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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
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymph Node Metastases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    January 16, 2019
    Last Updated
    July 2, 2019
    Sponsor
    Zhejiang University
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    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

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    Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma

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