Head Neck NeoplasmsNCT05749120
Recipient Vessels for Free Tissue Flaps in Advanced Oncologic Defects of the Midface and Scalp
A study testing Recipient vessel selected for microanastomosis in people with Head Neck Neoplasms, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to compare the postoperative outcomes based on superficial temporal versus cervical recipient vessels for midface and scalp advanced oncologic defects using free tissue flap for reconstruction. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Head Neck Neoplasms
- What is being tested?
- Recipient vessel selected for microanastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2018to 30 Jun 2022
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients submitted to subtotal, total, or extensive radical oncologic maxillectomy, or advanced scalp oncologic defect
- Complete medical records for at least 30 days after the intervention
- Patients eligible for microanastomosis in both cervical and superficial temporal recipient vessels
Who cannot join
- Pregnancy or breastfeeding;
- Serious diseases (sepsis, renal and hepatic failure, severe cardiovascular diseases, chronic obstructive pulmonary disease);
- Patients with HIV (human immunodeficiency virus) with or without AIDS (acquired immunodeficiency syndrome);
- Patients with synchronous malignant neoplasms of the upper airway-digestive tract;
- Patients who died within a period of less than 30 days or who were lost to follow-up for the same period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recipient Vessels for Free Tissue Flaps in Advanced Oncologic Defects of the Midface and Scalp: Prospective Randomized Study
The goal of this clinical trial is to compare the postoperative outcomes based on superficial temporal versus cervical recipient vessels for midface and scalp advanced oncologic defects using free tissue flap for reconstruction.
The main question it aims to answer is:
Read more
- Which recipient vessel is most suitable for performing microanastomosis using free flaps for advanced midface and scalp oncologic defect.
Participants will be undergo resection of advanced malignant tumors of the midface and scalp with subsequent oncological reconstruction using free tissue flap.
Researchers will compare two groups where those in whom superficial temporal vessels will be used as the recipient vessels (group A) and those in whom cervical vessels will be used as the recipient vessels (group B) to see if there is a recipient vessel who is most suitable for performing microanastomosis using free flaps for advanced midface and scalp oncologic defect.
Read the detailed description
Advanced oncologic defects of the midface and scalp are a significant challenge to the reconstructive head neck surgeon, who must consider the need for midfacial projection, rehabilitation, and function restoration. Free flaps reconstruction in the midface and scalp region are the gold standard for advanced cases. There is no consensus in the literature on which recipient vessel is most suitable for performing microanastomosis using free flaps for advanced midface and scalp oncologic defect. The aim of this clinical trial is prospectively compare the results of microvascular flap reconstruction of midface and scalp advanced oncologic defects using superficial temporal versus cervical as recipient vessels. This is a parallel trial with permuted block randomization of patients who will be undergone a midface and scalp oncologic reconstruction with free tissue flap. Two groups will be analyzed: those in whom superficial temporal vessels will be used as the recipient vessels (group A) and those in whom cervical vessels will be used as the recipient vessels (group B). Allocation ratio will de 1:1 participants. Patient gender and age, cause and localization of the defect, flap choice for reconstruction, recipient vessels, intraoperative outcome, postoperative course, and complications were recorded and analyzed. Considering that this is a disease with rare staging, the calculated sample size was 26, but it will be increased by 30% (total of 34 participants who will be selected) since the death rate of these patients ranges from 8-25% A Fisher's exact test will be used to compare outcomes between the 2 groups.
- Conditions
- Head Neck Neoplasms
- Being tested
- Recipient vessel selected for microanastomosis
- Keywords
- microanastomosis, free tissue flaps, cervical vessels, superficial temporal vessels, advanced reconstruction
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recipient vessel selected for microanastomosisProcedure or surgery
Free tissue flaps harvesting and microanastomosis were performed by the same surgeon and in a similar way in both group. Postoperative course, and complications were recorded and analyzed.
| Study group | Role | What they receive |
|---|---|---|
| Superficial temporal recipient vessels (group A) | Experimental | Participants in whom superficial temporal vessels were used as the recipient vessels. Receives: Procedure: Recipient vessel selected for microanastomosis |
| Cervical recipient vessels (group B) | Active comparator | Participants in whom cervical vessels were used as the recipient vessels. Receives: Procedure: Recipient vessel selected for microanastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the overall flap survival rate after the microanastomosis
Adequate perfusion of the free tissue flap was assessed using Doppler flowmetry, flap bleeding time after puncture, color, texture and turgor. Both venous and arterial thrombosis were evaluated by these methods in order to detect whether there was any evidence of low or absence of vascular perfusion of the flap.
