Extent of Central Lymph Node Dissection in Papillary Thyr... | NCT01149161

Studies
Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

NCT01149161

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Apr 21, 2016Estimated

Enrollment

2,000Estimated

Phase

Phase 2Phase 3

Conditions

Carcinoma

Interventions

Routine central neck dissection

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jun 2, 2010

First Submission Date that Met QC Criteria

Jun 22, 2010

First Posted Date

Jun 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2016

Last Update Posted Date

Apr 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
C group	Active Comparator	Routine central neck dissection	Procedure: Routine central neck dissection
N group	No Intervention	No central neck node dissection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Routine central neck dissection	Procedure	Level VI neck node dissection during thyroid operation	C group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Until 5 year follow-up. (Dec. 2016)

Secondary Outcomes

Measure	Description	Time Frame
The efficacy of sentinel lymph node biopsy in micro PTC		Until 5 year follow-up. (Dec. 2016)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jee Soo Kim, M.D., Ph.D.	Contact	82-2-3410-3479		js0507.kim@samsung.com

Overall Officials

Name	Affiliation	Role
Jee Soo Kim, M.D., Ph.D.	Samsung Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul		135-710	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Feb 7, 2022
Unrelease	Feb 7, 2022
Release	Feb 8, 2022
Unrelease	Feb 13, 2022
Release	Mar 21, 2022
Reset	Jul 15, 2022
Release	Aug 22, 2022
Reset	Jul 12, 2023
Release	Jul 25, 2023
Reset	Mar 1, 2024

Submission Tracking

Estimated Results First Submitted Date

Feb 7, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 7, 2022	Feb 7, 2022
Feb 8, 2022	Feb 13, 2022

Condition Browse Module

MeSH Terms

ID	Term
D002277	Carcinoma
D013959	Thyroid Diseases

Ancestor Terms

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided