No registrations found.
Source
Brief title
Health condition
benign euthyroid goitre
struma
Sponsors and support
- Flevoziekenhuis
Intervention
No registrations found.
Outcome measures
Primary outcome
reduction of symptoms 12 months after treatment measured with ThyPro Questionnaire
Secondary outcome
- Quality of life measured by EQ-5D-5L questionnaire after 6 months and 1-5 years
- Voice impairment after 6 months and 1-5 years as measured by the Voice Handicap
Index, a specific questionnaire for voice impairment detection a
- Effect of treatment on symptoms after 6 months, 2, 3, 4 and 5 years after treatment
as measurd by the ThyPRO questionnairre
- Goitre volume as measured on a CT-scan 12 months after treatment
- Serum TSH, T4 levels, PTH (standard 2-6 weeks after treatment or if measured under
routine care at any time during follow-up)
- Hypo- or hyperthyroidism
- Peri-operative complications: vocal cords palsy
- Complications of radioactive iodine
Background summary
Rationale: Euthyroid benign symptomatic goitre can be treated with radioactive 131-Iodine
or resection of the thyroid (hemithyroidectomy). Resection of a large goitre combines an
operative risk for bleeding/infection, vocal cord apraxia/palsy and a small risk of
hypothyroidism 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 goitre size. Both treatment options are currently performed, but have never been
compared in a randomised 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 goitre.
Study design: Prospective open-label randomised trial.
Study population: Patients with treatment desire or treatment indication for symptomatic
benign euthyroid goitre, including both one-sided as double-sided goitre with a total volume
of at least 40 ml (for one side). Patients should be candidates for both surgical treatment and
radioactive iodine treatment.
Intervention: Radioactive iodine treatment conform local treatment protocols or
hemithyroidectomy with resection of the largest lobe.
Main study parameters/endpoints: Primary outcome is the reduction of symptoms 12
months after treatment, as measured by a decrease of complaints on self-reported QoL
questionnaire (ThyPRO). Secondary outcomes are goitre volume as measured on a CT-scan
without contrast 1 year after treatment, complications (vocal cords palsy, hypo- or
hyperthyroidism) and self-reported QoL after two to five years after treatment..
Sample size calculation: We use a superiority design. In literature a decrease of symptoms
after surgery or RAI treatment is described around 50%-80%. Based on this literature we
expect a mean difference ThyPRO of 16 points (from 36 to 20) between the two groups, in
favour of hemithyroidectomy. Using a 2-sided alpha of 0.05 and a power of 80 percent 29
patients per group are necessary. Expecting a drop out of 10% 70 patients will be included.
Nature and extent of the burden and risks associated with participation, benefit and
group relatedness: Patients are currently treated with either radioactive iodine and
hemithyroidectomy, based on doctor’s or patient’s preference. Participation in this study does
not increase the existing risks of treatment. 12 months after treatment a CT-scan of the neck without contrast will be made as part of this study. The radiation exposure of a CT-scan of
the neck is estimated to be 3.5 mSv for the patients. The exposure is within the category IIb
(1-10mSv) of the International Commission on Radiological Protection (ICRP), which
qualifies as: intermediate risk.
Study objective
Treatment of patients with a benign euthyroid goitre, with either radioactive Iodine or hemithyroidectomy, has a different effect on symptoms and quality of life (QoL)
Study design
- baseline
- routine post-treatment
- 6 months
- 1, 2, 3, 4, 5 mars
Intervention
Radioactive iodine treatment
Hemithyroidectomy
E.J.M Nieveen van Dijkum
Amsterdam
The Netherlands
e.j.nieveenvandijkum@amc.nl
E.J.M Nieveen van Dijkum
Amsterdam
The Netherlands
e.j.nieveenvandijkum@amc.nl
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 6 months after treatment
- Able to undergo surgery as well as radioiodine treatment
- 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
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7041 |
NTR-old | NTR7246 |
CCMO | NL64148.018.17 |