Upper Aero-intestinal Tract CancerPATA-FixNCT06140160
Anterior Thoracic Perforating Artery (PATA); Systematization and Applications in Reconstructive Surgery of the Head and Neck
A study testing Doppler ultrasound in people with Upper Aero-intestinal Tract Cancer and Supraclavicular Flap, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The use of cutaneous or fasciocutaneous flaps is daily in reconstructive surgery ENT in patients with cancers of the upper aero-digestive tract (AVDS). Cancers of the oral cavity require reconstructions with thin flaps in order to best preserve the functions of swallowing and phonation via patients' joints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Aero-intestinal Tract Cancer, Supraclavicular Flap, Anterior Thoracic Perforator Artery
- What is being tested?
- Doppler ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2023to 19 Sep 2024
- 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
- Patient, man or woman over 18 years old,
- Patient admitted for an indication for Doppler ultrasound of the supra-aortic trunks (previously prescribed for any medical reason),
- Patient having received written information and collection of the non-opposition of the patient to participate in the study,
- Patient affiliated or beneficiary of a security regime social.
Who cannot join
- Minor patient,
- History of cervical surgery,
- Patients who have an inaccessible morphology to an exploration of the lower lateral cervical region, high, below and above the right and left clavicle such as the small necks, and/or with dermato-sclerosis,
- Patients who do not have the intellectual or physical allowing them to give their consent,
- Patient in period of exclusion due to another research still in progress at the time of inclusion,
- Refusal to participate in the patient's study,
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- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative,
- Pregnant, breastfeeding or parturient woman,
- Patient hospitalized without consent.
Trial locations and contacts
1 site in 1 country.
Marie Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Hôpital Privé Jean Mermoz
Lyon, 69008
Benjamin Peyrachon, MD, 06 63 12 95 72, benjamin.peyrachon@gmail.com
About this study
The use of cutaneous or fasciocutaneous flaps is daily in reconstructive surgery ENT in patients with cancers of the upper aero-digestive tract (AVDS). Cancers of the oral cavity require reconstructions with thin flaps in order to best preserve the functions of swallowing and phonation via patients' joints. Indeed, the flaps are inert tissues, which can only be mobilized by the residual muscles of the patients' tongue: their lightness and finesse facilitates this mobilization. The use of free flaps is regular but requires micro-surgical skill of the operator as well as a preserved general condition of the patients and appropriate post-operative care. Alternatively, there are some pedicled flaps with the appropriate thickness to reconstruct extensive loss of substances from the oral cavity in a suitable manner: the supraclavicular flap, the suprahyoid flap, the submental flap and the myo-mucosal flap pedicled on the facial artery being more limited in size. The creation of an anterior thoracic fasciocutaneous flap, pedicled on the anterior thoracic perforating artery (PATA) seems to be another suitable therapeutic option. Only one preliminary Chinese study describes it, on only eleven patients. According to the authors, it would offer a wide skin palette (up to 15x10cm). Its long pedicle (on average 9.2cm) would allow a significant axis of rotation so that the flap easily reaches the oral cavity. The authors underline the variability of the origin of this perforator, arising depending on the case from the transverse cervical trunk (9 cases) or from the supraclavicular artery (2 cases), branches of division of the thyro-cervical trunk.
However, when the PATA arises from the supraclavicular artery, its interest could be limited because the creation of a PATA perforator flap could compromise the creation of a secondary supraclavicular flap.
Thus, this study aims to clarify the feasibility of harvesting the PATA flap in the greatest number of patients. The objective is to study the variations of the anterior thoracic perforating artery necessary for the creation of this flap, by specifying its vascularization territory and its characteristics.
- Conditions
- Upper Aero-intestinal Tract Cancer, Supraclavicular Flap, Anterior Thoracic Perforator Artery
- Being tested
- Doppler ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasoundProcedure or surgery
To carry out an additional measurement using Doppler ultrasound (non-invasive examination). Doppler ultrasound measurements of the diameter and length of the perforating artery using a high-frequency Doppler ultrasound probe following a Doppler ultrasound of the supra-aortic trunks.
