Robotic Versus Thoracolaparoscopic Esophagectomy for Esophageal Cancer

Not Applicable

• Conditions: Esophageal Cancer
• Interventions: Procedure: Robotic esophagectomy; Procedure: Thoracolaparoscopic esophagectomy

• Registration Number: NCT03727126
• Lead Sponsor: GEM Hospital & Research Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-27
• Study First Submitted QC: 2018-10-30
• Study Start: 2018-11-01
• Study First Posted: 2018-11-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic esophagectomy	Robotic esophagectomy	Esophagectomy performed for esophageal cancer using the da Vinci robotic surgical system
Thoracolaparoscopic esophagectomy	Thoracolaparoscopic esophagectomy	Esophagectomy performed for esophageal cancer using conventional thoracoscopic and laparoscopic techniques

Primary Outcome Measures

Name	Time	Method
Lymph node yield	7 days after Index Surgery	Total number of lymph nodes harvested

Secondary Outcome Measures

Name	Time	Method
Surgical margin status	7 days after Index Surgery	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.
Hospital stay	During index admission or re admission within 30 days	Length of stay in hospital following surgery
Mortality	During index admission or within 90 days following surgery	Death following surgery
ICU stay	During index admission or within 30 days after surgery	Duration of stay in ICU following surgery
Complications	Up to 90 days after surgery	Intraoperative and post operative adverse events assessed by Clavien Dindo classification system
Duration of surgery	1 day after surgery	Time taken to complete the surgical procedure recorded in minutes
Blood loss	During surgery and up to 24 hours after index surgery	Amount of blood lost during and within 24 hours of surgery
Conversion rate	1 day after surgery	Need for conversion of the procedure to open or other alternate technique

Trial Locations

Locations (1)

GEM Hospital & Research Center; 🇮🇳 Coimbatore, Tamil Nadu, India