Gland and Hormone Related Diseases

All Conditions

Neoplasms

Thyroid Diseases

Thyroid Nodule

Endocrine System Diseases

Thyroid Neoplasms

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Herbal and Botanical

All Drugs and Chemicals

Spirulina

Preparation with Spirulina to ameliorate the size of benign thyroid nodules

Preparation with Spirulina

Placebo

Corin Badiu, M.D.

Clinical trial with a double-blind, placebo-controlled, crossover design; enrolls approximately 30 euthyroid patients with benign thyroid nodules, who will receive for 6 weeks a spirulina-based supplement, and for another 6 weeks placebo. Thyroid ecography will be performed three times for each patient, and blood tests including TSH, free T4, free T3 and ceruloplasmin/Copper will also be performed 3 times for each patient. It is expected that a decrease in the thyroid nodules occurs with the supplement administration. Compared with placebo there will be a decrease of at least 20% in the volume or the largest diameter of the nodules during the 6-week administration of the supplement.

Clinical trial with double-blind, placebo-controlled, crossover design; enrolls approximately 30 euthyroid patients with benign thyroid nodules, who will receive for 6 weeks a spirulina-based supplement, and for another 6 weeks placebo.

* The sequence of administration supplement - placebo is unknown to the doctor or the patients
* The supplement and placebo are placed in identical capsules and vials by DVR Pharm
* The respective capsules are administered twice a day Thyroid ecography will be performed three times for each patient, and blood tests including TSH, free T4, free T3 and ceruloplasmin/Copper will also be performed 3 times for each patient.
* Echography and blood tests will be performed for each patient initially, after 6 weeks, and after 12 weeks It is expected that a decrease in the thyroid nodules occurs with the supplement administration.
* there will be a direct comparison of the nodules dimensions on the ecographic examinations, in millimeters, and of the blood levels of the molecules which reflect thyroid function

Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules

Evaluation of the Efficacy of a Supplement With Spirulina for Amelioration of Benign Thyroid Nodules

Size of the thyroid nodules is measured by ultrasound, two perpendicular diameters, same incidence and operator at V1 and V2 Area of nodules is calculated as the product of the two diameters

Fundatia Bio-Forum

One patient who was on multiple medications at enrollment developed a generalized skin eruption with moderate prurit after a few days with the study substance; she interrupted the administration after talking with the investigator and afterwards it was revealed that she was taking placebo All participants who completed the study (n=34) received the AI (active ingredient) and 5 patients out of the 34 (n=29) received the AI-AI sequence, so that only 29 patients received placebo (P)

6 weeks bid Preparation with Spirulina

Preparation with Spirulina: Preparation with Spirulina to ameliorate the size of benign thyroid nodules

0 adverse reactions

Preparation With Spirulina

6 weeks bid Placebo

Placebo: Placebo administration for 6 weeks bid

One patient had a severe allergic reaction while she was on placebo and multiple other medications and withdrew from the study

Participants who received AI initially (first six weeks, V1 and V2) and P afterwards

AI-P Sequence (12)

Participants who received placebo (P) initially (first six weeks, V1 and V2) and AI afterwards

P-AI Sequence (17)

Participants who received AI initially (first six weeks, V1 and V2) and AI afterwards

AI-AI Sequence (5)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Surface of Thyroid Nodules

For the primary outcome we compared the effect of the AI vs P after the initial 6 weeks of the study (V1-V2). For this we combined the AI-AI sequence and AI-P sequence in one arm, and compared with the P-AI sequence arm.

Dr. Felician Stancioiu

6 weeks bid Preparation with Spirulina

Preparation with Spirulina: Preparation with Spirulina to ameliorate the size of benign thyroid nodules decrease of 19.88% (mean) +/- 15.55 (SD)

6 weeks bid Placebo

Placebo: Placebo administration for 6 weeks bid decrease of 9.21% (mean) +/- 14.29 (SD)

Effects of AI vs P between the two arms is calculated after the first 6 weeks (V1-V2, AI vs P). After 12 weeks (V1-V3) patients in each arm/sequence receive the same treatment in a different sequence (AI+P; vs P+AI) and no difference is expected.

