Oesophageal Squamous Cell CarcinomaNCT07201571
A Retrospective Cohort Study of Patients Who Underwent Curative-intent Esophagectomy for ESCC at a Tertiary Referral Center in South Korea
An observational study of Oesophageal Squamous Cell Carcinoma, run by Samsung Medical Center.
Trial summary
This retrospective cohort study was conducted using the Registry for Thoracic Cancer Surgery at Samsung Medical Center (Seoul, South Korea), which has included all patients who underwent thoracic surgery Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oesophageal Squamous Cell Carcinoma
- How many people
- 3,131 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 1994to 31 Aug 2025
- Phase
- Observational
- 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
Study population: Patients who underwent curative surgery for esophageal cancer
Who may be able to join
- Patients who underwent curative surgery for esophageal cancer
Who cannot join
- cervical esophageal cancer
- gastroesophageal junction cancer
- histology other than squamous cell carcinoma
- patients with Child-Pugh class B or C liver cirrhosis
About this study
This retrospective cohort study was conducted using the Registry for Thoracic Cancer Surgery at Samsung Medical Center (Seoul, South Korea), which has included all patients who underwent thoracic surgery
Read the detailed description
This retrospective cohort study was conducted using the Registry for Thoracic Cancer Surgery at Samsung Medical Center (Seoul, South Korea), which has included all patients who underwent thoracic surgery
- Conditions
- Oesophageal Squamous Cell Carcinoma
- Keywords
- Oesophageal Squamous Cell Carcinoma, Esophagectomy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
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 who underwent curative surgery for esophageal cancer | Patients who underwent curative surgery for esophageal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Complications related to fluid imbalance and portal hypertension, such as ascites, pleural effusion, and chyle leak; complications associated with impaired renal or hematologic function, including acute kidney injury, bleeding, and graft failure; and complications reflecting immune dysfunction and infection susceptibility, including pneumonia and empyema. Complications associated with impaired tissue healing, such as anastomotic leakage, were also analyzed. Liver failure and acute respiratory distress syndrome were considered separately. All complications were defined according to the Esophageal Complications Consensus Group, and their severity was assessed according to the Clavien-Dindo classification.
Measured: within 90 days after surgery
Secondary outcomes (1)
Overall survival
Interval from the date of surgery to death or censoring
Measured: 10 years 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 Oct 2025
- Study start6 Nov 1994
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal Squamous Cell CarcinomaStudies 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
- Retrospective
- Enrolment
- 3,131 participants (actual)
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
- NCT07201571
- Sponsor's protocol ID
- SMC-ESCC
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study of Patients Who Underwent Curative-intent Esophagectomy for ESCC at a Tertiary Referral Center in South Korea
- ClinicalTrials.gov ID
- NCT07201571
- Acronym / sponsor ID
- SMC-ESCC
- Conditions
- Oesophageal Squamous Cell Carcinoma
- Keywords
- Oesophageal Squamous Cell Carcinoma, Esophagectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,131 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 6 Nov 1994 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 1 Oct 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 retrospective cohort study was conducted using the Registry for Thoracic Cancer Surgery at Samsung Medical Center (Seoul, South Korea), which has included all patients who underwent thoracic surgery
Detailed description
This retrospective cohort study was conducted using the Registry for Thoracic Cancer Surgery at Samsung Medical Center (Seoul, South Korea), which has included all patients who underwent thoracic surgery
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent curative surgery for esophageal cancer | – | –Patients who underwent curative surgery for esophageal cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent curative surgery for esophageal cancer
Key inclusion criteria (1 listed)
- Patients who underwent curative surgery for esophageal cancer
Key exclusion criteria (4 listed)
- cervical esophageal cancer
- gastroesophageal junction cancer
- histology other than squamous cell carcinoma
- patients with Child-Pugh class B or C liver cirrhosis
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
Postoperative complications
Time frame: within 90 days after surgery
Complications related to fluid imbalance and portal hypertension, such as ascites, pleural effusion, and chyle leak; complications associated with impaired renal or hematologic function, including acute kidney injury, bleeding, and graft failure; and complications reflecting immune dysfunction and infection susceptibility, including pneumonia and empyema. Complications associated with impaired tissue healing, such as anastomotic leakage, were also analyzed. Liver failure and acute respiratory distress syndrome were considered separately. All complications were defined according to the Esophageal Complications Consensus Group, and their severity was assessed according to the Clavien-Dindo classification.
1 secondary outcome
Overall survival
Time frame: 10 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Oesophageal Squamous Cell Carcinoma, 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 1 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative complications (time frame: within 90 days after 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 1 Oct 2025.