Central Cervical Dissection for Clinical Node Negative Pa... | NCT03813173

Studies
Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma

NCT03813173

Sponsor

Zhejiang University

Status

Not yet recruiting

Last Update Posted

Jul 5, 2019Actual

Enrollment

6,000Estimated

Phase

Not Applicable

Conditions

Lymph Node Metastases

Interventions

lymph node dissection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2020Estimated

Primary Completion Date

Dec 2040Estimated

Completion Date

Dec 2040Estimated

First Submitted Date

Jan 16, 2019

First Submission Date that Met QC Criteria

Jan 19, 2019

First Posted Date

Jan 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2019

Last Update Posted Date

Jul 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is divided into three stages. In the first stage, the investigators try to explore the objective clinical imaging standard of cN0PTC on the basis of previous studies, formulate the "clinical imaging standard of cN0PTC", and randomly enroll 2000 patients under the premise of meeting the standard to establish the "predictive model of cN0-pN+PTC".

In the second stage, 2000 patients will be enrolled to test and improve the evaluation efficiency of "cN0-pN+PTC prediction model".

In the third stage, 2 000 patients without lymph node metastasis assessed by "cNo-pN+ PTC prediction model" will be randomly divided into experimental group and control group. The experimental group will be treated with pCND, while the experimental group will be treated without pCND. The central lymph node metastasis probability, the number and size of metastatic lymph nodes in the control group will be observed after operation. The two groups will be followed up for 5, 10, 15 and 20 years to observe the RFS and OS, so as to further evaluate the "cN0-pN+PTC prediction model" scientifically.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
central cervical dissection	Active Comparator		Procedure: lymph node dissection
non central cervical dissection	Experimental		Procedure: lymph node dissection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lymph node dissection	Procedure	The patient was operated under general anesthesia with cervical hyper extension. The affected side or bilateral glandular lobes were resected routinely, which was confirmed as PTC by frozen section. Then one or both central lymph node dissection were separately packed and sent for examination. Scope of lymph node dissection in central carotid region: hyoid bone at the upper border, anonymous artery at the lower border, bilateral common carotid artery at the inner edge, shallow from the superficial layer of deep cervical fascia, deep to the deep layer of deep cervical fascia (anterior fascia). The right recurrent laryngeal nerve (RLN) passes through the central area of the right neck and should be specially protected.

Measure	Description	Time Frame
Recurrence of thyroid cancer		Participants will be followed from the operation to 20 year (maximum)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Phase I and II:
1. aged 18 to 80 years old;
2. the primary treatment of patients with unilateral or bilateral PTC;
3. ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm;
4. ultrasonography of cervical VI lymph nodes: the shortest diameter < 4 mm, no calcification, no cystic change, no local or global echo enhancement;
5. CT scan of cervical VI lymph nodes: the shortest diameter < 4 mm, no calcification, no cystic change, no enhancement (CT value 40HU or not higher than banded muscle level), no cluster distribution;
6. patients will voluntarily enter the study after informed consent;

Phase III:

aged from 18 to 80 years old;
ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm;
Unilateral or bilateral PTC without lymph node metastasis assessed by "cNo-pN+ PTC prediction model";
patients will voluntarily enter the study after informed consent.

Exclusion Criteria:

(1) patients refused to participate in the study; (2) non first operation patients; (3) Lateral cervical lymph nodes or distant metastasis; (4) Hashimoto's disease; (5) history of neck trauma.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009362	Neoplasm Metastasis
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes