Resecable Esophageal or Gastroesophageal Junction CancerMIRO-2NCT07408999
Totally Versus Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer
A study testing Totally Minimally Invasive Esophagectomy (TMIE) and Hybrid Esophagectomy (HE) in people with Resecable Esophageal or Gastroesophageal Junction Cancer, run by University Hospital, Lille at 1 site in France.
Trial summary
Esophageal and gastroesophageal junction cancers remain associated with poor survival despite progress in multimodal treatment. Surgery, especially Ivor-Lewis esophagectomy, combined with peri-operative therapy improves survival but is burdened by major morbidity, mainly respiratory and anastomotic complications… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Resecable Esophageal or Gastroesophageal Junction Cancer
- What is being tested?
- Totally Minimally Invasive Esophagectomy (TMIE) and Hybrid Esophagectomy (HE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2026to 31 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 28Show fewer
- 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
Who cannot join
- 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
Show all 46Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Lille
Lille, 59037
Guillaume PIESSEN, Pr, 0320445506, guillaume.piessen@chu-lille.fr
About this study
Official title: Totally Versus Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer - A Multicentric Phase III Prospective Randomized Controlled Trial
Esophageal and gastroesophageal junction cancers remain associated with poor survival despite progress in multimodal treatment. Surgery, especially Ivor-Lewis esophagectomy, combined with peri-operative therapy improves survival but is burdened by major morbidity, mainly respiratory and anastomotic complications, which compromise recovery and adjuvant treatment.
Minimally invasive approaches such as totally minimally invasive esophagectomy (TMIE) have shown potential to reduce postoperative morbidity compared to the hybrid approach (HE). However, existing studies are heterogeneous, mostly retrospective, and insufficient to establish a standard.
This trial aims to provide high-level evidence comparing TMIE to HE, including robotic techniques, with integrated analyses of clinical outcomes, quality of life, and health economics.
- Being tested
- Totally Minimally Invasive Esophagectomy (TMIE), Hybrid Esophagectomy (HE)
- Keywords
- Cancer, oesophagectomy, minimally invasive, Robot-assisted surgery
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Totally Minimally Invasive Esophagectomy (TMIE)Procedure or surgery
All patients will undergo an Ivor-Lewis procedure with the same laparoscopic abdominal approach. The thoracic approach differs between the two groups: HE with open thoracotomy in the 5th or 6th intercostal space and TMIE with thoracoscopic approach. The main aspects of the surgical technique will be standardized. All patients will receive a transthoracic en-bloc esophagectomy with termino-lateral or latero-lateral anastomosis in the upper chest, including an abdominal lymphadenectomy (left and right paracardial regions along the lesser curve of the left gastric artery, celiac axis, origin of the common hepatic artery and splenic artery) and an extended en bloc mediastinal lymphadenectomy including paratracheal, subcarinal, left and right bronchial, lower posterior mediastinum, para-aortic, para-esophageal lymph with or without resection of the thoracic duct), i.e., an extended two- field lymphadenectomy. The esophagus will be replaced by the stomach in all cases.
Hybrid Esophagectomy (HE)Procedure or surgery
All patients will undergo an Ivor-Lewis procedure with the same laparoscopic abdominal approach. The thoracic approach differs between the two groups: HE with open thoracotomy in the 5th or 6th intercostal space and TMIE with thoracoscopic approach. The main aspects of the surgical technique will be standardized. All patients will receive a transthoracic en-bloc esophagectomy with termino-lateral or latero-lateral anastomosis in the upper chest, including an abdominal lymphadenectomy (left and right paracardial regions along the lesser curve of the left gastric artery, celiac axis, origin of the common hepatic artery and splenic artery) and an extended en bloc mediastinal lymphadenectomy including paratracheal, subcarinal, left and right bronchial, lower posterior mediastinum, para-aortic, para-esophageal lymph with or without resection of the thoracic duct), i.e., an extended two- field lymphadenectomy. The esophagus will be replaced by the stomach in all cases.
| Study group | Role | What they receive |
|---|---|---|
| Totally Minimally Invasive Esophagectomy (TMIE) | Experimental | Not described Receives: Procedure: Totally Minimally Invasive Esophagectomy (TMIE) |
| Hybrid Esophagectomy (HE) | Active comparator | Not described Receives: Procedure: Hybrid Esophagectomy (HE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe postoperative complications after surgery.
