Basedow DiseaseBALUNCT05784792
Clinical and Surgical Outcomes of Total Thyroidectomy in Basedow's Disease: the Effect of Lugol Solution
A study testing Lugol - in people with Basedow Disease, run by University of Padova at 1 site in Italy.
Trial summary
Preoperative preparation of patient with Basedow's disease is crucial to avoid severe thyrotoxicosis resulting from leakage of thyroid hormone into the circulation at the time of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basedow Disease
- What is being tested?
- Lugol -
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2020to 26 Apr 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Basedow disease candidate to total thyroidectomy
- age>18 years
Who cannot join
- age<18 years;
- presence of solitary toxic nodule
- fine-needle aspiration biopsy result indicating cancer or suspicious cytology
- anticoagulant usage or coagulation disorders
- a previous thyroid operation
- pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Università di Padova, Endocrine Surgery Unit
Padova, PD, 35121
About this study
Preoperative preparation of patient with Basedow's disease is crucial to avoid severe thyrotoxicosis resulting from leakage of thyroid hormone into the circulation at the time of surgery. Moreover, hyperthyroidism-related hypervascularization and tissue fragility caused by Basedow's disease thyroiditis may cause intraoperative bleeding that can reduce the visualization and preservation of parathyroid glands and laryngeal nerves with subsequent higher risk of related morbidity including neck hematoma, hypoparathyroidism and vocal cords paresis. Although some endocrine surgeons administer before surgery Lugol solution to decrease thyroid gland vascularity in Basedow's disease, there is still not an agreement on its effectiveness.
The aims of the present trial are to evaluate the impact of pre-operative short-term Lugol solution treatment (7 days) on surgical outcomes through modification of thyroid vascularity and surgical related morbidity, in patients with Basedow's disease.
Read the detailed description
The study will investigate the effects of Lugol solution treatment before surgery on thyroid vascularity and tissue fragility in patients with Basedow's disease, and if these changes are associated or not with different surgical outcomes.
Hyperthyroidism is associated with hemodynamic changes, decreasing peripheral resistance that are related to both direct cardio-stimulatory effects of thyroid hormone. Preoperative preparation of the patient is crucial to avoid intra-operative or postoperative thyroid storms and to decrease the vascularity of the gland.
Inorganic iodide (Lugol solution) decreases the synthesis of thyroid hormone and release of hormone from the thyroid in the short term. Iodine also seems to reduce thyroid cellularity and vascularity and therefore is used in the preparation of patients for thyroidectomy. This effect transiently blocks thyroid hormone generation, with thyroid hormone synthesis recovering in few days.
On this matter doppler techniques seem to be the best method to evaluate blood flow in the thyroid gland.
Thyroid vascularity in Basedow's disease patients can be evaluated by monitoring CD-34 and CD-31 expression using immunohistochemistry. The vascular density of different tissues has been assessed by counting vessels labeled using immunohistochemistry with antibodies against different endothelial markers on paraffin-embedded sections. Antibodies that are most commonly used are directed against the endothelial antigens factor eight-related antigen, CD-31 (platelet endothelial cell adhesion molecule), CD-34. CD-34 is the most sensitive and specific marker currently available for the detection of angiogenesis. The use of these markers reflects total vascular density.
Moreover some authors showed that iodide inhibits vascular endothelial growth factor (VEGF) expression in cultured human thyroid follicles, and, consequently, they suggest that pro-angiogenic and anti-angiogenic factors may at least partly account for the iodide-induced decrease in thyroid blood flow. Cross-talk between angiogenesis and inflammation has also been reported. T cells can deliver VEGF to inflammatory sites and VEGF can augment pro-inflammatory T cell differentiation and promote angiogenesis.
So the detection of VEGF could be useful in the demonstration of Lugol effect on pretreated patients.
Investigators hypothesize that Lugol solution might act through different mechanisms. It probably decreases both angiogenic stimuli and blood flow in Basedow's disease. Decreased angiogenesis and blood flow resulted in a significantly decreased number of visible vessels. Therefore, it is reasonable to think that increased vascular density could reflect increased angiogenic input to this disease. Lugol solution could also act directly to vessels wall, changing arteries and veins lumen.
