Esophageal CancerNCT03727126
Robotic Versus Thoracolaparoscopic Esophagectomy for Esophageal Cancer
A study testing Robotic esophagectomy and Thoracolaparoscopic esophagectomy in people with Esophageal Cancer, run by GEM Hospital & Research Center at 2 sites in India.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Robotic esophagectomy and Thoracolaparoscopic esophagectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Nov 2018to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Resectable esophageal carcinoma, either squamous cell carcinoma or adenocarcinoma in the middle or lower part the esophagus
Who cannot join
- American Society of Anesthesiologists (ASA) class 4 and above
- Esophagectomy for other non-malignant conditions
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Recruiting
GEM Hospital & Research Center
Chennai, Tamil Nadu
Bhushan Chittawadagi, MS, DNB
- Recruiting
GEM Hospital & Research Center
Coimbatore, Tamil Nadu, 641045
Shankar Balasubramanian
About this study
Official title: 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.
- Conditions
- Esophageal Cancer
- Being tested
- Robotic esophagectomy, Thoracolaparoscopic esophagectomy
- Keywords
- Esophagectomy, Robotic esophagectomy, Laparoscopic esophagectomy, Minimally invasive esophagectomy, Ivor Lewis esophagectomy, McKeown's esophagectomy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic esophagectomyProcedure or surgery
Removal of the esophagus and its draining lymph nodes using robotic surgical instruments
Thoracolaparoscopic esophagectomyProcedure or surgery
Removal of the esophagus and its draining lymph nodes using conventional thoracoscopic and laparoscopic techniques
| Study group | Role | What they receive |
|---|---|---|
| Robotic esophagectomy | Experimental | Esophagectomy performed for esophageal cancer using the da Vinci robotic surgical system Receives: Procedure: Robotic esophagectomy |
| Thoracolaparoscopic esophagectomy | Active comparator | Esophagectomy performed for esophageal cancer using conventional thoracoscopic and laparoscopic techniques Receives: Procedure: Thoracolaparoscopic esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph node yield
Total number of lymph nodes harvested
Measured: 7 days after Index Surgery
Secondary outcomes (8)
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.
Measured: 7 days after Index Surgery
Complications
Intraoperative and post operative adverse events assessed by Clavien Dindo classification system
Measured: Up to 90 days after surgery
ICU stay
Duration of stay in ICU following surgery
Measured: During index admission or within 30 days after surgery
Hospital stay
Length of stay in hospital following surgery
Measured: During index admission or re admission within 30 days
Mortality
Death following surgery
Measured: During index admission or within 90 days following surgery
Duration of surgery
Time taken to complete the surgical procedure recorded in minutes
Measured: 1 day after surgery
Blood loss
Amount of blood lost during and within 24 hours of surgery
Measured: During surgery and up to 24 hours after index surgery
Conversion rate
Need for conversion of the procedure to open or other alternate technique
Measured: 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start1 Nov 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GEM Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chinnusamy Palanivelu, MS, MCh, Principal investigator, GEM Hospital & Research CenterShankar Balasubramanian, MS, MRCS, Study director, GEM Hospital & Research CenterSandeep Sabnis, MS, DNB, Study director, GEM Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727126
- Sponsor's protocol ID
- GEMBOT
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2018
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Versus Thoracolaparoscopic Esophagectomy for Carcinoma Esophagus: a Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT03727126
- Acronym / sponsor ID
- GEMBOT
- Conditions
- Esophageal Cancer
- Keywords
- Esophagectomy, Robotic esophagectomy, Laparoscopic esophagectomy, Minimally invasive esophagectomy, Ivor Lewis esophagectomy, McKeown's esophagectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- GEM Hospital & Research CenterUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic esophagectomy | Experimental | Procedure: Robotic esophagectomyEsophagectomy performed for esophageal cancer using the da Vinci robotic surgical system |
| Thoracolaparoscopic esophagectomy | Active comparator | Procedure: Thoracolaparoscopic esophagectomyEsophagectomy performed for esophageal cancer using conventional thoracoscopic and laparoscopic techniques |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Resectable esophageal carcinoma, either squamous cell carcinoma or adenocarcinoma in the middle or lower part the esophagus
Key exclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) class 4 and above
- Esophagectomy for other non-malignant conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic esophagectomyRemoval of the esophagus and its draining lymph nodes using robotic surgical instruments | Procedure or surgery | Robotic esophagectomy |
| Thoracolaparoscopic esophagectomyRemoval of the esophagus and its draining lymph nodes using conventional thoracoscopic and laparoscopic techniques | Procedure or surgery | Thoracolaparoscopic esophagectomy |
Primary outcome
Lymph node yield
Time frame: 7 days after Index Surgery
Total number of lymph nodes harvested
8 secondary outcomes
Surgical margin status
Time frame: 7 days after Index Surgery
Complications
Time frame: Up to 90 days after surgery
ICU stay
Time frame: During index admission or within 30 days after surgery
Hospital stay
Time frame: During index admission or re admission within 30 days
Mortality
Time frame: During index admission or within 90 days following surgery
Duration of surgery
Time frame: 1 day after surgery
Blood loss
Time frame: During surgery and up to 24 hours after index surgery
Conversion rate
Time frame: 1 day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chinnusamy Palanivelu, MS, MCh principal investigator
GEM Hospital & Research Center
Shankar Balasubramanian, MS, MRCS study director
GEM Hospital & Research Center
Sandeep Sabnis, MS, DNB study director
GEM Hospital & Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic esophagectomy and Thoracolaparoscopic esophagectomy in people with Esophageal Cancer, run by GEM Hospital & Research Center at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shankar Balasubramanian (+919910766534, shanxar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymph node yield (time frame: 7 days after Index Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.