Hashimoto - a Surgical Disease. Total Thyroidectomy Makes Antibodies Disappear and Ameliorates Symptoms

• ClinicalTrials.gov Identifier: NCT02319538
• Recruitment Status: Completed
• First Posted: December 18, 2014
• Last Update Posted: January 17, 2018
• Sponsor: Sykehuset Telemark
• Collaborators: Helse Stavanger HF; Haukeland University Hospital
• Information provided by (Responsible Party): Ivar Guldvog, Sykehuset Telemark

Study Description

Brief Summary:

The investigators have already proven that absolute total thyroidectomy gives elimination of anti-TPO antibodies. Our hypothesis is that this elimination also eliminates the typical Hashimoto symptoms, namely: Serious tiredness, increased need of sleep, pain in musculature and joints and dryness in eyes and mouth. The prerequisite for this effect is that the total thyroidectomy is meticulously performed. There exists no other treatment that can eliminate the antibodies. The study is randomized between operation and ordinary conservative medical treatment with thyroxine control and supplementation. The symptoms in both groups are evaluated by 5 different Quality of Life schemes, internationally approved.

Condition or disease	Intervention/treatment	Phase
Hashimoto's Disease	Procedure: Total thyroidectomy performed	Not Applicable

Detailed Description:

The study hypothesis is that elimination of anti-TPO antibodies ameliorates the typical Hashimoto symptoms like tiredness,increased need of sleep, pain in musculature and joints and dryness in eyes and mouth. It is necessary that the total thyroidectomy is meticulously performed. We have proven the effect on the antibodies, and we have also proven that the operation procedure can be performed without more complications like recurrent nerve damage and hypocalcemia. Neutrality is secured by randomization done by a neutral institution, laryngoscopy by neutral doctors and instructions filling out the QoL-schemes performed by non-biased study nurses.

The study runs for at least 18 months with controls every 6 months. Blood samples are taken and international approved QoL-schemes are filled in. In addition to the randomised main group a side group of patients fulfilling 2 of the 3 inclusion criteria are followed in parallel in order to elucidate the spontaneous development of the disease and showing critical values of antibodies making the symptoms turn up.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Surgical Treatment of Hashimotos Disease. Effect on Antibodies and Clinical Symptoms.
• Actual Study Start Date: February 13, 2012
• Actual Primary Completion Date: July 15, 2017
• Actual Study Completion Date: July 15, 2017

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Non-surgical treatment only; Control arm. This arm receives standard medical hormone treatment (Thyroxine substitution) only and no surgical intervention.
Active Comparator: Total thyroidectomy performed; Surgical arm.The approach for total thyroidectomy will be a complete removal of all visible, and immunological active thyroid tissue with a high accuracy, with a special focus on three sites; 1) The angle where the recurrent laryngeal nerve enters the cricothyroid membrane, 2) The pyramidal lobe and 3) The hilus where the superior vessels are entering the field. Standard Thyroxine supplementation maintained as in the control group.	Procedure: Total thyroidectomy performed; Surgery combined with standard thyroxine treatment

Outcome Measures

Primary Outcome Measures :

1. Better outcome in Quality of Life by operation [ Time Frame: 18 months ]
   The patiens are followed for 18 months with blood samples and filling in Quality of Life schemes every 6 months

Secondary Outcome Measures :

1. Lowering of antibodies (Blood samples) [ Time Frame: 18 months ]
   Blood samples every 6 months

Other Outcome Measures:

1. Safety in performing absolute total thyroidectomy (recurrence nerve and long lasting hypocalcemia) [ Time Frame: 12 months ]
   Safety concerning the recurrence nerve and long lasting hypocalcemia. Interim analysis after 75 patients.
2. Interim analysis after 75 patients concerning safety (recurrent nerve control by laryngoscopy and hypocalcemia control by blood samples) [ Time Frame: 12 months ]
   The patients operated upon are investigated after 12 months concerning safety. The recurrent nerve control by laryngoscopy and hypocalcemia control by blood samples.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Patients referred due to typical symptoms, believed to be related to Hashimoto´s disease, but not relieved by thyroxin substitution. Optimal thyroid substitution treatment is already provided.
2. Anti-TPO>1000
3. Hypothyroidism with a need for thyroxin supplementation
4. Written informed consent by the patient - information particularly emphasising and quantifying the risk of complications (e.g. recurrent laryngeal nerve palsy). The patient should be informed by a medical endocrinologist as well as a surgeon.

Exclusion Criteria:

1. Patients <18 years of age.
2. Pregnancy.
3. Unable to comprehend information adequately to give informed consent.
4. General anaesthesiological contraindications.
5. An unexpected finding of cancer in the surgical group is not a reason for exclusion per se, but this group should be analyzed separately. It is expected that any different loading in Quality of life would bias the medically treated group.

Contacts and Locations

Locations

Norway

Telemark Hospital Trust, surgical department

Skien, Norway, 3710

Sponsors and Collaborators

Sykehuset Telemark

Helse Stavanger HF

Haukeland University Hospital

Investigators

• Principal Investigator: Ivar Guldvog, MD, PhD; Sykehuset Telemark
• Study Director: Hege Kersten, PhD; Sykehuset Telemark

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Guldvog I, Reitsma LC, Johnsen L, Lauzike A, Gibbs C, Carlsen E, Lende TH, Narvestad JK, Omdal R, Kvaloy JT, Hoff G, Bernklev T, Soiland H. Thyroidectomy Versus Medical Management for Euthyroid Patients With Hashimoto Disease and Persisting Symptoms: A Randomized Trial. Ann Intern Med. 2019 Apr 2;170(7):453-464. doi: 10.7326/M18-0284. Epub 2019 Mar 12.

• Responsible Party: Ivar Guldvog, Consultant, Sykehuset Telemark
• ClinicalTrials.gov Identifier: NCT02319538
• Other Study ID Numbers: DTG 031100-031230
• First Posted: December 18, 2014
• Last Update Posted: January 17, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Ivar Guldvog, Sykehuset Telemark:

Chronic thyroiditis; Total thyroidectomy; Anti-TPO; PROMs; SF36; Fatigue questionnaire; Fatigue; Autoimmune symptoms; HADs; FSS; fVAS

Additional relevant MeSH terms:

Hashimoto Disease; Thyroiditis, Autoimmune; Thyroiditis; Thyroid Diseases; Endocrine System Diseases