Clinical Trial: Sentinel Lymphnode in Patients With Papillary Thyroid Carcinoma and in Patients With Suspected Thyroid Neoplasia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Sentinel Node Investigation in Patients With Highly Differentiated Papillary Thyroid Carcinoma and in Patients With Thyroid Neoplasia of Unclear Malignant Potential

Brief Summary:

The standard surgical treatment for highly differentiated papillary thyroid cancer > 10 mm according to recent national and international guidelines, is total thyroidectomy and central lymphnode clearance, and for patients with cytology indicating thyroid neoplasia of unclear malignant potential hemithyroidectomy on the side of the tumour.

The study investigates if the sentinel lymphnode (SN)

  • Reliably (with high sensitivity and specificity), can predict the pathological findings of the lymphnodes in the central compartment in patients with highly differentiated papillary thyroid cancer
  • Is useful to aid in the final diagnosis and staging of thyroid neoplasias of unclear malignant potential, and could be used to select patients for further central lymphnode revision.

Detailed Summary:

The standard surgical treatment for highly differentiated papillary thyroid cancer > 10 mm according to recent national and international guidelines, is total thyroidectomy and central lymphnode clearance, and for patients with cytology indicating thyroid neoplasia of unclear malignant potential hemithyroidectomy on the side of the tumour.

There are however a number of clinical problems with these approaches:

  • For patients with papillary thyroid cancer, a significant proportion will receive unnecessary extensive surgical treatment
  • In papillary thyroid cancer, central lymphnode clearance increases the risk for complications, especially the risk for hypoparathyroidism.

According to a Scandinavian survey (Scandinavian Quality Register for Thyroid- and Parathyroid Surgery; www. thyroid-parathyroidsurgery.com),16 % of patients with unclear follicular neoplasia, will have a final histological diagnosis of thyroid cancer, and in half of them, this cancer will be of the papillary subtype. In patients with preoperatively suspected, but not proven malignancy by cytology, 30 % will receive a final histological diagnosis of thyroid cancer, and in these patients, 70 % will be of the papillary subtype. Typically these patients will undergo a second operation with a contralateral hemithyroidectomy. In many cases, due to risk for complications, central lymphnode clearance is avoided in these cases. Therefore, the staging of the cancer will be incomplete, and some patients will receive suboptimal surgical treatment.

The study is designed to compare SN investigation with the final histology of the central lymphnodes:


    Sponsor: Region Skane

    Current Primary Outcome: Sensitivity and specificity of SN histology compared with the final histology of the non SN central lymph nodes (metastasis or no metastasis) [ Time Frame: 14 days ]

    The histological investigation of the sentinel lymph node(s) (recorded as metastasis or no metastasis), will be compared to the definitive histological investigation of the non SN central lymphnodes (metastasis or no metastasis), cleared by surgery. Sensitivity and specificity of the histological SN investigation to predict the histological outcome of the non SN central lymphnodes (metastasis or no metastasis), will be calculated.


    Original Primary Outcome: Same as current

    Current Secondary Outcome: Sensitivity of 99mTc-nanocolloid albumin in the diagnosis of a sentinel lymphnode [ Time Frame: 1 day ]

    99mTc-nanocolloid albumin will be injected under guidence by ultrasonography. The sensitivity to detect a SN on preoperative imaging (detected SN on imaging/total number of investigations) and during surgery by a collimated probe for SN mapping(SN detected/total number of operations), will be calculated.


    Original Secondary Outcome: Same as current

    Information By: Region Skane

    Dates:
    Date Received: March 16, 2010
    Date Started: March 2010
    Date Completion: December 2018
    Last Updated: April 11, 2017
    Last Verified: April 2017