The Usefulness of Staining Lymph Nodes During Operations for Cancer Thyroid in Detecting the Nodes That Have Cancer

NCT00794053 | Completed Phase 3 DMC

• 1 other identifier: UAlexandria
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Detection of lymph nodes starting to be involved by cancer spreading from the thyroid gland during operation is useful. It saves the patient from having a second operation to remove these nodes later on when they become obvious. The problem is that there are many lymph nodes around the gland. The theory is that only one node will get the first spill of the tumour cells. In this study the investigators are trying to use an inert colored material to inject into the tumour. This should run in the same path as the tumour cells and should therefore stain the one lymph node that will be affected first should the tumour spread. The stained lymph node is excised and examined instantaneously for tumour affection. If it is found to be affected by the tumour, then the operation is extended to include removal of all its fellow lymph nodes. If it is found to be free from the tumour, then this patient does not have tumour spread.

Conditions

Thyroid Cancer; Lymph Node Metastasis

Keywords

Sentinel lymph node; thyroid cancer; neck dissection

Outcome Measures

Primary Outcomes (1)

• The lymph nodes around the thyroid tumour will be removed and examined under microscopy in all study subjects to verify that the stained node is a true representative to the state of lymph nodes as regards tumour spread

  the lymph nodes removed during the surgery will be examined the next day of the operation

Study Arms (1)

study group

EXPERIMENTAL

The members in this group will undergo intervention by having surgery and lymph node detection by dye staining

Procedure: detecting lymph node metastasis by staining

Interventions

detecting lymph node metastasis by staining PROCEDURE

this started by collar incision, development of sub-platysmal skin flaps and separation of strap muscles in the midline. This was followed by exposure of the thyroid gland; identification of the thyroid tumour; injection of the dye into the tumour; waiting for the dye to reach the lymph nodes; identifying the stained node; labeling it as the sentinel node (SLN); performing total thyroidectomy and bilateral central neck dissection.

Also known as: sentinel lymph node detection, staging of thyroid cancer

study group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed to have differentiated thyroid carcinoma and has no detectable cervical lymphadenopathy.

You may not qualify if:

• Previous neck surgery, pregnancy and known hypersensitivity to the dye used.

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Alexandria University Hospitals

Alexandria, Alexandria Governorate, 110226, Egypt

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yasser M Hamza, A Professor

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 19, 2008
• Study Start: December 1, 2002
• Primary Completion: December 1, 2008
• Study Completion: April 1, 2009
• Last Updated: July 15, 2009

Record last verified: 2009-07

Locations

EG (1)