EsophagectomyNCT07064655
Non-gastric Conduit Reconstruction After Esophagectomy
An observational study of Esophagectomy and Esophageal Cancer, run by Samsung Medical Center.
Trial summary
This study is to collect and analyze the clinical information of patients who underwent reconstruction using conduits other than the stomach, such as the colon and small intestine, after esophagectomy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Esophagectomy, Esophageal Cancer
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 30 Dec 2030
- How long will I take part?
- 6 Months
- 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 registered at Samsung Medical Center
Who may be able to join
- Patients who have voluntarily signed an informed consent form and are willing and able to complete all requirements of the study.
- Age 20 years or older.
- Patients who are scheduled for esophagectomy and reconstruction with a conduit other than a gastric conduit is planned.
Who cannot join
- Patients who do not consent to participate in this study
- The investigator determines that the patient should not participate in the study because the investigator believes that the patient will not be able to comply with the study procedures, requirements, and procedures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Observational Cohort Study of Patients Undergoing Non-gastric Conduit Reconstruction After Esophagectomy to Assess Surgical Outcomes
This study is to collect and analyze the clinical information of patients who underwent reconstruction using conduits other than the stomach, such as the colon and small intestine, after esophagectomy. Currently, reconstruction after esophagectomy is mainly performed using the stomach, and there is very little information on reconstruction using the colon and small intestine.
Therefore, this study aims to collect information on patients who underwent reconstruction using conduits other than the stomach, analyze the surgical performance, find clinical improvements, and build a foundation for future clinical quality improvement.
- Conditions
- Esophagectomy, Esophageal Cancer
- Keywords
- esophageal cancer, esophagectomy, non-gastric conduit reconstruction
- Medical subject headings
- Esophageal Neoplasms
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 |
|---|---|---|
| Non-gastric conduit group | Patients who received the reconstruction other than a gastric conduit after esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomotic leakage rate
Measured: From enrollment to 6 months after esophagectomy
rate of conduit necrosis
Measured: From enrollment to 6 months after esophagectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Jun 2030 (estimated)
- Study completion30 Dec 2030 (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 Samsung Medical CenterThe 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
- 25 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong Yong Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064655
- Sponsor's protocol ID
- SMC 2025-05-092
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) from this study, because the consent form did not include provisions for data sharing and institutional policy does not permit it.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study of Patients Undergoing Non-gastric Conduit Reconstruction After Esophagectomy to Assess Surgical Outcomes
- ClinicalTrials.gov ID
- NCT07064655
- Acronym / sponsor ID
- SMC 2025-05-092
- Conditions
- Esophagectomy, Esophageal Cancer
- Keywords
- esophageal cancer, esophagectomy, non-gastric conduit reconstruction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Jun 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 15 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 is to collect and analyze the clinical information of patients who underwent reconstruction using conduits other than the stomach, such as the colon and small intestine, after esophagectomy. Currently, reconstruction after esophagectomy is mainly performed using the stomach, and there is very little information on reconstruction using the colon and small intestine.
Therefore, this study aims to collect information on patients who underwent reconstruction using conduits other than the stomach, analyze the surgical performance, find clinical improvements, and build a foundation for future clinical quality improvement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-gastric conduit group | – | –Patients who received the reconstruction other than a gastric conduit after esophagectomy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients registered at Samsung Medical Center
Key inclusion criteria (3 listed)
- Patients who have voluntarily signed an informed consent form and are willing and able to complete all requirements of the study.
- Age 20 years or older.
- Patients who are scheduled for esophagectomy and reconstruction with a conduit other than a gastric conduit is planned.
Key exclusion criteria (2 listed)
- Patients who do not consent to participate in this study
- The investigator determines that the patient should not participate in the study because the investigator believes that the patient will not be able to comply with the study procedures, requirements, and procedures
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
anastomotic leakage rate
Time frame: From enrollment to 6 months after esophagectomy
rate of conduit necrosis
Time frame: From enrollment to 6 months after esophagectomy
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 15 Jul 2025.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) from this study, because the consent form did not include provisions for data sharing and institutional policy does not permit it.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagectomy and Esophageal Cancer, run by Samsung Medical Center.
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 3 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: opening soon, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Seong Yong Park, M.D., Ph.D (+821053885715, syparkcs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anastomotic leakage rate (time frame: From enrollment to 6 months after esophagectomy). The study lists 2 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 15 Jul 2025.