These modifications could cause a reduction of intra-operative bleeding that could allow better visualization and preservation of the surrounding nerves, vasculature, and parathyroid glands and so better surgical and clinical outcomes.
- Conditions
- Basedow Disease
- Being tested
- Lugol -
- Keywords
- Lugol Solution, Total Thyroidectomy
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lugol -Other
Patients that undergo total thyroidectomy without Lugol solution pretreatment
| Study group | Role | What they receive |
|---|---|---|
| Lugol - | No intervention | No pre-operative Lugol Solution preparation |
| Lugol + | Active comparator | Pre-operative Lugol preparation (10 drops per day orally three times a day for 7 days for an amount of 10,5 ml of Lugol solution that contains 1,68 gr of Iodine). Receives: Other: Lugol - |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra and post-operative blood loss (mL).
Blood loss volume (mL) as the amount of blood in the suction bottle and that absorbed by gauzes used during surgery was measured (volume calculated from the difference between dry gauzes weight and soaked gauzes weight). Evaluation of differences (if any) in this outcome in the two groups of the study (Lugol assumption/no Lugol assumption).
Measured: Intra and post-operative bleeding (1st and 2nd day after surgery)
Secondary outcomes (3)
Post-operative laryngeal nerves palsy.
Evaluation of vocal cords disfunction. Evaluation of differences (if any) in this outcome in the two groups of the study (Lugol assumption/no Lugol assumption).
Measured: Laryngeal ultrasound on 1st and 2nd day and indirect laryngoscopy in case of dysphonia
Intra and post-operative thyrotoxicosis.
Heart rate > 120 b/min detected during surgery or during post-operative hospital days. Evaluation of differences (if any) in this outcome in the two groups of the study (Lugol assumption/no Lugol assumption).
Measured: During surgery and on 1st and 2nd day after surgery
Post-operative hypocalcemia (hypoparathyroidism, hungry bone syndrome).
serum calcium level less than 2,00 (8 mg/dl), with serum PTH inappropriately low (<10 pg/mL). Evaluation of differences (if any) in this outcome in the two groups of the study (Lugol assumption/no Lugol assumption).
Measured: Blood sample on 1st and 2nd day after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Feb 2020
- Primary completion26 Jan 2023
- Study completion26 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Basedow DiseaseStudies 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
- Case-Control study
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Iacobone, University of Padova
- Investigators
- Maurizio Iacobone, Prof, Study director, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784792
- Sponsor's protocol ID
- UPd39962
- Acronym
- BALU
- Status last verified
- Mar 2024
- First submitted
- 27 Jan 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hope N, Kelly A. Pre-Operative Lugol's Iodine Treatment in the Management of Patients Undergoing Thyroidectomy for Graves' Disease: A Review of the Literature. Eur Thyroid J. 2017 Feb;6(1):20-25. doi: 10.1159/000450976. Epub 2016 Nov 22.
PubMed 28611944Erbil Y, Ozluk Y, Giris M, Salmaslioglu A, Issever H, Barbaros U, Kapran Y, Ozarmagan S, Tezelman S. Effect of lugol solution on thyroid gland blood flow and microvessel density in the patients with Graves' disease. J Clin Endocrinol Metab. 2007 Jun;92(6):2182-9. doi: 10.1210/jc.2007-0229. Epub 2007 Mar 27.
PubMed 17389702Yilmaz Y, Kamer KE, Ureyen O, Sari E, Acar T, Karahalli O. The effect of preoperative Lugol's iodine on intraoperative bleeding in patients with hyperthyroidism. Ann Med Surg (Lond). 2016 Jun 16;9:53-7. doi: 10.1016/j.amsu.2016.06.002. eCollection 2016 Aug.
PubMed 27408715Shinall MC Jr, Broome JT, Nookala R, Shinall JB, Kiernan C, Parks L 3rd, Solorzano CC. Total thyroidectomy for Graves' disease: compliance with American Thyroid Association guidelines may not always be necessary. Surgery. 2013 Nov;154(5):1009-15. doi: 10.1016/j.surg.2013.04.064. Epub 2013 Sep 26.
