Robotic Versus Thoracolaparoscopic Esophagectomy for Esophageal Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer
• Intervention / Treatment: Procedure: Robotic esophagectomy; Procedure: Thoracolaparoscopic esophagectomy

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shankar Balasubramanian; Phone Number: +919910766534; Email: shanxar@gmail.com

Study Locations

• India
  • Tamil Nadu
    • Chennai, Tamil Nadu, India
      • Recruiting
      • GEM Hospital & Research Center
      • Contact: Bhushan Chittawadagi, MS, DNB
    • Coimbatore, Tamil Nadu, India, 641045
      • Recruiting
      • GEM Hospital & Research Center
      • Contact: Shankar Balasubramanian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GEM Hospital & Research Center
• Investigators: Principal Investigator: Chinnusamy Palanivelu, MS, MCh, GEM Hospital & Research Center; Study Director: Shankar Balasubramanian, MS, MRCS, GEM Hospital & Research Center; Study Director: Sandeep Sabnis, MS, DNB, GEM Hospital & Research Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: October 27, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Esophagectomy; Robotic esophagectomy; Laparoscopic esophagectomy; Minimally invasive esophagectomy; Ivor Lewis esophagectomy; McKeown's esophagectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: GEMBOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No