Esophageal NeoplasmsNCT05740852
Analysis of Risk Factors of Postoperative Pulmonary Infection in Patients With Esophageal Cancer
An observational study of Esophageal Neoplasms and Pneumonia, run by Xijing Hospital.
Trial summary
The goal of this observational study is to learn about in describe participant population. The main questions it aims to answer are: What are the risk factors of postoperative pulmonary infection in patients with esophageal cancer？ Whether we could establish a clinical prediction model to provide basis for early… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Esophageal Neoplasms, Pneumonia
- How many people
- 1,688 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Jan 2023
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2016 to December 2021, patients with esophageal cancer were hospitalized for surgery in the Department of Gastroenterology, Xijing Hospital.
Who may be able to join
- Diagnosis of esophageal cancer;
- Radical resection of tumor for the first time;
- No distant metastasis was observed in preoperative examination
Who cannot join
- Patients with preoperative pulmonary infection or symptoms of pulmonary infection;
- Patients with tracheal intubation assisted ventilation before surgery;
- Patients with preoperative lung imaging changes or abnormal white blood cells in blood routine;
- Patients undergoing emergency surgery;
- Patients with other cancers;
- Patients with incomplete clinical data.
About this study
The goal of this observational study is to learn about in describe participant population. The main questions it aims to answer are:
- What are the risk factors of postoperative pulmonary infection in patients with esophageal cancer？
- Whether we could establish a clinical prediction model to provide basis for early clinical intervention or not? Participants will describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items. If there is a comparison group: Researchers will compare insert groups to see if insert effects.
Read the detailed description
Data were collected from the electronic medical records of Xijing Hospital. Each record is entered by two team members working simultaneously to ensure data accuracy.
- Conditions
- Esophageal Neoplasms, Pneumonia
- Medical subject headings
- Esophageal Neoplasms, Pneumonia
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 |
|---|---|---|
| Infection | Patients who developed pulmonary infection after radical resection of tumor | |
| Without infection | Patients without pulmonary infection after radical resection of tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumonia
Pulmonary infection in patients with esophageal cancer after radical resection of tumor
Measured: A week after radical resection of tumor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Jan 2016
- Primary completion31 Oct 2021
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,688 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740852
- Sponsor's protocol ID
- XijingHCJF
- Status last verified
- Jan 2023
- First submitted
- 13 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Risk Factors of Postoperative Pulmonary Infection in Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05740852
- Acronym / sponsor ID
- XijingHCJF
- Conditions
- Esophageal Neoplasms, Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,688 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 23 Feb 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 goal of this observational study is to learn about in describe participant population. The main questions it aims to answer are:
- What are the risk factors of postoperative pulmonary infection in patients with esophageal cancer？
- Whether we could establish a clinical prediction model to provide basis for early clinical intervention or not? Participants will describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items. If there is a comparison group: Researchers will compare insert groups to see if insert effects.
Detailed description
Data were collected from the electronic medical records of Xijing Hospital. Each record is entered by two team members working simultaneously to ensure data accuracy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infection | – | –Patients who developed pulmonary infection after radical resection of tumor |
| Without infection | – | –Patients without pulmonary infection after radical resection of tumor |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2016 to December 2021, patients with esophageal cancer were hospitalized for surgery in the Department of Gastroenterology, Xijing Hospital.
Key inclusion criteria (3 listed)
- Diagnosis of esophageal cancer;
- Radical resection of tumor for the first time;
- No distant metastasis was observed in preoperative examination
Key exclusion criteria (6 listed)
- Patients with preoperative pulmonary infection or symptoms of pulmonary infection;
- Patients with tracheal intubation assisted ventilation before surgery;
- Patients with preoperative lung imaging changes or abnormal white blood cells in blood routine;
- Patients undergoing emergency surgery;
- Patients with other cancers;
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
Pneumonia
Time frame: A week after radical resection of tumor
Pulmonary infection in patients with esophageal cancer after radical resection of tumor
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 23 Feb 2023.
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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 Esophageal Neoplasms and Pneumonia, run by Xijing Hospital.
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 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: finished, as of the sponsor's last update on 23 Feb 2023. 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?
Pneumonia (time frame: A week after radical resection of tumor). 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 23 Feb 2023.