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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03727126
Other study ID # GEMBOT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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