Measured: Participants were assessed twice a day for the first 10 days after the intervention and then weekly for 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Apr 2018
- Primary completion30 Apr 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Head Neck NeoplasmsStudies of the same condition, open and under way.
- 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
- Model description
- Parallel group trial design with allocation ratio of 1:1 and permuted block randomization
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bruno Albuquerque, MD, Instituto Nacional de Cancer, Brazil
- Investigators
- Bruno A Sousa, MD, Principal investigator, Brazilian National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749120
- Sponsor's protocol ID
- 89042418.7.0000.5274
- Status last verified
- Mar 2023
- First submitted
- 18 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Awwad L, Obed D, Vogt PM, Kaltenborn A, Koenneker S. Superficial Temporal Recipient Vessels for Craniofacial Microvascular Free-Flaps. J Craniofac Surg. 2022 Sep 1;33(6):e652-e657. doi: 10.1097/SCS.0000000000008768. Epub 2022 Jul 22.
PubMed 35864586Mata Ribeiro L, Tsao CK, Hung YL, Chu CH, Lin LC, Lin MH, Peng C, Cheong DC, Hung SY, Liao CT. Venous Size Discrepancy Is a Critical Factor When Using Superficial Temporal Vessels as Recipient Vessels for Free Flaps. J Reconstr Microsurg. 2022 Oct;38(8):654-663. doi: 10.1055/s-0042-1743165. Epub 2022 Feb 25.
PubMed 35213928Sudirman SR, Shih HS, Chen JC, Feng KM, Jeng SF. Superficial temporal vessels, both anterograde and retrograde limbs, are viable recipient vessels for recurrent head and neck reconstruction in patients with frozen neck. Head Neck. 2019 Oct;41(10):3618-3623. doi: 10.1002/hed.25886. Epub 2019 Jul 26.
PubMed 31347733Mattine S, Payne KFB. The evolving role of the superficial temporal vessels as anastomotic recipients in challenging microvascular reconstruction of the upper two-thirds of the face. J Plast Reconstr Aesthet Surg. 2022 Sep;75(9):3330-3339. doi: 10.1016/j.bjps.2022.04.089. Epub 2022 May 2.
PubMed 35710778
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recipient Vessels for Free Tissue Flaps in Advanced Oncologic Defects of the Midface and Scalp: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05749120
- Acronym / sponsor ID
- 89042418.7.0000.5274
- Conditions
- Head Neck Neoplasms
- Keywords
- microanastomosis, free tissue flaps, cervical vessels, superficial temporal vessels, advanced reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 1 Mar 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 goal of this clinical trial is to compare the postoperative outcomes based on superficial temporal versus cervical recipient vessels for midface and scalp advanced oncologic defects using free tissue flap for reconstruction.
The main question it aims to answer is:
- Which recipient vessel is most suitable for performing microanastomosis using free flaps for advanced midface and scalp oncologic defect.
Participants will be undergo resection of advanced malignant tumors of the midface and scalp with subsequent oncological reconstruction using free tissue flap.
Researchers will compare two groups where those in whom superficial temporal vessels will be used as the recipient vessels (group A) and those in whom cervical vessels will be used as the recipient vessels (group B) to see if there is a recipient vessel who is most suitable for performing microanastomosis using free flaps for advanced midface and scalp oncologic defect.
