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

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

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 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

Resource links provided by the National Library of Medicine


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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319538


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

Responsible Party: Ivar Guldvog, Consultant, Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT02319538     History of Changes
Other Study ID Numbers: DTG 031100-031230
First Posted: December 18, 2014    Key Record Dates
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
Antibodies
Immunologic Factors
Physiological Effects of Drugs