Thyroid NoduleNCT04580199
Surgical Versus Non Surgical Management of Thyroid Nodule
A study testing thyroidectomy in people with Thyroid Nodule, run by Mahmoud Fahd.
Trial summary
To compare between surgical (hemi thyroidectomy and total thyroidectomy) and non-surgical (medical, ethanol injection,thermal ablation and laser photo coagulation) management of simple thyroid nodule regarding: Outcome of every type of management Feasibility of minimally invasive technique in management of simple… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Dec 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- complicated thyroid nodule
Who cannot join
- less than 18 malignant thyroid nodule
About this study
Official title: Surgical (Total or Hemithyroidectomy)Versus Non Surgical (Ethanol Ablation ,RF Ablation ,Laser Ablation) Management of Thyroid Nodule
To compare between surgical (hemi thyroidectomy and total thyroidectomy) and non-surgical (medical, ethanol injection,thermal ablation and laser photo coagulation) management of simple thyroid nodule regarding:
- Outcome of every type of management
- Feasibility of minimally invasive technique in management of simple thyroid nodule in Asyut university
- Complication of every type of management
Read the detailed description
Thyroid nodules are very common in clinical practice; they are discovered by palpation in 3-7% and by ultrasound (US) in about 50% of the general population. The majority of thyroid nodules are benign and asymptomatic. The main management of benign thyroid nodules is observation and follow-up; however, a minority of them (10-15%) increase in size over time and may induce symptoms or cosmetic issues. Surgical excision has been established as a treatment for symptomatic benign thyroid nodules. thyroidectomy for benign thyroid disease continues to remain controversial, as there are many conflicting data published in the literature regarding the risk of hypothyroidism and recurrent laryngeal nerve injury stratified to indications for surgery, extent of thyroid resection and surgical volume .It carries a 2-10% risk of complications and neck scarring .Thyroid surgery is also costly and may not be appropriate for patients who have a high risk of surgical morbidity.Therefore, image-guided nonsurgical procedures such as ethanol ablation (EA) and thermal ablation have been proposed as alternative and less invasive approaches for the management of benign symptomatic thyroid nodules .These so-called thermoablative methods induce local thermodestruction, leading to nodule shrinkage and improvement of local symptoms. Monopolar radiofrequency ablation (RFA) and EA is widely used as a nonsurgical treatment usually for cystic (i.e., pure cyst) or predominantly cystic benign thyroid nodules (i.e., cystic portion > 50%). There is another method called US-guided percutaneous laser ablation (PLA) is a safe and effective therapeutic option as an alternative to surgery for benign symptomatic nodules
- Conditions
- Thyroid Nodule
- Being tested
- thyroidectomy
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroidectomyProcedure or surgery
Also called ethanol ablation RF ablation laser photocaugulation
to excise the thyroid gland
| Study group | Role | What they receive |
|---|---|---|
| total thyroidectomy | Active comparator | excision of thyroid gland Receives: Procedure: thyroidectomy |
| hemi thyroidectomy | Active comparator | excision half of thyroid gland Receives: Procedure: thyroidectomy |
| ethanol ingection | Active comparator | ingection of ethanol into thyroid nodule under guidance of ultrasound Receives: Procedure: thyroidectomy |
| monopolar radiofrequency | Active comparator | using radiofrequency for ablation of thyroid nodule Receives: Procedure: thyroidectomy |
| laser photocaugulation | Active comparator | using laser for ablation of thyroid nodule Receives: Procedure: thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
shrinkage of the thyroid nodule
decrease in the size of thyroid nodule
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- age above 18 male or female manifested thyroid nodule
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Fahd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Fahd, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580199
- Sponsor's protocol ID
- thyroid nodule
- Status last verified
- Oct 2020
- First submitted
- 2 Oct 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benjamin J, Hephzibah J, Cherian AJ, Mathew D, Shanthly N, Oommen R. Is hemi-thyroidectomy adequate in low risk differentiated thyroid cancer? World J Nucl Med. 2019 Apr-Jun;18(2):171-175. doi: 10.4103/wjnm.WJNM_70_18.
