Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma
Primary Purpose
Lymph Node Metastases
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lymph node dissection
Sponsored by
About this trial
This is an interventional treatment trial for Lymph Node Metastases
Eligibility Criteria
Inclusion Criteria:
Phase I and II:
- aged 18 to 80 years old;
- the primary treatment of patients with unilateral or bilateral PTC;
- ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm;
- ultrasonography of cervical VI lymph nodes: the shortest diameter < 4 mm, no calcification, no cystic change, no local or global echo enhancement;
- 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;
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
central cervical dissection
non central cervical dissection
Arm Description
Outcomes
Primary Outcome Measures
Recurrence of thyroid cancer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03813173
Brief Title
Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma
Official Title
Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma: a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
December 2040 (Anticipated)
Study Completion Date
December 2040 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymph Node Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
central cervical dissection
Arm Type
Active Comparator
Arm Title
non central cervical dissection
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
lymph node dissection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence of thyroid cancer
Time Frame
Participants will be followed from the operation to 20 year (maximum)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Phase I and II:
aged 18 to 80 years old;
the primary treatment of patients with unilateral or bilateral PTC;
ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm;
ultrasonography of cervical VI lymph nodes: the shortest diameter < 4 mm, no calcification, no cystic change, no local or global echo enhancement;
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;
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.
12. IPD Sharing Statement
Learn more about this trial
Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma
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