Laser Therapy of Benign Thyroid Nodules

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Статус

Спонзори

Odense University Hospital

КЛИНИЧКО ИСПИТУВАЊЕ: NCT00150150

BioSeek: nct00150150

Клучни зборови

Апстракт

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.

Датуми

Последен пат проверено:	02/28/2007
Прво доставено:	09/05/2005
Поднесено е проценето запишување:	09/05/2005
Прво објавено:	09/07/2005
Последното ажурирање е доставено:	03/25/2007
Последно ажурирање објавено:	03/26/2007
Крај на датумот на започнување на студијата:	12/31/2000
Проценет датум на завршување на студијата:	02/28/2006

Состојба или болест

Benign Solitary Solid

Cystic Thyroid Nodules

Интервенција / третман

Procedure: Interstitial laser photocoagulation

Фаза

Фаза 3

Критериуми за подобност

Возраст подобни за студии	20 Years До 20 Years
Полови квалификувани за студии	All
Прифаќа здрави волонтери	Да
Критериуми	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

Исход

Мерки на примарниот исход

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

Клучни зборови

thyroid nodule

рак

cystadenoma

треска

goiter