A second outcome compares results of all administrations of 6 weeks each of AI (39) and P (29)

Percent Change in Area of Thyroid Nodules

Mean modification in the area of the nodules in cm\^2, calculated as the difference between the initial and final nodule area after 6 weeks of administration of either AI (total 39 administrations) or P (total 29 administrations), and standard deviation

Number of all 6 weeks administrations of AI in all 34 patients and all sequences (AI-P, AI-AI, and P-AI)

All AI Administrations (n=39)

Number of all 6 weeks administrations of P in all 34 patients and all sequences (AI-P and P-AI)

All P Administrations (n=29)

The total number (instances) of 6 weeks administrations of either AI (n=39) or P (n=29)

Mean Change in Nodule Areas, All Administrations of 6 Weeks Each (n=68), AI (n=39) Versus P (n=29)

Patients in this sequence first received 6 weeks the Active Ingredient (Spirulina) bid, and afterwards 6 weeks Placebo bid

Sequence AI-P: Active Ingredient (Spirulina) Then Placebo

Placebo administration for 6 weeks bid; afterwards Active Ingredient (Spirulina) for 6 weeks bid

Sequence P-AI: Placebo Then Active Ingredient (Spirulina)

Patients receive Active Ingredient (AI) for 6 weeks bid, and afterwards Active Ingredient (AI) for 6 weeks bid

Sequence AI-AI (Active Ingredient, Then Active Ingredient)

First Intervention Weeks 0-6 (V1-V2)

Second Intervention Weeks 6-12 (V2-V3)

Treatment of symptomatic benign nodules with radiofrequency ablation as an alternative to surgical treatment

The procedure will include an ultrasound with radiofrequency ablation of the benign thyroid nodule percutaneously

Radiofrequency ablation

Claire RENAUD

The purpose of the present protocol is to evaluate the response rate to treatment of these symptomatic benign nodules with radiofrequency as an alternative to surgical treatment.

This thyroid nodules ablation with radiofrequency will be directed by a single percutaneous procedure guided by ultrasound. The procedure includes an ultrasound with percutaneously radiofrequency ablation of benign thyroid nodule. Clinical and ultrasonographic monitoring will last a year with consultations at 2 weeks (consultation only), 3 months, 6 months and 1 year (consultation, ultrasound TSH). The success of this procedure will be controlled with 3 successive ultrasounds the following year. The expected results are a decrease in the size of the nodule by at least 50% and a reduction in the functional and aesthetic discomfort, with less frequent complication than what is expected with surgery. The present study also intends to determine the medico economic impact of this technique compared to surgery.

Thyroid benign nodules represent a major public health problem because they are very common (subclinical nodules were found in half of woman beyond 60 years). The main risk factors include age, female gender, parity, smoking and family history of thyroid nodules or thyroiditis. The assessment is based on biology, ultrasound and fine needle aspiration and intends to determine the benign nature (95%) or cancer (5%) of the nodules and if they are functional or not (toxic nodule). Most benign nodules are asymptomatic but some of them because of their size and location can cause a functional disorder (compression or swallowing disorder) or aesthetic and psychological resounding.In current practice, these nodules are sometimes treated with surgery that impact on patient quality of life (need to take L-Thyroxine, difficulties related to the possible occurrence of complications like hypoparathyroidism or laryngeal paralysis) and socio-economic constraints especially when complications occur. To limit the number of unnecessary and potentially risky surgeries, patients should therefore be well selected. If surgery is the preferred treatment of thyroid cancer, alternative techniques like radiofrequency seem interesting for benign nodules.

Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules

Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules by Percutaneous Radiological Approach

First estimate of the procedure response rate (patient with complete procedure in percentage)

compared to the volume measured at inclusion. This reduction will be estimated in absolute value and in relative value (percentage reduction for a given subject)

Percentage of patients with a volume decrease of at least 50 percent, 6 months after the procedure. Patients for which the procedure could not be fully performed will be counted among patients who have not had a reduction of at least 50 percent

Percentage of patients with a volume decrease of at least 50 percent, 12 months after the procedure. Patients for which the procedure could not be fully performed will be counted among patients who have not had a reduction of at least 50 percent

The symptoms will be evaluated by a visual analogue scale of 0 to 10 as proposed by the Korean consensus. The symptoms assessed will be: cervical pain, dysphagia, foreign body sensation, discomfort, coughing.

