Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03813173
Recruitment Status : Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Luo Dingcun, Zhejiang University

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.


Condition or disease Intervention/treatment Phase
Lymph Node Metastases Procedure: lymph node dissection Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma: a Prospective Study
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2040
Estimated Study Completion Date : December 2040

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: central cervical dissection Procedure: lymph node dissection
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.

Experimental: non central cervical dissection Procedure: lymph node dissection
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 Measures :
  1. Recurrence of thyroid cancer [ Time Frame: Participants will be followed from the operation to 20 year (maximum) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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

Layout table for additonal information
Responsible Party: Luo Dingcun, vice president of hospital, Zhejiang University
ClinicalTrials.gov Identifier: NCT03813173     History of Changes
Other Study ID Numbers: ZhejiangU20190116
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Thyroid Neoplasms
Thyroid Cancer, Papillary
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Endocrine System Diseases
Thyroid Diseases
Adenocarcinoma, Papillary
Adenocarcinoma