Laser Therapy of Benign Thyroid Nodules

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2006-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Benign Solitary Solid Cystic Thyroid Nodules

Keywords

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Interventional ultrasound interstitial laser theraphy tumor ablation nodule reduction adverse effects patient satesfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Interstitial laser photocoagulation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Helle Døssing, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Department of Endocrinology, Odense University Hospital

Odense, Funen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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017

Identifier Type: -

Identifier Source: org_study_id