Lateral Neck Sentinel Lymph Node Biopsy(LSLNB)in PTC

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01137097
Collaborator
(none)
278
1
2
19
14.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Lateral sentinel lymph node biopsy
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
278 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Value of Sentinel Lymph Node Biopsy to Lateral Neck Lymph Node in Thyroid Carcinoma: Prospective Study
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Jan 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Lateral sentinel group

Lateral sentinel lymph node biopsy with radioisotope

Procedure: Lateral sentinel lymph node biopsy
Sentinel lymph node biopsy with radioisotope. Isotope injection and lymphoscintigraphy preoperatively

No Intervention: No intervention for lateral neck

No lateral sentinel lymph node biopsy with radioisotope

Outcome Measures

Primary Outcome Measures

  1. The usefulness of lateral sentinel lymph node biopsy in PTC [at Oct 2011]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of 135-710

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

  • Study Director: Se Kyung Lee, M.D, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jee soo Kim, Association professor, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01137097
Other Study ID Numbers:
  • 2009-07-101
First Posted:
Jun 4, 2010
Last Update Posted:
Apr 21, 2016
Last Verified:
Apr 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2016