An interventional study of Doppler ultrasound in Upper Aero-intestinal Tract Cancer, Supraclavicular Flap and Anterior Thoracic Perforator Artery, sponsored by Ramsay Générale de Santé. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Ramsay Générale de Santé · Not applicable, Interventional, and Basic science
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.
Ramsay Générale de Santé is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Procedure: Doppler ultrasound
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.
Existence of the anterior thoracic perforating artery
existence of the anterior thoracic perforating artery (PATA) : yes/no
Time frame: 1 hour
Presence of the anterior thoracic perforating artery
the presence of the anterior thoracic perforating artery on the left and right,
Time frame: 1 hour
Origin of anterior thoracic perforating artery
Origin of anterior thoracic perforating artery : transverse cervical trunk/ supraclavicular artery
Time frame: 1 hour
Started Sep 2023 (actual). Primary completion is estimated for Mar 2024, 6 months after the start.
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