Circulatory; ChangeNCT03724162
Evaluation of the Circulatory Status of Stomach Tube and Gastrooesophageal Anastomosis
An observational study of Circulatory; Change and Microcirculation, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
The incidence of anastomotic leaks after gastroesophageal anastomosis after thoracolaparoscopic cancer esophagus surgery is high at the Oslo University Hospital. The patients selected for operation shall be investigated for microcirculatory changes at the thoracic anastomosis site and followed up for any post… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Circulatory; Change, Microcirculation
- How many people
- 12 participants
- Where
- 2 sitesNorway
- Study dates
- 16 Jul 2018to 1 Oct 2020
- How long will I take part?
- 6 Months
- 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
- Child, Adult, Older adult
Study population: Only subjects selected for thoracolaparoscopic operation shall be included in this study.
Who may be able to join
- Patients with oesophageal carcinoma planned to have thoracolaparoscopic operation and thoracic gastroesophageal anastomosis shall be included.
- Exclusion Criteria: Patients who do not give written consent will not be included.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo University Hospital
Oslo, 0424
Department of vascular surgery, Oslo University Hospital
Oslo
About this study
Official title: Impact of Circulatory Changes on Thoracic Anastomosis in Patients Undergoing Thoracolaparoscopic Surgery for Oesophageal Carcinoma
The incidence of anastomotic leaks after gastroesophageal anastomosis after thoracolaparoscopic cancer esophagus surgery is high at the Oslo University Hospital. The patients selected for operation shall be investigated for microcirculatory changes at the thoracic anastomosis site and followed up for any post operative anastomotic leaks.
Read the detailed description
- Microcirculation shall be evaluated during the operation with trans serosal laser doppler flowmetry and visible light spectroscopy (LDFVLS). Different anatomical areas of the stomach and gastric tube shall be examined With LDFVLS to find any changes in SO2, rHb, flow, and velocity. Repeat measurements shall be taken to compare them with the baseline measurements.
- Conditions
- Circulatory; Change, Microcirculation
- Keywords
- cancer oesophagus
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of local microcirculatory changes on the thoracooesophegial anastomosis after cancer oesophagus surgery
Repeated measurements of microcirculation With laser dopper flometer and visible light spectrometry shall be performed trans serosally of the stoach and gastric tube to register changes in microcirculation. Patients shall be followed up for anastomotic leaks. Besides CT angiography shall be performed before surgery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start16 Jul 2018
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory; ChangeStudies of the same condition, open and under way.
- More trials run by Oslo 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
- Prospective
- Enrolment
- 12 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Sajid Hussain Kazmi, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724162
- Sponsor's protocol ID
- LDFLVS Ca oesophagus
- Status last verified
- Oct 2020
- First submitted
- 26 Jul 2018
- Last updated
- 6 Oct 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 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Circulatory Changes on Thoracic Anastomosis in Patients Undergoing Thoracolaparoscopic Surgery for Oesophageal Carcinoma
- ClinicalTrials.gov ID
- NCT03724162
- Acronym / sponsor ID
- LDFLVS Ca oesophagus
- Conditions
- Circulatory; Change, Microcirculation
- Keywords
- cancer oesophagus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 30 Oct 2018 (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 incidence of anastomotic leaks after gastroesophageal anastomosis after thoracolaparoscopic cancer esophagus surgery is high at the Oslo University Hospital. The patients selected for operation shall be investigated for microcirculatory changes at the thoracic anastomosis site and followed up for any post operative anastomotic leaks.
Detailed description
- Microcirculation shall be evaluated during the operation with trans serosal laser doppler flowmetry and visible light spectroscopy (LDFVLS). Different anatomical areas of the stomach and gastric tube shall be examined With LDFVLS to find any changes in SO2, rHb, flow, and velocity. Repeat measurements shall be taken to compare them with the baseline measurements.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Only subjects selected for thoracolaparoscopic operation shall be included in this study.
Key inclusion criteria (2 listed)
- Patients with oesophageal carcinoma planned to have thoracolaparoscopic operation and thoracic gastroesophageal anastomosis shall be included.
- Exclusion Criteria: Patients who do not give written consent will not be included.
Key exclusion criteria (0 listed)
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
Impact of local microcirculatory changes on the thoracooesophegial anastomosis after cancer oesophagus surgery
Time frame: 6 months
Repeated measurements of microcirculation With laser dopper flometer and visible light spectrometry shall be performed trans serosally of the stoach and gastric tube to register changes in microcirculation. Patients shall be followed up for anastomotic leaks. Besides CT angiography shall be performed before 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 6 Oct 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulatory; Change and Microcirculation, run by Oslo University Hospital at 2 sites in Norway.
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 0 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 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Impact of local microcirculatory changes on the thoracooesophegial anastomosis after cancer oesophagus surgery (time frame: 6 months). 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 6 Oct 2020.