search
Back to results

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

Primary Purpose

Hyperthyroidism

Status
Recruiting
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Iodine-Potassium Iodide 5%-10% Oral and Topical Solution
Sponsored by
Jan Calissendorff
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperthyroidism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Endocrinology, Karolinska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Iodine Potassium Iodide solution

No intervention

Arm Description

Participants receive Iodine Potassium Iodide solution oral drops 3 times per day for 10 Days prior to thyroidectomy in addition to standard preoperative treatment

Participants continue with standard preoperative treatment

Outcomes

Primary Outcome Measures

Temporary hypoparathyroidism
Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low parathormone (PTH), supplementation with per oral vitamin D or calcium.

Secondary Outcome Measures

Temporary laryngeal nerve palsy
Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy.
Permanent laryngeal nerve palsy
Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy.
Permanent hypoparathyroidism
Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low PTH, supplementation with per oral vitamin D or calcium.

Full Information

First Posted
April 6, 2021
Last Updated
October 3, 2023
Sponsor
Jan Calissendorff
search

1. Study Identification

Unique Protocol Identification Number
NCT04856488
Brief Title
Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter
Official Title
Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jan Calissendorff

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthyroidism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iodine Potassium Iodide solution
Arm Type
Experimental
Arm Description
Participants receive Iodine Potassium Iodide solution oral drops 3 times per day for 10 Days prior to thyroidectomy in addition to standard preoperative treatment
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Participants continue with standard preoperative treatment
Intervention Type
Drug
Intervention Name(s)
Iodine-Potassium Iodide 5%-10% Oral and Topical Solution
Other Intervention Name(s)
Lugol's solution
Intervention Description
Iodine Potassium Iodide 5% oral solution, administered 3 times per day for 10 days
Primary Outcome Measure Information:
Title
Temporary hypoparathyroidism
Description
Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low parathormone (PTH), supplementation with per oral vitamin D or calcium.
Time Frame
1 month postoperatively
Secondary Outcome Measure Information:
Title
Temporary laryngeal nerve palsy
Description
Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy.
Time Frame
1 month postoperatively
Title
Permanent laryngeal nerve palsy
Description
Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy.
Time Frame
6 months postoperatively
Title
Permanent hypoparathyroidism
Description
Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low PTH, supplementation with per oral vitamin D or calcium.
Time Frame
6 months postoperatively
Other Pre-specified Outcome Measures:
Title
Change from Baseline in Quality of Life on the Thyroid Specific Patient Reported Outcome 39 (ThyPRO 29) questionnaire
Description
ThyPRO 39 is a validated thyroid specific Quality of Life form. Self reported questionnaire filled out before and after surgery. ThyPRO consists of 39 items grouped in 11 scales. Each item is is rated from 0 to 5 on a 5 point Likert scale. Increasing scores indicating decreasing quality of life. Lower scores indicating better quality of life.
Time Frame
6 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Calissendorff, MD, PhD
Phone
+46(0)8 51770000
Email
jan.calissendorff@regionstockholm.se
First Name & Middle Initial & Last Name or Official Title & Degree
Fredric Hedberg, MD
Phone
+46(0)8 51770000
Email
fredric.hedberg@regionstockholm.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Calissendorff, MD, PhD
Organizational Affiliation
Department of Molecular Medicine and Surgery, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology, Karolinska University Hospital
City
Solna
State/Province
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Calissendorff, MD.PhD
Phone
0046 (0)8 51770000
Email
jan.calissendorff@regionstockholm.se
First Name & Middle Initial & Last Name & Degree
Fredric Hedberg, MD
Phone
0046 (0)8 51770000
Email
fredric.hedberg@regionstockholm.se

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The original contributions presented in the study are included in the article/supplementary material.
IPD Sharing Time Frame
The original contributions presented in the study are included in the article/supplementary material. Inquiries can be directed to the corresponding author after publication.
IPD Sharing Access Criteria
Further inquiries can be directed to the corresponding author.
Citations:
PubMed Identifier
27521067
Citation
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. Erratum In: Thyroid. 2017 Nov;27(11):1462.
Results Reference
background
PubMed Identifier
2457351
Citation
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.
Results Reference
background
PubMed Identifier
29108701
Citation
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.
Results Reference
background
PubMed Identifier
27769543
Citation
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.
Results Reference
background
PubMed Identifier
3967130
Citation
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.
Results Reference
background
PubMed Identifier
27408715
Citation
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.
Results Reference
background
PubMed Identifier
26546192
Citation
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.
Results Reference
background
PubMed Identifier
28325735
Citation
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.
Results Reference
background
PubMed Identifier
29075974
Citation
Calissendorff J, Falhammar H. Lugol's solution and other iodide preparations: perspectives and research directions in Graves' disease. Endocrine. 2017 Dec;58(3):467-473. doi: 10.1007/s12020-017-1461-8. Epub 2017 Oct 26.
Results Reference
background
PubMed Identifier
22021061
Citation
Spallek L, Krille L, Reiners C, Schneider R, Yamashita S, Zeeb H. Adverse effects of iodine thyroid blocking: a systematic review. Radiat Prot Dosimetry. 2012 Jul;150(3):267-77. doi: 10.1093/rpd/ncr400. Epub 2011 Oct 20.
Results Reference
background
PubMed Identifier
8498398
Citation
Nauman J, Wolff J. Iodide prophylaxis in Poland after the Chernobyl reactor accident: benefits and risks. Am J Med. 1993 May;94(5):524-532. doi: 10.1016/0002-9343(93)90089-8. No abstract available.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs