Evaluation of Central Compartment Dissection Without Thyroidectomy

Not Applicable

• Conditions: Thyroid Cancer; Thyroidectomy; Central Compartment Neck Dissction
• Interventions: Procedure: Conventional; Procedure: central neck dissection first

• Registration Number: NCT03454464
• Lead Sponsor: Fujian Medical University

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-06
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-18
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
number of the lymph node	2 day post operation	the number of the lymph node
The weight of the central compartment tissue.	introoperation	The weight of the central compartment tissue.
number of postive lymph node	2 day post operation	The number of postive lymph node

Secondary Outcome Measures

Name	Time	Method
thyroid volume	The day before the operation	thyroid volume
recurrent laryngeal nerve palsy	1 day ,2weeks,3months,6months post operation	the number of recurrent laryngeal nerve palsy

Trial Locations

Locations (1)

Wen-xin ZHAO; 🇨🇳 Fuzhou, Fujian, China