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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05798936

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Thyroid Nodule Thyroid Lump Thyroid Cyst	Drug: Polidocanol Drug: Alcohol	Phase 4

Detailed Description

Thyroid nodules are characterized by excessive structural growth, functional transformation, and/or cystic degeneration of one or several areas within the gland. According to various studies, 15-30% of thyroid nodules are cystic or predominantly cystic. Around 5% of patients with thyroid nodules may experience compressive symptoms or cosmetic concerns, and treatment may be required in these cases.

Simple aspiration is generally the initial management for the purpose of diagnosis and cyst volume reduction. However, the recurrence rate has been reported to be high (40% to 59%), depending on the number of aspirations and extent of fluid evacuation. After simple fine-needle aspiration, most cystic lesions (around 80%) refill and enlarge over time.

Surgery is a long-established therapeutic option for benign thyroid nodules. However, the cost of thyroid surgery, risk of temporary or permanent complications, and impact on quality of life remain relevant concerns.

Ultrasound-guided percutaneous ethanol injection (PEI) The mechanism of ethanol sclerotherapy is that ethanol induces cellular dehydration and protein denaturation, which are followed by coagulation necrosis, reactive fibrosis, and small-vessel thrombosis.

As regard (PEI)Pain is the most common side effect, other mild side effects or complications occurred in small numbers of patients like: Facial flushing, Mild dizziness, Intracystic haemorrhage, drunken sense, Perithyroidal leakage. There are other side effects, including transient vocal cord palsy, respiratory distress requiring emergency surgical treatment, and venous thrombosis, in sporadic cases.

Percutaneous Polidocanol sclerotherapy (PPI) may be a potential alternative to ethanol for the treatment of benign cystic and predominantly cystic thyroid nodules.Polidocanol is a liquid detergent sclerosant developed in 1936 as a topical and local anaesthetic consisting of 95% hydroxy poly ethoxydodecane and 5% ethyl alcohol. It has been used as a treatment for hemorrhoidal disease, venous malformations, symptomatic hepatic cysts, renal cysts, gastric varices, and digital mucous cysts.

The mechanism of treating cyst is probably destroying endothelial cells of capsular wall which causes aseptic inflammation; thus endothelial tissue atrophies and cyst cavity adhere and occlude.

The side effects are mild including mild localized pain and mild or moderate fever after PPI. So, PPI could be a safe and effective alternative to treat benign cystic or predominant cystic thyroid nodules.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 injectionBased 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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Polidocanol group Polidocanol is injected in the thyroid cyst under ultrasound guidance.	Drug: Polidocanol 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. Other Names: Polidocanol solution
Experimental: Alcohol group Alcohol is injected in the thyroid cyst under ultrasound guidance.	Drug: Alcohol 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. Other Names: Alcohol Ethyl

Arm

Intervention/Treatment

Experimental: Polidocanol group

Polidocanol is injected in the thyroid cyst under ultrasound guidance.

Drug: Polidocanol

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.

Other Names:

Polidocanol solution

Experimental: Alcohol group

Alcohol is injected in the thyroid cyst under ultrasound guidance.

Drug: Alcohol

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.

Other Names:

Alcohol Ethyl

Outcome Measures

Primary Outcome Measures

Size of the thyroid cystic nodule after sclerosing agent injection (polidocanol versus alcohol) [3 months]
Size of the thyroid cyst is measured by ultrasound after 3 months of sclerosing agent injection

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amna Ahmed Ali Ahmed, Doctor, Assiut University

ClinicalTrials.gov Identifier:

NCT05798936

Other Study ID Numbers:

US in benign Thyroid cysts

First Posted:

Apr 5, 2023

Last Update Posted:

Apr 5, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2023