NCT03454464

Brief Summary

In accordance with the current guidelines,papillary thyroid microcarcinoma such as turmo invasive nerve or trachea, requires total thyroidectomy for follow-up iodine-131 treatment.In the course of clinical work, if the patient can achieve R0 resection, most of the patients do not need iodine-131 treatment,Therefore, there is no need to continue total thyroidectomy.To evaluate the practicable, thoroughness and Clinical value of bilateral central compartment dissection while preserve contrary thyroid glands.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

12 months

First QC Date

February 7, 2018

Last Update Submit

September 17, 2018

Conditions

ThyroidectomyThyroid CancerCentral Compartment Neck Dissction

Outcome Measures

Primary Outcomes (3)

  • number of the lymph node

    the number of the lymph node

    2 day post operation

  • number of postive lymph node

    The number of postive lymph node

    2 day post operation

  • The weight of the central compartment tissue.

    The weight of the central compartment tissue.

    introoperation

Secondary Outcomes (2)

  • thyroid volume

    The day before the operation

  • recurrent laryngeal nerve palsy

    1 day ,2weeks,3months,6months post operation

Study Arms (2)

Conventional operation group

SHAM COMPARATOR

Conventional operation group,Thyroidectomy was performed first, and central compartment dissection was performed. This is a routine procedure.

Procedure: Conventional

central neck dissection first group

EXPERIMENTAL

central neck dissection first group,after FNA confirmed of thyroid carcinoma, the central compartment neck dissection was carried out before thyroidectomy , finally complement of central compartment neck dissection.

Procedure: central neck dissection first

Interventions

ConventionalPROCEDURE

Conventional operation ,Thyroidectomy was performed first, and central compartment dissection was performed. This is a routine procedure

Conventional operation group
central neck dissection firstPROCEDURE

central neck dissection first ,after FNA confirmed of thyroid carcinoma, the central compartment neck dissection was carried out before thyroidectomy , finally complement of central compartment neck dissection.

central neck dissection first group

Eligibility Criteria

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

You may qualify if:

  • Tumor diameter less than 1cm The tumor is located in the lower part of the gland No lateral cervical lymph node metastases Traditional open surgery

You may not qualify if:

  • Select the endoscopic surgery or robotic surgery patients Tumor invades the surrounding trachea and esophagus Patients refused to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wen-xin ZHAO

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • wen-xin zhao, md

    fujian meidcal university

    STUDY DIRECTOR

Central Study Contacts

wen-xin zhao, md

CONTACT

13365910359zhaowx@fjmu.edu.cn

bo wang, md

CONTACT

13705947900wangbo@fjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

February 7, 2018

First Posted

March 6, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Locations

CN(1)