Benign Thyroid NodulePhase 4NCT05798936
Comparative Study of Polidocanol and Absolute Alcohol for Percutaneous us Guided Treatment of Benign Thyroid Cyst
A Phase 4 study testing Polidocanol and Alcohol in people with Benign Thyroid Nodule and Thyroid Lump, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Benign Thyroid Nodule, Thyroid Lump, Thyroid Cyst
- What is being tested?
- Polidocanol and Alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study of Polidocanol and Absolute Alcohol for Percutaneous Ultrasound Guided Treatment of Benign Thyroid Cyst
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.
Read the 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.
- Conditions
- Benign Thyroid Nodule, Thyroid Lump, Thyroid Cyst
- Being tested
- Polidocanol, Alcohol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolidocanolDrug
Also called Polidocanol solution
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.
AlcoholDrug
Also called Alcohol Ethyl
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.
| Study group | Role | What they receive |
|---|---|---|
| Polidocanol group | Experimental | Polidocanol is injected in the thyroid cyst under ultrasound guidance. Receives: Drug: Polidocanol |
| Alcohol group | Experimental | Alcohol is injected in the thyroid cyst under ultrasound guidance. Receives: Drug: Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Thyroid NoduleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 injection
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amna Ahmed Ali Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798936
- Sponsor's protocol ID
- US in benign Thyroid cysts
- Status last verified
- Mar 2023
- First submitted
- 14 Feb 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Polidocanol and Absolute Alcohol for Percutaneous Ultrasound Guided Treatment of Benign Thyroid Cyst
- ClinicalTrials.gov ID
- NCT05798936
- Acronym / sponsor ID
- US in benign Thyroid cysts
- Conditions
- Benign Thyroid Nodule, Thyroid Lump, Thyroid Cyst
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 injection
| Arm | Type | Receives |
|---|---|---|
| Polidocanol group | Experimental | Drug: PolidocanolPolidocanol is injected in the thyroid cyst under ultrasound guidance. |
| Alcohol group | Experimental | Drug: AlcoholAlcohol is injected in the thyroid cyst under ultrasound guidance. |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolidocanolAlso: Polidocanol solutionPolidocanol 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. | Drug | Polidocanol group |
| AlcoholAlso: Alcohol EthylAlcohol 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. | Drug | Alcohol group |
Primary outcome
Size of the thyroid cystic nodule after sclerosing agent injection (polidocanol versus alcohol)
Time frame: 3 months
Size of the thyroid cyst is measured by ultrasound after 3 months of sclerosing agent injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polidocanol and Alcohol in people with Benign Thyroid Nodule and Thyroid Lump, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amna Ahmed (01095339383, amnabkar76@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of the thyroid cystic nodule after sclerosing agent injection (polidocanol versus alcohol) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.