PubMed 24075271Huang SM, Liao WT, Lin CF, Sun HS, Chow NH. Effectiveness and Mechanism of Preoperative Lugol Solution for Reducing Thyroid Blood Flow in Patients with Euthyroid Graves' Disease. World J Surg. 2016 Mar;40(3):505-9. doi: 10.1007/s00268-015-3298-8.
PubMed 26546192Yabuta T, Ito Y, Hirokawa M, Fukushima M, Inoue H, Tomoda C, Higashiyama T, Kihara M, Uruno T, Takamura Y, Kobayashi K, Miya A, Matsuzuka F, Miyauchi A. Preoperative administration of excess iodide increases thyroid volume of patients with Graves' disease. Endocr J. 2009;56(3):371-5. doi: 10.1507/endocrj.k08e-240. Epub 2009 Jan 9.
PubMed 19139595Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016 Oct 20;375(16):1552-1565. doi: 10.1056/NEJMra1510030. No abstract available.
PubMed 27797318Ansaldo GL, Pretolesi F, Varaldo E, Meola C, Minuto M, Borgonovo G, Derchi LE, Torre GC. Doppler evaluation of intrathyroid arterial resistances during preoperative treatment with Lugol's iodide solution in patients with diffuse toxic goiter. J Am Coll Surg. 2000 Dec;191(6):607-12. doi: 10.1016/s1072-7515(00)00755-9.
PubMed 11129808Erbil Y, Giris M, Salmaslioglu A, Ozluk Y, Barbaros U, Yanik BT, Kapran Y, Abbasoglu SD, Ozarmagan S. The effect of anti-thyroid drug treatment duration on thyroid gland microvessel density and intraoperative blood loss in patients with Graves' disease. Surgery. 2008 Feb;143(2):216-25. doi: 10.1016/j.surg.2007.07.036. Epub 2007 Dec 21.
PubMed 18242338Schiavone D, Crimi F, Cabrelle G, Pennelli G, Sacchi D, Mian C, Torresan F, Iacobone M. Role of Lugol solution before total thyroidectomy for Graves' disease: randomized clinical trial. Br J Surg. 2024 Aug 2;111(8):znae196. doi: 10.1093/bjs/znae196.
PubMed 39129619
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Surgical Outcomes of Total Thyroidectomy in Basedow's Disease: the Effect of Lugol Solution
- ClinicalTrials.gov ID
- NCT05784792
- Acronym / sponsor ID
- BALU / UPd39962
- Conditions
- Basedow Disease
- Keywords
- Lugol Solution, Total Thyroidectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 26 Apr 2024 (estimated)
- First posted
- 27 Mar 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.
Preoperative preparation of patient with Basedow's disease is crucial to avoid severe thyrotoxicosis resulting from leakage of thyroid hormone into the circulation at the time of surgery. Moreover, hyperthyroidism-related hypervascularization and tissue fragility caused by Basedow's disease thyroiditis may cause intraoperative bleeding that can reduce the visualization and preservation of parathyroid glands and laryngeal nerves with subsequent higher risk of related morbidity including neck hematoma, hypoparathyroidism and vocal cords paresis. Although some endocrine surgeons administer before surgery Lugol solution to decrease thyroid gland vascularity in Basedow's disease, there is still not an agreement on its effectiveness.
The aims of the present trial are to evaluate the impact of pre-operative short-term Lugol solution treatment (7 days) on surgical outcomes through modification of thyroid vascularity and surgical related morbidity, in patients with Basedow's disease.
Detailed description
The study will investigate the effects of Lugol solution treatment before surgery on thyroid vascularity and tissue fragility in patients with Basedow's disease, and if these changes are associated or not with different surgical outcomes.
Hyperthyroidism is associated with hemodynamic changes, decreasing peripheral resistance that are related to both direct cardio-stimulatory effects of thyroid hormone. Preoperative preparation of the patient is crucial to avoid intra-operative or postoperative thyroid storms and to decrease the vascularity of the gland.
