Evaluation of Central Compartment Dissection Without Thyroidectomy

NCT03454464 — Not applicable, Unknown, 100 participants, Fujian Medical University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT03454464
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	100 (Estimated)
Sponsor	Fujian Medical University (Other)
Conditions	Thyroidectomy, Thyroid Cancer, Central Compartment Neck Dissction
Interventions	Conventional, central neck dissection first (Procedure)
Dates	start 2018-01-01, primary completion 2018-12-31 (estimated), completion 2018-12-31 (estimated), first posted 2018-03-06, last updated 2018-09-18
Locations	1 site in China

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Conventional operation group	Sham comparator	Procedure: Conventional	Conventional operation group,Thyroidectomy was performed first, and central compartment dissection was performed. This is a routine procedure.
central neck dissection first group	Experimental	Procedure: 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.

Conventional (Procedure): Conventional operation ,Thyroidectomy was performed first, and central compartment dissection was performed. This is a routine procedure
central neck dissection first (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.

+Outcome measures

Primary outcomes

number of the lymph node [2 day post operation]: the number of the lymph node
number of postive lymph node [2 day post operation]: The number of postive lymph node
The weight of the central compartment tissue. [introoperation]: The weight of the central compartment tissue.

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
Wen-xin ZHAO	Fuzhou, Fujian	China	Recruiting

+Investigators

wen-xin zhao, md, Study director, fujian meidcal university

My Notes

Public

To Read Reading Read