Esophageal NeoplasmsNCT04973046
Tissue Oxygen Saturation for Esophagectomy
An observational study of Esophageal Neoplasms and Esophagostomy Complication, run by Shizuoka Cancer Center at 1 site in Japan.
Trial summary
Tissue oxygen saturation monitoring was a useful indicator of blood flow insufficiency in the gastric tube leading to anastomotic leakage during radical esophagectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Neoplasms, Esophagostomy Complication, Anastomotic Leak
- How many people
- 18 participants
- Where
- 1 siteJapan
- Study dates
- 1 Nov 2020to 30 Apr 2021
- 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: This was a retrospective study performed at the Shizuoka Cancer Center between November 2020 and March 2021. All 18 patients who underwent esophagectomy with gastric tube reconstruction were enrolled in the study
Who may be able to join
- Patients who underwent esophagectomy with gastric tube reconstruction from November 2020 to March 2021.
Who cannot join
- Patients who underwent esophagectomy with jejunum or colon reconstruction. patients who underwent two-stage operation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tissue Oxygen Saturation During Gastric Tube Reconstruction With Cervical Anastomosis for Esophagectomy
Tissue oxygen saturation monitoring was a useful indicator of blood flow insufficiency in the gastric tube leading to anastomotic leakage during radical esophagectomy.
Read the detailed description
One cause of anastomotic leakage after radical esophagectomy is blood flow insufficiency at the cervical anastomosis site. .
Eighteen patients, who underwent radical esophagectomy with gastric tube reconstruction, were studied. The regional tissue oxygen saturation (rSO2) was measured at the tip (point pre 0) and 2, 4, and 6 cm on the anal side of the tip (point pre 1, pre 2, and pre 3, respectively) before the gastric tube was raised to the cervical site through the retrosternal route. After that, rSO2 was measured at the tip, 2 and 4 cm on the anal side of the tip (points post 0, post 1, and post 2), the actual anastomotic site (point AN), and the chest skin as an indicator of whole-body oxygenation . The relationship between rSO2 scores and the rate of anastomotic leakage was determined.
- Keywords
- Esophagectomy, Tissue oxygen saturation, Gastric tube, Anastomotic leakage
- Medical subject headings
- Esophageal Neoplasms, Anastomotic Leak, Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
The tissue oxygen saturation score of gastric tube during esophagectomy
We measured the tissue oxygen saturation (0% - 99%) of several parts of gastric tube during esophagectomy with a use of tissue saturation monitor ''toccare''.
Measured: During surgery
Secondary outcomes (1)
The rate of anastomotic leakage
We investigated the rate of anastomotic leakage in the cervical site (0% - 100%).
Measured: 1month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Nov 2020
- Primary completion30 Mar 2021
- Study completion30 Apr 2021
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.
- 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
- 18 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
- NCT04973046
- Sponsor's protocol ID
- ShizuokaCC rSO2
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Oxygen Saturation During Gastric Tube Reconstruction With Cervical Anastomosis for Esophagectomy
- ClinicalTrials.gov ID
- NCT04973046
- Acronym / sponsor ID
- ShizuokaCC rSO2
- Keywords
- Esophagectomy, Tissue oxygen saturation, Gastric tube, Anastomotic leakage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Shizuoka Cancer CenterUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 22 Jul 2021 (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.
Tissue oxygen saturation monitoring was a useful indicator of blood flow insufficiency in the gastric tube leading to anastomotic leakage during radical esophagectomy.
Detailed description
One cause of anastomotic leakage after radical esophagectomy is blood flow insufficiency at the cervical anastomosis site. .
Eighteen patients, who underwent radical esophagectomy with gastric tube reconstruction, were studied. The regional tissue oxygen saturation (rSO2) was measured at the tip (point pre 0) and 2, 4, and 6 cm on the anal side of the tip (point pre 1, pre 2, and pre 3, respectively) before the gastric tube was raised to the cervical site through the retrosternal route. After that, rSO2 was measured at the tip, 2 and 4 cm on the anal side of the tip (points post 0, post 1, and post 2), the actual anastomotic site (point AN), and the chest skin as an indicator of whole-body oxygenation . The relationship between rSO2 scores and the rate of anastomotic leakage was determined.
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
- This was a retrospective study performed at the Shizuoka Cancer Center between November 2020 and March 2021. All 18 patients who underwent esophagectomy with gastric tube reconstruction were enrolled in the study
Key inclusion criteria (1 listed)
- Patients who underwent esophagectomy with gastric tube reconstruction from November 2020 to March 2021.
Key exclusion criteria (1 listed)
- Patients who underwent esophagectomy with jejunum or colon reconstruction. patients who underwent two-stage operation.
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
The tissue oxygen saturation score of gastric tube during esophagectomy
Time frame: During surgery
We measured the tissue oxygen saturation (0% - 99%) of several parts of gastric tube during esophagectomy with a use of tissue saturation monitor ''toccare''.
1 secondary outcome
The rate of anastomotic leakage
Time frame: 1month 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 22 Jul 2021.
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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.
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 Neoplasms and Esophagostomy Complication, run by Shizuoka Cancer Center at 1 site in Japan.
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 22 Jul 2021. 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 Japan. 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?
The tissue oxygen saturation score of gastric tube during 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 22 Jul 2021.