Inorganic iodide (Lugol solution) decreases the synthesis of thyroid hormone and release of hormone from the thyroid in the short term. Iodine also seems to reduce thyroid cellularity and vascularity and therefore is used in the preparation of patients for thyroidectomy. This effect transiently blocks thyroid hormone generation, with thyroid hormone synthesis recovering in few days.
On this matter doppler techniques seem to be the best method to evaluate blood flow in the thyroid gland.
Thyroid vascularity in Basedow's disease patients can be evaluated by monitoring CD-34 and CD-31 expression using immunohistochemistry. The vascular density of different tissues has been assessed by counting vessels labeled using immunohistochemistry with antibodies against different endothelial markers on paraffin-embedded sections. Antibodies that are most commonly used are directed against the endothelial antigens factor eight-related antigen, CD-31 (platelet endothelial cell adhesion molecule), CD-34. CD-34 is the most sensitive and specific marker currently available for the detection of angiogenesis. The use of these markers reflects total vascular density.
Moreover some authors showed that iodide inhibits vascular endothelial growth factor (VEGF) expression in cultured human thyroid follicles, and, consequently, they suggest that pro-angiogenic and anti-angiogenic factors may at least partly account for the iodide-induced decrease in thyroid blood flow. Cross-talk between angiogenesis and inflammation has also been reported. T cells can deliver VEGF to inflammatory sites and VEGF can augment pro-inflammatory T cell differentiation and promote angiogenesis.
So the detection of VEGF could be useful in the demonstration of Lugol effect on pretreated patients.
Investigators hypothesize that Lugol solution might act through different mechanisms. It probably decreases both angiogenic stimuli and blood flow in Basedow's disease. Decreased angiogenesis and blood flow resulted in a significantly decreased number of visible vessels. Therefore, it is reasonable to think that increased vascular density could reflect increased angiogenic input to this disease. Lugol solution could also act directly to vessels wall, changing arteries and veins lumen.
These modifications could cause a reduction of intra-operative bleeding that could allow better visualization and preservation of the surrounding nerves, vasculature, and parathyroid glands and so better surgical and clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Case-Control study
| Arm | Type | Receives |
|---|---|---|
| Lugol - | No intervention | –No pre-operative Lugol Solution preparation |
| Lugol + | Active comparator | Other: Lugol -Pre-operative Lugol preparation (10 drops per day orally three times a day for 7 days for an amount of 10,5 ml of Lugol solution that contains 1,68 gr of Iodine). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of Basedow disease candidate to total thyroidectomy
- age>18 years
Key exclusion criteria (6 listed)
- age<18 years;
- presence of solitary toxic nodule
- fine-needle aspiration biopsy result indicating cancer or suspicious cytology
- anticoagulant usage or coagulation disorders
- a previous thyroid operation
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 |
|---|---|---|
| Lugol -Patients that undergo total thyroidectomy without Lugol solution pretreatment | Other | Lugol + |
Primary outcome
Intra and post-operative blood loss (mL).
Time frame: Intra and post-operative bleeding (1st and 2nd day after surgery)
Blood loss volume (mL) as the amount of blood in the suction bottle and that absorbed by gauzes used during surgery was measured (volume calculated from the difference between dry gauzes weight and soaked gauzes weight). Evaluation of differences (if any) in this outcome in the two groups of the study (Lugol assumption/no Lugol assumption).
3 secondary outcomes
Post-operative laryngeal nerves palsy.
Time frame: Laryngeal ultrasound on 1st and 2nd day and indirect laryngoscopy in case of dysphonia
Intra and post-operative thyrotoxicosis.
Time frame: During surgery and on 1st and 2nd day after surgery
Post-operative hypocalcemia (hypoparathyroidism, hungry bone syndrome).
Time frame: Blood sample on 1st and 2nd day after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Results publication: PubMed 28611944Hope N, Kelly A. Pre-Operative Lugol's Iodine Treatment in the Management of Patients Undergoing Thyroidectomy for Graves' Disease: A Review of the Literature. Eur Thyroid J. 2017 Feb;6(1):20-25. doi: 10.1159/000450976. Epub 2016 Nov 22.
