Role of Methylene Blue in Parotid Surgery

Parotid Tumor Clinical Trial

Official title:

Role of Methylene Blue Dye in Identification of Facial Nerve in Parotid Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05401370
• Other study ID #: MB in parotid surgery
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: Assiut University
• Contact: Ismail Ali Mohamed
• Phone: 01124153353
• Email: ismailali203040[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

usefulness of the methylene blue staining for identification of facial nerve in parotid gland surgery

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All new cases presented with primary benign or malignant parotid tumors.

Exclusion Criteria:

• Cases with secondary tumors of the gland

Related Conditions & MeSH terms

• Parotid Neoplasms
• Parotid Tumor

Intervention

Procedure:
• Methylene blue dye
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.

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One year