Detailed description
Advanced oncologic defects of the midface and scalp are a significant challenge to the reconstructive head neck surgeon, who must consider the need for midfacial projection, rehabilitation, and function restoration. Free flaps reconstruction in the midface and scalp region are the gold standard for advanced cases. There is no consensus in the literature on which recipient vessel is most suitable for performing microanastomosis using free flaps for advanced midface and scalp oncologic defect. The aim of this clinical trial is prospectively compare the results of microvascular flap reconstruction of midface and scalp advanced oncologic defects using superficial temporal versus cervical as recipient vessels. This is a parallel trial with permuted block randomization of patients who will be undergone a midface and scalp oncologic reconstruction with free tissue flap. Two groups will be analyzed: those in whom superficial temporal vessels will be used as the recipient vessels (group A) and those in whom cervical vessels will be used as the recipient vessels (group B). Allocation ratio will de 1:1 participants. Patient gender and age, cause and localization of the defect, flap choice for reconstruction, recipient vessels, intraoperative outcome, postoperative course, and complications were recorded and analyzed. Considering that this is a disease with rare staging, the calculated sample size was 26, but it will be increased by 30% (total of 34 participants who will be selected) since the death rate of these patients ranges from 8-25% A Fisher's exact test will be used to compare outcomes between the 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel group trial design with allocation ratio of 1:1 and permuted block randomization
| Arm | Type | Receives |
|---|---|---|
| Superficial temporal recipient vessels (group A) | Experimental | Procedure: Recipient vessel selected for microanastomosisParticipants in whom superficial temporal vessels were used as the recipient vessels. |
| Cervical recipient vessels (group B) | Active comparator | Procedure: Recipient vessel selected for microanastomosisParticipants in whom cervical vessels were used as the recipient vessels. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients submitted to subtotal, total, or extensive radical oncologic maxillectomy, or advanced scalp oncologic defect
- Complete medical records for at least 30 days after the intervention
- Patients eligible for microanastomosis in both cervical and superficial temporal recipient vessels
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding;
- Serious diseases (sepsis, renal and hepatic failure, severe cardiovascular diseases, chronic obstructive pulmonary disease);
- Patients with HIV (human immunodeficiency virus) with or without AIDS (acquired immunodeficiency syndrome);
- Patients with synchronous malignant neoplasms of the upper airway-digestive tract;
- Patients who died within a period of less than 30 days or who were lost to follow-up for the same period
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 |
|---|---|---|
| Recipient vessel selected for microanastomosisFree tissue flaps harvesting and microanastomosis were performed by the same surgeon and in a similar way in both group. Postoperative course, and complications were recorded and analyzed. | Procedure or surgery | Cervical recipient vessels (group B), Superficial temporal recipient vessels (group A) |
Primary outcome
To compare the overall flap survival rate after the microanastomosis
Time frame: Participants were assessed twice a day for the first 10 days after the intervention and then weekly for 4 weeks.
Adequate perfusion of the free tissue flap was assessed using Doppler flowmetry, flap bleeding time after puncture, color, texture and turgor. Both venous and arterial thrombosis were evaluated by these methods in order to detect whether there was any evidence of low or absence of vascular perfusion of the flap.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Results publication: PubMed 35864586Awwad L, Obed D, Vogt PM, Kaltenborn A, Koenneker S. Superficial Temporal Recipient Vessels for Craniofacial Microvascular Free-Flaps. J Craniofac Surg. 2022 Sep 1;33(6):e652-e657. doi: 10.1097/SCS.0000000000008768. Epub 2022 Jul 22.
- Results publication: PubMed 35213928Mata Ribeiro L, Tsao CK, Hung YL, Chu CH, Lin LC, Lin MH, Peng C, Cheong DC, Hung SY, Liao CT. Venous Size Discrepancy Is a Critical Factor When Using Superficial Temporal Vessels as Recipient Vessels for Free Flaps. J Reconstr Microsurg. 2022 Oct;38(8):654-663. doi: 10.1055/s-0042-1743165. Epub 2022 Feb 25.
- Results publication: PubMed 31347733Sudirman SR, Shih HS, Chen JC, Feng KM, Jeng SF. Superficial temporal vessels, both anterograde and retrograde limbs, are viable recipient vessels for recurrent head and neck reconstruction in patients with frozen neck. Head Neck. 2019 Oct;41(10):3618-3623. doi: 10.1002/hed.25886. Epub 2019 Jul 26.
- Results publication: PubMed 35710778Mattine S, Payne KFB. The evolving role of the superficial temporal vessels as anastomotic recipients in challenging microvascular reconstruction of the upper two-thirds of the face. J Plast Reconstr Aesthet Surg. 2022 Sep;75(9):3330-3339. doi: 10.1016/j.bjps.2022.04.089. Epub 2022 May 2.
- Individual participant dataSharing planned: No
Related trials for Head Neck Neoplasms
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
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.
Bruno A Sousa, MD principal investigator
Brazilian National Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recipient vessel selected for microanastomosis in people with Head Neck Neoplasms, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 7 Mar 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare the overall flap survival rate after the microanastomosis (time frame: Participants were assessed twice a day for the first 10 days after the intervention and then weekly for 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05749120, which also lists 4 linked publications.
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 7 Mar 2023.