To compare the effect of radioactive Iodine or hemithyroidectomy on the symptoms and quality of life (QoL) of patients with a benign euthyroid goiter.
ID
Source
Brief title
Condition
- Thyroid gland disorders
- Endocrine gland therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the reduction of symptoms 12 months after treatment, as
measured by a decrease of complaints on self-reported QoL questionnaire
(THYRPRO).
Secondary outcome
Secondary outcomes are goiter volume as measured on a CT-scan without contrast
1 year after treatment and complications (vocal cords palsy, hypo- or
hyperthyroidism.
Background summary
Euthyroid benign symptomatic goiter can be treated with radioactive 131-Iodine
or resection of the thyroid. Resection of a large goiter combines an operative
risk for bleeding/infection and vocal cord apraxia/palsy with an almost 100%
relieve of symptoms. Radioactive Iodine treatment combines a risk for
hypothyroidism, hyperthyroidism or thyroiditis with an estimated 40-60%
reduction in goiter size. Both treatment options are currently performed, but
have never been compared in a randomised study.
Study objective
To compare the effect of radioactive Iodine or hemithyroidectomy on the
symptoms and quality of life (QoL) of patients with a benign euthyroid goiter.
Study design
Prospective open-label randomised trial
Intervention
Radioactive iodine treatment conform local treatment protocols or
hemithyroidectomy with resection of the largest lobe.
Study burden and risks
Patients are currently treated with both radioactive iodine and
hemithyroidectomy, based on doctor*s or patient*s preference. Participation in
this study does not increase the existing risks. The average dose of a CT scan
of the neck is estimated to be 6 mSv for the patients. The exposure is within
the category IIb (1-10mSv) of the Netherlands Commission on Radiation Dosimetry
and Subcommittee Radation Doses & Risk Estimation for Medical Diagnostics and
Research, which qualifies as a low level of risk.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Patients with symptomatic goitre
- Goitre size larger than 40 ml on one side determined on CT
- Patients accept both treatment modalities
- TSH between 0,5-5,0 mE/L (euthyroidism) without Thyroid suppletion
- Not pregnant or childwish within 64 months after treatment
- Able to undergo surgery as well as radioiodine treatment (hoe te definieren)
- Able to fill in questionnaires and give Informed Consent
- 18 years or older
Exclusion criteria
- Goitre suspicious of malignancy on imaging
- Bethesda 5 or 6 cytology
- Hyperthyroidism
- Previous history of thyroid surgery or radioactive iodine
- Not eligible for general anesthesia
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-005135-16-NL |
| CCMO | NL64148.018.18 |