EsophagectomyNCT05950438
Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy
An observational study of Esophagectomy, run by Northwestern University at 1 site in United States.
Trial summary
The primary goal of this study is to collect short-term and long-term health outcomes of a robotic transhiatal esophagectomy procedure. Clinical (or health) outcomes measure the effect of the procedure on your overall health status. During this procedure, the surgeon will remove all or part of your esophagus. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Esophagectomy
- What is being tested?
- Esophagectomy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2023to 25 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be identified in the Thoracic Surgery clinic or in the inpatient setting based on the surgeon's expertise who need to undergo an elective esophagectomy procedure.
Who may be able to join
- Adult patients (18 years or older)
- Patients undergoing elective esophagectomy for any indication
- Patients who have already had an elective esophagectomy for any indication
- Patients with consent providing capacity
Who cannot join
- Patients undergoing emergent esophagectomy
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Vulnerable Populations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Ankit Bharat, MD, 3129267628, ankit.bharat@northwestern.edu
Sara Krezalek, BSN, 3129267577, sara.krezalek@nm.org
About this study
Official title: A Prospective Clinical Registry Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy
The primary goal of this study is to collect short-term and long-term health outcomes of a robotic transhiatal esophagectomy procedure. Clinical (or health) outcomes measure the effect of the procedure on your overall health status. During this procedure, the surgeon will remove all or part of your esophagus. We want to identify patients who will have this procedure. We will look at data elements before, during, and after your procedure to understand the impact of this surgery on your post-operative clinical outcomes.
Read the detailed description
Esophagectomy is a complex surgical procedure performed to treat various esophageal disorders. The surgery involves the removal of all or part of the esophagus and reconstruction using other parts of the gastrointestinal tract. Different surgical approaches and techniques have been developed, including open (transthoracic or transhiatal), minimally invasive (video-assisted thoracoscopic surgery or robotic-assisted), and hybrid approaches. These techniques may yield different clinical outcomes, and there is still ongoing debate regarding the optimal approach. Nevertheless, minimally invasive approaches, including robotic esophagectomy, are generally preferred given the lower morbidity. This prospective clinical registry aims to investigate outcomes of elective robotic transhiatal esophagectomy, the preferred approach at Northwestern Memorial Hospital, for adult patients undergoing this procedure. By collecting clinical and demographic data prospectively, we hope to identify factors that contribute to improved outcomes and guide future surgical practice.
- Conditions
- Esophagectomy
- Being tested
- Esophagectomy
- Keywords
- Robotic Transhiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagectomyProcedure or surgery
Esophagectomy is a complex surgical procedure performed to treat various esophageal disorders. The surgery involves the removal of all or part of the esophagus and reconstruction using other parts of the gastrointestinal tract.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Anastomotic Leak
Postoperative Complication
Measured: During first 3 months postop
Number of Participants with Esophageal Stricture
Postoperative Complication
Measured: During first 3 months postop
Number of Participants with Pneumonia
Postoperative Complication
Measured: During first 3 months postop
Number of Participants Requiring Ventilation >48 Hours
Postoperative Complication
Measured: During first 3 months postop
Number of Participants with Empyema
Postoperative Complication
Measured: During first 3 months postop
Number of Participants with Pulmonary Embolism
Postoperative Complication
Measured: During first 3 months postop
Number of Participants with Deep Venous Thrombosis
Postoperative Complication
Measured: During first 3 months postop
Number of Participants with Gastric Outlet Obstruction
Postoperative Complication
Measured: During first 3 months postop
Number of Participants with Stroke
Postoperative Complication
Measured: During first 3 months postop
Number of Participants with Atrial Fibrillation
Postoperative Complication
Measured: During first 3 months postop
Number of Participants with Vocal Cord Paralysis
Postoperative Complication
Measured: During first 3 months postop
Number of Participants with Myocardial Infarction
Postoperative Complication
Measured: During first 3 months postop
Number of Participants with Chylothorax
Postoperative Complication
Measured: During first 3 months postop
Number of Participants with Acute Renal Injury
Postoperative Complication
Measured: During first 3 months postop
Number of Participants with Wound Infections
Postoperative Complication
Measured: During first 3 months postop
Rates of Re-operation
Postoperative Complication
Measured: During first 3 months postop
Rates of Re-Admission
Postoperative Complication
Measured: During first 3 months postop
Number of Participants with Intensive Care Unit (ICU) Stay
Postoperative Complication
Measured: During first 3 months postop
Rates of Length of Hospital Stay
Postoperative Complication
Measured: Postoperative
Rates of 30-day Survival
Postoperative Complication
Measured: Postoperative
Rates of 90-day Survival Rates
Postoperative Complication
Measured: Postoperative
Secondary outcomes (5)
Operative Time of Surgery
Length of Surgery
Measured: Intraoperative
Rates of Blood Loss
Did the Participant Lose Any Blood During the Surgery
Measured: Intraoperative
Number of Participants with Conversion Rates to Open Esophagectomy
Measured: Intraoperative
Number of Participants with Lymph nodes in the Final Specimen
Pathological Variables
Measured: Intraoperative
Number of Participants with Proximal and Distal Margins
Pathological Variables
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start11 Jul 2023
- Primary completion25 May 2028 (estimated)
- Study completion25 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagectomyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ankit Bharat, Northwestern University
- Investigators
- Ankit Bharat, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950438
- Sponsor's protocol ID
- STU00219267
- Status last verified
- May 2026
- First submitted
- 11 Jul 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Registry Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy
- ClinicalTrials.gov ID
- NCT05950438
- Acronym / sponsor ID
- STU00219267
- Conditions
- Esophagectomy
- Keywords
- Robotic Transhiatal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 25 May 2028 (estimated)
- Study completion
- 25 May 2028 (estimated)
- First posted
- 18 Jul 2023 (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.
