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Recruiting NCT04856488

Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter

Phase III Interventional Hyperthyroidism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Iodine-Potassium Iodide 5%-10% Oral and Topical Solution.
Who it may be relevant to
Registry conditions: Hyperthyroidism. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The purpose of this study is to assess if preoperative treatment with Lugol's solution prior to thyroidectomy can reduce the surgical complications hypoparathyroidism and laryngeal nerve palsy

Detailed description

Current practice in Sweden before thyroidectomy due to hyperthyroidism is preoperative treatment with antithyroid drugs (ATD) to all patients with Graves' disease and in cases of toxic nodular goiter with pronounced hyperthyroidism. Iodine solution is administered preoperatively in selected cases of Graves' disease where ATD is intolerable. In the cases where iodine is used it is in the form of extemporaneous prepared iodine potassium iodide solution (Lugol 5%). The dose varies in clinical studies. In American and Swedish guidelines the dose is 5-10 drops 3 times per day for 10 days prior to surgery. American guidelines recommend iodine as preoperative treatment i Graves' disease but this is based on sparse evidence. Iodine as preoperative treatment in toxic nodular goiter has yet not been studied.

The purpose of this study is to assess if preoperative treatment with Lugol's solution prior to thyroidectomy due to hyperthyroidism reduce the surgical complications hypoparathyroidism and laryngeal nerve palsy.

Before including toxic nodular goiters accepted for surgery, a pilot study will be performed on 20 patients with toxic nodular goiter. They will receive Lugol solution 3 times per day for ten days and thyroid hormone levels will be measured day 0, day 3-4, day 6-7 and after 10 days of Lugol treatment. Heart rate assessed and ThyPRO39 filled out before and after treatment.

Interventions

  • Drug Iodine-Potassium Iodide 5%-10% Oral and Topical Solution
    Iodine Potassium Iodide 5% oral solution, administered 3 times per day for 10 days

Primary outcome measures

  • Temporary hypoparathyroidism [Time frame: 1 month postoperatively]
Secondary outcome measures (3)
  • Temporary laryngeal nerve palsy [Time frame: 1 month postoperatively]
  • Permanent laryngeal nerve palsy [Time frame: 6 months postoperatively]
  • Permanent hypoparathyroidism [Time frame: 6 months postoperatively]

Eligibility criteria

Inclusion criteria

  • Hyperthyroidism accepted for thyroidectomy due to toxic nodular goiter with free T4 <30 pmol/L or Graves' disease
  • Signed informed consent

Exclusion criteria

  • Unstable coronary artery disease
  • Previous thyroid surgery
  • Congestive heart failure
  • Renal insufficiency
  • Hepatic failure
  • Current infection
  • Treatment with steroids or anticoagulants
  • Thyroid associated orbitopathy CAS > 2
  • Diabetes mellitus type 1
  • Active cancer
  • Severe psychiatric illness
  • Amiodarone treatment
  • Pregnancy
  • Breast feeding
  • Women of child bearing potential not using contraceptive
  • Inability to comprehend the meaning of the study
  • Iodine hypersensitivity

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Department of Endocrinology, Karolinska University Hospital — Solna

Publications

  • Ross DS, Burch HB, Cooper DS, Greenlee MC, Laurberg P, Maia AL, Rivkees SA, Samuels M, Sosa JA, Stan MN, Walter MA. 2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis. Thyroid. 2016 Oct;26(10):1343-1421. doi: 10.1089/thy.2016.0229. PMID 27521067
  • Kaur S, Parr JH, Ramsay ID, Hennebry TM, Jarvis KJ, Lester E. Effect of preoperative iodine in patients with Graves' disease controlled with antithyroid drugs and thyroxine. Ann R Coll Surg Engl. 1988 May;70(3):123-7. PMID 2457351
  • Randle RW, Bates MF, Long KL, Pitt SC, Schneider DF, Sippel RS. Impact of potassium iodide on thyroidectomy for Graves' disease: Implications for safety and operative difficulty. Surgery. 2018 Jan;163(1):68-72. doi: 10.1016/j.surg.2017.03.030. Epub 2017 Nov 3. PMID 29108701
  • Whalen G, Sullivan M, Maranda L, Quinlan R, Larkin A. Randomized trial of a short course of preoperative potassium iodide in patients undergoing thyroidectomy for Graves' disease. Am J Surg. 2017 Apr;213(4):805-809. doi: 10.1016/j.amjsurg.2016.07.015. Epub 2016 Aug 4. PMID 27769543
  • Marigold JH, Morgan AK, Earle DJ, Young AE, Croft DN. Lugol's iodine: its effect on thyroid blood flow in patients with thyrotoxicosis. Br J Surg. 1985 Jan;72(1):45-7. doi: 10.1002/bjs.1800720118. PMID 3967130
  • Yilmaz 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. PMID 27408715
  • Huang 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. PMID 26546192
  • Calissendorff J, Falhammar H. Rescue pre-operative treatment with Lugol's solution in uncontrolled Graves' disease. Endocr Connect. 2017 May;6(4):200-205. doi: 10.1530/EC-17-0025. Epub 2017 Mar 21. PMID 28325735

Identifiers

NCT: NCT04856488 · LugolProtocol001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