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Sentinel Lymphnode in Patients With Papillary Thyroid Carcinoma and in Patients With Suspected Thyroid Neoplasia

Information source: Region Skane
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thyroid Neoplasms; Thyroid Cancer

Intervention: Histological investigation of the SN (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Region Skane

Official(s) and/or principal investigator(s):
Anders Bergenfelz, MD, PhD, Principal Investigator, Affiliation: Department of Surgery, Skåne University Hospital, Lund

Overall contact:
Anders Bergenfelz, MD, PhD, Phone: + 46 46 17 20 86, Email: anders.bergenfelz@med.lu.se

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Sensitivity and specificity of SN histology compared with the final histology of the non SN central lymph nodes (metastasis or no metastasis)

Secondary outcome: Sensitivity of 99mTc-nanocolloid albumin in the diagnosis of a sentinel lymphnode

Detailed description: 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:

- Pretracheal and bilateral paratracheal for patients with preoperatively diagnosed

papillary thyroid cancer

- Pretracheal and ipsilateral paratracheal for tumours of uncertain malignant potential

on cytology The identification of SN will be aided by preoperative ultrasound guided injection of 99m- Tc- nanocolloid albumin in the thyroid tumour. The results of the histological investigation of SN will be compared to that of the results from the central lymphnode clearance.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with first time surgery for proven papillary thyroid cancer > 10 mm

- Patients with first time surgery for a cytologic diagnosis of follicular neoplasia or

suspected (not proven) malignancy Exclusion Criteria:

- Age below 18 years

- Pregnancy or lactation

- Inability to understand written and oral information or to comply with scheduled

follow-up

Locations and Contacts

Anders Bergenfelz, MD, PhD, Phone: + 46 46 17 20 86, Email: anders.bergenfelz@med.lu.se

Department of Surgery and Department of Imaging, Skåne University Hospital, Lund 221 85, Sweden; Recruiting
Anders OJ Bergenfelz, MD, PhD, Phone: + 46 46 17 20 86, Email: anders.bergenfelz@med.lu.se
Erik Nordenström, MD, PhD, Phone: + 46 46 17 23 05, Email: erik.nordenstrom@skane.se
Martin Almqvist, MD, PhD, Sub-Investigator
Helene Almquist, MD, PhD, Sub-Investigator
Zoran Mijovic, MD, Sub-Investigator
Julian Willner, MD, Sub-Investigator
Erik Nordenström, MD, PhD, Sub-Investigator
Additional Information

Starting date: March 2010
Last updated: May 5, 2015

Page last updated: August 23, 2015

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