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New study tests if All-Keyhole surgery beats hybrid approach for esophageal cancer

NCT ID NCT07408999

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 327 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CHU de Lille

    Lille, 59037, France

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Other studies related to the condition(s) this trial covers.