CHU de Lille
Lille, 59037, France
NCT Number: NCT07408999
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Lille, 59037, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for screening - part A (for patients receiving a neo-adjuvant treatment)
Inclusion criteria
before surgery (after neo-adjuvant treatment or for patients receiving primary surgery)
Exclusion criteria
Non inclusion criteria for screening - part A (for patients receiving a neo-adjuvant treatment)
Patient-related non-inclusion criteria
Disease-related non-inclusion criteria
Non inclusion criteria before surgery (after neo-adjuvant treatment or for patients receiving primary surgery)
Disease-related non-inclusion criteria
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.
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.
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.
Time frame: 90 days
Clavien-Dindo (grade III : requiring surgical, endoscopic or radiological intervention (not under general anesthesia) to grade V : death of a patient.
Time frame: 90 days
Time frame: 90 days
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
Time frame: 90 days
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.
Time frame: 90 days
The mortality is defined as any death occurring within 90 days of surgery.
Time frame: 90 days
The length of stay in the ICU is defined as the number of postoperative days within 90 days of surgery
Time frame: 90 days
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.
Time frame: 14 days
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.
Time frame: 6 months
neuropathic pain will be assessed using the Neuropathic Pain Symptom Inventory (NPSI) (from 0 = not present to 10 = worst imaginable).
Time frame: 1 months, 6 months, 1 year, 3 years, 5 years
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.
Time frame: 1 months, 6 months, 1 year, 3 years, 5 years
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.
Contact information is provided by the study sponsor or research team.
Guillaume PIESSEN, Pr
CONTACT
Thibault VORON, Dr
CONTACT
University Hospital, Lille
Other
Totally Versus Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer - A Multicentric Phase III Prospective Randomized Controlled Trial
Acronym: MIRO-2
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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