NCT03727126

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

October 27, 2018

Last Update Submit

October 12, 2020

Conditions

Esophageal Cancer

Keywords

EsophagectomyRobotic esophagectomyLaparoscopic esophagectomyMinimally invasive esophagectomyIvor Lewis esophagectomyMcKeown's esophagectomy

Outcome Measures

Primary Outcomes (1)

  • Lymph node yield

    Total number of lymph nodes harvested

    7 days after Index Surgery

Secondary Outcomes (8)

  • Surgical margin status

    7 days after Index Surgery

  • Complications

    Up to 90 days after surgery

  • ICU stay

    During index admission or within 30 days after surgery

  • Hospital stay

    During index admission or re admission within 30 days

  • Mortality

    During index admission or within 90 days following surgery

  • +3 more secondary outcomes

Study Arms (2)

Robotic esophagectomy

EXPERIMENTAL

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

Procedure: Robotic esophagectomy

Thoracolaparoscopic esophagectomy

ACTIVE COMPARATOR

Esophagectomy performed for esophageal cancer using conventional thoracoscopic and laparoscopic techniques

Procedure: Thoracolaparoscopic esophagectomy

Interventions

Robotic esophagectomyPROCEDURE

Removal of the esophagus and its draining lymph nodes using robotic surgical instruments

Robotic esophagectomy
Thoracolaparoscopic esophagectomyPROCEDURE

Removal of the esophagus and its draining lymph nodes using conventional thoracoscopic and laparoscopic techniques

Thoracolaparoscopic esophagectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Resectable esophageal carcinoma, either squamous cell carcinoma or adenocarcinoma in the middle or lower part the esophagus

You may not qualify if:

  • American Society of Anesthesiologists (ASA) class 4 and above
  • Esophagectomy for other non-malignant conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GEM Hospital & Research Center

Chennai, Tamil Nadu, India

RECRUITING

GEM Hospital & Research Center

Coimbatore, Tamil Nadu, 641045, India

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Chinnusamy Palanivelu, MS, MCh

    GEM Hospital & Research Center

    PRINCIPAL INVESTIGATOR

  • Shankar Balasubramanian, MS, MRCS

    GEM Hospital & Research Center

    STUDY DIRECTOR

  • Sandeep Sabnis, MS, DNB

    GEM Hospital & Research Center

    STUDY DIRECTOR

Central Study Contacts

Shankar Balasubramanian

CONTACT

+919910766534shanxar@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2018

First Posted

November 1, 2018

Study Start

November 1, 2018

Primary Completion

December 31, 2020

Study Completion

January 1, 2021

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

IN(2)