This improvement will be evaluated with a 4-level scale (no clinically detectable nodule 0, palpable nodule 1, visible nodule on swallowing 2, spontaneously visible nodule 3) as proposed by the Korean consensus. The improvement will be defined by the transition to the lower category.

In particular, the following will be investigated: signs of cutaneous involvement such as burns, hematoma and intra-nodular bleeding, recurrent paralysis, superinfections, tracheal or esophageal wounds.

Evaluation of the pain during the procedure using a visual analogue scale from 0 to 10 established at the end of the procedure

Percentage of patients requiring L-thyroxine replacement therapy

evaluation, from the point of view of the hospital, of the production cost of the new technique

Percentage of patients who have used analgesics during and after the procedure

Evaluation, from the point of view of health insurance, of the cost of the care of patients who benefited from the new technique

University Hospital, Toulouse

Behaviors and Mental Disorders

Quality of Life

Patients who are going to undergo a thyroid surgery due to symptomatic non-toxic multinodular goiter, uncontrolled thyrotoxicosis or suspicious FNA

Patients with benign thyroid disease, not undergoing thyroidectomy

Thyroidectomy

Theodosios Papavramidis, Asst. Prof.

To detect any changes in Quality of Life in patients with benign thyroid diseases who undergo thyroidectomy compared to patients with benign thyroid diseases and conservative treatment and healthy subjects.

Benign thyroid diseases are a common public health problem. It has been reported that thyroid diseases can affect Quality of Life (QoL), but this is not easy to be assessed. Therefore, a valid instrument is necessary. Such an instrument is Thyroid-related patient-reported outcomes questionnaire (ThyPRO). ThyPRO has been recently translated and validated in Greek language. The questionnaire consists of 85 items grouped in 14 scales concerning goiter, hypothyroidism, hyperthyroidism and eye symptoms, tiredness, cognitive impairment, anxiety, depression, emotional susceptibility, cosmetic complaints and impaired social, and daily and sex life, as well as overall quality of life.

A few studies have demonstrated that various thyroid therapies may improve some aspects of QoL. The aim of the present study is to address the impact of thyroidectomy in QoL in patients with benign thyroid diseases.

Alterations in Quality of Life After Thyroidectomy for Benign Thyroid Disease

To detect any changes in Quality of Life in patients with benign thyroid diseases who undergo thyroidectomy compared to patients with benign thyroid diseases and conservative treatment. The Greek, cross-cultural validated, version of ThyPRO questionnaire will be used, as it comprises a reliable and validated instrument to measure thyroid-related quality of life. The 84 questions of ThyPRO are categorized in 13 scales that involve: goiter, hypothyroidism, hyperthyroidism and eyes symptoms, tiredness, cognitive impairment, anxiety, depressivity, emotional susceptibility, cosmetic complaints and impaired social, and daily and sex life. The scales are all scored and the final scores were transformed to a scale from 0 to 100. Lower scores reflect a better thyroid-related quality of life, whereas higher scores reflect a worse quality of life.

Correlation of alterations in Quality of Life after thyroidectomy for benign thyroid disease with secondary characteristics of the patients ( eg age, thyroid autoimmunity, thyroid function, Vitamin D levels)

Aristotle University Of Thessaloniki

Assistant Professor of surgery

Central Nervous System Depressants

Anesthetics

Device: Cryoablation Single session with an argon-based device; a V-probe 17-G applicator will be used for the treatments; gas release 100%; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;

Single session with an RF device; an antenna will be used for the treatments; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;

