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the Dissection of Lymph Node Posterior to Right Recurrent Laryngeal Nerve for 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:

    1. aged from 18 years old to 80 years old;
    2. the primary treatment of patients with right or bilateral PTC;
    3. patients will voluntarily enter the study after informed consent.

Phase II:

  1. aged from 18 years old to 80 years old;
  2. the primary treatment of patients with right or bilateral PTC predicted to have no LN-prRLN metastasis by the "prediction model of LN-prRLN";
  3. 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. other malignant tumor history;
  4. distant metastasis;
  5. history of neck trauma.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    LN-prRLN dissection

    no LN-prRLN 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
    NCT03813706
    Brief Title
    the Dissection of Lymph Node Posterior to Right Recurrent Laryngeal Nerve for Papillary Thyroid Carcinoma
    Official Title
    Prospective Study for the Dissection of Lymph Node Posterior to Right Recurrent Laryngeal Nerve for Papillary Thyroid Carcinoma
    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 was completed in two stages. In the first stage, 2000 participants were enrolled according to the criteria. Following the principle of informed consent and voluntary consent of patients, the standard operation was "right or bilateral thyroidectomy + isthmus resection + right area VI lymph node dissection + left area VI lymph node dissection + lateral neck lymph node dissection". The age of participants, the size of right thyroid tumors, the invasion of the capsule and the number of lateral neck lymph node metastasis were counted to validate and improve the predictive model of lymph node posterior to the right recurrent laryngeal nerve in papillary thyroid cancer (Y=-0.029×age+0.771×tumor size+0.660×capsular invasion+1.331×right lateral lymph node metastasis-1.687, Y ≥0.16 means right recurrent laryngeal nerve posterior lymph node metastasis). In the second stage, 2000 participants assessed by the model without posterior right recurrent laryngeal nerve metastasis were randomly divided into experimental group and control group according to the principle of informed consent and voluntary. The right recurrent laryngeal nerve posterior lymph nodes were not dissected in experimental group, while the right recurrent laryngeal nerve posterior lymph nodes were routinely dissected in control group. Through long-term follow-up and comparison of RFS and OS between the two groups, the investigators can scientifically evaluate the effectiveness of the "prediction model of lymph node posterior to right recurrent laryngeal nerve metastasis in papillary thyroid carcinoma", and seek evidence for accurate treatment of lymph node posterior to the right recurrent laryngeal nerve in thyroid papillary carcinoma.

    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
    4000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LN-prRLN dissection
    Arm Type
    Active Comparator
    Arm Title
    no LN-prRLN dissection
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    lymph node dissection
    Intervention Description
    The right cervical central compartment VI is subdivided into right cervical central VI-1 subzone and VI-2 subzone. Right central VI-1 subzone lies anterior to the RLN bounded by the hyoid bone superiorly, the suprasternal notch inferiorly, the inner edge of the common carotid artery laterally, and the midline of the trachea medially. Right central VI-2 subzone lies posterior to the right RLN. The superior, inferior, lateral, and medial borders are the laryngeal entry points of RLN, the intersection of the RLN with the innominate artery (near the right apical pleura), the inner edge of the common carotid artery, and esophagus, respectively. The floor of right central VI-2 is the prevertebral fascia.
    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: aged from 18 years old to 80 years old; the primary treatment of patients with right or bilateral PTC; patients will voluntarily enter the study after informed consent. Phase II: aged from 18 years old to 80 years old; the primary treatment of patients with right or bilateral PTC predicted to have no LN-prRLN metastasis by the "prediction model of LN-prRLN"; patients will voluntarily enter the study after informed consent. Exclusion Criteria: patients refused to participate in the study; non first operation patients; other malignant tumor history; distant metastasis; history of neck trauma.

    12. IPD Sharing Statement

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