NCT05446441

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
634

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

July 6, 2022

Status Verified

June 1, 2022

Enrollment Period

1.2 years

First QC Date

June 30, 2022

Last Update Submit

June 30, 2022

Conditions

Thyroid Cancer

Keywords

Thyroid CancerEndoscopic surgeryOpen surgeryRadical thyroidectomy

Outcome Measures

Primary Outcomes (1)

  • Number of retrieved central lymph nodes

    The number of central lymph nodes removed during the operation

    1 month after operation

Study Arms (2)

Intervention;

EXPERIMENTAL

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

Procedure: Endoscopic surgery;

Control

ACTIVE COMPARATOR

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

Procedure: Endoscopic surgery;

Interventions

Endoscopic surgery;PROCEDURE

Endoscopic thyroidectomy group is the papillary thyroid carcinoma patient group who underwent endoscopic thyroid surgery using a gasless, trans-axillary approach.

ControlIntervention;

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Minghua Ge, Doctor

    Zhejiang Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Minghua Ge, Doctor

CONTACT

86057187666666geminghua@hmc.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PH.D

Study Record Dates

First Submitted

June 30, 2022

First Posted

July 6, 2022

Study Start

June 28, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2025

Last Updated

July 6, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share