- Results publication: PubMed 17389702Erbil Y, Ozluk Y, Giris M, Salmaslioglu A, Issever H, Barbaros U, Kapran Y, Ozarmagan S, Tezelman S. Effect of lugol solution on thyroid gland blood flow and microvessel density in the patients with Graves' disease. J Clin Endocrinol Metab. 2007 Jun;92(6):2182-9. doi: 10.1210/jc.2007-0229. Epub 2007 Mar 27.
- Results publication: PubMed 27408715Yilmaz Y, Kamer KE, Ureyen O, Sari E, Acar T, Karahalli O. The effect of preoperative Lugol's iodine on intraoperative bleeding in patients with hyperthyroidism. Ann Med Surg (Lond). 2016 Jun 16;9:53-7. doi: 10.1016/j.amsu.2016.06.002. eCollection 2016 Aug.
- Results publication: PubMed 24075271Shinall MC Jr, Broome JT, Nookala R, Shinall JB, Kiernan C, Parks L 3rd, Solorzano CC. Total thyroidectomy for Graves' disease: compliance with American Thyroid Association guidelines may not always be necessary. Surgery. 2013 Nov;154(5):1009-15. doi: 10.1016/j.surg.2013.04.064. Epub 2013 Sep 26.
- Results publication: PubMed 26546192Huang SM, Liao WT, Lin CF, Sun HS, Chow NH. Effectiveness and Mechanism of Preoperative Lugol Solution for Reducing Thyroid Blood Flow in Patients with Euthyroid Graves' Disease. World J Surg. 2016 Mar;40(3):505-9. doi: 10.1007/s00268-015-3298-8.
- Results publication: PubMed 19139595Yabuta T, Ito Y, Hirokawa M, Fukushima M, Inoue H, Tomoda C, Higashiyama T, Kihara M, Uruno T, Takamura Y, Kobayashi K, Miya A, Matsuzuka F, Miyauchi A. Preoperative administration of excess iodide increases thyroid volume of patients with Graves' disease. Endocr J. 2009;56(3):371-5. doi: 10.1507/endocrj.k08e-240. Epub 2009 Jan 9.
- Results publication: PubMed 27797318Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016 Oct 20;375(16):1552-1565. doi: 10.1056/NEJMra1510030. No abstract available.
- Results publication: PubMed 11129808Ansaldo GL, Pretolesi F, Varaldo E, Meola C, Minuto M, Borgonovo G, Derchi LE, Torre GC. Doppler evaluation of intrathyroid arterial resistances during preoperative treatment with Lugol's iodide solution in patients with diffuse toxic goiter. J Am Coll Surg. 2000 Dec;191(6):607-12. doi: 10.1016/s1072-7515(00)00755-9.
- Results publication: PubMed 18242338Erbil Y, Giris M, Salmaslioglu A, Ozluk Y, Barbaros U, Yanik BT, Kapran Y, Abbasoglu SD, Ozarmagan S. The effect of anti-thyroid drug treatment duration on thyroid gland microvessel density and intraoperative blood loss in patients with Graves' disease. Surgery. 2008 Feb;143(2):216-25. doi: 10.1016/j.surg.2007.07.036. Epub 2007 Dec 21.
- Derived from this study: PubMed 39129619Schiavone D, Crimi F, Cabrelle G, Pennelli G, Sacchi D, Mian C, Torresan F, Iacobone M. Role of Lugol solution before total thyroidectomy for Graves' disease: randomized clinical trial. Br J Surg. 2024 Aug 2;111(8):znae196. doi: 10.1093/bjs/znae196.
- 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.
Maurizio Iacobone, Prof study director
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lugol - in people with Basedow Disease, run by University of Padova at 1 site in Italy.
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 2 inclusion and 6 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Intra and post-operative blood loss (mL). (time frame: Intra and post-operative bleeding (1st and 2nd day after surgery)). 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 NCT05784792, which also lists 10 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 20 Mar 2024.