Prospective Study on the Clinical Prognosis of Bilateral Central Lymph Node Dissection in the Patients With Unilateral Thyroid Papillary Carcinoma

NCT ID: NCT02648399

Last Updated: 2016-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Papillary Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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control group

only unilateral center lymph node dissection

Group Type PLACEBO_COMPARATOR

surgery:UCND(unilateral central lymph node dissection)

Intervention Type PROCEDURE

experimental group

bilateral center lymph node dissection

Group Type EXPERIMENTAL

surgery:BCND(bilateral central lymph node dissection)

Intervention Type PROCEDURE

Interventions

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surgery:BCND(bilateral central lymph node dissection)

Intervention Type PROCEDURE

surgery:UCND(unilateral central lymph node dissection)

Intervention Type PROCEDURE

Other Intervention Names

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aad another central lymph node dissection only unilateral central lymph node dissection

Eligibility Criteria

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Inclusion Criteria

* 1.Unilateral thyroid papillary carcinoma 2.TNM staging: T1\~2N0M0

Exclusion Criteria

* 1.Bilateral thyroid papillary carcinoma 2.isthmus thyroid carcinoma 3.TNM staging: T3orT4 4.Clinic N1orM1
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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wenxin zhao

Director,Vise Head of Acscular and Thyroid Department,Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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wenxin zhao, doctor

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University Union Hospital

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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wenxin zhao, doctor

Role: CONTACT

08613365910359

shouyi yan, master

Role: CONTACT

0861598230279

Facility Contacts

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wenxin zhao, doctor

Role: primary

08613365910359

shouyi yan, master

Role: backup

08615980230279

Other Identifiers

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wzhao

Identifier Type: -

Identifier Source: org_study_id

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