The primary goal of this study is to collect short-term and long-term health outcomes of a robotic transhiatal esophagectomy procedure. Clinical (or health) outcomes measure the effect of the procedure on your overall health status. During this procedure, the surgeon will remove all or part of your esophagus. We want to identify patients who will have this procedure. We will look at data elements before, during, and after your procedure to understand the impact of this surgery on your post-operative clinical outcomes.
Detailed description
Esophagectomy is a complex surgical procedure performed to treat various esophageal disorders. The surgery involves the removal of all or part of the esophagus and reconstruction using other parts of the gastrointestinal tract. Different surgical approaches and techniques have been developed, including open (transthoracic or transhiatal), minimally invasive (video-assisted thoracoscopic surgery or robotic-assisted), and hybrid approaches. These techniques may yield different clinical outcomes, and there is still ongoing debate regarding the optimal approach. Nevertheless, minimally invasive approaches, including robotic esophagectomy, are generally preferred given the lower morbidity. This prospective clinical registry aims to investigate outcomes of elective robotic transhiatal esophagectomy, the preferred approach at Northwestern Memorial Hospital, for adult patients undergoing this procedure. By collecting clinical and demographic data prospectively, we hope to identify factors that contribute to improved outcomes and guide future surgical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be identified in the Thoracic Surgery clinic or in the inpatient setting based on the surgeon's expertise who need to undergo an elective esophagectomy procedure.
Key inclusion criteria (4 listed)
- Adult patients (18 years or older)
- Patients undergoing elective esophagectomy for any indication
- Patients who have already had an elective esophagectomy for any indication
- Patients with consent providing capacity
Key exclusion criteria (6 listed)
- Patients undergoing emergent esophagectomy
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
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 |
|---|---|---|
| EsophagectomyEsophagectomy is a complex surgical procedure performed to treat various esophageal disorders. The surgery involves the removal of all or part of the esophagus and reconstruction using other parts of the gastrointestinal tract. | Procedure or surgery | – |
Primary outcome
Number of Participants with Anastomotic Leak
Time frame: During first 3 months postop
Postoperative Complication
Number of Participants with Esophageal Stricture
Time frame: During first 3 months postop
Postoperative Complication
Number of Participants with Pneumonia
Time frame: During first 3 months postop
Postoperative Complication
Number of Participants Requiring Ventilation >48 Hours
Time frame: During first 3 months postop
Postoperative Complication
Number of Participants with Empyema
Time frame: During first 3 months postop
Postoperative Complication
Number of Participants with Pulmonary Embolism
Time frame: During first 3 months postop
Postoperative Complication
Number of Participants with Deep Venous Thrombosis
Time frame: During first 3 months postop
Postoperative Complication
Number of Participants with Gastric Outlet Obstruction
Time frame: During first 3 months postop
Postoperative Complication
Number of Participants with Stroke
Time frame: During first 3 months postop
Postoperative Complication
Number of Participants with Atrial Fibrillation
Time frame: During first 3 months postop
Postoperative Complication
Number of Participants with Vocal Cord Paralysis
Time frame: During first 3 months postop
Postoperative Complication
Number of Participants with Myocardial Infarction
Time frame: During first 3 months postop
Postoperative Complication
Number of Participants with Chylothorax
Time frame: During first 3 months postop
Postoperative Complication
Number of Participants with Acute Renal Injury
Time frame: During first 3 months postop
Postoperative Complication
Number of Participants with Wound Infections
Time frame: During first 3 months postop
Postoperative Complication
Rates of Re-operation
Time frame: During first 3 months postop
Postoperative Complication
Rates of Re-Admission
Time frame: During first 3 months postop
Postoperative Complication
Number of Participants with Intensive Care Unit (ICU) Stay
Time frame: During first 3 months postop
Postoperative Complication
Rates of Length of Hospital Stay
Time frame: Postoperative
Postoperative Complication
Rates of 30-day Survival
Time frame: Postoperative
Postoperative Complication
Rates of 90-day Survival Rates
Time frame: Postoperative
Postoperative Complication
5 secondary outcomes
Operative Time of Surgery
Time frame: Intraoperative
Rates of Blood Loss
Time frame: Intraoperative
Number of Participants with Conversion Rates to Open Esophagectomy
Time frame: Intraoperative
Number of Participants with Lymph nodes in the Final Specimen
Time frame: Intraoperative
Number of Participants with Proximal and Distal Margins
Time frame: Intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
Related trials for Esophagectomy
Recruiting
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RecruitingPhase 3
Modular Robot-Assisted Versus Conventional Minimally Invasive Esophagectomy for Esophageal Cancer
Esophageal Cancer
RecruitingPhase 2
OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy
Anastomotic Leak Esophagus
Active, not recruitingObservational study
Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
Esophageal Cancer, Esophagus Cancer
RecruitingObservational study
Evaluation of Seismocardiography(SCG) for Assessing Fitness and Predicting Outcomes in Oesophageal Cancer Surgery
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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.
Ankit Bharat, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagectomy, run by Northwestern University at 1 site in United States.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ankit Bharat, MD (312-926-7628, ankit.bharat@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Anastomotic Leak (time frame: During first 3 months postop). The study lists 21 primary outcomes in all. 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 26 May 2026.