Robotic Versus Thoracolaparoscopic Esophagectomy for Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03727126
• Other study ID #: GEMBOT
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: October 2020
• Source: GEM Hospital & Research Center
• Contact: Shankar Balasubramanian
• Phone: +919910766534
• Email: shanxar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• Robotic esophagectomy
Removal of the esophagus and its draining lymph nodes using robotic surgical instruments
• Thoracolaparoscopic esophagectomy
Removal of the esophagus and its draining lymph nodes using conventional thoracoscopic and laparoscopic techniques

Locations

Country	Name	City	State
India	GEM Hospital & Research Center	Chennai	Tamil Nadu
India	GEM Hospital & Research Center	Coimbatore	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
GEM Hospital & Research Center

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymph node yield	Total number of lymph nodes harvested	7 days after Index Surgery
Secondary	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
Secondary	Complications	Intraoperative and post operative adverse events assessed by Clavien Dindo classification system	Up to 90 days after surgery
Secondary	ICU stay	Duration of stay in ICU following surgery	During index admission or within 30 days after surgery
Secondary	Hospital stay	Length of stay in hospital following surgery	During index admission or re admission within 30 days
Secondary	Mortality	Death following surgery	During index admission or within 90 days following surgery
Secondary	Duration of surgery	Time taken to complete the surgical procedure recorded in minutes	1 day after surgery
Secondary	Blood loss	Amount of blood lost during and within 24 hours of surgery	During surgery and up to 24 hours after index surgery
Secondary	Conversion rate	Need for conversion of the procedure to open or other alternate technique	1 day after surgery