Patients Undergoing Robot-assisted EsophagectomyNCT07050030
Association of Preoperative Coronary Calcium Score and Postoperative Atrial Arrythmia in Patients Undergoing Robot-assisted Esophagectomy: Prospective Observational Study
An observational study of Patients Undergoing Robot-assisted Esophagectomy, run by Yonsei University at 1 site in South Korea.
Trial summary
This study aimed to evaluate the relationship between coronary artery calcium score measured before surgery and the incidence of atrial fibrillation after robot-assisted esophagectomy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients Undergoing Robot-assisted Esophagectomy
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jul 2025to 7 Jan 2030
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing robotic esophagectomy
Who may be able to join
- Patients aged 20 years or older undergoing robotic esophagectomy
- Patients who underwent preoperative coronary computed tomography (CT) with a valid coronary artery calcium score
Who cannot join
- emergency surgery
- patients who cannot read consent forms(e.g., illiterate, foreigner, etc.)
- patients with cognitive dysfunction
- pregnant, lactating women
- history of atrial fibrillation prior to surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, 03722
About this study
This study aimed to evaluate the relationship between coronary artery calcium score measured before surgery and the incidence of atrial fibrillation after robot-assisted esophagectomy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing robot-assisted esophagectomy | Adult patients aged 20 years or older and who underg robot-assisted esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative atrial fibrillation
Incidence of postoperative atrial fibrillation within 30 days after surgery.
Measured: within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start7 Jul 2025 (estimated)
- Primary completion7 Jul 2029 (estimated)
- Study completion7 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Robot-assisted EsophagectomyStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050030
- Sponsor's protocol ID
- 4-2025-0388
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Preoperative Coronary Calcium Score and Postoperative Atrial Arrythmia in Patients Undergoing Robot-assisted Esophagectomy: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07050030
- Acronym / sponsor ID
- 4-2025-0388
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Jul 2025 (estimated)
- Primary completion
- 7 Jul 2029 (estimated)
- Study completion
- 7 Jan 2030 (estimated)
- First posted
- 3 Jul 2025 (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.
This study aimed to evaluate the relationship between coronary artery calcium score measured before surgery and the incidence of atrial fibrillation after robot-assisted esophagectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing robot-assisted esophagectomy | – | –Adult patients aged 20 years or older and who underg robot-assisted esophagectomy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing robotic esophagectomy
Key inclusion criteria (2 listed)
- Patients aged 20 years or older undergoing robotic esophagectomy
- Patients who underwent preoperative coronary computed tomography (CT) with a valid coronary artery calcium score
Key exclusion criteria (5 listed)
- emergency surgery
- patients who cannot read consent forms(e.g., illiterate, foreigner, etc.)
- patients with cognitive dysfunction
- pregnant, lactating women
- history of atrial fibrillation prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative atrial fibrillation
Time frame: within 30 days postoperatively
Incidence of postoperative atrial fibrillation within 30 days after surgery.
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 3 Jul 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Patients Undergoing Robot-assisted Esophagectomy, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 3 Jul 2025. 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 South Korea. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative atrial fibrillation (time frame: within 30 days postoperatively). 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 3 Jul 2025.