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Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

Primary Purpose

Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Routine central neck dissection

About this trial

This is an interventional treatment trial for Carcinoma focused on measuring neck dissection, sentinel lymph node, Carcinoma, Papillary, thyroid, dissection

Eligibility Criteria

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

Inclusion Criteria:

papillary carcinoma of thyroid (less than 4cm)
no evidence of lymph node metastasis in preoperative work-up result
the patients who accept this study

Exclusion Criteria:

large thyroid cancer( > 4cm)
morbid
anticoagulation agent usage
endoscopic or robotic thyroid operation
evidence of lymph node metastasis or extrathyroidal extension in preoperative US and CT scan

Sites / Locations

Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

C group

N group

Arm Description

Routine central neck dissection

No central neck node dissection

Outcomes

Primary Outcome Measures

Is routine neck node dissection necessary in micro PTC?

To see the necessity of routine neck node dissection in micro PTC, we will compare the recurrence rate and other complication (e.g. hoarseness and hypocalcemia) between group I(no dissection) and group III(routine dissection) after completion of study(after 5 year f/u). To check the safety of this study, our result will be checked by korea institutional reveiw board every one year.

Secondary Outcome Measures

The efficacy of sentinel lymph node biopsy in micro PTC

Full Information

NCT ID

NCT01149161

First Posted

June 2, 2010

Last Updated

April 20, 2016

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01149161

Brief Title

Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

Official Title

Sentinel Lymph Node Biopsy in the Thyroid Carcinoma; Randomized, Prospective Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2009 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

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

Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role of lymph node dissection in the treatment of microPTC remains controversial. The investigators want to investigate the usefulness routine central dissection and sentinel lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study. The investigators started this study from May of 2009 and this study will be continued until Dec. 2011.

Detailed Description

The investigators will assign all patients to three groups; no dissection group (Group I), sentinel lymph node biopsy only group (Group II) and routine central neck dissection group (Group III). At first, to know the necessity of routine central neck node dissection for micro PTC,the investigators will compare the result of group I and group III. Additionally, the investigators can analyze the usefulness of sentinel lymph node biopsy for substitution of routine central neck node dissection for micro PTC.

6. Conditions and Keywords

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

Carcinoma

Keywords

neck dissection, sentinel lymph node, Carcinoma, Papillary, thyroid, dissection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

C group

Arm Type

Active Comparator

Arm Description

Routine central neck dissection

Arm Title

N group

Arm Type

No Intervention

Arm Description

No central neck node dissection

Intervention Type

Procedure

Intervention Name(s)

Routine central neck dissection

Intervention Description

Level VI neck node dissection during thyroid operation

Primary Outcome Measure Information:

Title

Is routine neck node dissection necessary in micro PTC?

Description

Time Frame

Until 5 year follow-up. (Dec. 2016)

Secondary Outcome Measure Information:

Title

The efficacy of sentinel lymph node biopsy in micro PTC

Time Frame

Until 5 year follow-up. (Dec. 2016)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: papillary carcinoma of thyroid (less than 4cm) no evidence of lymph node metastasis in preoperative work-up result the patients who accept this study Exclusion Criteria: large thyroid cancer( > 4cm) morbid anticoagulation agent usage endoscopic or robotic thyroid operation evidence of lymph node metastasis or extrathyroidal extension in preoperative US and CT scan

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jee Soo Kim, M.D., Ph.D.

Phone

82-2-3410-3479

js0507.kim@samsung.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jee Soo Kim, M.D., Ph.D.

Organizational Affiliation

Samsung Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jee Soo Kim, M.D., Ph.D.

Phone

82-2-3410-3479

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

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