Esophageal CancerNCT04219410
Assessment of a Modified Minimally Invasive Esophagectomy
An observational study of Esophageal Cancer, run by Kaiser Permanente.
Trial summary
This is a retrospective case series of a novel fully minimally invasive esophagectomy procedure for patients with primary esophageal cancer. 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?
- Fully minimally invasive esophagectomy
- Type of treatment
- Surgery or procedure
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 Aug 2016
- 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: Consecutive sample of all patients undergoing the novel minimally invasive esophagectomy procedure at the Kaiser Permanente Northern California Oakland Medical Center during the study period
Who may be able to join
- patient with primary esophageal cancer of any cell type
- underwent the novel minimally invasive esophagectomy procedure at the Kaiser Permanente Northern California Oakland Medical Center by one of the study author-surgeons
Who cannot join
- non-elective procedure
- less than 90 days of post-discharge follow-up
About this study
This is a retrospective case series of a novel fully minimally invasive esophagectomy procedure for patients with primary esophageal cancer.
- Conditions
- Esophageal Cancer
- Being tested
- Fully minimally invasive 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.
Fully minimally invasive esophagectomyProcedure or surgery
Esophagectomy using a novel fully minimally invasive approach
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients who underwent minimally invasive esophagectomy with this novel procedure at Kaiser Permanente, Northern California, Oakland Medical Center Receives: Procedure: Fully minimally invasive esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Hospital length of stay
Measured: Through study completion, an average of 2.9 years
Secondary outcomes (6)
Intensive care unit length of stay
Intensive care unit length of stay
Measured: Through study completion, an average of 2.9 years
Feeding tube placement
Feeding tube placement
Measured: Intra-operatively
Number of patients with inpatient mortality
Number of patients with inpatient mortality
Measured: Through study completion, an average of 2.9 years
90-day total mortality
90-day total mortality
Measured: 90 days post discharge
Number of patients with hospital readmission within 30 days
Number of patients with hospital readmission within 30 days
Measured: 30 days post discharge
Number of patients with complications
Number of patients with medical and surgical complications both inpatient and post-discharge
Measured: Hospital stay and 30 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Jan 2013
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
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 Kaiser PermanenteThe 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
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andy Avins, Kaiser Permanente
- Investigators
- Andrew Avins, MD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219410
- Sponsor's protocol ID
- 1279152-4
- Status last verified
- Jan 2020
- First submitted
- 3 Jan 2020
- Last updated
- 7 Jan 2020
- 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 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Modified Minimally Invasive Esophagectomy
- ClinicalTrials.gov ID
- NCT04219410
- Acronym / sponsor ID
- 1279152-4
- Conditions
- Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 7 Jan 2020 (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 is a retrospective case series of a novel fully minimally invasive esophagectomy procedure for patients with primary esophageal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Procedure: Fully minimally invasive esophagectomyPatients who underwent minimally invasive esophagectomy with this novel procedure at Kaiser Permanente, Northern California, Oakland Medical Center |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive sample of all patients undergoing the novel minimally invasive esophagectomy procedure at the Kaiser Permanente Northern California Oakland Medical Center during the study period
Key inclusion criteria (2 listed)
- patient with primary esophageal cancer of any cell type
- underwent the novel minimally invasive esophagectomy procedure at the Kaiser Permanente Northern California Oakland Medical Center by one of the study author-surgeons
Key exclusion criteria (2 listed)
- non-elective procedure
- less than 90 days of post-discharge follow-up
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 |
|---|---|---|
| Fully minimally invasive esophagectomyEsophagectomy using a novel fully minimally invasive approach | Procedure or surgery | Cases |
Primary outcome
Hospital length of stay
Time frame: Through study completion, an average of 2.9 years
Hospital length of stay
6 secondary outcomes
Intensive care unit length of stay
Time frame: Through study completion, an average of 2.9 years
Feeding tube placement
Time frame: Intra-operatively
Number of patients with inpatient mortality
Time frame: Through study completion, an average of 2.9 years
90-day total mortality
Time frame: 90 days post discharge
Number of patients with hospital readmission within 30 days
Time frame: 30 days post discharge
Number of patients with complications
Time frame: Hospital stay and 30 days post discharge
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 7 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
Andrew Avins, MD, MPH principal investigator
Kaiser Permanente
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Kaiser Permanente.
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 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 7 Jan 2020. 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?
Hospital length of stay (time frame: Through study completion, an average of 2.9 years). 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 7 Jan 2020.