Single session with an argon-based cryoablation device; an specific applicator will be used for the treatments; gas release 100% for cryoablation; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;

cryoablation

Single session with a radio frequency ablation device; an specific applicator will be used for the treatments; high impedance rates for RFA with moving-shot technique; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;

radiofrequency ablation

Freitas

Sakamoto

Denise Sakamoto

Ricardo Freitas, MD, PhD

This study will evaluate the clinical response and safety of ultrasound guided percutaneous cryoablation and a radiofrequency ablation in the treatment of benign thyroid nodules as an alternative to the surgery. Ablation of benign thyroid nodules with cryoablation will be directed to patients with benign thyroid lesions (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component; patients must present with serum free thyroxine (T4) and thyroid stimulating hormone (TSH) between the normal range values, with no signs of thyroiditis by serum antibodies over 100% of the standard values; calcitonin levels in the normal range values. The cryoablation or RFA will be directed in a non-randomized fashion. Clinical, laboratorial and imaging monitoring will be performed in 12 months, including contrast-enhanced ultrasound when indicated, by 1, 3, 6 and 12 months.

Palpable nodular thyroid disease is common in up to 6.4% of the population, and it becomes more common when the thyroid is examined by ultrasound. The vast majority of nodules are benign and, over time, do not change considerably in size. The main treatment indications for a euthyroid patient with a benign thyroid nodule that is not hyperfunctioning are compression of the trachea or esophagus, growth of the nodule, and recurrence of a cystic nodule after aspiration. Other indications for treatment are neck discomfort, cosmetic concern, and patient anxiety about the lump. The main therapeutic options are surgery (unilateral lobectomy) and treatment with thyroxine. Thermal ablative therapy has become a treatment option for solid thyroid lesions, with extensive reports in the medical literature on safety and efficacy with laser and radiofrequency devices, including long-term follow-up studies (10 years). In our country, several radiofrequency thermal ablation (RFA) devices are available for use in the treatment of benign thyroid nodules, although some ablation devices do not have the manufacturer's registration for this purpose. Additionally, there is no record in the medical literature of the use of cryoablation devices for the ablation of benign thyroid nodules, although they are used for the treatment of tumor lesions in different sites (hepatic, renal, pulmonary, bone and cervical lymph nodes).The objective of this research is to evaluate, in a pilot study, the safety and efficacy of cryoablation in the treatment of benign thyroid nodules. Additionally, the same evaluation is possible using an RFA device not yet tested for this purpose.

Cryoablation and RFA of Benign Thyroid Nodules: Pilot Study

Thermal Ablation of Benign Thyroid Nodules With Cryoablation or Radiofrequency

Defined as the ability to puncture the nodule and perform the ablation as preoperatively planned.

Evaluation of minor and major complication rates, immediately after and 1 month after ablation \[designed as a safety measure: yes\]. The safety endpoint for this study is to evaluate the incidence and severity of the procedure or device-related adverse events, as reported by the CTCAE V5.2017.

Technical success is defined as to achieve a nodular volume ablation of 50% at 12-month follow up compared to baseline. Nodule volume measurement is performed with the ellipsoid formula: length x width x depth x 0.524.

University of Sao Paulo General Hospital

Symptoms and General Pathology

Cysts

Pathological Conditions, Anatomical

Anti-Infective Agents

Pharmaceutical Solutions

Ethanol

Polidocanol

Anti-Infective Agents, Local

Sclerosing Solutions

Polidocanol is injected in the thyroid cyst under ultrasound guidance.

Alcohol is injected in the thyroid cyst under ultrasound guidance.

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.

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.

Alcohol

Amna Ahmed

Hany Seif

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.

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

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

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

Size of the thyroid cyst is measured by ultrasound after 3 months of sclerosing agent injection

Assiut University

Doctor

A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements

A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements

The video is approximately 6 1/2 minutes in length and portrays an emotionally supportive conversation between a patient and surgeon during which the surgeon discusses: the diagnosis, prognosis, available treatment options, benefits and harms of the options, and need for decision making. The surgeon speaks for the majority of the simulated visit and discusses total and hemi-thyroidectomy with the addition of emotionally supportive statements and gestures.

