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Trial Title:
Anterior Thoracic Perforating Artery (PATA); Systematization and Applications in Reconstructive Surgery of the Head and Neck
NCT ID:
NCT06140160
Condition:
Upper Aero-intestinal Tract Cancer
Supraclavicular Flap
Anterior Thoracic Perforator Artery
Conditions: Official terms:
Aortic Dissection
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Doppler ultrasound
Description:
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.
Arm group label:
Patient with an indication for Doppler ultrasound of the supra-aortic trunks
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. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital Privé Jean Mermoz
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Recruiting
Contact:
Last name:
Benjamin Peyrachon, MD
Phone:
06 63 12 95 72
Email:
benjamin.peyrachon@gmail.com
Start date:
September 19, 2023
Completion date:
September 19, 2024
Lead sponsor:
Agency:
Ramsay Générale de Santé
Agency class:
Other
Collaborator:
Agency:
mermoz hospital
Agency class:
Other
Source:
Ramsay Générale de Santé
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06140160
