Prospective Study on the Clinical Prognosis of Bilateral Central Lymph Node Dissection in the Patients With Unilateral Thyroid Papillary Carcinoma
1 other identifier
interventional
300
1 country
1
Brief Summary
This study recruit the patients with unilateral papillary thyroid cancer before operation,the patients agree to enter the test,and divided into experimental and control group.experimental group patients receive the surgery including unilateral thyroid lobectomy and bilateral central lymph node dissection.and control group receive the surgery including unilateral thyroid lobectomy and unilateral central lymph node dissection.last the investigators compare numbers of patient with tumor recurrence and metastasis rate of 5 years,numbers of metastatic lymph node,and numbers of participants with adverse events related to treatment between two groups in order to evaluate the significance of bilateral lymph node dissection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 13, 2015
CompletedFirst Posted
Study publicly available on registry
January 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 7, 2016
January 1, 2016
1 year
December 13, 2015
January 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
tumor recurrence
numbers of patients with tumor recurrence
5 years
numbers of metastatic lymph node
numbers of metastatic lymph node
1 years
adverse events related to treatment
numbers of participants with adverse events including recurrent nerve injury，parathyroid injury，hemorrhage
1 years
Secondary Outcomes (2)
relations between the lymph metastasis and TNM staging
1 years
relations between the lymph metastasis and tumor location
1 years
Study Arms (2)
control group
PLACEBO COMPARATORonly unilateral center lymph node dissection
experimental group
EXPERIMENTALbilateral center lymph node dissection
Interventions
Eligibility Criteria
You may qualify if:
- Unilateral thyroid papillary carcinoma 2.TNM staging: T1\~2N0M0
You may not qualify if:
- Bilateral thyroid papillary carcinoma 2.isthmus thyroid carcinoma 3.TNM staging: T3orT4 4.Clinic N1orM1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
wenxin zhao, doctor
Fujian Medical University Union Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director,Vise Head of Acscular and Thyroid Department,Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
December 13, 2015
First Posted
January 7, 2016
Study Start
December 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 7, 2016
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will not share