Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05798936 |
| Other study ID # |
US in benign Thyroid cysts |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2023 |
| Est. completion date |
June 1, 2025 |
Study information
| Verified date |
March 2023 |
| Source |
Assiut University |
| Contact |
Amna Ahmed |
| Phone |
01095339383 |
| Email |
amnabkar76[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
