Interventional procedure consultation document

Minimally invasive video-assisted thyroidectomy

If the thyroid gland is overactive or enlarged, or if cancer is suspected, it may be necessary to remove all or part of it. Minimally invasive video-assisted thyroidectomy removes the thyroid gland through ‘keyhole surgery’ using specially designed instruments.

The National Institute for Health and Care Excellence (NICE) is examining minimally invasive video-assisted thyroidectomy (MIVAT) and will publish guidance on its safety and efficacy to the NHS. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of specialist advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about MIVAT.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website.

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 25 April 2014

Target date for publication of guidance: 27 May 2014

 

 

 

 

 

1                      Provisional recommendations

1.1                  Current evidence on the efficacy and safety of minimally invasive video‑assisted thyroidectomy is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit.

1.2                  Patient selection is very important and, along with treatment, should only be done in units specialising in thyroid surgery.

1.3                  Minimally invasive video‑assisted thyroidectomy should only be done by clinicians with specific training and a regular practice in the procedure.

 

 

 

 

2                      Indications and current treatments

2.1                  Hyperthyroidism causes symptoms, which may include anxiety, weight loss, breathlessness, tiredness and eye problems. The overactive thyroid is usually enlarged and visible (goitre). The most common cause of hyperthyroidism is Graves’s Disease, an autoimmune disease in which antibodies stimulate the thyroid cells to secrete excess thyroid hormone. Other causes include toxic adenoma and toxic multinodular goitre.

2.2                  First-line treatment for hyperthyroidism includes medication to reduce the production of thyroxine or radioiodine treatment to destroy some of the thyroid tissue. Surgical removal of the thyroid (partial or total thyroidectomy) can be used if treatment with medication is unsuccessful, if radioiodine treatment cannot be used (for example, in pregnancy) or if the size of the gland is causing problems in the neck.

2.3                  Thyroid cancer usually develops slowly and the most common first sign is a painless lump in the neck. Other symptoms include hoarseness, swollen lymph nodes in the neck, difficulty swallowing or breathing, and pain in the throat or neck. The most common types of thyroid cancer are papillary and follicular thyroid cancer.

2.4                  The most common treatment for thyroid cancer is partial or total thyroidectomy. This is sometimes followed by radioactive iodine treatment or radiotherapy.

2.5                  Conventional open thyroidectomy is done through a transverse neck incision, typically 4‑8 cm long. Endoscopic techniques have been developed that use smaller incisions, with the aims of reducing pain after surgery and improving cosmesis.

 

 

 

 

3                      The procedure

3.1                  Minimally invasive video‑assisted thyroidectomy is usually done with the patient under general anaesthesia. A small incision is made above the sternal notch. An endoscope is inserted through the incision and dissection of the thyroid lobe(s) is carried out. The operative space is maintained using external retraction: gas insufflation is not used. Care is taken to identify and preserve the recurrent laryngeal nerve.

 

 

 

 

4                      Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

4.1                  A non-randomised comparative study of 234 patients with papillary thyroid cancer treated by minimally invasive video‑assisted thyroidectomy (MIVAT) or conventional thyroidectomy reported that 87% (148/171) and 76% (38/50) of patients respectively were disease-free at mean follow-up of 3.6 years (no significant difference). There were no recurrences and no thyroid cancer-related deaths in either group. A non-randomised comparative study of 68 patients with papillary thyroid microcarcinoma treated by MIVAT or conventional thyroidectomy reported that there were no recurrences and no thyroid cancer-related deaths in either group during a mean follow-up of 5 years. A mixed case series of 300 patients with benign or malignant thyroid disease reported no recurrences after a mean follow-up of 12 months.

4.2                  The non-randomised comparative study of 234 patients with papillary thyroid cancer reported that 7% (13/184) of MIVAT procedures were converted to conventional  thyroidectomy. A case series of 833 patients reported that 2% (16/833) of MIVAT procedures were converted to conventional thyroidectomy. The case series of 300 patients reported that MIVAT was converted to open thyroidectomy in 1% (2/300) of patients with benign thyroid nodules and in 6% (18/300) of patients with malignancy, after frozen sections revealed differentiated thyroid carcinoma.

