Evaluation of Central Compartment Dissection Without Thyroidectomy

NCT ID: NCT03454464

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-12-31

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.

Detailed Description

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.This study assesses new procedures by adjusting the sequence of procedures. complications and the thoroughness of the operation were evaluated, thus Clinical value of bilateral central compartment dissection with preserve contrary thyroid glands were ananlyed.

Conditions

Thyroidectomy; Thyroid Cancer; Central Compartment Neck Dissction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Conventional operation group

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

Group Type: SHAM_COMPARATOR

Conventional

Intervention Type: PROCEDURE

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

central neck dissection first group

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.

Group Type: EXPERIMENTAL

central neck dissection first

Intervention Type: PROCEDURE

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.

Interventions

Conventional

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

Intervention Type: PROCEDURE

central neck dissection first

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Bo Wang,MD

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

wen-xin zhao, md

Role: STUDY_DIRECTOR

fujian meidcal university

Locations

Wen-xin ZHAO

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

wen-xin zhao, md

Role: CONTACT

zhaowx@fjmu.edu.cn

13365910359

bo wang, md

Role: CONTACT

wangbo@fjmu.edu.cn

13705947900

Facility Contacts

Wen-xin ZHAO, MD

Role: primary

zhaowx@fjmu.edu.cn

8613365910359

Bo WANG, MD

Role: backup

wangbo@fjmu.edu.cn

8613705947900

Other Identifiers

CCD

Identifier Type: -

Identifier Source: org_study_id