Evaluation of Central Compartment Dissection Without Thyroidectomy

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

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.

Study Overview

• Status: Unknown
• Conditions: Thyroid Cancer; Thyroidectomy; Central Compartment Neck Dissction
• Intervention / Treatment: Procedure: Conventional; Procedure: central neck dissection first

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Wen-xin ZHAO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Conventional operation group; Conventional operation group,Thyroidectomy was performed first, and central compartment dissection was performed. This is a routine procedure.	Procedure: Conventional; Conventional operation ,Thyroidectomy was performed first, and central compartment dissection was performed. This is a routine procedure
EXPERIMENTAL: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of the lymph node	the number of the lymph node	2 day post operation
number of postive lymph node	The number of postive lymph node	2 day post operation
The weight of the central compartment tissue.	The weight of the central compartment tissue.	introoperation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
thyroid volume	thyroid volume	The day before the operation
recurrent laryngeal nerve palsy	the number of recurrent laryngeal nerve palsy	1 day ,2weeks,3months,6months post operation

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Investigators: Study Director: wen-xin zhao, md, fujian meidcal university

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): December 31, 2018
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (ACTUAL): March 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: CCD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No