Video-assisted Thoracoscopic Surgery (VATS)NCT03227380
Morphologic Study of the Intersegmental Plane After Fully Thoracoscopic Segmentectomy
A study testing thoracic densitometry with contrast in people with Video-assisted Thoracoscopic Surgery (VATS) and Segmentectomy, run by Institut Mutualiste Montsouris at 2 sites in France.
Trial summary
The objective of this study is to determine whether stapling adversely affects the pulmonary parenchyma and the vascularisation of the adjacent segments. The aim of our work is to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Video-assisted Thoracoscopic Surgery (VATS), Segmentectomy
- What is being tested?
- thoracic densitometry with contrast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 31 Mar 2017to 30 Aug 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolment in the study will be offered to all patients having undergone a programmed scheduled video-assisted thoracoscopic segmentectomy, whatever the aetiology.
- Men or women aged 18 years or greater
- Absence of severe hepatic insufficiency
- signed and dated informed consent
- candidate for segmentectomy
- Registration in a national healthcare system.
- Women of child-bearing age using effective oral or barrier contraception
Who cannot join
- Proven intolerance to iodinated contrast agents
- Know allergy or non-controlled asthma - pregnancy
- Severe hepatic insufficiency (creatinine clearance < 30ml/min, by Cockroft's method)
- Pregnant or breastfeeding women
- Patients under trusteeship or curators
- Diabetic patients or patients receiving oral antidiabetic medication
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Institut Mutualiste montsouris
Paris, 75014
- Recruiting
Institut mutualiste montsouris
Paris, 75014
Isabelle SAURET
About this study
The objective of this study is to determine whether stapling adversely affects the pulmonary parenchyma and the vascularisation of the adjacent segments. The aim of our work is to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy, 3 or 6 months post-surgery. the investigator will assess venous drainage and the arterial vascularisation of the remaining segments, possible modifications of the adjacent parenchyma and whether there is a defect of pleuro-pulmonary adhesion (residual pneumothorax).
Read the detailed description
Scheduled anatomical segmentectomies are increasingly popular, due to the development of minimally invasive techniques, the increased incidence of early-stage tumours, and the possibility of caring for patients with compromised health and/or limited respiratory function without compromising the oncological outcome, compared to current alternatives such as stereotactic ablative radiotherapy (1).
One of the challenges in the development of the thoracoscopic segmentectomy technique we have published (2-5) is the orientation (6-7) and the division of the intersegmental plane, by contrast to segmentectomy by thoracotomy where this is helped by palpation and the manual traction which can be used on the segment, along the intersegmental vein. The most commonly used technique to separate two adjacent segments remains stapling, despite its high cost and sometimes giving a less anatomical section, with a risk to encroach on the intersegmental vein. Moreover, there can be a partial plicator of the spared segment(s) which could in theory make them less functional.
We have however shown that the postoperative morbidity and mortality rates were much lower than that of patients who had a thoracotomy, dropping from 42% for thoracotomies to 16% for thoracoscopies, the surgical approach being an independent predictive factor for postoperative complications (8).
- Being tested
- thoracic densitometry with contrast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic densitometry with contrastOther
injected CT scan at 3 or 6 months after segmentectomy VATS
| Study group | Role | What they receive |
|---|---|---|
| radiological evaluation | Other | to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy Receives: Other: thoracic densitometry with contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measure of the remaining segments after stapling the intersegmental plane by injected CT scan
The aim of investigators work is to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy, from 3 to 6 months post-surgery. The investigators will assess venous drainage and the arterial vascularisation of the remaining segments, possible modifications of the adjacent parenchyma and whether there is a defect of pleuro-pulmonary adhesion (residual pneumothorax).