| Study group | Role | What they receive |
|---|---|---|
| Patient with an indication for Doppler ultrasound of the supra-aortic trunks | Experimental | Not described Receives: Procedure: Doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Existence of the anterior thoracic perforating artery
existence of the anterior thoracic perforating artery (PATA) : yes/no
Measured: 1 hour
Presence of the anterior thoracic perforating artery
the presence of the anterior thoracic perforating artery on the left and right,
Measured: 1 hour
Origin of anterior thoracic perforating artery
Origin of anterior thoracic perforating artery : transverse cervical trunk/ supraclavicular artery
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start19 Sep 2023
- Primary completion19 Mar 2024 (estimated)
- Study completion19 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Aero-intestinal Tract CancerStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- mermoz hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140160
- Sponsor's protocol ID
- 2023-A00784-41
- Acronym
- PATA-Fix
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Thoracic Perforating Artery (PATA); Systematization and Applications in Reconstructive Surgery of the Head and Neck
- ClinicalTrials.gov ID
- NCT06140160
- Acronym / sponsor ID
- PATA-Fix / 2023-A00784-41
- Conditions
- Upper Aero-intestinal Tract Cancer, Supraclavicular Flap, Anterior Thoracic Perforator Artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- mermoz hospital
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 19 Mar 2024 (estimated)
- Study completion
- 19 Sep 2024 (estimated)
- First posted
- 18 Nov 2023 (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 use of cutaneous or fasciocutaneous flaps is daily in reconstructive surgery ENT in patients with cancers of the upper aero-digestive tract (AVDS). Cancers of the oral cavity require reconstructions with thin flaps in order to best preserve the functions of swallowing and phonation via patients' joints. Indeed, the flaps are inert tissues, which can only be mobilized by the residual muscles of the patients' tongue: their lightness and finesse facilitates this mobilization. The use of free flaps is regular but requires micro-surgical skill of the operator as well as a preserved general condition of the patients and appropriate post-operative care. Alternatively, there are some pedicled flaps with the appropriate thickness to reconstruct extensive loss of substances from the oral cavity in a suitable manner: the supraclavicular flap, the suprahyoid flap, the submental flap and the myo-mucosal flap pedicled on the facial artery being more limited in size. The creation of an anterior thoracic fasciocutaneous flap, pedicled on the anterior thoracic perforating artery (PATA) seems to be another suitable therapeutic option. Only one preliminary Chinese study describes it, on only eleven patients. According to the authors, it would offer a wide skin palette (up to 15x10cm). Its long pedicle (on average 9.2cm) would allow a significant axis of rotation so that the flap easily reaches the oral cavity. The authors underline the variability of the origin of this perforator, arising depending on the case from the transverse cervical trunk (9 cases) or from the supraclavicular artery (2 cases), branches of division of the thyro-cervical trunk.
However, when the PATA arises from the supraclavicular artery, its interest could be limited because the creation of a PATA perforator flap could compromise the creation of a secondary supraclavicular flap.
Thus, this study aims to clarify the feasibility of harvesting the PATA flap in the greatest number of patients. The objective is to study the variations of the anterior thoracic perforating artery necessary for the creation of this flap, by specifying its vascularization territory and its characteristics.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with an indication for Doppler ultrasound of the supra-aortic trunks | Experimental | Procedure: Doppler ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient, man or woman over 18 years old,
- Patient admitted for an indication for Doppler ultrasound of the supra-aortic trunks (previously prescribed for any medical reason),
- Patient having received written information and collection of the non-opposition of the patient to participate in the study,
- Patient affiliated or beneficiary of a security regime social.
Key exclusion criteria (9 listed)
- Minor patient,
- History of cervical surgery,
- Patients who have an inaccessible morphology to an exploration of the lower lateral cervical region, high, below and above the right and left clavicle such as the small necks, and/or with dermato-sclerosis,
- Patients who do not have the intellectual or physical allowing them to give their consent,
- Patient in period of exclusion due to another research still in progress at the time of inclusion,
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 |
|---|---|---|
| Doppler ultrasoundTo carry out an additional measurement using Doppler ultrasound (non-invasive examination). Doppler ultrasound measurements of the diameter and length of the perforating artery using a high-frequency Doppler ultrasound probe following a Doppler ultrasound of the supra-aortic trunks. | Procedure or surgery | Patient with an indication for Doppler ultrasound of the supra-aortic trunks |
Primary outcome
Existence of the anterior thoracic perforating artery
Time frame: 1 hour
existence of the anterior thoracic perforating artery (PATA) : yes/no
Presence of the anterior thoracic perforating artery
Time frame: 1 hour
the presence of the anterior thoracic perforating artery on the left and right,
Origin of anterior thoracic perforating artery
Time frame: 1 hour
Origin of anterior thoracic perforating artery : transverse cervical trunk/ supraclavicular artery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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.
Marie Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler ultrasound in people with Upper Aero-intestinal Tract Cancer and Supraclavicular Flap, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site 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 4 inclusion and 9 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 18 Nov 2023. 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 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 Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Existence of the anterior thoracic perforating artery (time frame: 1 hour). The study lists 3 primary outcomes in all. 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 18 Nov 2023.