Pregnant or breastfeeding woman or patient expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 6 months after the last dose of adjuvant chemotherapy * ASA score\> 3 * IESG ≤ -5 (Very high risk patients) Disease-related non-inclusion criteria * Histology other than squamous cell carcinoma or adenocarcinoma * Tumors of the upper third of the thoracic esophagus, cervical esophagus or pharyngo-esophageal junction or tumor of the esogastric junction Siewert 3 * Supraclavicular nodes invaded clinically or on puncture * Recurrent nerve paralysis * Evidence of extension to the tracheobronchial tree * Signs of mediastinal invasion (vertebral adhesion, aortic overlap \> 90°, invasion of unresectable neighboring organs such as the aorta, trachea…) * Distant metastatic extension
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Lille
Lille, 59037, France
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