Severe postoperative complications after surgery, defined as any postoperative complication of grade 3 or higher according to the Clavien-Dindo (grade III : requiring surgical, endoscopic or radiological intervention (not under general anesthesia) to grade V : death of a patient.
Measured: 90 days
Secondary outcomes (11)
Rate of patients experiencing complication equal to or greater than 2 according to the Clavien-Dindo classification
Clavien-Dindo (grade III : requiring surgical, endoscopic or radiological intervention (not under general anesthesia) to grade V : death of a patient.
Measured: 90 days
Rate of patients experiencing complication equal to or greater than 2 according to the Comprehensive Complication Index scale (0 = no complications, 100 = Death)
Measured: 90 days
Respiratory complication rate
respiratory complication rate is defined as any respiratory event detailed by the ECCG classification (Esophagectomy Complications Consensus Group), including pneumonia, pleural effusion requiring additional drainage procedure, pneumothorax requiring intervention, atelectasis mucous plugging requiring bronchoscopy, respiratory failure requiring reintubation, acute respiratory distress syndrome, acute aspiration, tracheobronchial injury and chest drain requirement for air leak for more than 10 days postoperatively
Measured: 90 days
Anastomotic leak rate
anastomotic leak rate defined as full thickness GI defect involving esophagus, anastomosis, staple line, or conduit irrespective of presentation or method of identification. Anastomotic leaks will be classified into 3 types according to the treatment required, according to the international classification.
Measured: 90 days
Mortality rate
The mortality is defined as any death occurring within 90 days of surgery.
Measured: 90 days
Length of stay in the ICU.
The length of stay in the ICU is defined as the number of postoperative days within 90 days of surgery
Measured: 90 days
Length of hospital stay.
The length of hospital stay is defined by the number of postoperative days the patient spends in the intensive care unit or in a conventional ward.
Measured: 90 days
Level of pain
The level of pain during the first 14 days after surgery is assessed by visual analog scale (score from 0 = no pain, to 10 = wort imaginable pain) on a daily basis, from the day of surgery until 14 days after surgery or until discharge of the patient.
Measured: 14 days
Presence of neuropathic pain
neuropathic pain will be assessed using the Neuropathic Pain Symptom Inventory (NPSI) (from 0 = not present to 10 = worst imaginable).
Measured: 6 months
Change from baseline in quality of life level
The change from baseline (before surgery, V1) in quality of life level on validated EORTC QLQC-30 (European Organisation for Research and Treatment of Cancer Quality of Life Core 30) questionnaire at 1 month, 6 months, 1 year, 3 years and 5 years postoperatively.
Measured: 1 months, 6 months, 1 year, 3 years, 5 years
Change from baseline in quality of life level
The change from baseline (before surgery, V1) in quality of life level on validated EQ-5D-5L (EuroQol 5-Dimension 5-Level) questionnaire at 1 month, 6 months, 1 year, 3 years and 5 years postoperatively.
Measured: 1 months, 6 months, 1 year, 3 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start31 Mar 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resecable Esophageal or Gastroesophageal Junction CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- National, multicentric, phase III, open-label, randomized controlled trial with two parallel arms.
- Masking
- None (open label)
- Enrolment
- 327 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408999
- Sponsor's protocol ID
- 2023_0831
- Acronym
- MIRO-2
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Totally Versus Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer - A Multicentric Phase III Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07408999
- Acronym / sponsor ID
- MIRO-2 / 2023_0831
- Keywords
- Cancer, oesophagectomy, minimally invasive, Robot-assisted surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 327 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Esophageal and gastroesophageal junction cancers remain associated with poor survival despite progress in multimodal treatment. Surgery, especially Ivor-Lewis esophagectomy, combined with peri-operative therapy improves survival but is burdened by major morbidity, mainly respiratory and anastomotic complications, which compromise recovery and adjuvant treatment.
