Comparative Study of Polidocanol and Absolute Alcohol for Percutaneous us Guided Treatment of Benign Thyroid Cyst

NCT05798936 | Unknown Phase 4

• 1 other identifier: US in benign Thyroid cysts
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare the efficacy and safety of ultrasound-guided percutaneous ethanol injection and percutaneous polidocanol injection for the treatment of benign cystic and predominantly cystic thyroid nodules.

Conditions

Benign Thyroid Nodule; Thyroid Lump; Thyroid Cyst

Outcome Measures

Primary Outcomes (1)

• Size of the thyroid cystic nodule after sclerosing agent injection (polidocanol versus alcohol)

  Size of the thyroid cyst is measured by ultrasound after 3 months of sclerosing agent injection

  3 months

Study Arms (2)

Polidocanol group

EXPERIMENTAL

Polidocanol is injected in the thyroid cyst under ultrasound guidance.

Drug: Polidocanol

Alcohol group

EXPERIMENTAL

Alcohol is injected in the thyroid cyst under ultrasound guidance.

Drug: Alcohol

Interventions

Polidocanol DRUG

Polidocanol is injected under complete aseptic conditions. Before the treatment the diameter and volume of each nodule is calculated. To prevent serious hemorrhage, vessels located along the approach route will be carefully evaluated by using Doppler US.

Also known as: Polidocanol solution

Polidocanol group

Alcohol DRUG

Alcohol is injected under complete aseptic conditions. Before the treatment the diameter and volume of each nodule is calculated. To prevent serious hemorrhage, vessels located along the approach route will be carefully evaluated by using Doppler US.

Also known as: Alcohol Ethyl

Alcohol group

Eligibility Criteria

• Age: 10 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Single cystic or predominantly cystic nodules.
• Pressure symptoms or cosmetic problems.
• No malignant or indeterminate cytologic results after ultrasound-guided fine-needle aspiration.
• Normal serum thyroid hormone levels

You may not qualify if:

• Association of a nodules showing malignant features on us examinations.
• Malignant or indeterminate cytologic results after ultrasound-guided fine-needle aspiration.
• Abnormal serum thyroid hormone levels

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Polidocanol; Ethanol

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Amna Ahmed

CONTACT

01095339383; amnabkar76@gmail.com

Hany Seif

CONTACT

01005618665; hanyseifrad@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Based on determining the main outcome variable, the estimated minimum required sample size is 30 patients (15 patient in each group). The sample was calculated using G\*power software 3.1.9.2., based on the following assumptions: Main outcome variable is the difference between mean value of: Group (A): 15 patients will be treated by Ultrasound-Guided Percutaneous Polidocanol Injection Group (B): 15 patients will be treated by Ultrasound-Guided percutaneous ethanol injection

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: April 5, 2023
• Study Start: April 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 5, 2023

Record last verified: 2023-03