search
Back to results

Lateral Neck Sentinel Lymph Node Biopsy(LSLNB)in PTC (LSLNB)

Primary Purpose

Thyroid Neoplasm

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lateral sentinel lymph node biopsy
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Neoplasm

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Cases with tumors larger than 1 cm in size or with suspicious central neck node metastasis in Papillary thyroid cancer

Exclusion Criteria:

  • The patient with definite metastatic lymph node in lateral neck compartment

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Lateral sentinel group

No intervention for lateral neck

Arm Description

Lateral sentinel lymph node biopsy with radioisotope

No lateral sentinel lymph node biopsy with radioisotope

Outcomes

Primary Outcome Measures

The usefulness of lateral sentinel lymph node biopsy in PTC

Secondary Outcome Measures

Full Information

First Posted
June 2, 2010
Last Updated
April 20, 2016
Sponsor
Samsung Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01137097
Brief Title
Lateral Neck Sentinel Lymph Node Biopsy(LSLNB)in PTC
Acronym
LSLNB
Official Title
Value of Sentinel Lymph Node Biopsy to Lateral Neck Lymph Node in Thyroid Carcinoma: Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective: To investigate the incidence of lateral neck node occult metastasis and to show the usefulness of sentinel lymph node biopsy (SLNB) in the detection of lateral neck node metastasis in thyroid carcinoma, the investigators used a radioisotope to detect the sentinel lymph node. Summary Background Data: Although occult lymph node metastasis to the lateral neck compartment is common in papillary thyroid carcinoma, the incidence and patterns of lateral neck node metastasis in papillary carcinoma are not known.
Detailed Description
On the day of the operation, patients underwent preoperative lymphoscintigraphy after the intratumoral injection of a Tc-99m phytate 1 mCi in 0.1-0.2 mL 0.9% NaCl under ultrasonographic guidance. Total thyroidectomy or lobectomy with central neck dissection preceded SLN detection to avoid interference by primary tumor radioactivity. After total thyroidectomy or lobectomy, the dissections were performed toward the internal jugular chain beneath the sternocleidomastoid muscle. A handheld, collimated gamma probe and lymphoscintigraphy were used to scan the lateral compartments (through skin and under the SCM) for "radioactive" lymph nodes. Removed SLNs were submitted immediately for frozen biopsy. If any of the SLNs were positive for metastasis on the frozen sections, MRND was performed immediately. In cases for which the frozen section was negative but the final pathology report detailed microscopic positivity in the lateral sentinel nodes, RAI ablations were performed without additional MRND.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lateral sentinel group
Arm Type
Active Comparator
Arm Description
Lateral sentinel lymph node biopsy with radioisotope
Arm Title
No intervention for lateral neck
Arm Type
No Intervention
Arm Description
No lateral sentinel lymph node biopsy with radioisotope
Intervention Type
Procedure
Intervention Name(s)
Lateral sentinel lymph node biopsy
Intervention Description
Sentinel lymph node biopsy with radioisotope. Isotope injection and lymphoscintigraphy preoperatively
Primary Outcome Measure Information:
Title
The usefulness of lateral sentinel lymph node biopsy in PTC
Time Frame
at Oct 2011

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cases with tumors larger than 1 cm in size or with suspicious central neck node metastasis in Papillary thyroid cancer Exclusion Criteria: The patient with definite metastatic lymph node in lateral neck compartment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se Kyung Lee, M.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lateral Neck Sentinel Lymph Node Biopsy(LSLNB)in PTC

We'll reach out to this number within 24 hrs