Tongue Squamous Cell Carcinoma Clinical Trial
Official title:
Oncological Outcome of Contralateral Submental Artery Island Flap Versus Primary Closure in Tongue Squamous Cell Carcinoma (Randomize Noninferiority Clinical Trial)
The purpose of this study is to compare the oncological and functional results of the contralateral submental flap with primary closure for reconstruction of tongue squamous cell carcinoma.
Resection of tongue malignancies remains one of most surgical challenges because of its
adverse effects on speech articulation, swallowing, and eventual quality of life.
A variety of local flaps such as infrahyoid flap and the Platysma flap, and free flaps like
the radial forearm and anterolateral thigh (ALT) flap have been available for reconstruction
of tongue. However, all these options have their shortcomings.
When reconstructing particular oral cavity defect the tissue used should be reliable;
functional and cosmetically acceptable with minimum donor site morbidity and match the
recipient site in terms of color, texture and thickness. The submental island flap (SMI-flap)
which has been first introduced by Martin et al in 1990, meets all these requirements and due
to its optimal location, ease of harvest, and favorable arc of rotation, the SMI-flap has
gained acceptance as a simple, reliable and convenient to repair defects of tongue and oral
cavity cancer.
The oncological safety of submental flap in oral cancer patient still debate, this is due to
its proximity to the main nodal basins of levels 1A and 1B and the possibility of transfer of
occult metastatic lymph node to the recipient site during reconstruction.
in addition some authors has not been recommended submental flap for cases with clinically or
radiologically established nodal disease as it might compromise the oncological resection and
continuity of neck dissection and so alternative options should be considered. The
contralateral submental island flap (CSMI-flap) is believed to offer such alternate option
for patient with contralateral negative node.
our a priori-hypothesis is that utilization of the CSMI-flap is not related to an altered
prognosis in tongue squamous cell carcinoma patients. In order to test this hypothesis, we
will compare the oncological outcome of group of patients receive CSMI-flap with the results
of another group of patients not receive CSMI-flap and close tongue defect by primary
closure, which is another well-established concept of management tongue cancer defect.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04333537 -
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
|
Phase 2/Phase 3 |