Clinical trial NCT03257930: Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules
Official title: Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thyroid Nodule
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 1
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Use of ethanol injection in treatment of cystic thyroid nodule

Detailed description: Thyroid nodules are common discreet lesions in the parenchyma of thyroid gland which can either be palpated or made out during imaging like ultrasonography (USG).Clinically palpable thyroid nodules have a prevalence of 4-7% in the general population . However, the prevalence increases to 20-76% when USG is used for detection.

Goiter and the associated thyroid nodules result in anxiety, cosmetic disfigurement, and rarely compressive symptoms necessitating surgical removal, a procedure inherently associated with risks and complications Percutaneous sclerotherapy has been suggested to be an effective alternative, especially in patients with cystic nodules. Simple cystic (purely cystic) constitutes 6-28% of all thyroid nodules, are usually benign, filled with cellular debris or blood, and are a result of degeneration or hemorrhage into a hyperplastic nodule.

Among the various compounds (sodium tetradocyl sulfate, hydroxypolyethoxydodecan, tetracycline, and ethanol) tried for sclerosis of cystic thyroid nodules, outcomes are best and most studied with ethanol. However, data on outcomes of percutaneous aspiration and ethanol injection (PEI) in resolution of thyroid nodules is highly variable in different studies (success rate: 38-85%), which may be due to different populations studied and the heterogeneous nature of thyroid nodules evaluated.

Eligibility criteria: Inclusion Criteria:

1. Adult male or female patient with cystic thyroid nodule
2. Presence of pressure symptoms or cosmetic problems
3. Benign lesions confirmed by histopathological examination by FNAC.
4. Serum levels of thyroid hormone thyrotropin, within normal limits.

Exclusion Criteria:

1. Nodules showing malignant features(ie, speculated margin, markedly hypo echoic, micro- or macro calcifications) at US
2. solid thyroid nodule
3. mixed thyroid nodule(cystic with solid component)

Primary outcomes:
measure: Reduction of volume of the cyst about 96.9%
timeFrame: Reduction of volume of the cyst about 96.9% within 6 month
Secondary outcomes:
measure: symptomatic improvement
timeFrame: 3 month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
citation: Vogel D, Durham AC, de Marcillac GD. Metastable aggregates in the polymerisation of tobacco-mosaic-virus protein. Eur J Biochem. 1977 Sep 15;79(1):161-71. doi: 10.1111/j.1432-1033.1977.tb11794.x. No abstract available.
citation: Monzani F, Lippi F, Goletti O, Del Guerra P, Caraccio N, Lippolis PV, Baschieri L, Pinchera A. Percutaneous aspiration and ethanol sclerotherapy for thyroid cysts. J Clin Endocrinol Metab. 1994 Mar;78(3):800-2. doi: 10.1210/jcem.78.3.8126160.