Emotionally Supportive Video

The video is approximately 5 minutes in length and portrays a standard conversation between a patient and surgeon during which the surgeon discusses: the diagnosis, prognosis, available treatment options, benefits and harms of the options, and need for decision making. The surgeon speaks for the majority of the simulated visit and discusses total and hemi-thyroidectomy.

Standard Video

Corrine Voils, PhD

118 adults with benign thyroid nodules who were seen at a UW Health clinic for a fine needle biopsy and do not need surgery will be enrolled and can expect to be on study for a one-time visit of up to 60 minutes. Each participant will be randomized to watch one of two videos simulating a patient-surgeon discussion about treatment options for low-risk thyroid cancer with or without emotionally supportive statements.

In this study, the investigators will test the extent to which emotionally supportive communication from a surgeon is associated with patient preference for total thyroidectomy. The investigators will conduct a hypothetical choice experiment with "analogue" patients, defined as those with a benign thyroid nodule not requiring surgery.

Baseline measures will be collected, then participants will be randomized to watch a video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer with or without emotionally supportive statements.

The investigators hypothesize that increased emotionally supportive communication by the surgeon will decrease the likelihood of patients choosing total thyroidectomy, reduce anxiety and thyroid cancer fear, and increase decisional confidence, perceived physician empathy, trust in physician, and information recall.

The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer

The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer: a Randomized Hypothetical Choice Experiment

Data collected for this study will be transferred and analyzed at the University of Michigan. After the study is completed, the de-identified, archived data may be transmitted to and stored at a data repository for use by other researchers including those outside of the study. Permission to transmit data to the University of Michigan and data repository will be included in the informed consent.

The investigators will measure which treatment participants would choose if they were the patient with thyroid cancer in the video (total thyroidectomy or lobectomy) immediately after they finish watching the video.

Decisional Confidence in treatment option is measured using a single-item 10-point Likert scale where 1 is 'not confident at all' and 10 is 'completely confident'

The STAI brief is a 6-item survey about how the participant is feeling in the moment (calm, tense, upset, relaxed, content, worried) scored on a 4 point likert scale. The total possible range of scores is 6 to 24 with higher scores indicating higher anxiety.

The adapted Thyroid Cancer Fear Scale is a 8-item survey originally designed to assess fear of breast cancer in patients undergoing cancer screening. Items are rated on a 5-point scale from strongly disagree (1) to strongly agree (5) with a total possible range of scores from 8-40 where higher scores indicate increased fear of cancer.

This 5-question instrument assesses patient perceptions of physician empathy, scored on a 7-point Likert scale ranging from 'strongly disagree' (1) to 'strongly agree' (7). Items are summed, with a max score of 35, higher values indicate a perception of more empathy.

This 5-question instrument assesses patient trust in a physician, scored on a 5-point Likert scale ranging from 'strongly disagree' (1) to 'strongly agree' (5). Responses are summed and scores are on a scale of 5 to 25, with higher values indicating more trust.

National Cancer Institute (NCI)

University of Michigan

University of Wisconsin, Madison

The current study will pose minimal risk to the participants. Although no problems or adverse events are expected, any study related adverse events will be documented and reported to the local IRB per institutional policy.

A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements

Emotionally Supportive Video: The video is approximately 6 1/2 minutes in length and portrays an emotionally supportive conversation between a patient and surgeon during which the surgeon discusses: the diagnosis, prognosis, available treatment options, benefits and harms of the options, and need for decision making. The surgeon speaks for the majority of the simulated visit and discusses total and hemi-thyroidectomy with the addition of emotionally supportive statements and gestures.

A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements

Standard Video: The video is approximately 5 minutes in length and portrays a standard conversation between a patient and surgeon during which the surgeon discusses: the diagnosis, prognosis, available treatment options, benefits and harms of the options, and need for decision making. The surgeon speaks for the majority of the simulated visit and discusses total and hemi-thyroidectomy.

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Education Level

Number of Participants with Bilateral Nodules

Number of participants who self-reported that their largest nodule biopsied was in the size category indication: less than or equal to 2 cm, greater than 2 cm, or unknown (meaning that the patient did not know).

