Esophageal CancerNCT04683601
Generation of a Surgical Field in the Left Lateral Decubitus Position
An observational study of Esophageal Cancer and Thoracic Diseases, run by Shizuoka Cancer Center.
Trial summary
The generation of a good surgical field at the mid-lower mediastinum during thoracoscopic esophagectomy in the left lateral decubitus position is often complicated. The investigators developed a simple and useful technique for surgical field generation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer, Thoracic Diseases
- What is being tested?
- Thoracoscopic esophagectomy in left decubitus
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Dec 2019
- 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: 154 patients underwent thoracoscopic esophagectomy in left decubitus position during that period.
Who may be able to join
- Patients who underwent thoracoscopic esophageal resection from April 2015 to December 2019 in our hospital.
Who cannot join
- patients who underwent open thoracotomy
About this study
Official title: Generation of a Surgical Field at the Mid-lower Mediastinum for Thoracoscopic Esophagectomy in the Left Lateral Decubitus Position
The generation of a good surgical field at the mid-lower mediastinum during thoracoscopic esophagectomy in the left lateral decubitus position is often complicated. The investigators developed a simple and useful technique for surgical field generation.
- Conditions
- Esophageal Cancer, Thoracic Diseases
- Being tested
- Thoracoscopic esophagectomy in left decubitus
- Keywords
- Left decubitus position, Mid-lower mediastinum, Thoracoscopic esophagectomy
- Medical subject headings
- Esophageal Neoplasms, Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoscopic esophagectomy in left decubitusOther
Making surgical field at thoracoscopic esophagectomy in left decubitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate of thoracoscopic esophagectomy
The rate of completion of thoracic esophagectomy with our method for the generation of surgical field in mid-lower mediastinum.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study startApr 2015
- Primary completionDec 2019
- Study completionDec 2019
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.
- 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
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shizuoka Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenjiro Ishii, Shizuoka Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683601
- Sponsor's protocol ID
- ShizuokaCC 2
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- 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 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of a Surgical Field at the Mid-lower Mediastinum for Thoracoscopic Esophagectomy in the Left Lateral Decubitus Position
- ClinicalTrials.gov ID
- NCT04683601
- Acronym / sponsor ID
- ShizuokaCC 2
- Conditions
- Esophageal Cancer, Thoracic Diseases
- Keywords
- Left decubitus position, Mid-lower mediastinum, Thoracoscopic esophagectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Shizuoka Cancer CenterUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 24 Dec 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.
The generation of a good surgical field at the mid-lower mediastinum during thoracoscopic esophagectomy in the left lateral decubitus position is often complicated. The investigators developed a simple and useful technique for surgical field generation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 154 patients underwent thoracoscopic esophagectomy in left decubitus position during that period.
Key inclusion criteria (1 listed)
- Patients who underwent thoracoscopic esophageal resection from April 2015 to December 2019 in our hospital.
Key exclusion criteria (1 listed)
- patients who underwent open thoracotomy
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 |
|---|---|---|
| Thoracoscopic esophagectomy in left decubitusMaking surgical field at thoracoscopic esophagectomy in left decubitus | Other | – |
Primary outcome
Completion rate of thoracoscopic esophagectomy
Time frame: During surgery
The rate of completion of thoracic esophagectomy with our method for the generation of surgical field in mid-lower mediastinum.
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 24 Dec 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.
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 Cancer and Thoracic Diseases, run by Shizuoka Cancer 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 1 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 24 Dec 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?
Completion rate of thoracoscopic esophagectomy (time frame: During 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 24 Dec 2020.