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

Jan Calissendorff

Status and phase: Enrolling; Phase 3

Conditions: Hyperthyroidism

Treatments: Drug: Iodine-Potassium Iodide 5%-10% Oral and Topical Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04856488

LugolProtocol001

Details and patient eligibility

About

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

Full 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.

Enrollment: 182 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Iodine Potassium Iodide solution

Experimental group

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

Treatment:

Drug: Iodine-Potassium Iodide 5%-10% Oral and Topical Solution

No intervention

No Intervention group

Description:

Participants continue with standard preoperative treatment