OPEN Research Support
head

Physician
Jesper Roed Sørensen
Department of ORL Head & Neck surgery and Audiology, Odense University Hospital


Projekt styring
Projekt status    Planning
 
Data indsamlingsdatoer
Start 01.05.2019  
Slut 30.04.2022  
 



The impact of laser thermal ablation on quality of life in patients with simple nodular goiter

Short summary

Benign non-toxic goiter affects approximately 10% of the Danish population. There are several treatment options including various types of thyroidectomy, radioactive iodine treatment, and ultrasound guided interventions such as laser thermal ablation (LTA). LTA is a safe treatment when guided by the ultrasound (US). A recent systematic review identified a 13-82% reduction in thyroid nodule volume 12 months after LTA. The reduction of side effects of LTA compared to surgery is well described. However, a similar study of LTA on the impact on QoL remains to be conducted in order to complete a comparison of this treatment to surgery.


Rationale

Benign non-toxic goiter affects approximately 10% of the Danish population. The aetiology is multifactorial and related to genetic factors interacting with environmental factors such as iodine deficiency, cigarette smoking, various drugs, and infections. When thyroid dysfunction, autoimmunity, and malignancy are ruled out, the condition is called simple goiter. The pathophysiology of a gradual increase in goiter size and nodularity may lead to a variety of manifestations. These include: compression of the oesophagus, trachea, and related nerves, which can lead to dysphagia, globus sensation, choking sensation, voice alterations as well as cosmetic complaints.

There are several treatment options including various types of thyroidectomy, radioactive iodine treatment, and ultrasound guided interventions such as laser thermal ablation (LTA).

Surgery is used for large goiters, or if thyroid malignancy is suspected. It is effective for reducing symptoms and improving quality of life (QoL), bringing QoL close to the level of the general population11. However, this option is not devoid of complications based on the risk of recurrent nerve damage (2%), short term postoperative voice changes (up to 40%), postoperative bleeding (4%), and need for postoperative levothyroxine substitution (18%). Therefore, a treatment option with fewer side effects has been warranted.

LTA is a safe treatment when guided by the ultrasound (US). The technique is used for smaller nodular goiters. This procedure is performed in the outpatient clinic using local anesthesia and guided by the US. A recent systematic review identified a 13-82% reduction in thyroid nodule volume 12 months after LTA. A large retrospective multicenter study including 1531 patients 20 had a mean nodular volume reduction of 72±11% from baseline [mean 27±24 mL (range 1.4-216 mL) to 8±8 mL (range: not described)] 12 months after treatment. Eighty-three percent of the patients were treated with a single session and small, medium, and large nodules had similar relative volume reductions. Only eight of the 1531 patients (0.5%) experienced complications, such as transient postoperative voice changes, and no patients required surgical repair or overnight admission, which is a significant advantage in comparison to surgery. Our own data from LTA treatment at Odense University Hospital shows that LTA treatment significantly reduces pressure symptoms on a VAS scale, from 3.0 to 0.0 points.

The reduction of side effects of LTA compared to surgery is well described. However, a similar study of LTA on the impact on QoL remains to be conducted in order to complete a comparison of this treatment to surgery.


Description of the cohort

This is a prospective clinical study, with a paired design, investigating the effect of LTA on improvement of symptoms and quality of life before, three months and six months after treatment in patients with nodular goiter. The study group is compared to a historical control group from a random selection of individuals from the Danish civic registry with 739 participants responding on the ThyPRO questionnaire. 

We estimate that approximately 50 patients are eligible for inclusion in this study from May 2019 – May 2022. 


Data and biological material

Questionaire data and clinical thyroid ultrasound data


Collaborating researchers and departments

Research unit of ORL Head & Neck surgery and Audiology, OUH

  • MD, PhD Jesper R. Sørensen

Department of ORL Head & Neck surgery and Audiology, OUH 

  • MD, PhD, Helle Døssing

Department of Endocrinology, OUH

  • MD, PhD, Lars Folkestad
  • Professor, Steen J. Bonnema