The radiological evaluation criteria will be:
- Presence and quantification of a defect in pulmonary expansion (residual pneumothorax)
- Abnormal venous and arterial vascularisation of the remaining segments
- Defect of the pulmonary parenchyma in contact with the staples line (atelectasis, vascularisation defect)
Measured: 3 or 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start31 Mar 2017
- Primary completion20 Feb 2018 (estimated)
- Study completion30 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-assisted Thoracoscopic Surgery (VATS)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients undergo anatomic segmentectomy by video-assisted thoracoscopic surgery (VATS)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227380
- Sponsor's protocol ID
- THO-2016-01
- Status last verified
- Jul 2017
- First submitted
- 19 Jun 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphologic Study of the Intersegmental Plane After Fully Thoracoscopic Segmentectomy
- ClinicalTrials.gov ID
- NCT03227380
- Acronym / sponsor ID
- THO-2016-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 20 Feb 2018 (estimated)
- Study completion
- 30 Aug 2018 (estimated)
- First posted
- 24 Jul 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 objective of this study is to determine whether stapling adversely affects the pulmonary parenchyma and the vascularisation of the adjacent segments. The aim of our work is to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy, 3 or 6 months post-surgery. the investigator will assess venous drainage and the arterial vascularisation of the remaining segments, possible modifications of the adjacent parenchyma and whether there is a defect of pleuro-pulmonary adhesion (residual pneumothorax).
Detailed description
Scheduled anatomical segmentectomies are increasingly popular, due to the development of minimally invasive techniques, the increased incidence of early-stage tumours, and the possibility of caring for patients with compromised health and/or limited respiratory function without compromising the oncological outcome, compared to current alternatives such as stereotactic ablative radiotherapy (1).
One of the challenges in the development of the thoracoscopic segmentectomy technique we have published (2-5) is the orientation (6-7) and the division of the intersegmental plane, by contrast to segmentectomy by thoracotomy where this is helped by palpation and the manual traction which can be used on the segment, along the intersegmental vein. The most commonly used technique to separate two adjacent segments remains stapling, despite its high cost and sometimes giving a less anatomical section, with a risk to encroach on the intersegmental vein. Moreover, there can be a partial plicator of the spared segment(s) which could in theory make them less functional.
We have however shown that the postoperative morbidity and mortality rates were much lower than that of patients who had a thoracotomy, dropping from 42% for thoracotomies to 16% for thoracoscopies, the surgical approach being an independent predictive factor for postoperative complications (8).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients undergo anatomic segmentectomy by video-assisted thoracoscopic surgery (VATS)
| Arm | Type | Receives |
|---|---|---|
| radiological evaluation | Other | Other: thoracic densitometry with contrastto explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Enrolment in the study will be offered to all patients having undergone a programmed scheduled video-assisted thoracoscopic segmentectomy, whatever the aetiology.
- Men or women aged 18 years or greater
- Absence of severe hepatic insufficiency
- signed and dated informed consent
- candidate for segmentectomy
Key exclusion criteria (6 listed)
- Proven intolerance to iodinated contrast agents
- Know allergy or non-controlled asthma - pregnancy
- Severe hepatic insufficiency (creatinine clearance < 30ml/min, by Cockroft's method)
- Pregnant or breastfeeding women
- Patients under trusteeship or curators
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 |
|---|---|---|
| thoracic densitometry with contrastinjected CT scan at 3 or 6 months after segmentectomy VATS | Other | radiological evaluation |
Primary outcome
The measure of the remaining segments after stapling the intersegmental plane by injected CT scan
Time frame: 3 or 6 months after surgery
The aim of investigators work is to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy, from 3 to 6 months post-surgery. The investigators will assess venous drainage and the arterial vascularisation of the remaining segments, possible modifications of the adjacent parenchyma and whether there is a defect of pleuro-pulmonary adhesion (residual pneumothorax). The radiological evaluation criteria will be: * Presence and quantification of a defect in pulmonary expansion (residual pneumothorax) * Abnormal venous and arterial vascularisation of the remaining segments * Defect of the pulmonary parenchyma in contact with the staples line (atelectasis, vascularisation defect)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracic densitometry with contrast in people with Video-assisted Thoracoscopic Surgery (VATS) and Segmentectomy, run by Institut Mutualiste Montsouris at 2 sites in France.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Jul 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agathe SEGUIN-GIVELET, MD (0156616240, agathe.seguin-givelet@imm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measure of the remaining segments after stapling the intersegmental plane by injected CT scan (time frame: 3 or 6 months 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 24 Jul 2017.