Esophageal CancerNCT03378869
Perioperative Management and Outcomes of Minimally Invasive Esophagectomy
An observational study of Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators retrospectively reviewed the data of all patients who had undergone esophagectomy and reconstruction in 2015. Patient characteristics, the surgery performed, method of anesthesia, postoperative hospitalization course, and additional surgical interventions were reviewed and analyzed. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- esophagectomy
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2017to 15 Sep 2017
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with esophageal cancer undergoing esophageal reconstruction in 2015.
Who may be able to join
- patients received esophageal reconstruction in 2015.
Who cannot join
- age <18
- not malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Management and Outcomes of Minimally Invasive Esophagectomy- Experience of a High-volume Tertiary Center in Taiwan
The investigators retrospectively reviewed the data of all patients who had undergone esophagectomy and reconstruction in 2015. Patient characteristics, the surgery performed, method of anesthesia, postoperative hospitalization course, and additional surgical interventions were reviewed and analyzed.
- Conditions
- Esophageal Cancer
- Being tested
- esophagectomy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophagectomyProcedure or surgery
all the included participants had received esophagectomy, either Ivor Lewis or tri-incision, or more complex procedures.
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
rate of 30-day mortality
Measured: 30 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Jun 2017
- Primary completion1 Aug 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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 only
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ya-Jung Cheng, MD. PHD, Study chair, Chief of Department of Anesthesiology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378869
- Sponsor's protocol ID
- 201708054RINB
- Status last verified
- Dec 2017
- First submitted
- 15 Dec 2017
- Last updated
- 20 Dec 2017
- 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 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Management and Outcomes of Minimally Invasive Esophagectomy- Experience of a High-volume Tertiary Center in Taiwan
- ClinicalTrials.gov ID
- NCT03378869
- Acronym / sponsor ID
- 201708054RINB
- Conditions
- Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 20 Dec 2017 (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 investigators retrospectively reviewed the data of all patients who had undergone esophagectomy and reconstruction in 2015. Patient characteristics, the surgery performed, method of anesthesia, postoperative hospitalization course, and additional surgical interventions were reviewed and analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with esophageal cancer undergoing esophageal reconstruction in 2015.
Key inclusion criteria (1 listed)
- patients received esophageal reconstruction in 2015.
Key exclusion criteria (2 listed)
- age <18
- not malignancy
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 |
|---|---|---|
| esophagectomyall the included participants had received esophagectomy, either Ivor Lewis or tri-incision, or more complex procedures. | Procedure or surgery | – |
Primary outcome
30-day mortality
Time frame: 30 day after surgery
rate of 30-day mortality
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 20 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Ya-Jung Cheng, MD. PHD study chair
Chief of Department of Anesthesiology, National Taiwan University Hospital
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 Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 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: finished, as of the sponsor's last update on 20 Dec 2017. 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 Taiwan. 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?
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?
30-day mortality (time frame: 30 day 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 20 Dec 2017.