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Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

Primary Purpose

Thyroid Cancer

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Prophylactic central lymph node dissection
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring Papillary thyroid carcinoma, Lymph node dissection, Lymph node metastasis, Prophylactic node dissection, Central lymph node metastasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

UniCND

BiCND

NoCND

Arm Description

Limited/ipsilateral central lymph node dissection

Comprehensive/bilateral central lymph node dissection

No central lymph node dissection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative complications(hypocalcemia, hoarseness)

Full Information

First Posted
November 19, 2008
Last Updated
April 13, 2016
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00795782
Brief Title
Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma
Official Title
Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The extent, the advantage and disadvantage of prophylactic central lymph node dissection was not fully established up to now in papillary thyroid microcarcinoma. Prophylactic bilateral central lymph node dissection can give a important clinical information about the status of lymph nodes, and possibly guide a further adjuvant treatment. However, it causes high postoperative morbidity, including hypocalcemia and hoarseness. In this respect, some advocate no central lymph node dissection in prophylactic settings. Thus, we aimed to prove the efficacy of prophylactic ipsilateral central lymph node dissection in thyroid papillary microcarcinoma, compared to the bilateral dissection and no dissection. Type of Study design: Prospective randomized, controlled double-blinded (to subjects and observers) study. Group I: Limited/ipsilateral central lymph node dissection (UniCND) Group II: Comprehensive/bilateral central lymph node dissection (BiCND) Group III: No central lymph node dissection (NoCND) Outcomes: vocal cord palsy, hypocalcemia, locoregional recurrence, distant metastasis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
Papillary thyroid carcinoma, Lymph node dissection, Lymph node metastasis, Prophylactic node dissection, Central lymph node metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UniCND
Arm Type
Experimental
Arm Description
Limited/ipsilateral central lymph node dissection
Arm Title
BiCND
Arm Type
Active Comparator
Arm Description
Comprehensive/bilateral central lymph node dissection
Arm Title
NoCND
Arm Type
No Intervention
Arm Description
No central lymph node dissection
Intervention Type
Procedure
Intervention Name(s)
Prophylactic central lymph node dissection
Intervention Description
prophylactic ipsilateral versus bilateral central lymph node dissection
Primary Outcome Measure Information:
Title
Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools)
Time Frame
3 year after initial treatment
Secondary Outcome Measure Information:
Title
Postoperative complications(hypocalcemia, hoarseness)
Time Frame
up to 3 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: History of radiation treatment to head and neck area History of other malignancy except thyroid cancer Poor performance status (ECOG 3-4)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Sin Jeong, MD, PhD
Organizational Affiliation
Samsung Medical Center, Department of Otorhinolaryngology-Head and Neck Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18459004
Citation
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.
Results Reference
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Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

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