Parotid TumorNCT05401370
Role of Methylene Blue in Parotid Surgery
A study testing Methylene blue dye in people with Parotid Tumor, run by Assiut University at 1 site in Egypt.
Trial summary
usefulness of the methylene blue staining for identification of facial nerve in parotid gland surgery Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parotid Tumor
- What is being tested?
- Methylene blue dye
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2022to Dec 2023
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All new cases presented with primary benign or malignant parotid tumors.
Who cannot join
- Cases with secondary tumors of the gland
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university
Asyut
Ismail Ali Mohamed, 01124153353, ismailali203040@gmail.com
About this study
Official title: Role of Methylene Blue Dye in Identification of Facial Nerve in Parotid Surgery
usefulness of the methylene blue staining for identification of facial nerve in parotid gland surgery
Read the detailed description
The specific surgical morbidity remains significant in parotid gland surgery. In addition to temporary facial weakness and permanent facial nerve injury, postparotidectomy depression and Frey's syndrome (gustatory sweating) are specific for this type of surgery. To reduce the surgical morbidity, several modifications of parotidectomy have been implemented but postsurgical complications remain especially facial nerve injury . To overcome this difficulty, an identification method might be used such as preoperative intravital staining of the gland with methylene blue (MB).
Although MB staining is not designed to be used as a sole technique, it can be combined with other techniques such as identification of the anatomic landmarks. MB staining is simple, inexpensive, and not time consuming technique.It is an indirect facial nerve identification technique, because there is no nerve handling,thus decreasing iatrogenic nerve impairment.After injection of the parotid gland with MB dye, fine white nerve fibers can be observed . Tumors in the parotid gland are also easily seen because they are not stained and will be visible in the surgical field.
- Conditions
- Parotid Tumor
- Being tested
- Methylene blue dye
- Medical subject headings
- Parotid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene blue dyeProcedure or surgery
For MB group, the staining of the glandular tissue will be obtained with 3-4 mL of 1% MB that will be introduced into the gland via the salivary duct several minutes before the surgery.The trans-oral catheterization of the Stensen's duct will be performed and the solution will be injected via intravenous cannula.The glandular tissue will turn dark blue.
| Study group | Role | What they receive |
|---|---|---|
| MB group | Active comparator | Mb group will undergo surgeries with methylene blue staining Receives: Procedure: Methylene blue dye |
| Control group | No intervention | Control group will undergo surgeries without methylene blue staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases that don't develop post surgical parotidectomy facial nerve weakness after using preoperative intravital staining of the gland with methylene blue dye.
Twenty cases presented to outpatient clinic in Assiut university hospital with benign or primary malignant parotid gland tumors will be included in the study, clinically evaluated, confirmation of diagnosis will be achieved by CT, MRI, or CT/MRI investigations , ultrasonography and fine-needle aspiration biopsy (FNAB).
then Divide the selected cases into two groups randomly; group A for surgeries with MB staining and group B for surgeries without MB staining that serves as control group. type of surgery will be chosen according to CT or MRI data and fine-needle aspiration biopsy (FNAB)then Follow up facial nerve injury manifestations for the included cases for one year for comparison between 2 groups
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parotid TumorStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Ali Mohamed Ismail, Assiut University
- Investigators
- Ismail Ali Mohamed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401370
- Sponsor's protocol ID
- MB in parotid surgery
- Status last verified
- May 2022
- First submitted
- 25 Apr 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Age,sex,clinical diagnosis.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Methylene Blue Dye in Identification of Facial Nerve in Parotid Surgery
- ClinicalTrials.gov ID
- NCT05401370
- Acronym / sponsor ID
- MB in parotid surgery
- Conditions
- Parotid Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Jun 2022 (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.
usefulness of the methylene blue staining for identification of facial nerve in parotid gland surgery
Detailed description
The specific surgical morbidity remains significant in parotid gland surgery. In addition to temporary facial weakness and permanent facial nerve injury, postparotidectomy depression and Frey's syndrome (gustatory sweating) are specific for this type of surgery. To reduce the surgical morbidity, several modifications of parotidectomy have been implemented but postsurgical complications remain especially facial nerve injury . To overcome this difficulty, an identification method might be used such as preoperative intravital staining of the gland with methylene blue (MB).
Although MB staining is not designed to be used as a sole technique, it can be combined with other techniques such as identification of the anatomic landmarks. MB staining is simple, inexpensive, and not time consuming technique.It is an indirect facial nerve identification technique, because there is no nerve handling,thus decreasing iatrogenic nerve impairment.After injection of the parotid gland with MB dye, fine white nerve fibers can be observed . Tumors in the parotid gland are also easily seen because they are not stained and will be visible in the surgical field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MB group | Active comparator | Procedure: Methylene blue dyeMb group will undergo surgeries with methylene blue staining |
| Control group | No intervention | –Control group will undergo surgeries without methylene blue staining |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All new cases presented with primary benign or malignant parotid tumors.
Key exclusion criteria (1 listed)
- Cases with secondary tumors of the gland
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 |
|---|---|---|
| Methylene blue dyeFor MB group, the staining of the glandular tissue will be obtained with 3-4 mL of 1% MB that will be introduced into the gland via the salivary duct several minutes before the surgery.The trans-oral catheterization of the Stensen's duct will be performed and the solution will be injected via intravenous cannula.The glandular tissue will turn dark blue. | Procedure or surgery | MB group |
Primary outcome
Number of cases that don't develop post surgical parotidectomy facial nerve weakness after using preoperative intravital staining of the gland with methylene blue dye.
Time frame: One year
Twenty cases presented to outpatient clinic in Assiut university hospital with benign or primary malignant parotid gland tumors will be included in the study, clinically evaluated, confirmation of diagnosis will be achieved by CT, MRI, or CT/MRI investigations , ultrasonography and fine-needle aspiration biopsy (FNAB). then Divide the selected cases into two groups randomly; group A for surgeries with MB staining and group B for surgeries without MB staining that serves as control group. type of surgery will be chosen according to CT or MRI data and fine-needle aspiration biopsy (FNAB)then Follow up facial nerve injury manifestations for the included cases for one year for comparison between 2 groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: Yes. Age,sex,clinical diagnosis.
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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.
Ismail Ali Mohamed principal investigator
Assiut 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 Methylene blue dye in people with Parotid Tumor, run by Assiut 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 1 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 2 Jun 2022. 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?
Contact Ismail Ali Mohamed (01124153353, ismailali203040@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases that don't develop post surgical parotidectomy facial nerve weakness after using preoperative intravital staining of the gland with methylene blue dye. (time frame: One year). 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 2 Jun 2022.