Laser Therapy of Benign Thyroid Nodules

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Status

Patrocinadores

Odense University Hospital

ENSAIO CLÍNICO: NCT00150150

BioSeek: nct00150150

Palavras-chave

Resumo

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:

1. Randomized study of interstitial laser photocoagulation for benign solitary cold thyroid nodules - one versus two or three treatments

2. Randomized study of interstitial laser photocoagulation for benign solitary autonomous thyroid nodules - 131I versus laser ablation

3. Interstitial laser photocoagulation for benign thyroid cystadenomas. - a feasibility study.

datas

Última verificação:	02/28/2007
Enviado pela primeira vez:	09/05/2005
Inscrição estimada enviada:	09/05/2005
Postado pela primeira vez:	09/07/2005
Última atualização enviada:	03/25/2007
Última atualização postada:	03/26/2007
Data real de início do estudo:	12/31/2000
Data Estimada de Conclusão do Estudo:	02/28/2006

Condição ou doença

Benign Solitary Solid

Cystic Thyroid Nodules

Intervenção / tratamento

Procedure: Interstitial laser photocoagulation

Fase

Fase 3

Critério de eleição

Idades qualificadas para estudar	20 Years Para 20 Years
Sexos elegíveis para estudo	All
Aceita Voluntários Saudáveis	sim
Critério	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

Resultado

Medidas de Resultado Primário

1. To evaluate the efficacy and feasibility repeated ILP treatments in a prospective randomised study where the nodule and thyroid volume are measured 1, 3, 6 and 12 months after the ILP. [undefined]

2. In the study of patients with a cystadenoma the measures will be done like wise, but also the recurrence of the cystic part will be measured. [undefined]

3. Patients with an autonomous functioning nodule measurements of thyroid function are performed 1,2, 3, 6, 9 and 12 months after the ILP or 131I therapy. [undefined]

Laser Therapy of Benign Thyroid Nodules

Palavras-chave

thyroid nodule

cancro

cystadenoma

febre

bócio