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Endoscopic Thyroidectomy Versus Open Thyroidectomy for Papillary Thyroid Carcinoma

Primary Purpose

Thyroid Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endoscopic surgery;
Sponsored by
Zhejiang Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring Thyroid Cancer, Endoscopic surgery, Open surgery, Radical thyroidectomy

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18 years;
  • The pathological type is papillary thyroid carcinoma;
  • Tumor diameter <2 cm；
  • No extraglandular invasion, or minimal extrathyroidal extension invading only anterior thyroid capsule or sternothyoid muscle；
  • cN0 or cN+ without fusion and fixation of metastatic lymph nodes；
  • no obvious contraindication for thyroidectomy ;
  • Good comply with the research visit plan and other program requirements;
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • patients with severe systemic diseases who can not tolerate general anesthesia or routine surgical posture;
  • previous history of neck surgery, radiotherapy or thermal ablation;
  • hyperthyroidism and substernal goiter;
  • dedifferentiated thyroid carcinoma；
  • accompanied with severe thyroiditis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention;

    Control

    Arm Description

    Endoscopic thyroidectomy was performed in a standardized fashion by multi-institutional Chinese experienced surgeons using the same gasless unilateral transaxillary approach.

    Conventional open surgery was performed in a standardized fashion by multi-institutional Chinese experienced surgeons.

    Outcomes

    Primary Outcome Measures

    Number of retrieved central lymph nodes
    The number of central lymph nodes removed during the operation

    Secondary Outcome Measures

    Full Information

    First Posted
    June 30, 2022
    Last Updated
    June 30, 2022
    Sponsor
    Zhejiang Provincial People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05446441
    Brief Title
    Endoscopic Thyroidectomy Versus Open Thyroidectomy for Papillary Thyroid Carcinoma
    Official Title
    Endoscopic Thyroidectomy Using Gasless Unilateral Transaxillary Approach Versus Conventional Open Thyroidectomy for Papillary Thyroid Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 28, 2022 (Anticipated)
    Primary Completion Date
    August 31, 2023 (Anticipated)
    Study Completion Date
    August 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zhejiang Provincial People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. This study is aimed to compare multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.
    Detailed Description
    Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Endoscopic thyroidectomy using gasless unilateral transaxillary approach which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction. Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. In this study, we designed a prospective study comparing multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Cancer
    Keywords
    Thyroid Cancer, Endoscopic surgery, Open surgery, Radical thyroidectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Single (Outcomes Assessor)
    Allocation
    Randomized
    Enrollment
    634 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention;
    Arm Type
    Experimental
    Arm Description
    Endoscopic thyroidectomy was performed in a standardized fashion by multi-institutional Chinese experienced surgeons using the same gasless unilateral transaxillary approach.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Conventional open surgery was performed in a standardized fashion by multi-institutional Chinese experienced surgeons.
    Intervention Type
    Procedure
    Intervention Name(s)
    Endoscopic surgery;
    Intervention Description
    Endoscopic thyroidectomy group is the papillary thyroid carcinoma patient group who underwent endoscopic thyroid surgery using a gasless, trans-axillary approach.
    Primary Outcome Measure Information:
    Title
    Number of retrieved central lymph nodes
    Description
    The number of central lymph nodes removed during the operation
    Time Frame
    1 month after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years; The pathological type is papillary thyroid carcinoma; Tumor diameter <2 cm； No extraglandular invasion, or minimal extrathyroidal extension invading only anterior thyroid capsule or sternothyoid muscle； cN0 or cN+ without fusion and fixation of metastatic lymph nodes； no obvious contraindication for thyroidectomy ; Good comply with the research visit plan and other program requirements; Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: patients with severe systemic diseases who can not tolerate general anesthesia or routine surgical posture; previous history of neck surgery, radiotherapy or thermal ablation; hyperthyroidism and substernal goiter; dedifferentiated thyroid carcinoma； accompanied with severe thyroiditis.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Minghua Ge, Doctor
    Phone
    86057187666666
    Ext
    86057185335800
    Email
    geminghua@hmc.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Minghua Ge, Doctor
    Organizational Affiliation
    Zhejiang Provincial People's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Endoscopic Thyroidectomy Versus Open Thyroidectomy for Papillary Thyroid Carcinoma

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