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

Primary Purpose

Thyroid Cancer, Lymph Node Metastasis

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
detecting lymph node metastasis by staining
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Cancer focused on measuring Sentinel lymph node, thyroid cancer, neck dissection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Alexandria University Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 18, 2008
Last Updated
July 14, 2009
Sponsor
University of Alexandria
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1. Study Identification

Unique Protocol Identification Number
NCT00794053
Brief Title
The Usefulness of Staining Lymph Nodes During Operations for Cancer Thyroid in Detecting the Nodes That Have Cancer
Official Title
The Role of Sentinel Lymph Node Biopsy (SLNB) In the Management of Differentiated Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alexandria

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The study includes 45 consecutive patients diagnosed as differentiated thyroid cancer by clinical examination and/or fine needle aspiration cytology (FNAC). Exclusion criteria are: previous neck surgery, pregnancy and known hypersensitivity to the dye used. An informed consent was obtained from all the patients. Peroperative workup includes history taking, clinical examination, relevant laboratory investigations including thyroid hormone assay, ultrasonography of the neck with special emphasis on the thyroid focal lesion and cervical lymph nodes. FNAC was attempted in all patients. All patients were then subjected to operation: A systematized surgical approach was adopted for the purpose of the study: 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. The resected specimen was fixed by formaldehyde, stained with hematoxylin and eosin and examined with light microscopy. If the SLN was found to be free of malignant deposits, it was further examined by immunohistochemical staining. Statistical analysis: Descriptive statistics were used to analyze demographic data. Sensitivity, specificity and predictive value of the SLN were calculated. The histopathological report of the excised specimen was considered the criterion standard.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Lymph Node Metastasis
Keywords
Sentinel lymph node, thyroid cancer, neck dissection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
The members in this group will undergo intervention by having surgery and lymph node detection by dye staining
Intervention Type
Procedure
Intervention Name(s)
detecting lymph node metastasis by staining
Other Intervention Name(s)
sentinel lymph node detection, staging of thyroid cancer
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Time Frame
the lymph nodes removed during the surgery will be examined the next day of the operation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient diagnosed to have differentiated thyroid carcinoma and has no detectable cervical lymphadenopathy. Exclusion Criteria: Previous neck surgery, pregnancy and known hypersensitivity to the dye used.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasser M Hamza, A Professor
Organizational Affiliation
University of Alexandria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria University Hospitals
City
Alexandria
ZIP/Postal Code
110226
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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