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Enrolling by invitation NCT07258199

TACE Treats Nodular Goiter

No phase Interventional Nodular Goiter

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TACE.
Who it may be relevant to
Registry conditions: Nodular Goiter. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Transarterial Chemoembolization With Bleomycin: A Promising Treatment of Giant Nodular Goiter

Overview

transarterial bleomycin chemoembolization represents a novel minimally invasive therapeutic approach for the management of giant nodular goiter.

Interventions

  • Procedure TACE
    TACE, 15,000U bleomycin and 200-400μm drug-loaded microspheres

Primary outcome measures

  • volume [Time frame: 1-, 3-, 6-, 12-month follow up]
Secondary outcome measures (2)
  • longest diameter [Time frame: 1-, 3-, 6-, 12-month follow-up]
  • lesion shrinkage [Time frame: 1-, 3-, 6-, 12-month follow-up]

Eligibility criteria

Inclusion criteria

  • Clinical criteria: thyroid enlargement, mostly painless, with compressive symptoms (such as dysphagia, dyspnea) being less common; thyroid function is mostly normal, and a small number may be accompanied by hyperthyroidism or hypothyroidism.
  • Imaging examinations: ultrasound shows multiple solid or cystic-solid nodules with clear boundaries and no malignant signs such as microcalcification and a vertical-to-horizontal diameter ratio >1.
  • Pathological criteria: follicular epithelial cell hyperplasia, no nuclear atypia, and no malignant cellular characteristics (such as mitotic figures, infiltrative growth, etc.). In this study, a thyroid goiter with at least one diameter exceeding 4 cm was considered a giant goiter

Exclusion criteria

  • abnormal coagulation profiles;
  • hepatic or renal impairment;
  • allergy to contrast media;
  • refusal of interventional therapy and requirement for surgical treatment or other therapies

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT07258199 · TACE treats nodular goiter

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