Tongue Squamous Cell CarcinomaNCT03440151
Oncological Outcome of Contralateral Submental Artery Island Flap Versus Primary Closure in Tongue Squamous Cell Carcinoma
A study testing contralateral submental flap for tongue cancer defect and primary closure for tongue cancer defect in people with Tongue Squamous Cell Carcinoma, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tongue Squamous Cell Carcinoma
- What is being tested?
- contralateral submental flap for tongue cancer defect and primary closure for tongue cancer defect
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Feb 2018to Nov 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with T1\&T2 tongue squamous cell carcinoma.
Who cannot join
- Patients with contralateral N positive.
- Patients with previous neck surgery that interrupt contralateral facial artery or vein.
- Patients with prior radiotherapy to the neck.
- Patients with lesions crossing the midline, or those reaching the base of tongue requiring total glossectomy.
- Patients second primary tumors at the time of diagnosis.
- Patient with recurrent tongue squamous cell carcinoma.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Tongue Squamous Cell Carcinoma
- Being tested
- contralateral submental flap for tongue cancer defect, primary closure for tongue cancer defect
- Keywords
- Tongue Squamous Cell Carcinoma,, Contralateral Submental Flap, Submental Flap, oncological safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contralateral submental flap for tongue cancer defectProcedure or surgery
Tumor resection will be star first this accomplish with 1- 2 cm safety margin, Simultaneous neck dissection will be performed in all patient.
Flap dissection begins from the opposite side of the pedicle in the subplatysmal plane. Then the level 1a is dissected, the distal facial artery and facial vein to the branching point of the submental pedicle are ligated. The anterior belly of the digastric muscle on ipsilateral to the pedicle and strip of mylohyoid muscle will dissected off the mandible and the hyoid bone and included with the flap. This results in complete mobilization of the flap.A tunnel will be created between the defect and the donor site and the skin paddle of the flap will be transported through it intraorally and the flap is insetted.
primary closure for tongue cancer defectProcedure or surgery
Under general anesthesia the tumor will be resected with Preserving floor of mouth mucosa as much as possible to avoid restriction of tongue mobility. After Obtaining meticulous hemostasis, the tongue defect will be closed in layers.
| Study group | Role | What they receive |
|---|---|---|
| contralateral submental flap for tongue cancer defect | Experimental | Not described Receives: Procedure: contralateral submental flap for tongue cancer defect |
| primary closure for tongue cancer defect | Active comparator | Not described Receives: Procedure: primary closure for tongue cancer defect |
What is being measured
The primary outcome is the main question the study is designed to answer.
local recurrence
Measured: at least one year post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start21 Feb 2018
- Primary completionOct 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tongue Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer mohammed jamali, Cairo University
- Investigators
- Omer M Jamali, phd student, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440151
- Sponsor's protocol ID
- 513
- Status last verified
- Apr 2020
- First submitted
- 14 Feb 2018
- Last updated
- 14 Apr 2020
- 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 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncological Outcome of Contralateral Submental Artery Island Flap Versus Primary Closure in Tongue Squamous Cell Carcinoma (Randomize Noninferiority Clinical Trial)
- ClinicalTrials.gov ID
- NCT03440151
- Acronym / sponsor ID
- 513
- Conditions
- Tongue Squamous Cell Carcinoma
- Keywords
- Tongue Squamous Cell Carcinoma,, Contralateral Submental Flap, Submental Flap, oncological safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 20 Feb 2018 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| contralateral submental flap for tongue cancer defect | Experimental | Procedure: contralateral submental flap for tongue cancer defect |
| primary closure for tongue cancer defect | Active comparator | Procedure: primary closure for tongue cancer defect |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with T1\&T2 tongue squamous cell carcinoma.
Key exclusion criteria (6 listed)
- Patients with contralateral N positive.
- Patients with previous neck surgery that interrupt contralateral facial artery or vein.
- Patients with prior radiotherapy to the neck.
- Patients with lesions crossing the midline, or those reaching the base of tongue requiring total glossectomy.
- Patients second primary tumors at the time of diagnosis.
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 |
|---|---|---|
| contralateral submental flap for tongue cancer defectTumor resection will be star first this accomplish with 1- 2 cm safety margin, Simultaneous neck dissection will be performed in all patient. Flap dissection begins from the opposite side of the pedicle in the subplatysmal plane. Then the level 1a is dissected, the distal facial artery and facial vein to the branching point of the submental pedicle are ligated. The anterior belly of the digastric muscle on ipsilateral to the pedicle and strip of mylohyoid muscle will dissected off the mandible and the hyoid bone and included with the flap. This results in complete mobilization of the flap.A tunnel will be created between the defect and the donor site and the skin paddle of the flap will be transported through it intraorally and the flap is insetted. | Procedure or surgery | contralateral submental flap for tongue cancer defect |
| primary closure for tongue cancer defectUnder general anesthesia the tumor will be resected with Preserving floor of mouth mucosa as much as possible to avoid restriction of tongue mobility. After Obtaining meticulous hemostasis, the tongue defect will be closed in layers. | Procedure or surgery | primary closure for tongue cancer defect |
Primary outcome
local recurrence
Time frame: at least one year post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- 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.
Omer M Jamali, phd student principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contralateral submental flap for tongue cancer defect and primary closure for tongue cancer defect in people with Tongue Squamous Cell Carcinoma, run by Cairo University at 1 site in Egypt.
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 1 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 14 Apr 2020. 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local recurrence (time frame: at least one year post operative). 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 14 Apr 2020.