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Robotic Versus Thoracolaparoscopic Esophagectomy for Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Robotic esophagectomy
Thoracolaparoscopic esophagectomy
Sponsored by
GEM Hospital & Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophagectomy, Robotic esophagectomy, Laparoscopic esophagectomy, Minimally invasive esophagectomy, Ivor Lewis esophagectomy, McKeown's esophagectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GEM Hospital & Research CenterRecruiting
  • GEM Hospital & Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic esophagectomy

Thoracolaparoscopic esophagectomy

Arm Description

Esophagectomy performed for esophageal cancer using the da Vinci robotic surgical system

Esophagectomy performed for esophageal cancer using conventional thoracoscopic and laparoscopic techniques

Outcomes

Primary Outcome Measures

Lymph node yield
Total number of lymph nodes harvested

Secondary Outcome Measures

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.
Complications
Intraoperative and post operative adverse events assessed by Clavien Dindo classification system
ICU stay
Duration of stay in ICU following surgery
Hospital stay
Length of stay in hospital following surgery
Mortality
Death following surgery
Duration of surgery
Time taken to complete the surgical procedure recorded in minutes
Blood loss
Amount of blood lost during and within 24 hours of surgery
Conversion rate
Need for conversion of the procedure to open or other alternate technique

Full Information

First Posted
October 27, 2018
Last Updated
October 12, 2020
Sponsor
GEM Hospital & Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03727126
Brief Title
Robotic Versus Thoracolaparoscopic Esophagectomy for Esophageal Cancer
Official Title
Robotic Versus Thoracolaparoscopic Esophagectomy for Carcinoma Esophagus: a Prospective Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GEM Hospital & Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophagectomy, Robotic esophagectomy, Laparoscopic esophagectomy, Minimally invasive esophagectomy, Ivor Lewis esophagectomy, McKeown's esophagectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic esophagectomy
Arm Type
Experimental
Arm Description
Esophagectomy performed for esophageal cancer using the da Vinci robotic surgical system
Arm Title
Thoracolaparoscopic esophagectomy
Arm Type
Active Comparator
Arm Description
Esophagectomy performed for esophageal cancer using conventional thoracoscopic and laparoscopic techniques
Intervention Type
Procedure
Intervention Name(s)
Robotic esophagectomy
Intervention Description
Removal of the esophagus and its draining lymph nodes using robotic surgical instruments
Intervention Type
Procedure
Intervention Name(s)
Thoracolaparoscopic esophagectomy
Intervention Description
Removal of the esophagus and its draining lymph nodes using conventional thoracoscopic and laparoscopic techniques
Primary Outcome Measure Information:
Title
Lymph node yield
Description
Total number of lymph nodes harvested
Time Frame
7 days after Index Surgery
Secondary Outcome Measure Information:
Title
Surgical margin status
Description
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.
Time Frame
7 days after Index Surgery
Title
Complications
Description
Intraoperative and post operative adverse events assessed by Clavien Dindo classification system
Time Frame
Up to 90 days after surgery
Title
ICU stay
Description
Duration of stay in ICU following surgery
Time Frame
During index admission or within 30 days after surgery
Title
Hospital stay
Description
Length of stay in hospital following surgery
Time Frame
During index admission or re admission within 30 days
Title
Mortality
Description
Death following surgery
Time Frame
During index admission or within 90 days following surgery
Title
Duration of surgery
Description
Time taken to complete the surgical procedure recorded in minutes
Time Frame
1 day after surgery
Title
Blood loss
Description
Amount of blood lost during and within 24 hours of surgery
Time Frame
During surgery and up to 24 hours after index surgery
Title
Conversion rate
Description
Need for conversion of the procedure to open or other alternate technique
Time Frame
1 day after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shankar Balasubramanian
Phone
+919910766534
Email
shanxar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chinnusamy Palanivelu, MS, MCh
Organizational Affiliation
GEM Hospital & Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shankar Balasubramanian, MS, MRCS
Organizational Affiliation
GEM Hospital & Research Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sandeep Sabnis, MS, DNB
Organizational Affiliation
GEM Hospital & Research Center
Official's Role
Study Director
Facility Information:
Facility Name
GEM Hospital & Research Center
City
Chennai
State/Province
Tamil Nadu
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhushan Chittawadagi, MS, DNB
Facility Name
GEM Hospital & Research Center
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641045
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shankar Balasubramanian

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Robotic Versus Thoracolaparoscopic Esophagectomy for Esophageal Cancer

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