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Robotic Versus Thoracolaparoscopic Esophagectomy for Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT03727126
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Procedure: Robotic esophagectomy Procedure: Thoracolaparoscopic esophagectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic Versus Thoracolaparoscopic Esophagectomy for Carcinoma Esophagus: a Prospective Comparative Study
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Lymph node yield [ Time Frame: 7 days after Index Surgery ]
    Total number of lymph nodes harvested


Secondary Outcome Measures :
  1. Surgical margin status [ Time Frame: 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.

  2. Complications [ Time Frame: Up to 90 days after surgery ]
    Intraoperative and post operative adverse events assessed by Clavien Dindo classification system

  3. ICU stay [ Time Frame: During index admission or within 30 days after surgery ]
    Duration of stay in ICU following surgery

  4. Hospital stay [ Time Frame: During index admission or re admission within 30 days ]
    Length of stay in hospital following surgery

  5. Mortality [ Time Frame: During index admission or within 90 days following surgery ]
    Death following surgery

  6. Duration of surgery [ Time Frame: 1 day after surgery ]
    Time taken to complete the surgical procedure recorded in minutes

  7. Blood loss [ Time Frame: During surgery and up to 24 hours after index surgery ]
    Amount of blood lost during and within 24 hours of surgery

  8. Conversion rate [ Time Frame: 1 day after surgery ]
    Need for conversion of the procedure to open or other alternate technique



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727126


Contacts
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Contact: Shankar Balasubramanian +919910766534 shanxar@gmail.com

Locations
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India
GEM Hospital & Research Center Recruiting
Chennai, Tamil Nadu, India
Contact: Bhushan Chittawadagi, MS, DNB         
GEM Hospital & Research Center Recruiting
Coimbatore, Tamil Nadu, India, 641045
Contact: Shankar Balasubramanian         
Sponsors and Collaborators
GEM Hospital & Research Center
Investigators
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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

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Responsible Party: GEM Hospital & Research Center
ClinicalTrials.gov Identifier: NCT03727126     History of Changes
Other Study ID Numbers: GEMBOT
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GEM Hospital & Research Center:
Esophagectomy
Robotic esophagectomy
Laparoscopic esophagectomy
Minimally invasive esophagectomy
Ivor Lewis esophagectomy
McKeown's esophagectomy
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases