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

NCT ID: NCT01089335

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2018-12-31

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 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.

Conditions

Thyroid Neoplasms; Thyroid Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Papillary thyroid cancer

Patients with preoperatively diagnosed highly differentiated papillary thyroid cancer

Histological investigation of the SN

Intervention Type: PROCEDURE

99m Tc- nanocolloid albumin, 10-15 MBq (volume 0.1-0.3 ml) is injected under ultrasound guidance in the thyroid tumour. Imaging (lymphoscintigraphy)with anterior and oblique projections is performed at 60 and 120 min after the injection. SN are mapped intraoperatively by a dedicated SN navigator and excised for final histology.

Tumour of uncertain malignant potential

Thyroid tumours with preoperative cytology indicating follicular neoplasia, or on cytology suspected but not proven malignancy

Histological investigation of the SN

Intervention Type: PROCEDURE

99m Tc- nanocolloid albumin, 10-15 MBq (volume 0.1-0.3 ml) is injected under ultrasound guidance in the thyroid tumour. Imaging (lymphoscintigraphy)with anterior and oblique projections is performed at 60 and 120 min after the injection. SN are mapped intraoperatively by a dedicated SN navigator and excised for final histology.

Interventions

Histological investigation of the SN

99m Tc- nanocolloid albumin, 10-15 MBq (volume 0.1-0.3 ml) is injected under ultrasound guidance in the thyroid tumour. Imaging (lymphoscintigraphy)with anterior and oblique projections is performed at 60 and 120 min after the injection. SN are mapped intraoperatively by a dedicated SN navigator and excised for final histology.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Bergenfelz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Skåne University Hospital, Lund

Locations

Department of Surgery and Department of Imaging, Skåne University Hospital

Lund, , Sweden

Countries

Sweden

Other Identifiers

2009/71

Identifier Type: -

Identifier Source: org_study_id