PubMed 31040749Mauri G, Nicosia L, Della Vigna P, Varano GM, Maiettini D, Bonomo G, Giuliano G, Orsi F, Solbiati L, De Fiori E, Papini E, Pacella CM, Sconfienza LM. Percutaneous laser ablation for benign and malignant thyroid diseases. Ultrasonography. 2019 Jan;38(1):25-36. doi: 10.14366/usg.18034. Epub 2018 Sep 17.
PubMed 30440161Hahn SY, Shin JH, Na DG, Ha EJ, Ahn HS, Lim HK, Lee JH, Park JS, Kim JH, Sung JY, Lee JH, Baek JH, Yoon JH, Sim JS, Lee KH, Baek SM, Jung SL, Kim YK, Choi YJ; Korean Society of Thyroid Radiology (KSThR); Korean Society of Radiology. Ethanol Ablation of the Thyroid Nodules: 2018 Consensus Statement by the Korean Society of Thyroid Radiology. Korean J Radiol. 2019 Apr;20(4):609-620. doi: 10.3348/kjr.2018.0696.
PubMed 30887743Dobnig H, Amrein K. Monopolar Radiofrequency Ablation of Thyroid Nodules: A Prospective Austrian Single-Center Study. Thyroid. 2018 Apr;28(4):472-480. doi: 10.1089/thy.2017.0547. Epub 2018 Mar 20.
PubMed 29490593Rahal Junior A, Falsarella PM, Mendes GF, Hidal JT, Andreoni DM, Lucio JFF, Queiroz MRG, Garcia RG. Percutaneous laser ablation of benign thyroid nodules: a one year follow-up study. Einstein (Sao Paulo). 2018 Nov 29;16(4):eAO4279. doi: 10.31744/einstein_journal/2018AO4279.
PubMed 30517361
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical (Total or Hemithyroidectomy)Versus Non Surgical (Ethanol Ablation ,RF Ablation ,Laser Ablation) Management of Thyroid Nodule
- ClinicalTrials.gov ID
- NCT04580199
- Acronym / sponsor ID
- thyroid nodule
- Conditions
- Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mahmoud FahdUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 8 Oct 2020 (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.
To compare between surgical (hemi thyroidectomy and total thyroidectomy) and non-surgical (medical, ethanol injection,thermal ablation and laser photo coagulation) management of simple thyroid nodule regarding:
- Outcome of every type of management
- Feasibility of minimally invasive technique in management of simple thyroid nodule in Asyut university
- Complication of every type of management
Detailed description
Thyroid nodules are very common in clinical practice; they are discovered by palpation in 3-7% and by ultrasound (US) in about 50% of the general population. The majority of thyroid nodules are benign and asymptomatic. The main management of benign thyroid nodules is observation and follow-up; however, a minority of them (10-15%) increase in size over time and may induce symptoms or cosmetic issues. Surgical excision has been established as a treatment for symptomatic benign thyroid nodules. thyroidectomy for benign thyroid disease continues to remain controversial, as there are many conflicting data published in the literature regarding the risk of hypothyroidism and recurrent laryngeal nerve injury stratified to indications for surgery, extent of thyroid resection and surgical volume .It carries a 2-10% risk of complications and neck scarring .Thyroid surgery is also costly and may not be appropriate for patients who have a high risk of surgical morbidity.Therefore, image-guided nonsurgical procedures such as ethanol ablation (EA) and thermal ablation have been proposed as alternative and less invasive approaches for the management of benign symptomatic thyroid nodules .These so-called thermoablative methods induce local thermodestruction, leading to nodule shrinkage and improvement of local symptoms. Monopolar radiofrequency ablation (RFA) and EA is widely used as a nonsurgical treatment usually for cystic (i.e., pure cyst) or predominantly cystic benign thyroid nodules (i.e., cystic portion > 50%). There is another method called US-guided percutaneous laser ablation (PLA) is a safe and effective therapeutic option as an alternative to surgery for benign symptomatic nodules
