NCT00795782

Brief Summary

The purpose of this study is to determine whether the prophylactic ipsilateral central lymph node dissection is equally effective in the management of papillary thyroid microcarcinoma(PTMC) to the bilateral central lymph node dissection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 15, 2016

Status Verified

July 1, 2011

Enrollment Period

3.4 years

First QC Date

November 19, 2008

Last Update Submit

April 13, 2016

Conditions

Thyroid Cancer

Keywords

Papillary thyroid carcinomaLymph node dissectionLymph node metastasisProphylactic node dissectionCentral lymph node metastasis

Outcome Measures

Primary Outcomes (1)

  • Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools)

    3 year after initial treatment

Secondary Outcomes (1)

  • Postoperative complications(hypocalcemia, hoarseness)

    up to 3 years after surgery

Study Arms (3)

UniCND

EXPERIMENTAL

Limited/ipsilateral central lymph node dissection

Procedure: Prophylactic central lymph node dissection

BiCND

ACTIVE COMPARATOR

Comprehensive/bilateral central lymph node dissection

Procedure: Prophylactic central lymph node dissection

NoCND

NO INTERVENTION

No central lymph node dissection

Interventions

Prophylactic central lymph node dissectionPROCEDURE

prophylactic ipsilateral versus bilateral central lymph node dissection

BiCNDUniCND

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 to 70
  • Sonographically node-negative cytology confirmed thyroid papillary carcinoma
  • Tumor size less than 1 cm in sonography
  • Tumor confined to the one lobe of the thyroid gland
  • One who provides the informed consent

You may not qualify if:

  • History of radiation treatment to head and neck area
  • History of other malignancy except thyroid cancer
  • Poor performance status (ECOG 3-4)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

  • Son YI, Jeong HS, Baek CH, Chung MK, Ryu J, Chung JH, So YK, Jang JY, Choi J. Extent of prophylactic lymph node dissection in the central neck area of the patients with papillary thyroid carcinoma: comparison of limited versus comprehensive lymph node dissection in a 2-year safety study. Ann Surg Oncol. 2008 Jul;15(7):2020-6. doi: 10.1245/s10434-008-9928-8. Epub 2008 May 6.

    PMID: 18459004BACKGROUND

MeSH Terms

Conditions

Thyroid NeoplasmsThyroid Cancer, PapillaryLymphatic Metastasis

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesAdenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Han-Sin Jeong, MD, PhD

    Samsung Medical Center, Department of Otorhinolaryngology-Head and Neck Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2008

First Posted

November 21, 2008

Study Start

January 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2014

Last Updated

April 15, 2016

Record last verified: 2011-07

Locations

KR(1)