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

Primary Purpose

Hashimoto's Disease

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Total thyroidectomy performed

About this trial

This is an interventional treatment trial for Hashimoto's Disease focused on measuring Chronic thyroiditis, Total thyroidectomy, Anti-TPO, PROMs, SF36, Fatigue questionnaire, Fatigue, Autoimmune symptoms, HADs, FSS, fVAS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Anti-TPO>1000
Hypothyroidism with a need for thyroxin supplementation
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:

Patients <18 years of age.
Pregnancy.
Unable to comprehend information adequately to give informed consent.
General anaesthesiological contraindications.
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.

Sites / Locations

Telemark Hospital Trust, surgical department

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Non-surgical treatment only

Total thyroidectomy performed

Arm Description

Control arm. This arm receives standard medical hormone treatment (Thyroxine substitution) only and no surgical intervention.

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.

Outcomes

Primary Outcome Measures

Better outcome in Quality of Life by operation

The patiens are followed for 18 months with blood samples and filling in Quality of Life schemes every 6 months

Secondary Outcome Measures

Lowering of antibodies (Blood samples)

Blood samples every 6 months

Full Information

NCT ID

NCT02319538

First Posted

December 15, 2014

Last Updated

January 12, 2018

Sponsor

Sykehuset Telemark

Collaborators

Helse Stavanger HF, Haukeland University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02319538

Brief Title

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

Official Title

Surgical Treatment of Hashimotos Disease. Effect on Antibodies and Clinical Symptoms.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

February 13, 2012 (Actual)

Primary Completion Date

July 15, 2017 (Actual)

Study Completion Date

July 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sykehuset Telemark

Collaborators

Helse Stavanger HF, Haukeland University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hashimoto's Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Non-surgical treatment only

Arm Type

No Intervention

Arm Description

Control arm. This arm receives standard medical hormone treatment (Thyroxine substitution) only and no surgical intervention.

Arm Title

Total thyroidectomy performed

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Total thyroidectomy performed

Intervention Description

Surgery combined with standard thyroxine treatment

Primary Outcome Measure Information:

Title

Better outcome in Quality of Life by operation

Description

The patiens are followed for 18 months with blood samples and filling in Quality of Life schemes every 6 months

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Lowering of antibodies (Blood samples)

Description

Blood samples every 6 months

Time Frame

18 months

Other Pre-specified Outcome Measures:

Title

Safety in performing absolute total thyroidectomy (recurrence nerve and long lasting hypocalcemia)

Description

Safety concerning the recurrence nerve and long lasting hypocalcemia. Interim analysis after 75 patients.

Time Frame

12 months

Title

Interim analysis after 75 patients concerning safety (recurrent nerve control by laryngoscopy and hypocalcemia control by blood samples)

Description

The patients operated upon are investigated after 12 months concerning safety. The recurrent nerve control by laryngoscopy and hypocalcemia control by blood samples.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Anti-TPO>1000 Hypothyroidism with a need for thyroxin supplementation 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: Patients <18 years of age. Pregnancy. Unable to comprehend information adequately to give informed consent. General anaesthesiological contraindications. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ivar Guldvog, MD, PhD

Organizational Affiliation

Sykehuset Telemark

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hege Kersten, PhD

Organizational Affiliation

Sykehuset Telemark

Official's Role

Study Director

Facility Information:

Facility Name

Telemark Hospital Trust, surgical department

City

Skien

ZIP/Postal Code

3710

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30856652

Citation

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.

Results Reference

derived

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

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