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- age above 18 male or female manifested thyroid nodule
| Arm | Type | Receives |
|---|---|---|
| total thyroidectomy | Active comparator | Procedure: thyroidectomyexcision of thyroid gland |
| hemi thyroidectomy | Active comparator | Procedure: thyroidectomyexcision half of thyroid gland |
| ethanol ingection | Active comparator | Procedure: thyroidectomyingection of ethanol into thyroid nodule under guidance of ultrasound |
| monopolar radiofrequency | Active comparator | Procedure: thyroidectomyusing radiofrequency for ablation of thyroid nodule |
| laser photocaugulation | Active comparator | Procedure: thyroidectomyusing laser for ablation of thyroid nodule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- complicated thyroid nodule
Key exclusion criteria (1 listed)
- less than 18 malignant thyroid nodule
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 |
|---|---|---|
| thyroidectomyAlso: ethanol ablation RF ablation laser photocaugulationto excise the thyroid gland | Procedure or surgery | ethanol ingection, hemi thyroidectomy, laser photocaugulation, monopolar radiofrequency, total thyroidectomy |
Primary outcome
shrinkage of the thyroid nodule
Time frame: 2 years
decrease in the size of thyroid nodule
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Background: PubMed 31040749Benjamin J, Hephzibah J, Cherian AJ, Mathew D, Shanthly N, Oommen R. Is hemi-thyroidectomy adequate in low risk differentiated thyroid cancer? World J Nucl Med. 2019 Apr-Jun;18(2):171-175. doi: 10.4103/wjnm.WJNM_70_18.
- Background: PubMed 30440161Mauri G, Nicosia L, Della Vigna P, Varano GM, Maiettini D, Bonomo G, Giuliano G, Orsi F, Solbiati L, De Fiori E, Papini E, Pacella CM, Sconfienza LM. Percutaneous laser ablation for benign and malignant thyroid diseases. Ultrasonography. 2019 Jan;38(1):25-36. doi: 10.14366/usg.18034. Epub 2018 Sep 17.
- Background: PubMed 30887743Hahn SY, Shin JH, Na DG, Ha EJ, Ahn HS, Lim HK, Lee JH, Park JS, Kim JH, Sung JY, Lee JH, Baek JH, Yoon JH, Sim JS, Lee KH, Baek SM, Jung SL, Kim YK, Choi YJ; Korean Society of Thyroid Radiology (KSThR); Korean Society of Radiology. Ethanol Ablation of the Thyroid Nodules: 2018 Consensus Statement by the Korean Society of Thyroid Radiology. Korean J Radiol. 2019 Apr;20(4):609-620. doi: 10.3348/kjr.2018.0696.
- Background: PubMed 29490593Dobnig H, Amrein K. Monopolar Radiofrequency Ablation of Thyroid Nodules: A Prospective Austrian Single-Center Study. Thyroid. 2018 Apr;28(4):472-480. doi: 10.1089/thy.2017.0547. Epub 2018 Mar 20.
- Background: PubMed 30517361Rahal Junior A, Falsarella PM, Mendes GF, Hidal JT, Andreoni DM, Lucio JFF, Queiroz MRG, Garcia RG. Percutaneous laser ablation of benign thyroid nodules: a one year follow-up study. Einstein (Sao Paulo). 2018 Nov 29;16(4):eAO4279. doi: 10.31744/einstein_journal/2018AO4279.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing thyroidectomy in people with Thyroid Nodule, run by Mahmoud Fahd.
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 1 inclusion and 1 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 9 Oct 2020. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shrinkage of the thyroid nodule (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04580199, which also lists 5 linked publications.
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 9 Oct 2020.