4.3                  A systematic review of 9 studies including 697 patients, which compared 119 patients treated by MIVAT against 118 patients treated by conventional thyroidectomy for thyroid nodular disease, reported that pain scores (measured on a 10‑point visual analogue scale [VAS], with higher scores representing more severe pain) were lower 6 hours after surgery in patients treated by MIVAT than in those treated by conventional thyroidectomy (outcome reported in 3 studies [n=68 versus 69]; mean difference 11.5, 95% CI −17.8 to −5.2, p=0.0003). There were no statistically significant differences 24 and 48 hours after surgery. A non-randomised comparative study of 982 patients with benign or malignant thyroid disease reported that pain scores were significantly lower 36 hours after surgery in patients treated by MIVAT than in patients treated by conventional thyroidectomy (1.1 versus 1.9, p<0.05).

4.4                  The systematic review of 9 studies including 697 patients reported that patients in the MIVAT group in 5 studies had higher levels of satisfaction with their cosmetic result (weighted difference 2.59, 95% CI 1.52 to 3.65, p<0.00001; graded on a scale from 0 to 10, with higher scores being better). The non-randomised comparative study of 982 patients reported higher satisfaction scores (scale 0–10, with higher scores being better) for MIVAT and for minimally invasive open thyroidectomy compared with conventional thyroidectomy (7, 8, and 5 respectively, p<0.05). A non-randomised comparative study of 798 patients treated by MIVAT or conventional thyroidectomy reported that the aesthetic result (method of assessment not described) in the MIVAT group was excellent in 90% (189/211) of patients, good in 9% (19/211) and sufficient in 1% (2/211) (results were not reported for the conventional thyroidectomy group).

4.5                  The specialist advisers listed key efficacy outcomes as reduced pain after surgery, cosmesis and patient satisfaction.

 

 

 

 

5                      Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1                  Total complication rates of 10% (28/289) and 14% (43/316) were reported for minimally invasive video‑assisted thyroidectomy (MIVAT) and conventional thyroidectomy respectively (p=0.08) in a systematic review of 9 studies including 697 patients.

5.2                  Superior laryngeal nerve injury was reported in 2% (5/300) of patients in a case series of 300 patients.

5.3                  Postoperative bleeding that needed reoperation was reported in less than 1% (1/833) and 4% (5/116) of patients in 2 case series of 833 and 116 patients respectively.

5.4                  Wound sepsis was reported in less than 1% (2/833) of patients in the case series of 833 patients.

5.5                  Transient hypoparathyroidism was reported in 3% (5/171) and 2% (4/191) of patients treated by MIVAT or conventional thyroidectomy respectively (p=0.69) in the systematic review of 9 studies including 697 patients. Permanent hypoparathyroidism was reported in 6% (2/34 and 4/65) of patients treated by either MIVAT or conventional thyroidectomy respectively in a non-randomised comparative study of 99 patients. Severe symptomatic hypoparathyroidism was reported in 2% (2/116) of patients in the case series of 116 patients.

5.6                  Symptomatic hypocalcaemia was reported in 8% (16/211) and 12% (73/587) of patients treated by MIVAT and conventional thyroidectomy respectively (p=0.41) in a non-randomised comparative study of 798 patients; serological hypocalcaemia was reported in 28% (59/211) and 43% (254/587) of patients respectively (p<0.001). Permanent hypocalcaemia needing substitutive therapy was reported in less than 1% (2/510 total thyroidectomies) of patients in the case series of 833 patients.

5.7                  Voice and swallowing alterations scores (measured on a 10‑point VAS, with 10 representing the worst possible outcome) 24 hours after surgery were significantly lower for patients treated by MIVAT than for patients treated by conventional thyroidectomy (1.5 versus 3, p<0.01) in a non-randomised comparative study of 68 patients.

5.8                  A skin burn was reported in 1% (2/211) of patients treated by MIVAT in the non-randomised comparative study of 798 patients and in 2% (5/300) of patients in the case series of 300 patients.

5.9                  The specialist advisers listed additional theoretical adverse events as neck haematoma and trocar injury to local neuro-vascular structures or the trachea/oesophagus.

 

 

 

6                      Committee comments

6.1                  The Committee was advised that minimally invasive video‑assisted thyroidectomy needs skills additional to those of open thyroid surgery, and that adequate training is very important for thyroid surgeons who wish to use this procedure.

6.2                  The Committee was advised that this procedure is suitable only for the minority of patients with thyroid disease who need surgical treatment and whose thyroid glands are of appropriate size.

 

 

 

 

7                      Further information

7.1                  For related NICE guidance see the NICE website.

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee
April, 2014

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

_{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}