A Phase 4 interventional study of Polidocanol and Alcohol in Benign Thyroid Nodule, Thyroid Lump and Thyroid Cyst, sponsored by Assiut University. Not yet recruiting. Open to participants aged 10 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-05.
Sponsored by Assiut University · Phase 4, Interventional, and Treatment
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.
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.
67 studies on the registry are indexed under Cysts; 16 are open to participants now.
This study's planned enrollment of 30 is below the median of 48 across 40 interventional studies indexed under Cysts.
Browse Cysts studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Polidocanol is injected in the thyroid cyst under ultrasound guidance.
Drug: Polidocanol
Alcohol is injected in the thyroid cyst under ultrasound guidance.
Drug: Alcohol
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
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
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
Time frame: 3 months
No study locations are listed for this record.
This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Polidocanol · Ethanol