Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01149161

Enrollment

2000

Registered

2010-06-23

Start date

2009-05-31

Completion date

2020-12-31

Last updated

2016-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma

Keywords

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

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.

Interventions

PROCEDURERoutine central neck dissection

Level VI neck node dissection during thyroid operation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Is routine neck node dissection necessary in micro PTC?	Until 5 year follow-up. (Dec. 2016)	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

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

Countries

South Korea

Contacts

Primary ContactJee Soo Kim, M.D., Ph.D.

js0507.kim@samsung.com82-2-3410-3479

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026