Minimally invasive approaches such as totally minimally invasive esophagectomy (TMIE) have shown potential to reduce postoperative morbidity compared to the hybrid approach (HE). However, existing studies are heterogeneous, mostly retrospective, and insufficient to establish a standard.
This trial aims to provide high-level evidence comparing TMIE to HE, including robotic techniques, with integrated analyses of clinical outcomes, quality of life, and health economics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- National, multicentric, phase III, open-label, randomized controlled trial with two parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Totally Minimally Invasive Esophagectomy (TMIE) | Experimental | Procedure: Totally Minimally Invasive Esophagectomy (TMIE) |
| Hybrid Esophagectomy (HE) | Active comparator | Procedure: Hybrid Esophagectomy (HE) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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
Key exclusion criteria (46 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Totally Minimally Invasive Esophagectomy (TMIE)All patients will undergo an Ivor-Lewis procedure with the same laparoscopic abdominal approach. The thoracic approach differs between the two groups: HE with open thoracotomy in the 5th or 6th intercostal space and TMIE with thoracoscopic approach. The main aspects of the surgical technique will be standardized. All patients will receive a transthoracic en-bloc esophagectomy with termino-lateral or latero-lateral anastomosis in the upper chest, including an abdominal lymphadenectomy (left and right paracardial regions along the lesser curve of the left gastric artery, celiac axis, origin of the common hepatic artery and splenic artery) and an extended en bloc mediastinal lymphadenectomy including paratracheal, subcarinal, left and right bronchial, lower posterior mediastinum, para-aortic, para-esophageal lymph with or without resection of the thoracic duct), i.e., an extended two- field lymphadenectomy. The esophagus will be replaced by the stomach in all cases. | Procedure or surgery | Totally Minimally Invasive Esophagectomy (TMIE) |
| Hybrid Esophagectomy (HE)All patients will undergo an Ivor-Lewis procedure with the same laparoscopic abdominal approach. The thoracic approach differs between the two groups: HE with open thoracotomy in the 5th or 6th intercostal space and TMIE with thoracoscopic approach. The main aspects of the surgical technique will be standardized. All patients will receive a transthoracic en-bloc esophagectomy with termino-lateral or latero-lateral anastomosis in the upper chest, including an abdominal lymphadenectomy (left and right paracardial regions along the lesser curve of the left gastric artery, celiac axis, origin of the common hepatic artery and splenic artery) and an extended en bloc mediastinal lymphadenectomy including paratracheal, subcarinal, left and right bronchial, lower posterior mediastinum, para-aortic, para-esophageal lymph with or without resection of the thoracic duct), i.e., an extended two- field lymphadenectomy. The esophagus will be replaced by the stomach in all cases. | Procedure or surgery | Hybrid Esophagectomy (HE) |
Primary outcome
Severe postoperative complications after surgery.
Time frame: 90 days
Severe postoperative complications after surgery, defined as any postoperative complication of grade 3 or higher according to the Clavien-Dindo (grade III : requiring surgical, endoscopic or radiological intervention (not under general anesthesia) to grade V : death of a patient.
11 secondary outcomes
Rate of patients experiencing complication equal to or greater than 2 according to the Clavien-Dindo classification
Time frame: 90 days
Rate of patients experiencing complication equal to or greater than 2 according to the Comprehensive Complication Index scale (0 = no complications, 100 = Death)
Time frame: 90 days
Respiratory complication rate
Time frame: 90 days
Anastomotic leak rate
Time frame: 90 days
Mortality rate
Time frame: 90 days
Length of stay in the ICU.
Time frame: 90 days
Length of hospital stay.
Time frame: 90 days
Level of pain
Time frame: 14 days
Presence of neuropathic pain
Time frame: 6 months
Change from baseline in quality of life level
Time frame: 1 months, 6 months, 1 year, 3 years, 5 years
Change from baseline in quality of life level
Time frame: 1 months, 6 months, 1 year, 3 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Totally Minimally Invasive Esophagectomy (TMIE) and Hybrid Esophagectomy (HE) in people with Resecable Esophageal or Gastroesophageal Junction Cancer, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thibault VORON, Dr (0171970187, thibault.voron@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe postoperative complications after surgery. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.