Robotic Versus Thoracolaparoscopic Esophagectomy for Esophageal Cancer

Study Overview
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Brief Summary
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Esophageal cancer is a debilitating condition. The treatment involved is complex requiring a combination of chemotherapy and surgery in most cases. Complete removal of the tumor and the adjacent lymph nodes is of utmost importance in improving the survival. Lymph node yield following surgery helps in proper staging of the disease and is an important prognosticating variable. It is hypothesized that the lymph node yield following robotic esophagectomy is higher than that following thoracolaparoscopic esophagectomy. The study aims to compare the short term oncological outcomes following robotic esophagectomy and thoracolaparoscopic esophagectomy for carcinoma esophagus.

Official Title
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Robotic Versus Thoracolaparoscopic Esophagectomy for Carcinoma Esophagus: a Prospective Comparative Study

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Procedure: Robotic esophagectomy
* Procedure: Thoracolaparoscopic esophagectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Resectable esophageal carcinoma, either squamous cell carcinoma or adenocarcinoma in the middle or lower part the esophagus Exclusion Criteria: American Society of Anesthesiologists (ASA) class 4 and above Esophagectomy for other non-malignant conditions
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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic esophagectomy<br>Esophagectomy performed for esophageal cancer using the da Vinci robotic surgical system | Procedure: Robotic esophagectomy<br>* Removal of the esophagus and its draining lymph nodes using robotic surgical instruments<br>|
| Active Comparator: Thoracolaparoscopic esophagectomy<br>Esophagectomy performed for esophageal cancer using conventional thoracoscopic and laparoscopic techniques | Procedure: Thoracolaparoscopic esophagectomy<br>* Removal of the esophagus and its draining lymph nodes using conventional thoracoscopic and laparoscopic techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph node yield | Total number of lymph nodes harvested | 7 days after Index Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical margin status | The proximal, distal and circumferential surgical margins will be assessed by pathological evaluation for the presence of tumor and will be assigned an R category as defined by the College of American Pathologists. R0 would indicate no evidence of residual tumor. Presence of microscopic tumor at margins would be designated as R1 whereas the presence of macroscopically visible tumor at margins would be designated as R2. | 7 days after Index Surgery | 
| Complications | Intraoperative and post operative adverse events assessed by Clavien Dindo classification system | Up to 90 days after surgery | 
| ICU stay | Duration of stay in ICU following surgery | During index admission or within 30 days after surgery | 
| Hospital stay | Length of stay in hospital following surgery | During index admission or re admission within 30 days | 
| Mortality | Death following surgery | During index admission or within 90 days following surgery | 
| Duration of surgery | Time taken to complete the surgical procedure recorded in minutes | 1 day after surgery | 
| Blood loss | Amount of blood lost during and within 24 hours of surgery | During surgery and up to 24 hours after index surgery | 
| Conversion rate | Need for conversion of the procedure to open or other alternate technique | 1 day after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagectomy, Robotic esophagectomy, Laparoscopic esophagectomy, Minimally invasive esophagectomy, Ivor Lewis esophagectomy, McKeown's esophagectomy