Laser Therapy of Benign Thyroid Nodules

O

Odense University Hospital

Status and phase

Unknown
Phase 3

Conditions

Cystic Thyroid Nodules
Benign Solitary Solid

Treatments

Procedure: Interstitial laser photocoagulation

Study type

Interventional

Funder types

Other

Identifiers

NCT00150150
017

Details and patient eligibility

About

Nodular goitre is common in the general population and less than 5% of the patients who undergo surgery for solitary thyroid nodules have cancer, in absence of clinical suspicion. Nodules left untreated seem to have a slight growth potential in borderline iodine-deficient areas. Interstitial laser photo-coagulation (ILP) is a procedure for local hyperthermia and photocoagulation, allowing minimally invasive treatment of benign tumors, including thyroid nodules. The aim of these studies are to evaluate if ILP will be useful in reducing the volume of the benign thyroid nodule and thyroid function will be unaffected in euthyroid patients, and normalized in pretoxic- and toxic thyroid nodules. The investigations are listed below: Randomized study of interstitial laser photocoagulation for benign solitary cold thyroid nodules - one versus two or three treatments Randomized study of interstitial laser photocoagulation for benign solitary autonomous thyroid nodules - 131I versus laser ablation Interstitial laser photocoagulation for benign thyroid cystadenomas. - a feasibility study.

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with a solitary solid thyroid nodule confirmed by ultrasonography
  • Patients with a solitary cystadenoma (cystic part more than 2 mL) confirmed by ultrasonography
  • Patients with an autonomous functioning thyroid nodule.

Exclusion criteria

  • No family history of thyroid cancer
  • Prior radiation towards the neck
  • Fine needle biopsy without valid diagnostic criteria for benign thyroid disease
  • Nodules larger than 4 cm (largest diameter)
  • Suspicion of malignancy
  • Increased serum calcitonin
  • Pregnancy or lactation
  • Alcohol, medicine or drug abuse
  • No safe contraception
  • Physical or psychic condition that hinders corporation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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