A Comparison Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy

Study Overview
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Brief Summary
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Surgery is still the main treatment for esophageal cancer, however, the complication and mortality rate of open esophagectomy is high. As a result, the thoracoscopic- laparoscopic minimally invasive esophagectomy (MIE) was developed. The MIE mainly comprised two surgical approaches: MIE McKeown approach (cervical anastomosis) and MIE Ivor-Lewis approach (intrathoracicanastomosis). The MIE with intrathoracic anastomosis (Ivor-Lewis) is increasingly used for the treatment of mid and lower esophageal cancers. Our study is trying to compare the safety, feasibility, and short-term and long- term outcomes between MIE Ivor-Lewis approach and MIE McKeown approach for the treatment of lower thoracic esophageal cancer and esophageal- gastric junction.

Official Title
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A Comparison of Short-term and Long- Term Outcomes Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Procedure: MIE Ivor- Lewis
* Procedure: MIE McKeown


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (I) Patients with clinically staged T1-3N0-2M0 tumors; good cardiopulmonary function; (II) Patients with lower thoracic esophageal tumors and esophageal- gastric junction tumor; (III) Patients without a previous history of cancer; (IV) Patients without a previous history of neck or chest surgery; Exclusion Criteria: (I) cardiopulmonary function not good enough for surgery; (II) Patients with hybrid MIE

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivor-Lewis group<br>minimally invasive esophagectomy (MIE) with intrathoracic anastomosis | Procedure: MIE Ivor- Lewis<br>* minimally invasive esophagectomy (MIE) with intrathoracic anastomosis<br>|
| Active Comparator: McKeown group<br>minimally invasive esophagectomy (MIE) with cervical anastomosis | Procedure: MIE McKeown<br>* minimally invasive esophagectomy (MIE) with cervical anastomosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time | Operating time in minutes | 1 day | 
| Blood loss | Blood loss in milliliter | 1 day | 
| Lymph nodes harvested | Lymph nodes harvested in number | 1 day | 
| Pulmonary complication | Pulmonary complication in rate | 1 month | 
| Anastomotic leakage | Anastomotic leakage in rate | within one month | 
| Anastomotic stenosis | Anastomotic stenosis in rate | within three months | 
| recurrent laryngeal nerve injury | recurrent laryngeal nerve injury in rate | within three months | 
| Chylothorax | Chylothorax in rate | within one month | 
| Cardiac arrhythmia | Cardiac arrhythmia in rate | within one month | 
| Hospital stay | Hospital stay in days | within 60 days | 
| mortality | mortality in rate | within 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | progression-free survival in rate | within 5 years | 
| overall survival | overall survival in rate | within 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracoscopic, laparoscopic, esophagectomy