Evaluation of Central Compartment Dissection Without Thyroidectomy

Thyroid Cancer Clinical Trial

Official title:

To Evaluate the Practicable, Thoroughness and Clinical Value of Bilateral Central Compartment Dissection While Preserve Contrary Thyroid Glands

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03454464
• Other study ID #: CCD
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2018
• Source: Fujian Medical University
• Contact: wen-xin zhao, md
• Phone: 13365910359
• Email: zhaowx[@]fjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Compartment Neck Dissction
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroidectomy

Intervention

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

Locations

Country	Name	City	State
China	Wen-xin ZHAO	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of the lymph node	the number of the lymph node	2 day post operation
Primary	number of postive lymph node	The number of postive lymph node	2 day post operation
Primary	The weight of the central compartment tissue.	The weight of the central compartment tissue.	introoperation
Secondary	thyroid volume	thyroid volume	The day before the operation
Secondary	recurrent laryngeal nerve palsy	the number of recurrent laryngeal nerve palsy	1 day ,2weeks,3months,6months post operation