Nodule Size

Participants were asked: Before your thyroid nodule(s) was biopsied, were you experiencing any symptoms from your thyroid nodule(s)? Symptoms might include problems with your swallowing, voice, or neck pressure.

Number of Participants with Symptomatic Nodule

Hypothyroidism

Baseline information provided for analysis population.

Treatment Choice

Participant Decisional Confidence Score

Baseline

Post-Intervention

State Trait Anxiety Inventory Brief (STAI Brief) Score

baseline

Adapted Thyroid Cancer Fear Scale Score

Adapted Jefferson Scale of Patient's Perceptions of Physician's Empathy Score

Adapted Trust in Physician Scale Score

Overall Study

Test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA)

Control group receiving traditional open thyroidectomy

Transoral endoscopic thyroidectomy vestibular approach (TOETVA)

Open thyroidectomy via trans-cervical approach

Traditional Open Thyroidectomy

Cherrie Ng

Thomas Hui

Jason YK Chan

Zenon Yeung

To determine if transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a safe and effective procedure compared to traditional open thyroidectomy. Surgical outcomes, patients' satisfaction, voice and swallowing outcomes will be assessed.

This is a prospective case control study involving a total 40 patients, with 20 stratified into the test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA) and 20 patients to the control group under traditional open approach. Subjects will be assigned to either group without randomization. Patients satisfactory score, voice and swallowing quality of life outcomes will be assessed using Voice Handicap Index (VHI) and MD Anderson Dysphagia Inventory (MDADI) outcomes. Surgical outcomes, for instance, lower lip numbness, skin injury, operative time, blood loss, vocal cord paralysis, temporary and permanent hypoparathyroidism will be assessed.

A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy

Voice Handicap Index - 30 assessing functional, physical and emotional scales

Lower lip numbness, skin bruising or injury, wound infection, vocal cord paralysis, temporary hypoparathyroidism

Lower lip numbness, vocal cord paralysis, permanent hypoparathyroidism

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules	NCT03535974	Benign Thyroid ...	Preparation wit... Placebo	18 Years -	Fundatia Bio-Forum
Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules	NCT03646383	Benign Thyroid ...	Radiofrequency ...	18 Years -	University Hospital, Toulouse
Alterations in Quality of Life After Thyroidectomy for Benign Thyroid Disease	NCT03566537	Benign Thyroid ... Quality of Life	Thyroidectomy	18 Years -	Aristotle University Of Thessaloniki
Cryoablation and RFA of Benign Thyroid Nodules: Pilot Study	NCT06014229	Benign Thyroid ...	cryoablation radiofrequency ...	18 Years -	University of Sao Paulo General Hospital
Comparative Study of Polidocanol and Absolute Alcohol for Percutaneous us Guided Treatment of Benign Thyroid Cyst	NCT05798936	Benign Thyroid ... Thyroid Lump Thyroid Cyst	Polidocanol Alcohol	10 Years - 75 Years	Assiut University
Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules	NCT03535974	Benign Thyroid ...	Preparation wit... Placebo	18 Years -	Fundatia Bio-Forum
The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer	NCT05132478	Thyroid Cancer Thyroid Nodule Benign Thyroid ...	Emotionally Sup... Standard Video	18 Years -	University of Wisconsin, Madison
Comparative Study of Polidocanol and Absolute Alcohol for Percutaneous us Guided Treatment of Benign Thyroid Cyst	NCT05798936	Benign Thyroid ... Thyroid Lump Thyroid Cyst	Polidocanol Alcohol	10 Years - 75 Years	Assiut University
A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy	NCT06225765	Benign Thyroid ... Suspicious Mali...	Transoral endos... Traditional Ope...	18 Years -	Tseung Kwan O Hospital, Hong Kong
Cryoablation and RFA of Benign Thyroid Nodules: Pilot Study	NCT06014229	Benign Thyroid ...	cryoablation radiofrequency ...	18 Years -	University of Sao Paulo General Hospital

Spots Global Cancer Trial Database for benign thyroid nodule