The Comparison of Single and Multi-incision MIE for Esophageal Cancer

Study Overview
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Brief Summary
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Minimally invasive esophagectomy (MIE) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. Previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in MIE (SIMIE).The preliminary clinical results showed that SIMIE can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to MIE performed with multi-incision (MIMIE). The goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of SIMIE and MIMIE.

Detailed Description
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Surgery remains the main stay of treating esophageal cancer. However, esophagectomy is a complex and technical demanding surgical procedure harboring substantial morbidity and mortality. Minimally invasive esophagectomy (MIE) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. The standardized procedure including lymph node dissection, esophageal mobilization and reconstruction can be effectively performed under minimized wound incision whereas rendering the patients a possibility of faster postoperative recovery and reduced risk of perioperative postoperative pulmonary complication. The procedure of MIE including the thoracoscopic and laparoscopic phases which are usually performed multiple incisional wounds. Previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in MIE (SIMIE). The preliminary clinical results showed that SIMIE can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to MIE performed with multi-incision (MIMIE). The goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of SIMIE and MIMIE.

Official Title
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The Comparison of Single and Multi-incision Minimally Invasive Esophagectomy for Treating Esophageal Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Procedure: Minimally invasive esophagectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of esophageal cancer Age between 35 to 75 years old Resectable tumor as evaluation by preoperative imaging studies. Exclusion Criteria: Previous surgery in the chest or abdomen. Receiving definitive chemoradiation (5500 cGy or more). Tumor invasion to the trachea, spine or aorta. Liver cirrhosis with esophageal varices or liver cirrhosis refractory to medical treatment, Child C classification. Previous history of cerebral vascular attack.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-incision MIE<br>Esophageal cancer patients received single-incision Minimally invasive esophagectomy | Procedure: Minimally invasive esophagectomy<br>* Minimally invasive esophagectomy is a surgical procedure for esophageal resection<br>|
| Active Comparator: multi-incision MIE<br>Esophageal cancer patients received multi-incision Minimally invasive esophagectomy | Procedure: Minimally invasive esophagectomy<br>* Minimally invasive esophagectomy is a surgical procedure for esophageal resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate | Overall survival rate of the participants after surgery | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score as assessed by the face rating scale | The scale range of face rating scale is ranging from 0 (happy face) to 10 (crying face). Higher values represent a worse outcome. | 1,7,14,28 days | 
| Ratio of ambulation | 30-minute walk test | post-operative day 2 (POD2) | 
| Postoperative force vital capacity | Force vital capacity (FVC) is one of the most common parameters for pulmonary function measured in spirometry | 1 and 3 months | 
| Post operative forced expiratory volume in one second | Forced expiratory volume in one second (FEV1) is one of the most common parameters for pulmonary function measured in spirometry | 1 and 3 months | 
| Postoperative pulmonary complication | pulmonary complication after esophagectomy | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal cancer, Minimally invasive esophagectomy (MIE), single-incision Minimally invasive esophagectomy (SIMIE)